Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-31 @ 1:33 PM
Study NCT ID:
NCT04142034
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2019-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility Trial of the iAMHealthy Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jylee@uams.edu', 'phone': '5015266712', 'title': 'Jeannette Lee', 'organization': 'University of Arkansas for Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Using standard definitions of adverse events, adverse events were reported during the intervention period.\n\nAll-cause mortality, serious and other (not including serious) adverse events were not reporting during the recruitment period for those in the consecutive recruitment or traditional recruitment arms.', 'eventGroups': [{'id': 'EG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 1, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper limb', 'notes': 'Broken elbow after participant increased physical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participant Recruitment Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Consecutive Recruitment Method', 'description': 'Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.\n\nConsecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records'}, {'id': 'OG001', 'title': 'Traditional Recruitment Method', 'description': 'Flyers, advertisements, and other materials will be used to recruit potential participants to the study.\n\nTraditional Recruitment: Recruitment of potential participants through flyers and advertisements'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month for each recruitment option plus a 1 month catch-up period', 'description': 'Measure participant recruitment rate for both recruitment options', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Potential study participants who were approached about the study using one of the two recruitment methods'}, {'type': 'SECONDARY', 'title': 'Participant Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'OG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Calculate participant retention as the percent of randomized participants who remain in the study through the final measurement point.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study participants who were randomized to one of the two behavioral interventions'}, {'type': 'SECONDARY', 'title': 'Change in Child Body Mass Index From Baseline to Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'OG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'This measure is derived from subtracting the child body mass index (BMI) taken at baseline from the child BMI taken at the end of the intervention period', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had child BMI measurements at baseline and at the end of the intervention period and were at sites that did not have data quality issues with height and weight measurements.'}, {'type': 'SECONDARY', 'title': 'Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'OG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "This measure is derived from subtracting the child BMIz taken at baseline from the child BMIz adjusted for age and sex at the end of the intervention period. The BMIz is the body mass index adjusted for sex and age, and is a z-score normalized for the mean and standard deviation of the body mass index for the child's age and sex. A BMI z-score over 1.96 indicates that the child's body mass index is above the 95th percentile for his/her age.", 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had child BMI adjusted for age and sex measurements at baseline and at the end of the intervention period and were at sites that did not have data quality issues with height and weight measurements.'}, {'type': 'SECONDARY', 'title': 'Change in Caregiver Body Mass Index From Baseline to Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'OG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.32', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '3.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The baseline caregiver body mass index (BMI) is subtracted from the caregiver BMI taken at the end of the intervention period', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had caregiver BMI measurements at baseline and at the end of the intervention period and were from sites that did not have data quality issues with height and weight measurements.'}, {'type': 'SECONDARY', 'title': 'Change in Daily Servings of Sweetened Drinks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'OG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '0.80', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'This measure is difference in the daily servings of sweetened drinks consumed from baseline to the end of the intervention period', 'unitOfMeasure': 'daily servings of sweetened drinks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for whom data on the daily servings of sweetened drinks consumed was available at baseline and at the end of the intervention period'}, {'type': 'SECONDARY', 'title': 'Change in Number of Servings of Fruits and Vegetables Consumed Daily From Baseline to Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'OG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'This measure is the change in the number of servings of fruits and vegetables consumed daily from baseline to after the intervention period', 'unitOfMeasure': 'Daily fruit/vegetable servings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for whom data on the number of servings of fruits and vegetables consumed daily was available at baseline and at the end of the intervention period'}, {'type': 'SECONDARY', 'title': 'Change in Number of Red Food Servings Consumed Daily From Baseline to Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'OG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.78', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '2.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'This measure shows the change in the number of red food servings consumed daily from baseline to after the intervention period. Red foods are defined as those with greater than or equal to 7 grams of fat and/or greater than or equal to 12 grams of sugar per serving.', 'unitOfMeasure': 'daily red food servings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for whom information on the number of daily servings of red food were available at baseline and post-intervention'}, {'type': 'SECONDARY', 'title': 'Change in the Daily Minutes Spent in Moderate to Vigorous Physical Activity (MVPA) From Baseline to Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'OG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.64', 'spread': '39.88', 'groupId': 'OG000'}, {'value': '-28.74', 'spread': '65.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The number of minutes spent in moderate to vigorous physical activity (MVPA) is measured using an activity monitor worn by the participant. This measure is the change in minutes in MVPA from baseline to after the intervention period', 'unitOfMeasure': 'daily minutes of MVPA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for whom baseline and post-intervention measurements of minutes of MVPA were available at baseline and post-intervention and were at sites without data quality issues related to activity monitors.'}, {'type': 'SECONDARY', 'title': 'Change in the % of Time Spent in Moderate to Vigorous Physical Activity (MVPA ) While Wearing Activity Monitor From Baseline to Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'OG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.79', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '-1.60', 'spread': '2.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The denominator for this measure is the number of minutes that the participant is wearing the activity monitor. The % of moderate to vigorous physical time (MVPA) is the percent of that time that the participant is spent in moderate to vigorous physical activity. This measure describes the change in that percent of time from baseline to after intervention.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for whom the % of MVPA was available from the activity monitor at baseline and post-intervention and were at sites that did not have data quality issues with the activity monitors.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants in the iAmHealthy+ Newsletter Behavioral Intervention Who Receive at Least 80% of the Planned Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Participants who receive at least 80% of the planned intervention (dose) among those participants randomized to the iAmHealthy behavioral intervention arm who are retained through the final measurement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is the study participants randomized to the iAmHealthy + Newsletter behavioral intervention who were retained through the 6-month intervention period'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Staff Blinding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'OG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "Blinding index as described by Bang (Bang et cl. Assessment of blinding in clinical trials. Control Clin Trials 2004: 25(2):143-156. It ranges from -1 to 1 where a value of 0 indicates fully successful blinding; a value of 1 indicates lack of blinding meaning that individuals were able to correctly identify participants' assigned intervention, and -1 indicates that individuals typically guessed the incorrect assignment.", 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized to one of the two behavioral interventions'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Consecutive Recruitment Method', 'description': 'Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.\n\nConsecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records'}, {'id': 'FG001', 'title': 'Traditional Recruitment Method', 'description': 'Flyers, advertisements, and other materials will be used to recruit potential participants to the study.\n\nTraditional Recruitment: Recruitment of potential participants through flyers and advertisements'}, {'id': 'FG002', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'FG003', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}], 'periods': [{'title': 'Recruitment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '535'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The recruitment period included a hiatus in recruitment due to the pandemic', 'groupId': 'FG000', 'numSubjects': '99'}, {'comment': 'The recruitment period included a hiatus in recruitment due to the pandemic', 'groupId': 'FG001', 'numSubjects': '5'}, {'comment': 'the intervention arm is only relevant during period 2', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'intervention arm is only relevant in period 2', 'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '436'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Recruitment method is only relevant in period 1', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Recruitment method is only relevant in period 1', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'There were 104 participants recruited into the intervention part of the study; half were randomized to the iAmHealthy + newsletter behavioral intervention.', 'groupId': 'FG002', 'numSubjects': '52'}, {'comment': 'There were 104 participants recruited into the intervention part of the study; half were randomized to the Newsletter intervention.', 'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants (children) were recruited through two approached: consecutive recruitment method or traditional recruitment method. The data shown for these methods is the number of individuals approached about the clinical trial and the number who were successfully recruited into the clinical trial and randomized into one of the two intervention arms\n\nCaregivers are not participant but are evaluated for efficacy in terms of body mass index'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'iAmHealthy + Newsletter Behavorial Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.\n\nthe iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician'}, {'id': 'BG001', 'title': 'NewsLetter Intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.\n\nNewsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '9.2', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '9.3', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Child body mass index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.15', 'spread': '5.52', 'groupId': 'BG000'}, {'value': '23.04', 'spread': '3.71', 'groupId': 'BG001'}, {'value': '24.48', 'spread': '4.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements'}, {'title': 'Child body mass index adjusted for age and sex', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.56', 'spread': '1.41', 'groupId': 'BG000'}, {'value': '1.86', 'spread': '0.55', 'groupId': 'BG001'}, {'value': '2.19', 'spread': '1.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements'}, {'title': 'Caregiver body mass index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35.54', 'spread': '9.93', 'groupId': 'BG000'}, {'value': '34.97', 'spread': '8.48', 'groupId': 'BG001'}, {'value': '35.24', 'spread': '9.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements'}, {'title': 'Daily sweetened drink servings', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.16', 'spread': '1.30', 'groupId': 'BG000'}, {'value': '1.18', 'spread': '1.20', 'groupId': 'BG001'}, {'value': '1.17', 'spread': '1.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'daily sweetened drink servings', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Analysis population includes participants who have post-intervention measurements'}, {'title': 'Daily fruit and vegetable servings', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.42', 'spread': '1.21', 'groupId': 'BG000'}, {'value': '2.62', 'spread': '1.43', 'groupId': 'BG001'}, {'value': '2.53', 'spread': '1.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'daily fruit and vegetable servings', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Analysis population is participants with post-intervention measures'}, {'title': 'Daily servings of red foods', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.30', 'spread': '1.83', 'groupId': 'BG000'}, {'value': '6.39', 'spread': '2.11', 'groupId': 'BG001'}, {'value': '6.35', 'spread': '1.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Red foods are defined as those with greater than or equal to 7 grams of fat and/or greater than or equal to 12 grams of sugar per serving.', 'unitOfMeasure': 'daily servings of red foods', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Analysis population includes participants with post-intervention measurements'}, {'title': 'Average daily minutes of moderate to vigorous physical activity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.92', 'spread': '36.92', 'groupId': 'BG000'}, {'value': '55.46', 'spread': '62.70', 'groupId': 'BG001'}, {'value': '47.76', 'spread': '52.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Daily minutes of moderate to vigorous physical activity (MVPA) information was measured using an actigraph', 'unitOfMeasure': 'daily minutes of MVPA', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Analysis population excluded participants from a site where there were concerns regarding actigraph data quality, and participants who did not have post-intervention measures'}, {'title': 'MVPA (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.15', 'spread': '2.58', 'groupId': 'BG000'}, {'value': '6.13', 'spread': '3.45', 'groupId': 'BG001'}, {'value': '5.70', 'spread': '3.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This measure is the percent of time that the participant was wearing the activity monitor that he/she was engaged in moderate to vigorous physical activity (MVPA).', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Analysis population excludes participants from a site where there were data quality issues from the actigraph, and participants without post-intervention measurements'}], 'populationDescription': 'The baseline analysis population is participants who were recruited to the study and randomized to one of the two interventions: iAmHealthy + Newsletter behavioral intervention or newsletter intervention'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-04', 'size': 1833693, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-01T12:23', 'hasProtocol': True}, {'date': '2020-05-28', 'size': 259757, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-01T12:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Each clinics will recruit up to 28 child/caregiver pairs.The site awardee investigators will be blinded. The site awardee investigator will also identify a back-up,research-trained blinded assessor from the awardee site. The blinded coordinator will not have access to clinic charts. The clinic coordinator will instruct participants not discuss the trial or previous weights/data collected. He or she, or the designated backup, will take the height and weight measurements at baseline and six months. In case the ISPCTN site-awardee coordinator is accidentally unblinded, the backup assessor will take over all assessments for that participant.\n\nAt each measurement time point, the blinded assessor will enter data into the electronic data capture system only for that time point-the system will blind them to data from any/all other data-collection time points. The blinded site coordinator will perform the 24-hour food recalls at recruitment and six months.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This feasibility trial is a multisite, RCT with two parts. In part 1, sites will be randomized into the order in which two recruitment methods, traditional or consecutive, are used to recruit study participants. In part 2, recruited participants will be randomized to receive a newsletter or newsletter plus the iAmHealthy behavioral intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-26', 'studyFirstSubmitDate': '2019-10-25', 'resultsFirstSubmitDate': '2022-03-24', 'studyFirstSubmitQcDate': '2019-10-25', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-29', 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participants in the iAmHealthy+ Newsletter Behavioral Intervention Who Receive at Least 80% of the Planned Intervention', 'timeFrame': '6 months', 'description': 'Participants who receive at least 80% of the planned intervention (dose) among those participants randomized to the iAmHealthy behavioral intervention arm who are retained through the final measurement.'}, {'measure': 'Staff Blinding', 'timeFrame': '6 months', 'description': "Blinding index as described by Bang (Bang et cl. Assessment of blinding in clinical trials. Control Clin Trials 2004: 25(2):143-156. It ranges from -1 to 1 where a value of 0 indicates fully successful blinding; a value of 1 indicates lack of blinding meaning that individuals were able to correctly identify participants' assigned intervention, and -1 indicates that individuals typically guessed the incorrect assignment."}], 'primaryOutcomes': [{'measure': 'Participant Recruitment Rate', 'timeFrame': '1 month for each recruitment option plus a 1 month catch-up period', 'description': 'Measure participant recruitment rate for both recruitment options'}], 'secondaryOutcomes': [{'measure': 'Participant Retention', 'timeFrame': '6 months', 'description': 'Calculate participant retention as the percent of randomized participants who remain in the study through the final measurement point.'}, {'measure': 'Change in Child Body Mass Index From Baseline to Post-intervention', 'timeFrame': '6 months', 'description': 'This measure is derived from subtracting the child body mass index (BMI) taken at baseline from the child BMI taken at the end of the intervention period'}, {'measure': 'Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention', 'timeFrame': '6 months', 'description': "This measure is derived from subtracting the child BMIz taken at baseline from the child BMIz adjusted for age and sex at the end of the intervention period. The BMIz is the body mass index adjusted for sex and age, and is a z-score normalized for the mean and standard deviation of the body mass index for the child's age and sex. A BMI z-score over 1.96 indicates that the child's body mass index is above the 95th percentile for his/her age."}, {'measure': 'Change in Caregiver Body Mass Index From Baseline to Post-intervention', 'timeFrame': '6 months', 'description': 'The baseline caregiver body mass index (BMI) is subtracted from the caregiver BMI taken at the end of the intervention period'}, {'measure': 'Change in Daily Servings of Sweetened Drinks', 'timeFrame': '6 months', 'description': 'This measure is difference in the daily servings of sweetened drinks consumed from baseline to the end of the intervention period'}, {'measure': 'Change in Number of Servings of Fruits and Vegetables Consumed Daily From Baseline to Post-intervention', 'timeFrame': '6 months', 'description': 'This measure is the change in the number of servings of fruits and vegetables consumed daily from baseline to after the intervention period'}, {'measure': 'Change in Number of Red Food Servings Consumed Daily From Baseline to Post-intervention', 'timeFrame': '6 months', 'description': 'This measure shows the change in the number of red food servings consumed daily from baseline to after the intervention period. Red foods are defined as those with greater than or equal to 7 grams of fat and/or greater than or equal to 12 grams of sugar per serving.'}, {'measure': 'Change in the Daily Minutes Spent in Moderate to Vigorous Physical Activity (MVPA) From Baseline to Post-intervention', 'timeFrame': '6 months', 'description': 'The number of minutes spent in moderate to vigorous physical activity (MVPA) is measured using an activity monitor worn by the participant. This measure is the change in minutes in MVPA from baseline to after the intervention period'}, {'measure': 'Change in the % of Time Spent in Moderate to Vigorous Physical Activity (MVPA ) While Wearing Activity Monitor From Baseline to Post-intervention', 'timeFrame': '6 months', 'description': 'The denominator for this measure is the number of minutes that the participant is wearing the activity monitor. The % of moderate to vigorous physical time (MVPA) is the percent of that time that the participant is spent in moderate to vigorous physical activity. This measure describes the change in that percent of time from baseline to after intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity; Rurality']}, 'referencesModule': {'references': [{'pmid': '34118426', 'type': 'BACKGROUND', 'citation': 'Davis AM, Darden PM, Snowden J, Simon AE, McCulloh RJ, Bimali M, Lee J. Rationale and protocol for a cluster randomized, cross-over trial of recruitment methods of rural children in primary care clinics: A feasibility study of a pediatric weight control trial in the IDeA States Pediatric Clinical Trials Network. Contemp Clin Trials. 2021 Aug;107:106476. doi: 10.1016/j.cct.2021.106476. Epub 2021 Jun 9.'}, {'pmid': '38172325', 'type': 'DERIVED', 'citation': 'Zhang E, Davis AM, Jimenez EY, Lancaster B, Serrano-Gonzalez M, Chang D, Lee J, Lai JS, Pyles L, VanWagoner T, Darden P. Validation of remote anthropometric measurements in a rural randomized pediatric clinical trial in primary care settings. Sci Rep. 2024 Jan 3;14(1):411. doi: 10.1038/s41598-023-50790-1.'}, {'pmid': '37036783', 'type': 'DERIVED', 'citation': 'Nguyen L, Phan TL, Falini L, Chang D, Cottrell L, Dawley E, Hockett CW, VanWagoner T, Darden PM, Davis AM. Rural Family Satisfaction With Telehealth Delivery of an Intervention for Pediatric Obesity and Associated Family Characteristics. Child Obes. 2024 Apr;20(3):147-154. doi: 10.1089/chi.2022.0210. Epub 2023 Apr 10.'}, {'pmid': '36445709', 'type': 'DERIVED', 'citation': 'Darden PM 2nd, Davis AM, Lee JY, Bimali M, Simon AE, Atz AM, Lim CS, Phan TT, Roberts JR, McCulloh RJ, Pyles L, Shaffer M, Snowden JN. Active vs Traditional Methods of Recruiting Children for a Clinical Trial in Rural Primary Care Clinics: A Cluster-Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2244040. doi: 10.1001/jamanetworkopen.2022.44040.'}]}, 'descriptionModule': {'briefSummary': "This research study is being done to find out which of 2 ways works best to get rural participants interested in joining a research study about children who weigh more than is considered healthy. One method researchers will use is the traditional method of reaching out to potential participants. The traditional method includes using flyers, posters, and booklets. The other method will be to target people who might be especially interested in the study. The second method uses medical records to find potential participants who are most likely to qualify for the study. This study is also being done to what works to help keep participants in a study like this.\n\nAnother goal of the study is to find out what methods work well to help get and keep children's and caregiver's weight in the healthy range. Researchers also want to see what works well to help children with a high Body Mass Index be more physically active and to eat healthier foods. The test methods researchers will use for this part of the study are (1) newsletters only and (2) newsletters plus online meetings. Participants will be randomly assigned to 1 of the 2 groups (newsletter or newsletter plus meetings.)\n\nThe newsletter-only group will receive monthly newsletters about children's health; this group will receive these letters for 6 months. The 'newsletter plus meeting group' will also receive the same monthly newsletter for 6 months. The latter group will also have online meetings with other children and adults as well as a group leader. Those in the 'newsletter plus meeting group' will also individually meet with a dietician.\n\nThis study will involve children and one of their caregivers (parent/guardian). The child and caregiver must live in a rural area. The child must be 6 to 11 years old. The child must be considered to have an unhealthy weight (high Body Mass Index). Both the child and caregiver must speak English. Up to 224 children will enter into this study. Participants will be consented through 4 different sites that are part of the IDeA States Pediatric Network.", 'detailedDescription': 'Conduct a multisite feasibility trial for the iAmHealthy intervention with two randomized controlled recruitment options (consecutive recruitment and traditional recruitment). We will examine retention, dose, and blinding that will inform the development of a larger, treatment-outcome fully powered randomized controlled trial (RCT) of the iAmHealthy behavioral intervention in the IDeA States Pediatric Clinical Trials Network (ISPCTN).\n\nThe study team will perform the iAmHealthy trial will be performed in four ISPCTN site-awardee states. Specifically, the study team will perform the iAmHealthy trial in one clinic per state.\n\nRandomization of recruitment options occurs at the clinic level. Each clinic, in a randomly ordered sequence, will implement two methods of recruitment. Recruitment of Participants, for more detail on the two methods of recruitment.\n\nRandomization of participants into intervention arms will occur at the individual level.\n\nNewsletter-only Intervention Arm\n\nChild/caregiver pairs in the newsletter-only intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period.\n\niAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician.\n\nThe iAmHealthy behavioral intervention psychologists/social worker will individualize group sessions and the iAmHealthy behavioral intervention dietician will adapt individual sessions by focusing on local cultural, religious, and ethnic factors relevant to the recommended changes in eating and activity habits. The iAmHealthy behavioral intervention includes 26 contact hours (15 hours of group sessions and 11 hours of individual sessions).\n\nThis feasibility trial will provide information toward the implementation of a fully powered, multisite, randomized behavior intervention trial that will compare the effectiveness of the iAmHealthy behavioral intervention to a newsletter-only intervention for the treatment of obesity among rural and underserved children and their primary caregivers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Child is rural. The child lives in a rural area, as defined by the United States Department of Agriculture (USDA) Rural Urban Commuting Area (RUCA) codes (greater than or equal to 4). We will calculate this using the 2010 Zip Code, RUCA Code crosswalk.\n2. Child is ages 6-11 years at the time of consent. At the time of consent, a child must be 6 to 11 years of age. A narrow age range is necessary to decrease developmental variability. Clinics may enroll a child no earlier than her or his sixth birthday (6 years, 0 months, 0 days), and may enroll a child up to her or his 12th birthday (11 years, 11 months, 30 days).\n3. Child BMI percentile is ≥85th. We will use the 85th percentile as a minimal cutoff for participation, as this is the minimal criteria for the definition of overweight. There is no upper limit on BMI percentile for inclusion.\n4. Child and primary caregiver speak English. For the initial feasibility pilot, we will ask that both the child and primary caregiver speak English. For the larger trial that will follow, we will accommodate Spanish-speaking participants.\n5. For the iAmHealthy behavioral intervention arm, the child and primary caregiver are available when the behavioral intervention team offers the intervention for the participating clinic. The child and primary caregiver must be available for most of the iAmHealthy behavioral intervention sessions when the behavioral intervention psychologist/social worker offers the group sessions at the participants' clinic. The behavioral team will conduct these sessions via video conference and families will attend via tablets.\n\n \\-\n\nExclusion Criteria:\n\n1. Child has a physical limitation or injury that substantially limits physical mobility or has a planned medical treatment during the course of the trial that will substantially limit physical mobility. Because this trial recommends physical activity, we will exclude children who cannot comply with this health behavior.\n2. Child has a known medical issue that could affect protocol compliance (e.g., cancer). If a child has a significant medical issue known to the clinic that could affect protocol compliance, we will exclude this child, as the protocol involves an intense intervention commitment.\n3. Child and/or primary caregiver has a developmental delay or cognitive impairment that could affect protocol compliance. We will exclude primary caregivers and/or children with a known developmental delay, as this could negatively affect participation and measurement completion.\n4. Child is enrolled in a weight-loss trial. If a child is enrolled in a weight-loss trial, we will exclude the child to avoid cross-pollination of trial interventions.\n5. Child has a sibling who has already enrolled in the trial. If multiple children from the same family attempt to enroll, the statistical team will randomly select one child for enrollment. We will always allow siblings to attend the intervention, but we will not officially enroll them."}, 'identificationModule': {'nctId': 'NCT04142034', 'acronym': 'iAmHealthy', 'briefTitle': 'Feasibility Trial of the iAMHealthy Intervention', 'organization': {'class': 'NETWORK', 'fullName': 'IDeA States Pediatric Clinical Trials Network'}, 'officialTitle': 'Feasibility Trial of the iAMHealthy Intervention for Healthy Weight in Rural Children Recruited From Primary Care Clinics', 'orgStudyIdInfo': {'id': '249932'}, 'secondaryIdInfos': [{'id': 'U24OD024957', 'link': 'https://reporter.nih.gov/quickSearch/U24OD024957', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iAmHealthy Behavioral Intervention', 'description': 'This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.', 'interventionNames': ['Behavioral: the iAmHealthy Behavioral Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NewsLetter intervention', 'description': 'This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.', 'interventionNames': ['Behavioral: Newsletter only arm']}, {'type': 'OTHER', 'label': 'Consecutive Recruitment method', 'description': 'Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.', 'interventionNames': ['Other: Consecutive Recruitment']}, {'type': 'OTHER', 'label': 'Traditional Recruitment method', 'description': 'Flyers, advertisements, and other materials will be used to recruit potential participants to the study.', 'interventionNames': ['Other: Traditional Recruitment']}], 'interventions': [{'name': 'the iAmHealthy Behavioral Intervention', 'type': 'BEHAVIORAL', 'description': 'iAmHealthy Behavioral Intervention Arm\n\nChild/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:\n\n* usual care at their clinic for all issues, including overweight and obesity;\n* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);\n* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial\'s iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;\n* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician', 'armGroupLabels': ['iAmHealthy Behavioral Intervention']}, {'name': 'Newsletter only arm', 'type': 'BEHAVIORAL', 'description': 'Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise', 'armGroupLabels': ['NewsLetter intervention']}, {'name': 'Consecutive Recruitment', 'type': 'OTHER', 'description': 'Recruitment of study participants through identifying potential participants through their medical records', 'armGroupLabels': ['Consecutive Recruitment method']}, {'name': 'Traditional Recruitment', 'type': 'OTHER', 'description': 'Recruitment of potential participants through flyers and advertisements', 'armGroupLabels': ['Traditional Recruitment method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nemours/Alfred I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '26330', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Ann Davis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}, {'name': 'Paul Darden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Per data and sharing polices of National Institute of Health (NIH) and the IDeA States Pediatric Clinical Trials Network (ISPCTN).', 'ipdSharing': 'YES', 'description': 'We will conduct this trial in accordance with the following publication and data sharing policies and regulations:\n\n* NIH Public Access Policy. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.\n* ISPCTN Publications and Presentations Policy, which ensures accurate, responsible, and efficient communication of findings from ISPCTN clinical trials. The ISPCTN Steering Committee has approved and ratified the ISPCTN Publications and Presentations Policy, which includes representatives from all site awardees, as well as representatives from the NIH and the DCOC.\n* NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission Rule. Other researchers my request data from this trial by contacting Jeannette Lee, PhD, at the DCOC.', 'accessCriteria': 'To be announced (TBA)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IDeA States Pediatric Clinical Trials Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}