Clinical trial NCT02890056: A Community-based Study to Target Childhood Obesity
Official title: A Culturally-tailored Narrative Intervention to Target Disparities in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: sugar-sweetened beverage consumption
water consumption
dietary behaviors
youth
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-09-07
Enrollment: 207
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

* ages 9-12 years
* current member at the Boys and Girls Club study site
* able to understand and communicate in English
* able and willing to provide consent
* parental/caregiver permission to participate

Child Exclusion Criteria:

- medical condition that limits ability to change beverage consumption behaviors

Parent/Caregiver Inclusion Criteria:

* ages 18+ years
* parent/caregiver to a Boys and Girls Club child member
* able to understand and communicate in English
* able and willing to provide consent

Parent/Caregiver Exclusion Criteria:

- medical condition that limits ability to change beverage consumption behaviors

Primary outcomes:
measure: Sugar-sweetened beverage consumption
timeFrame: Change from baseline to 6 months
measure: Water consumption
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Body mass index percentile (age- and sex-specific)
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Pblic Health
state: Massachusetts
Study officials:
affiliation: Boston University
name: Monica Wang, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.