Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents
BASH
Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents
2 other identifiers
interventional
224
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 25, 2006
CompletedFirst Posted
Study publicly available on registry
September 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedAugust 10, 2012
August 1, 2012
5.3 years
September 25, 2006
August 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body mass index (BMI)
Change through 2 years
Study Arms (2)
1
EXPERIMENTALProvision of non-caloric beverages to home
2
NO INTERVENTIONInterventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (2)
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.
PMID: 16510646BACKGROUNDEbbeling 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.
PMID: 22998339DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cara B Ebbeing, PhD
Boston Children's Hospital
- PRINCIPAL INVESTIGATOR
David S Ludwig, MD, PhD
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2006
First Posted
September 27, 2006
Study Start
September 1, 2006
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
August 10, 2012
Record last verified: 2012-08