NCT02890056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

August 29, 2016

Last Update Submit

June 11, 2019

Conditions

Obesity

Keywords

sugar-sweetened beverage consumptionwater consumptiondietary behaviorsyouth

Outcome Measures

Primary Outcomes (2)

  • Sugar-sweetened beverage consumption

    Measured through self-report survey

    Change from baseline to 6 months

  • Water consumption

    Measured through self-report survey

    Change from baseline to 6 months

Secondary Outcomes (1)

  • Body mass index percentile (age- and sex-specific)

    Change from baseline to 6 months

Study Arms (2)

H2GO! intervention

EXPERIMENTAL

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!

Comparison

NO INTERVENTION

Usual care will take place at the comparison site (standard programming at the Boys and Girls Club comparison site).

Interventions

H2GO!BEHAVIORAL
H2GO! intervention

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • 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
  • \- medical condition that limits ability to change beverage consumption behaviors
  • 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
  • \- medical condition that limits ability to change beverage consumption behaviors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University School of Pblic Health

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

  • 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.

    PMID: 31362753DERIVED

  • 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.

    PMID: 27829397DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Monica Wang, ScD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 7, 2016

Study Start

September 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

June 12, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)