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Completed

NCT Number: NCT02890056

A Community-based Study to Target Childhood Obesity

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.

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Key information

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University School of Pblic Health

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

H2GO!

Behavioral

Primary outcomes

  1. Sugar-sweetened beverage consumption

    Time frame: Change from baseline to 6 months

    Measured through self-report survey

  2. Water consumption

    Time frame: Change from baseline to 6 months

    Measured through self-report survey

Secondary outcomes

  1. Body mass index percentile (age- and sex-specific)

    Time frame: Change from baseline to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

A Culturally-tailored Narrative Intervention to Target Disparities in Obesity

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2016
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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