BASH: Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents

Sponsor

Boston Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00381160

Collaborator

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

224

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this study is to examine the effect of a multi-component intervention, designed to reduce consumption of sugar-sweetened beverages, on weight gain, total energy intake, and diet quality in adolescents. The secondary aim is to evaluate whether outcomes of the intervention differ between adolescents for whom 100% fruit juice vs. other products (i.e., soda, fruit punch, lemonade, iced tea, coffee drinks, energy drinks, sports drinks) constitutes the primary source of sugar from beverages.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity	Behavioral: Reduction of sugar-sweetened beverage consumption	N/A

Detailed Description

We are partnering with community organizations (including high schools) in the greater Boston area and a major regional supermarket. Participants will be 240 high school students who drink at least 1 serving of sugar-sweetened beverage (including 100% fruit juices) per day and who have a BMI ≥ 85th percentile. They will be randomly assigned to an intervention or control group. The intervention, of 1-year duration, will target the home/family environment in combination with a behavioral intervention provided during brief check-in visits. The environment will be changed by delivering non-caloric beverages to the homes of adolescents who regularly consume sugar-sweetened beverages. Parents will be counseled by telephone to serve as role models in consuming non-caloric beverages. The behavioral intervention for the adolescents will include didactic and experiential components during the check-in visits. Study outcomes will be assessed at baseline, 1 year (end of intervention period), and 2 years (end of follow-up period).

Additional relevant material based on the original proposal (NIH grant application) is provided below:

Each outcome will be compared between groups using a general linear model, adjusted for baseline covariates that could affect body weight: sex, race, ethnicity (Hispanic vs non-Hispanic), household income, parents' education, BMI, beverage consumption (sugar-sweetened, artificially sweetened, unsweetened), energy intake (total, sugar-sweetened beverages, fruit juice), physical activity level, and daily television viewing. Each covariate will be tested for confounding, mediation, and interaction effects on the primary outcome. Stratum-specific estimates of the group difference will be constructed for any covariates showing significant interaction.

Study Design

Study Type:

Interventional

Actual Enrollment :

224 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Provision of non-caloric beverages to home	Behavioral: Reduction of sugar-sweetened beverage consumption Multi-component intervention aimed at reducing sugar-sweetened beverage consumption. Components include delivery of non-caloric beverages to home in combination with behavioral modification (telephone counseling with parent; check in visit with participant).
No Intervention: 2

Arm

Intervention/Treatment

Experimental: 1

Provision of non-caloric beverages to home

Behavioral: Reduction of sugar-sweetened beverage consumption

Multi-component intervention aimed at reducing sugar-sweetened beverage consumption. Components include delivery of non-caloric beverages to home in combination with behavioral modification (telephone counseling with parent; check in visit with participant).

No Intervention: 2

Outcome Measures

Primary Outcome Measures

Body mass index (BMI) [Change through 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Enrolled in grade 9 or 10
BMI ≥ 85th percentile for age and gender
Residing in predominately one household, with access to a working telephone
Consumption of 12 fluid ounces sugar-sweetened beverages (including 100% fruit juices) per day