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临床试验/NCT02890056
NCT02890056已完成不适用

A Culturally-tailored Narrative Intervention to Target Disparities in Obesity

Boston University2 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
207
试验地点
2
主要终点
Sugar-sweetened beverage consumption

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Sugar-sweetened beverage consumption

时间窗: Change from baseline to 6 months

Measured through self-report survey

Water consumption

时间窗: Change from baseline to 6 months

Measured through self-report survey

次要结局

  • Body mass index percentile (age- and sex-specific)(Change from baseline to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Monica Li-Sha Wang

Assistant Professor

Boston University

研究点 (2)

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