NCT00285558

Brief Summary

The purpose of this study is to determine whether adding a peer-based intervention based on an outward bound model is more effective than a standard behavioral weight intervention for helping adolescents lose weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable obesity

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

August 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

3.8 years

First QC Date

January 31, 2006

Last Update Submit

October 5, 2017

Conditions

Keywords

obesityadolescentweight lossbody mass indexevaluation studiespeer groupbehavior therapydietexerciseself efficacyparents

Outcome Measures

Primary Outcomes (1)

  • Change in Adolescent Body Mass Index (BMI)

    12 and 24 months

Secondary Outcomes (1)

  • Self concept

    12 and 24 months

Study Arms (2)

CBT with peer-enhanced activities

EXPERIMENTAL

Cognitive behavioral treatment (CBT) with peer-enhanced adventure therapy. The peer intervention, ''adventure therapy,'' is based on the principles of Outward Bound and was expected to affect weight status through a positive effect on self-concept.

Behavioral: CBT with peer-enhanced activities

CBT with supervised aerobic exercise

ACTIVE COMPARATOR

Cognitive behavioral treatment (CBT) with supervised aerobic exercise. Activities for the supervised exercise intervention included use of treadmills, stationary bicycles, and other aerobic activities selected by participants, including dance videos and brisk walking within the clinic setting.

Behavioral: CBT with supervised aerobic exercise

Interventions

CBT with peer-enhanced activities
CBT with supervised aerobic exercise

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents 13-16 years old
  • % overweight with reference gender and age
  • At least 1 parent who can participate
  • English speaking
  • Agree to study participation and random assignment
  • Be available for long-term follow-up

You may not qualify if:

  • Current involvement in another weight loss program
  • Unable to adhere to prescribed dietary plan and physical activity due to medical condition
  • Unable to understand intervention materials
  • In treatment for or diagnosed with psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bradley Hasbro Children's Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • Jelalian E, Lloyd-Richardson EE, Mehlenbeck RS, Hart CN, Flynn-O'Brien K, Kaplan J, Neill M, Wing RR. Behavioral weight control treatment with supervised exercise or peer-enhanced adventure for overweight adolescents. J Pediatr. 2010 Dec;157(6):923-928.e1. doi: 10.1016/j.jpeds.2010.05.047. Epub 2010 Jul 23.

  • Rancourt D, Barker DH, Jelalian E. Sex as a Moderator of Adolescents' Weight Loss Treatment Outcomes. J Adolesc Health. 2018 May;62(5):591-597. doi: 10.1016/j.jadohealth.2017.12.002. Epub 2018 Mar 7.

MeSH Terms

Conditions

ObesityWeight LossMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Officials

  • Elissa Jelalian, PhD

    Brown University Medical School; Lifespan Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 2, 2006

Study Start

August 1, 2003

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations