Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents (BASH)
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|ClinicalTrials.gov Identifier: NCT00381160|
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : August 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Reduction of sugar-sweetened beverage consumption||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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|
- Body mass index (BMI) [ Time Frame: Change through 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|