Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents

Obesity Clinical Trial

— BASH  

Official title:

Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381160
• Other study ID #: DK73025A
• Secondary ID: R01DK073025
• Status: Completed
• Phase: N/A
• First received: September 25, 2006
• Last updated: August 8, 2012
• Start date: September 2006
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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).

Locations

Country	Name	City	State
United States	Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index (BMI)		Change through 2 years	No