Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents (BASH)
|Overweight Obesity||Behavioral: Reduction of sugar-sweetened beverage consumption|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents|
- Body mass index (BMI) [ Time Frame: Change through 2 years ]
|Study Start Date:||September 2006|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381160
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|Study Director:||Cara B Ebbeing, PhD||Boston Children’s Hospital|
|Principal Investigator:||David S Ludwig, MD, PhD||Boston Children’s Hospital|