Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents (BASH)
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Purpose
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 |
|---|---|
|
Overweight Obesity |
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 |
- 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.
Eligibility| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00381160
| United States, Massachusetts | |
| Children's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Study Director: | Cara B Ebbeing, PhD | Children's Hospital Boston | |
| Principal Investigator: | David S Ludwig, MD, PhD | Children's Hospital Boston |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Children's Hospital Boston |
| ClinicalTrials.gov 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 obesity sugar-sweetened beverages diet adolescence |
Additional relevant MeSH terms:
|
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on March 03, 2015