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

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 Intervention
Behavioral: Reduction of sugar-sweetened beverage consumption

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents

Resource links provided by NLM:

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Body mass index (BMI) [ Time Frame: Change through 2 years ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: September 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00381160

United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Study Director: Cara B Ebbeing, PhD Children's Hospital Boston
Principal Investigator: David S Ludwig, MD, PhD Children's Hospital Boston
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Children's Hospital Boston Identifier: NCT00381160     History of Changes
Other Study ID Numbers: DK73025A, R01DK073025
Study First Received: September 25, 2006
Last Updated: August 8, 2012
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Boston:
weight loss
sugar-sweetened beverages

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on April 15, 2014