Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents

NCT ID: NCT00381160

Last Updated: 2012-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2011-12-31

Brief 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.

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.

Conditions

Overweight; Obesity

Keywords

weight loss; obesity; sugar-sweetened beverages; diet; adolescence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Provision of non-caloric beverages to home

Group Type: EXPERIMENTAL

Reduction of sugar-sweetened beverage consumption

Intervention Type: BEHAVIORAL

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).

2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cara B Ebbeing, PhD

Role: STUDY_DIRECTOR

Boston Children's Hospital

David S Ludwig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Children's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16510646 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22998339 (View on PubMed)

Other Identifiers

R01DK073025

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK73025A

Identifier Type: -

Identifier Source: org_study_id