Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT02324361
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2014-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'szan@mail.harvard.edu', 'phone': '4259856430', 'title': 'Study Project Manager', 'organization': 'Partners Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Having participants self-select the technology platform used to deliver an mHealth intervention may promote intervention engagement this lack of randomization potentially limits the generalizability of the results.'}}, 'adverseEventsModule': {'timeFrame': '90 days, over the entire duration of the study', 'eventGroups': [{'id': 'EG000', 'title': 'Facebook Group', 'description': "The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.", 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Text Messaging (SMS) Group', 'description': 'The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.\n\nThe automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Parent/Guardian Knowledge of Healthy Family Routines and of Parenting Strategies That Are Preventive of Child Overweight and Obesity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facebook Group', 'description': "The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study."}, {'id': 'OG001', 'title': 'Text Messaging (SMS) Group', 'description': 'The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.\n\nThe automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '1.7'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': "We designed a scale for use in this study containing 8 questions on each of the family routines that we assessed (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours). Each of the eight questions were assigned one point value. The scale was summative such that the lowest possible score was 0 and highest possible score was 8, from adding up scores to all eight questions. Higher scores indicated a better outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facebook Group', 'description': "The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study."}, {'id': 'OG001', 'title': 'Text Messaging (SMS) Group', 'description': 'The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.\n\nThe automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '0.7'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Baseline to 90-days post-intervention change in child sleep duration (hours per day)', 'unitOfMeasure': 'hours per day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Child Screen Time Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facebook Group', 'description': "The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study."}, {'id': 'OG001', 'title': 'Text Messaging (SMS) Group', 'description': 'The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.\n\nThe automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '0.1'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Baseline to 90-days post-intervention change in child screen time exposure (hours per day)', 'unitOfMeasure': 'hours per day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Sugar Sweetened Beverage Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facebook Group', 'description': "The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study."}, {'id': 'OG001', 'title': 'Text Messaging (SMS) Group', 'description': 'The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.\n\nThe automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.2'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Baseline to 90-days post-intervention change in child sugar sweetened beverage intake (servings per day)', 'unitOfMeasure': 'servings per day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Facebook Group', 'description': "The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study."}, {'id': 'FG001', 'title': 'Text Messaging (SMS) Group', 'description': 'The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.\n\nThe automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.\n\nAll index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'From July to October 2014, attempts were made to solicit the participation of primary caregivers of all children receiving care since 2013 at Quincy Pediatric Associates (QPA) via mailed recruitment letters.', 'preAssignmentDetails': 'Caregivers were phone-screened for English fluency, internet access, computer/smartphone ownership, and ownership of a Facebook account. Those with significant functional impairments or co-morbidities, those enrolled in another weight management intervention program, or had a sibling already enrolled in the study were excluded from participation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Facebook Group', 'description': 'The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for Facebook posts on a private study Facebook group.\n\nParticipating parents/guardians will have access to all features of the secret study Facebook group (e.g., create and view postings, comment and like existing posts and view user names of other members of the group (existing study participants and staff) for the duration of the study.\n\nAll index children will be provided with a Physical Activity Monitor to wear during waking hours for the duration of the study.'}, {'id': 'BG001', 'title': 'Text Messaging', 'description': "The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.\n\nThe automated text-messaging algorithm consists of the delivery of two types of text messages: 1-way messages, in which participating parents/guardians will receive a piece of education or motivation on the dimension topic that they're being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '40.2', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '39.3', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age of caregiver', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '5.0', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age of index child', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sex of index child', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregiver ethnicity', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'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': '4', 'groupId': 'BG001'}, {'value': '4', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregiver race', 'unitOfMeasure': 'Participants'}], 'populationDescription': '1 participant from the Facebook group was unresponsive to contact and subsequently omitted from baseline analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants were given a choice to select one of the two interventions, which were made clear to them. There was no masking of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '2-arm interventional study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-27', 'studyFirstSubmitDate': '2014-07-07', 'resultsFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2014-12-23', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-27', 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parent/Guardian Knowledge of Healthy Family Routines and of Parenting Strategies That Are Preventive of Child Overweight and Obesity', 'timeFrame': '90 days', 'description': "We designed a scale for use in this study containing 8 questions on each of the family routines that we assessed (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours). Each of the eight questions were assigned one point value. The scale was summative such that the lowest possible score was 0 and highest possible score was 8, from adding up scores to all eight questions. Higher scores indicated a better outcome."}], 'secondaryOutcomes': [{'measure': 'Change in Sleep', 'timeFrame': '90 days', 'description': 'Baseline to 90-days post-intervention change in child sleep duration (hours per day)'}, {'measure': 'Change in Child Screen Time Exposure', 'timeFrame': '90 days', 'description': 'Baseline to 90-days post-intervention change in child screen time exposure (hours per day)'}, {'measure': 'Change in Sugar Sweetened Beverage Intake', 'timeFrame': '90 days', 'description': 'Baseline to 90-days post-intervention change in child sugar sweetened beverage intake (servings per day)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric', 'Obesity', 'Intervention', 'Information and Communication Technologies', 'Social Media', 'Text Messaging', 'Mobile Health'], 'conditions': ['Pediatric Obesity']}, 'descriptionModule': {'briefSummary': 'To date, approaches that show the most promise for preventing and/or reversing the course of childhood obesity involve the delivery of intensive lifestyle interventions within a family-based context, emphasizing the necessity of parental involvement and making changes in family routines and the home environment. Considering that the current demand for pediatric weight management programs far exceed availability, as well as the high attrition rates observed in such programs, there is a great need for more accessible and efficient means of delivering these interventions to reduce the burden of childhood obesity.\n\nThe goal of this study is to understand whether text messaging and social media platforms can be leveraged to address the important issue of childhood obesity by engaging parent/guardians in one of these strategies, and whether these strategies produce similar outcomes. No existing study has compared these strategies head-to-head, and the investigators believe that this project will be instrumental in understanding the determinants of success in these strategies and allow us to collect sufficient intelligence to be able to deploy these meaningfully to patients as part of usual care.', 'detailedDescription': "The goal of this pilot study is to evaluate and compare the feasibility and effectiveness of two platforms, text messaging and Facebook, for delivering an evidence-based, family-centric childhood obesity intervention to parent/guardians of children between the ages of 3-6 with a BMI of 90th percentile and above. The investigators hypothesize that the use of both platforms for delivering a childhood obesity intervention will help establish healthier family routines and be equally engaging and accepted by parent/guardians and children.\n\nThe primary aim of this study is to assess the effect of the intervention on:\n\n* Parent/guardian knowledge of healthy family routines (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours) and of parenting strategies that are preventive of child overweight and obesity\n* Parent/guardian readiness, confidence, and perceived self-efficacy to make and maintain changes in family routines known to be associated with healthy weight outcomes\n\nThe secondary aims of the study are to assess the effect of the intervention on:\n\n* The adoption of healthy family routines and parenting strategies that are preventive of child overweight and obesity\n* Daily objective physical activity in the index child by accelerometry (using a physical activity tracking device)\n* Index children's BMI percentile, using data collected during regular clinic visits from the electronic medical record\n* To assess the level of engagement with the intervention, measured via daily activity tracker wear by the index child, parent/guardian views of Facebook posts or responses to 2-way text messages"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Index child's BMI ≥90th percentile\n* Index child age between 3 and 7 years of age at time of enrollment in study\n* The child is under the care of a primary care provider at the Quincy Pediatric Associates practice\n* The family is not planning to move from the Greater Boston area during the study period\n\nThe participating parent/guardian:\n\n* Is 18 years or older\n* Is the primary caregiver for the child\n* Has regular access to the Internet\n* Has regular access to a personal computer with USB connection OR a smartphone with a mobile operating system that is compatible with the physical activity tracker\n* Owns a Facebook account AND a cellphone with text messaging capability and if choosing the text-messaging intervention, is willing to receive a maximum of 62 text messages/month for 3 months on their personal cellphone\n* Is fluent in English (spoken and written)\n\nExclusion Criteria:\n\n* Children who are diagnosed with underlying medical or pharmacologic factors that may contribute to obesity and/or affect participation in physical activity\n* Significant medical or psychiatric co-morbidities in the participating parent/guardian\n* Visual, hearing, or cognitive impairments in the participating parent/guardian\n* Index child or parent/guardian currently enrolled in another weight control program\n* Children who have a sibling already enrolled in the study"}, 'identificationModule': {'nctId': 'NCT02324361', 'acronym': 'QFYT', 'briefTitle': 'Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study', 'orgStudyIdInfo': {'id': '2014P000873'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Facebook group', 'description': 'The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for Facebook posts on a private study Facebook group.\n\nParticipating parents/guardians will have access to all features of the secret study Facebook group (e.g., create and view postings, comment and like existing posts and view user names of other members of the group (existing study participants and staff) for the duration of the study.\n\nAll index children will be provided with a Physical Activity Monitor to wear during waking hours for the duration of the study.', 'interventionNames': ['Other: Physical Activity', 'Behavioral: Evidence-based information on healthy family routines']}, {'type': 'EXPERIMENTAL', 'label': 'Text messaging', 'description': "The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.\n\nThe automated text-messaging algorithm consists of the delivery of two types of text messages: 1-way messages, in which participating parents/guardians will receive a piece of education or motivation on the dimension topic that they're being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.\n\nAll index children will be provided with a Physical Activity Monitor to wear during waking hours for the duration of the study.", 'interventionNames': ['Other: Physical Activity', 'Behavioral: Evidence-based information on healthy family routines']}], 'interventions': [{'name': 'Physical Activity', 'type': 'OTHER', 'otherNames': ['Change in Physical Activity'], 'description': 'The Fitbit Zip is a wireless physical activity monitor that will be worn by the index child during waking hours, and will be used to assess daily active time for the duration of the study.', 'armGroupLabels': ['Facebook group', 'Text messaging']}, {'name': 'Evidence-based information on healthy family routines', 'type': 'BEHAVIORAL', 'description': "Educational dimensions include nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours.", 'armGroupLabels': ['Facebook group', 'Text messaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02169', 'city': 'Quincy', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Quincy Pediatric Associates', 'geoPoint': {'lat': 42.25288, 'lon': -71.00227}}], 'overallOfficials': [{'name': 'Kamal Jethwani, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dermatologist', 'investigatorFullName': 'Joseph C. Kvedar', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}