Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents (BASH)

This study has been completed.
Information provided by (Responsible Party):
Children's Hospital Boston Identifier:
First received: September 25, 2006
Last updated: August 8, 2012
Last verified: August 2012

September 25, 2006
August 8, 2012
September 2006
December 2011   (final data collection date for primary outcome measure)
Body mass index (BMI) [ Time Frame: Change through 2 years ] [ Designated as safety issue: No ]
Body mass index (BMI)
Complete list of historical versions of study NCT00381160 on Archive Site
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Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents
Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents

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.

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.

Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Overweight
  • Obesity
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).
  • Experimental: 1
    Provision of non-caloric beverages to home
    Intervention: Behavioral: Reduction of sugar-sweetened beverage consumption
  • No Intervention: 2

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
December 2011   (final data collection date for primary outcome measure)

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

Exclusion Criteria:

  • Sibling participating in the study
  • Intention to change location of residence during the 2 years post-randomization
  • Plans to be away from home for 5 weeks or longer during the study period
  • Physician diagnosis of a major medical illness or eating disorder
  • Chronic use of any medication that may affect body weight or composition
  • Current smoking
  • Physical, mental, or cognitive handicaps that prevent participation
13 Years to 17 Years
Contact information is only displayed when the study is recruiting subjects
United States
DK73025A, R01DK073025
Not Provided
Children's Hospital Boston
Children's Hospital Boston
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Director: Cara B Ebbeing, PhD Children's Hospital Boston
Principal Investigator: David S Ludwig, MD, PhD Children's Hospital Boston
Children's Hospital Boston
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP