- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00381160
Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents (BASH)
Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: 2
|
|
EXPERIMENTAL: 1
Provision of non-caloric beverages to home
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body mass index (BMI)
Time Frame: Change through 2 years
|
Change through 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Cara B Ebbeing, PhD, Boston Children's Hospital
Publications and helpful links
General Publications
- Ebbeling CB, Feldman HA, Osganian SK, Chomitz VR, Ellenbogen SJ, Ludwig DS. Effects of decreasing sugar-sweetened beverage consumption on body weight in adolescents: a randomized, controlled pilot study. Pediatrics. 2006 Mar;117(3):673-80. doi: 10.1542/peds.2005-0983.
- Ebbeling CB, Feldman HA, Chomitz VR, Antonelli TA, Gortmaker SL, Osganian SK, Ludwig DS. A randomized trial of sugar-sweetened beverages and adolescent body weight. N Engl J Med. 2012 Oct 11;367(15):1407-16. doi: 10.1056/NEJMoa1203388. Epub 2012 Sep 21.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK73025A
- R01DK073025 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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