An interventional study of H2GO! in Obesity, sponsored by Boston University. Completed at 1 site in United States. Open to participants aged 9 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-12.
Sponsored by Boston University · Not applicable, Interventional, and Prevention
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.
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.
The 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.
The 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.
The 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.
Child 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.
Study assessments will take place at baseline, 2 months, and 6 months.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 207 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Boston University is the lead sponsor of 266 studies on the registry; 37 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.
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This study recruits parent/caregiver-child pairs. The inclusion and exclusion criteria are further specified based on parent/caregiver participants and child participants.
Child Inclusion Criteria:
Child Exclusion Criteria:
Parent/Caregiver Inclusion Criteria:
Parent/Caregiver Exclusion Criteria:
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.
Behavioral: H2GO!
Usual care will take place at the comparison site (standard programming at the Boys and Girls Club comparison site).
Sugar-sweetened beverage consumption
Measured through self-report survey
Time frame: Change from baseline to 6 months
Water consumption
Measured through self-report survey
Time frame: Change from baseline to 6 months
Body mass index percentile (age- and sex-specific)
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.
Time frame: Change from baseline to 6 months
Plan to share: No
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Boston University