Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT02890056
Status:
COMPLETED
Last Update Posted:
2019-06-12
First Post:
2016-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Community-based Study to Target Childhood Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-11', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2016-08-31', 'lastUpdatePostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sugar-sweetened beverage consumption', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Measured through self-report survey'}, {'measure': 'Water consumption', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Measured through self-report survey'}], 'secondaryOutcomes': [{'measure': 'Body mass index percentile (age- and sex-specific)', 'timeFrame': 'Change from baseline to 6 months', 'description': "Trained staff will obtain child participants' height (inches) and weight (pounds) using standardized equipment. Height and weight will then be used to calculate body mass index (kg/m\\^2). Body mass index percentiles will be calculated using age- and sex-specific body mass index-based growth trajectories."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sugar-sweetened beverage consumption', 'water consumption', 'dietary behaviors', 'youth'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '31362753', 'type': 'DERIVED', 'citation': 'Wang ML, Otis M, Rosal MC, Griecci CF, Lemon SC. Reducing sugary drink intake through youth empowerment: results from a pilot-site randomized study. Int J Behav Nutr Phys Act. 2019 Jul 30;16(1):58. doi: 10.1186/s12966-019-0819-0.'}, {'pmid': '27829397', 'type': 'DERIVED', 'citation': 'Wang ML, Lemon SC, Clausen K, Whyte J, Rosal MC. Design and methods for a community-based intervention to reduce sugar-sweetened beverage consumption among youth: H2GO! study. BMC Public Health. 2016 Nov 9;16(1):1150. doi: 10.1186/s12889-016-3803-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of a community-based behavioral intervention (H2GO!) on decreasing sugar-sweetened beverage consumption and promoting water consumption among school-aged youth and parents/caregivers. We hypothesize that participants in the intervention site will demonstrate reduced sugar-sweetened beverage intake intake and increased water intake compared to participants in the comparison site at 2 and 6 months follow-up.', 'detailedDescription': "This study aims to assess the efficacy of a community-based behavioral intervention (H2GO!) targeting sugar-sweetened beverage and water consumption among 108 parent-child pairs (N=216) through a site-randomized trial.\n\nThe study setting includes 2 Boys and Girls Club sites in Massachusetts, USA that were pair-matched for size and racial/ethnic composition. The Boys and Girls of America is a national organization that provides affordable after-school programs for a large population (\\~4 million annually) of diverse youth (33% White, 30% Black, 23% Latino) from predominantly low socioeconomic backgrounds through over 4,000 club facilities across the U.S.\n\nThe H2GO! intervention was designed to address two behavioral targets: reducing the number of sugar-sweetened beverage servings consumed per day (recommended guideline of zero servings per day) and promoting water consumption (approximately 5-8 cups per day for youth participants and 8 cups per day for parental participants). Informed by the Social Cognitive Theory and the Social Ecological Model, the H2GO! Intervention was designed to target child and parent participants' knowledge, attitudes (self-efficacy, outcome expectations, perceived social norms) and behavioral capabilities related to sugar-sweetened beverage and water consumption.\n\nThe 6-week behavioral intervention consists of group-based weekly sessions (1-hour sessions twice a week) delivered by trained Boys and Girls Club program staff at the Boys and Girls Club site. Each intervention session consists of a 1-hour health module followed by a 1-hour narrative module. Topics of the health modules include: understanding the benefits of water, sampling different types of fruit-flavored water, identifying sugar-sweetened beverages, exploring the local grocery store, identifying barriers and facilitators to drinking water, and managing triggers for sugar-sweetened beverages. The narrative modules include intervention objectives and activities that reinforce knowledge, attitudes, skills, and behaviors targeted in the previous health component.\n\nChild participants will receive a reusable water bottle and a pictorial intervention booklet. Developed by the study principal investigator (PI) and research assistants, the brightly-colored booklet was culturally and linguistically-tailored to the study population and included intervention activity worksheets, parent-child take-home activities, fun facts and quizzes, and beverage consumption tracking sheets. Activity worksheets will be completed by participants during intervention sessions; and parent-child take-home activities will be completed following each session.\n\nStudy assessments will take place at baseline, 2 months, and 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'This study recruits parent/caregiver-child pairs. The inclusion and exclusion criteria are further specified based on parent/caregiver participants and child participants.\n\nChild Inclusion Criteria:\n\n* ages 9-12 years\n* current member at the Boys and Girls Club study site\n* able to understand and communicate in English\n* able and willing to provide consent\n* parental/caregiver permission to participate\n\nChild Exclusion Criteria:\n\n\\- medical condition that limits ability to change beverage consumption behaviors\n\nParent/Caregiver Inclusion Criteria:\n\n* ages 18+ years\n* parent/caregiver to a Boys and Girls Club child member\n* able to understand and communicate in English\n* able and willing to provide consent\n\nParent/Caregiver Exclusion Criteria:\n\n\\- medical condition that limits ability to change beverage consumption behaviors'}, 'identificationModule': {'nctId': 'NCT02890056', 'briefTitle': 'A Community-based Study to Target Childhood Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'A Culturally-tailored Narrative Intervention to Target Disparities in Obesity', 'orgStudyIdInfo': {'id': 'H-34445'}, 'secondaryIdInfos': [{'id': '1K01DK102447', 'link': 'https://reporter.nih.gov/quickSearch/1K01DK102447', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'H2GO! intervention', 'description': 'H2GO! is a community-based behavioral intervention to reduce sugar-sweetened beverage consumption and promote water intake among school-age youth and parents.The intervention consists of 6 weekly group-based sessions (1-hour sessions twice a week) that target beverage knowledge, attitudes, and behaviors through interactive activities, youth-produced narratives, and parent-child activities. The intervention is delivered through a youth-based community setting (Boys and Girls Clubs of America) by trained Boys and Girls Club staff.', 'interventionNames': ['Behavioral: H2GO!']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison', 'description': 'Usual care will take place at the comparison site (standard programming at the Boys and Girls Club comparison site).'}], 'interventions': [{'name': 'H2GO!', 'type': 'BEHAVIORAL', 'armGroupLabels': ['H2GO! intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University School of Pblic Health', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Monica Wang, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Monica Li-Sha Wang', 'investigatorAffiliation': 'Boston University'}}}}