NCT00381160

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

5.3 years

First QC Date

September 25, 2006

Last Update Submit

August 8, 2012

Conditions

Keywords

weight lossobesitysugar-sweetened beveragesdietadolescence

Outcome Measures

Primary Outcomes (1)

  • Body mass index (BMI)

    Change through 2 years

Study Arms (2)

1

EXPERIMENTAL

Provision of non-caloric beverages to home

Behavioral: Reduction of sugar-sweetened beverage consumption

2

NO INTERVENTION

Interventions

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).

1

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

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: 16510646BACKGROUND
  • 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.

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Cara B Ebbeing, PhD

    Boston Children's Hospital

    STUDY DIRECTOR
  • David S Ludwig, MD, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

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

Locations