Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents (BASH)

This study has been completed.

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Boston Children’s Hospital

ClinicalTrials.gov Identifier:

NCT00381160

First received: September 25, 2006

Last updated: August 8, 2012

Last verified: August 2012

History of Changes

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

Further study details as provided by Boston Children’s Hospital:

Primary Outcome Measures:

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 (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381160

Locations


United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Boston Children’s Hospital

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

Investigators


Study Director:	Cara B Ebbeing, PhD	Boston Children’s Hospital
Principal Investigator:	David S Ludwig, MD, PhD	Boston Children’s Hospital

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Boston Children’s Hospital
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 Boston Children’s Hospital:


weight loss obesity sugar-sweetened beverages diet adolescence

Additional relevant MeSH terms:


Overweight Body Weight Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2016

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