NCT00301197

Brief Summary

Obesity is a major public health problem. At least 15 million American adults are obese, and the number is rising. Childhood obesity is also increasing in prevalence and currently affects approximately 11-22 percent of children aged 6 to 11. Childhood obesity is associated with serious negative physical, emotional, and social consequences. Obese children are at high risk for becoming obese as adults; 24-44 percent of obese adults were obese as children. The risk of an obese child becoming an obese adult is especially high when at least one parent is obese. To date, adult obesity is known to be resistant to treatment. In contrast, promising long-term effects have been found with children who received behavioral family-based weight loss treatment. However, even with state-of-the-science programs, a substantial percentage of children (i.e., over 40 percent) regain all or most of the weight lost once treatment ends. The proposed study examined the efficacy of two intervention strategies designed to improve the long-term maintenance of weight loss in children relative to discontinued treatment contact following an active weight loss treatment phase (no maintenance treatment control (NTC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 1999

Longer than P75 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, 1999

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
Last Updated

March 10, 2006

Status Verified

March 1, 2006

First QC Date

March 8, 2006

Last Update Submit

March 8, 2006

Conditions

Keywords

Childhood obesityinterventionobesityweight lossbehavior therapypeer groupsocial support networkchildclinical researchhuman subject

Outcome Measures

Primary Outcomes (1)

  • Weight (child and parent)

Secondary Outcomes (2)

  • Weight related behaviors

  • Psychological functioning (specific and general)

Interventions

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child:
  • %-100% overweight
  • years old
  • At least one parent:
  • At least 20% overweight
  • Actively participates in program along with participating child
  • Both participating family members:
  • Can read and speak English at a 3rd grade level

You may not qualify if:

  • Either participating child or parent:
  • has current psychopathology and is not in ongoing psychiatric care
  • has an active substance abuse problem
  • is not taking weight-affecting medications
  • does not have a medical condition for which a weight loss program would be contraindicated
  • does not have a physical disability of illness that limits their ability to do physical activity
  • does not have major dietary restrictions
  • is not participating in an active weight loss treatment
  • All family members:
  • do not have an active eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Wilfley DE, Stein RI, Saelens BE, Mockus DS, Matt GE, Hayden-Wade HA, Welch RR, Schechtman KB, Thompson PA, Epstein LH. Efficacy of maintenance treatment approaches for childhood overweight: a randomized controlled trial. JAMA. 2007 Oct 10;298(14):1661-73. doi: 10.1001/jama.298.14.1661.

MeSH Terms

Conditions

ObesityPediatric ObesityWeight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Denise E Wilfley, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

March 8, 2006

First Posted

March 10, 2006

Study Start

August 1, 1999

Study Completion

April 1, 2004

Last Updated

March 10, 2006

Record last verified: 2006-03

Locations