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A Community-based Study to Target Childhood Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890056
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Monica Li-Sha Wang, Boston University

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: H2GO! Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Culturally-tailored Narrative Intervention to Target Disparities in Obesity
Actual Study Start Date : September 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: H2GO! intervention
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!
No Intervention: Comparison
Usual care will take place at the comparison site (standard programming at the Boys and Girls Club comparison site).



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890056


Locations
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United States, Massachusetts
Boston University School of Pblic Health
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Monica Wang, ScD Boston University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Monica Li-Sha Wang, Assistant Professor, Boston University
ClinicalTrials.gov Identifier: NCT02890056    
Other Study ID Numbers: H-34445
1K01DK102447 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Monica Li-Sha Wang, Boston University:
sugar-sweetened beverage consumption
water consumption
dietary behaviors
youth
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight