Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-04-21 @ 9:36 AM
Study NCT ID:
NCT02124460
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2014-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'elsie.taveras@mgh.harard.edu', 'phone': '617-726-8555', 'title': 'Dr. Elsie Taveras', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.', 'otherNumAtRisk': 361, 'otherNumAffected': 0, 'seriousNumAtRisk': 361, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Health Coaching', 'description': "The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program.\n\nParent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community.\n\nParents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study.", 'otherNumAtRisk': 360, 'otherNumAffected': 0, 'seriousNumAtRisk': 360, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in BMI z Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '-0.02'}, {'value': '-0.09', 'groupId': 'OG001', 'lowerLimit': '-0.13', 'upperLimit': '-0.05'}]}]}], 'analyses': [{'pValue': '0.3928', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.03', 'estimateComment': 'Health Coaching group compared to Enhanced Primary Care', 'statisticalMethod': 'Linear repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Multiple imputation was used for missing follow-up data.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and one year', 'description': 'Height and weight will be measured by the medical assistants at each site using standard protocols. BMI measures will be obtained from the electronic health record (EHR) as provided through usual care. BMI measures will be converted to z-scores using CDC age and sex-specific normative data for children between 2 and 20 years old. This will allow the research team to combine data across children of different ages.', 'unitOfMeasure': 'BMI z score units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '-0.38', 'upperLimit': '1.67'}, {'value': '1.53', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '2.56'}]}]}], 'analyses': [{'pValue': '0.2306', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '2.33', 'estimateComment': 'Health Coaching group compared to Enhanced Primary Care', 'statisticalMethod': 'Linear repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Multiple imputation used for missing data at follow-up'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and one year', 'description': 'The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children with chronic conditions such as obesity. Parents will be asked to complete 4 subscales: physical health, school, social, and emotional functioning which exists for parental report of children as young as 2 years of age. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Parent Resource Empowerment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.35'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.29'}]}]}], 'analyses': [{'pValue': '.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.16', 'estimateComment': 'Health Coaching group compared to Enhanced Primary Care.', 'statisticalMethod': 'Linear repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Multiple imputation used for missing data at follow-up'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to one-year follow-up', 'description': "The five items in the scale assessed parents' perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. For each question, parents responded strongly disagree, disagree, agree, or strongly agree, which were worth 1 to 4 points, respectively. Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach's α for this score was 0.87.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Screen Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.00'}, {'value': '-0.56', 'groupId': 'OG001', 'lowerLimit': '-0.78', 'upperLimit': '-0.34'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '-0.19', 'statisticalMethod': 'Linear repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Multiple imputation used for missing data at follow-up.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and one year', 'description': 'Average hours/day spent watching television, videos, or playing games displayed on media such as television, desktop computers, laptops, portable DVD players, iPads or smartphones.', 'unitOfMeasure': 'hours/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.16', 'upperLimit': '0.12'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '0.55'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.22', 'ciUpperLimit': '0.62', 'pValueComment': 'Multiple imputation used for missing data at follow-up.', 'statisticalMethod': 'Linear repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 1 year', 'description': 'Average hours/day spent sleeping', 'unitOfMeasure': 'hours/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.40'}, {'value': '0.33', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.58'}]}]}], 'analyses': [{'pValue': '0.3043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.53', 'statisticalMethod': 'Linear repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Multiple imputation used for missing data at follow-up.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 1 year', 'description': 'In the past week, how many days the child was physically active for a total of at least 60 minutes per day.', 'unitOfMeasure': 'days/week', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fruit and Vegetable Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.36'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.33', 'upperLimit': '0.68'}]}]}], 'analyses': [{'pValue': '0.0113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.56', 'statisticalMethod': 'Linear repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Multiple imputation used for missing data at follow-up.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 1 year', 'description': 'Number of times the child consumed of vegetables and fruits yesterday', 'unitOfMeasure': 'times/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Consumption of Sugar-sweetened Beverages and Juice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-0.20', 'upperLimit': '0.14'}, {'value': '-0.25', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '-0.08'}]}]}], 'analyses': [{'pValue': '0.0792', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.03', 'statisticalMethod': 'Linear repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Multiple imputation used for missing data at follow-up.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 1 year', 'description': 'Number of time child consumed juice (e.g., orange juice, apple juice, or grape juice), fruit-flavored drinks (e.g., Kool-Aid, sports drinks, Goya juice, etc.), regular soda, soft drinks, or Malta yesterday.', 'unitOfMeasure': 'times/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Increased Satisfaction With Care at Harvard Vanguard Medical Associates (HVMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'This is a feasibility and acceptability measure from the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.'}, {'type': 'POST_HOC', 'title': 'Parent Very Satisfied With Content of Connect 4 Health Text Messages or Emails.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'This is a feasibility and acceptability measure from the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses. Additionally, only those who responded Yes to the previous question asking if they received text messages were included in this analysis.'}, {'type': 'POST_HOC', 'title': 'Received Information From Connect 4 Health About Resources in the Community', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'This is a feasibility and acceptability measure from the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.'}, {'type': 'POST_HOC', 'title': 'Received Text Messages or Emails From Connect 4 Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'This is a feasibility and acceptability measure from the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.'}, {'type': 'POST_HOC', 'title': 'Parent Very Satisfied With Information he/She Received About Resources in the Community', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'OG001', 'title': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}], 'classes': [{'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'This is a feasibility and acceptability measure from the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses. Additionally, only those who responded Yes to the previous question asking if they received community resources were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'FG001', 'title': 'Health Coaching', 'description': "The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program.\n\nParent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community.\n\nParents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '360'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '328'}, {'groupId': 'FG001', 'numSubjects': '336'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '721', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enhanced Primary Care', 'description': 'Arm: No Intervention: Enhanced Primary Care We will provide current "best practice" to the control arm. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'id': 'BG001', 'title': 'Health Coaching', 'description': 'Arm: Experimental: Health Coaching The intervention for this study will consist of three elements: visits with a health coach, connection to community resources and an interactive text messaging program.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '361', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '721', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '8.1', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '8.0', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '353', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '361', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '721', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI z score', 'classes': [{'categories': [{'measurements': [{'value': '1.90', 'spread': '0.51', 'groupId': 'BG000'}, {'value': '1.86', 'spread': '0.52', 'groupId': 'BG001'}, {'value': '1.88', 'spread': '0.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'BMI z score units', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pediatric Quality of Life (PedsQL) Summary Score', 'classes': [{'categories': [{'measurements': [{'value': '86.0', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '85.4', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '85.7', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parent Resource Empowerment', 'classes': [{'categories': [{'measurements': [{'value': '2.93', 'spread': '0.59', 'groupId': 'BG000'}, {'value': '2.96', 'spread': '0.53', 'groupId': 'BG001'}, {'value': '2.95', 'spread': '0.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The five items in the scale assessed parents' perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. Responses ranged from Strongly disagree to Strongly agree (range = 1-4). Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach's α for this score was 0.87.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 721}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-24', 'studyFirstSubmitDate': '2014-04-14', 'resultsFirstSubmitDate': '2016-10-28', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-24', 'studyFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BMI z Score', 'timeFrame': 'baseline and one year', 'description': 'Height and weight will be measured by the medical assistants at each site using standard protocols. BMI measures will be obtained from the electronic health record (EHR) as provided through usual care. BMI measures will be converted to z-scores using CDC age and sex-specific normative data for children between 2 and 20 years old. This will allow the research team to combine data across children of different ages.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'baseline and one year', 'description': 'The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children with chronic conditions such as obesity. Parents will be asked to complete 4 subscales: physical health, school, social, and emotional functioning which exists for parental report of children as young as 2 years of age. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.'}, {'measure': 'Change in Parent Resource Empowerment', 'timeFrame': 'Baseline to one-year follow-up', 'description': "The five items in the scale assessed parents' perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. For each question, parents responded strongly disagree, disagree, agree, or strongly agree, which were worth 1 to 4 points, respectively. Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach's α for this score was 0.87."}], 'secondaryOutcomes': [{'measure': 'Change in Screen Time', 'timeFrame': 'baseline and one year', 'description': 'Average hours/day spent watching television, videos, or playing games displayed on media such as television, desktop computers, laptops, portable DVD players, iPads or smartphones.'}, {'measure': 'Change in Sleep', 'timeFrame': 'baseline and 1 year', 'description': 'Average hours/day spent sleeping'}, {'measure': 'Change in Physical Activity', 'timeFrame': 'baseline and 1 year', 'description': 'In the past week, how many days the child was physically active for a total of at least 60 minutes per day.'}, {'measure': 'Change in Fruit and Vegetable Consumption', 'timeFrame': 'baseline and 1 year', 'description': 'Number of times the child consumed of vegetables and fruits yesterday'}, {'measure': 'Change in Consumption of Sugar-sweetened Beverages and Juice', 'timeFrame': 'baseline and 1 year', 'description': 'Number of time child consumed juice (e.g., orange juice, apple juice, or grape juice), fruit-flavored drinks (e.g., Kool-Aid, sports drinks, Goya juice, etc.), regular soda, soft drinks, or Malta yesterday.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pediatric', 'Obesity', 'Overweight', 'Intervention'], 'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '39218948', 'type': 'DERIVED', 'citation': 'Simione M, Ferreira P, Luo M, Hoover C, Perkins M, Fiechtner L, Taveras EM. Psychometrics of the modified family-centered care assessment short version for childhood obesity. Health Qual Life Outcomes. 2024 Sep 2;22(1):71. doi: 10.1186/s12955-024-02284-5.'}, {'pmid': '38798356', 'type': 'DERIVED', 'citation': 'Simione M, Ferreira P, Luo M, Hoover C, Perkins M, Fiechtner L, Taveras EM. Psychometrics of the modified Family-Centered Care Assessment short version for childhood obesity. Res Sq [Preprint]. 2024 May 15:rs.3.rs-4365570. doi: 10.21203/rs.3.rs-4365570/v1.'}, {'pmid': '32527270', 'type': 'DERIVED', 'citation': 'Simione M, Sharifi M, Gerber MW, Marshall R, Avalon E, Fiechtner L, Horan C, Orav EJ, Skelton J, Taveras EM. Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool. Health Qual Life Outcomes. 2020 Jun 11;18(1):179. doi: 10.1186/s12955-020-01431-y.'}, {'pmid': '30925139', 'type': 'DERIVED', 'citation': "Baskind MJ, Taveras EM, Gerber MW, Fiechtner L, Horan C, Sharifi M. Parent-Perceived Stress and Its Association With Children's Weight and Obesity-Related Behaviors. Prev Chronic Dis. 2019 Mar 28;16:E39. doi: 10.5888/pcd16.180368."}, {'pmid': '30894004', 'type': 'DERIVED', 'citation': 'Bala N, Price SN, Horan CM, Gerber MW, Taveras EM. Use of Telehealth to Enhance Care in a Family-Centered Childhood Obesity Intervention. Clin Pediatr (Phila). 2019 Jun;58(7):789-797. doi: 10.1177/0009922819837371. Epub 2019 Mar 20.'}, {'pmid': '28682745', 'type': 'DERIVED', 'citation': 'Fiechtner L, Puente GC, Sharifi M, Block JP, Price S, Marshall R, Blossom J, Gerber MW, Taveras EM. A Community Resource Map to Support Clinical-Community Linkages in a Randomized Controlled Trial of Childhood Obesity, Eastern Massachusetts, 2014-2016. Prev Chronic Dis. 2017 Jul 6;14:E53. doi: 10.5888/pcd14.160577.'}, {'pmid': '28586856', 'type': 'DERIVED', 'citation': 'Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Gerber MW, Orav EJ, Price SN, Sequist T, Slater D. Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions: A Randomized Clinical Trial. JAMA Pediatr. 2017 Aug 7;171(8):e171325. doi: 10.1001/jamapediatrics.2017.1325. Epub 2017 Aug 7.'}, {'pmid': '26427562', 'type': 'DERIVED', 'citation': 'Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Orav J, Price SN, Sequist T, Slater D. Connect for Health: Design of a clinical-community childhood obesity intervention testing best practices of positive outliers. Contemp Clin Trials. 2015 Nov;45(Pt B):287-295. doi: 10.1016/j.cct.2015.09.022. Epub 2015 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'Health care system (HCS)-based interventions have been limited by their inattention to social and environmental barriers that impede improvement in obesity-related behaviors. Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity. HCSs often lack the organizational structure to provide longitudinal care for children with chronic illnesses, the clinicians to manage and support patients with chronic illnesses outside of clinic, and/or the health information systems that support the use of evidence-based practices at the point-of-care. Thus, the research question this study is designed to address is whether a novel approach to care delivery that leverages delivery system and community resources and addresses socio-contextual factors will improve family-centered childhood obesity outcomes.\n\nThe primary specific aims are to examine the extent to which the intervention, compared to the control condition, results in:\n\n1. A smaller age-associated increase in BMI over a 12-month period.\n2. Improved parental and child ratings of pediatric health-related quality of life.\n\nThe secondary aims are:\n\n1. To examine parental ratings of quality and family-centeredness of pediatric obesity care and compare outcomes among participants in the intervention with the control condition\n2. To assess change in weight-related behaviors and compare outcomes among participants in the intervention with the control condition\n3. To assess the following process measures:\n\n * Reach\n * Extent of implementation\n * Fidelity to protocol\n * Parent satisfaction\n4. To examine the extent to which neighborhood environments modify observed intervention effects\n5. To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* child is age 2.0 through 12.9 years at baseline primary care visit,\n* child's BMI is equal to or exceeds the 85th percentile for age and sex at baseline primary care visit,\n* at least 1 parent has an active email address,\n* at least one parent is comfortable reading and speaking in English.\n\nExclusion Criteria:\n\n* children who do not have at least one parent/legal guardian who is able to follow study procedures for 1 year,\n* families who plan to leave HVMA within the study time frame,\n* families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties,\n* children who have a sibling already enrolled in the study,\n* children with chronic conditions that substantially interfere with growth or physical activity participation."}, 'identificationModule': {'nctId': 'NCT02124460', 'briefTitle': 'Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers', 'orgStudyIdInfo': {'id': 'IH-1304-6739'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Enhanced Primary Care', 'description': 'We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages.'}, {'type': 'EXPERIMENTAL', 'label': 'Health Coaching', 'description': 'The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.', 'interventionNames': ['Behavioral: Health Coaching']}], 'interventions': [{'name': 'Health Coaching', 'type': 'BEHAVIORAL', 'description': "Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. During these visits, the health coach will coach the parent/child duos on improving obesity-related behaviors .\n\nThe health coach will also help the family identify supports to assist with behavior change; discuss family health habits and the home environment; and review and encourage use of materials related to both specific target behaviors and available resources in the community.\n\nFollowing the first call with the health coach, parents will receive semi-weekly text messages designed by the study team. The messages will alternate in structure between 2 types of messages; 1) skills training messages will deliver tips and motivational messages to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond to the message and track health behaviors important to this study.", 'armGroupLabels': ['Health Coaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Vanguard Medical Associates', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Elsie M Taveras, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard Vanguard Medical Associates', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of General Academic Pediatrics', 'investigatorFullName': 'Elsie Taveras, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}