NCT00177229

Brief Summary

The purpose of this study is to determine if a family based diet and exercise program is helpful for extremely overweight children aged 8-12, and to compare this approach to standard medical management of severe pediatric obesity.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2001

Longer than P75 for not_applicable

Status
completed

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

July 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 18, 2008

Status Verified

February 1, 2008

Enrollment Period

4.8 years

First QC Date

September 12, 2005

Last Update Submit

February 15, 2008

Conditions

Behavior

Outcome Measures

Primary Outcomes (1)

  • BMI and cardiovascular risk factors

    0,6,12,18

Secondary Outcomes (1)

  • Eating, activity, and psychosocial functioning

    0,6,12,18

Study Arms (2)

A

NO INTERVENTION

Enhanced usual care: 2 free, individual consultations with a nutritionist over first 6 months. Medical monitoring throughout study period.

B

EXPERIMENTAL
Behavioral: Family-based treatment

Interventions

Family-based treatmentBEHAVIORAL

20 weekly group contacts with individual coaching over first 6 months, brief monthly contacts over next 6 months, no contacts over last 6 months. Medical monitoring throughout study period.

B

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Be \>150% of ideal body weight for height and age based on norms of the World Health Organization.
  • Have at least one parent or guardian who will participate in the treatment program with child.

You may not qualify if:

  • Mental retardation, pervasive developmental disorder or psychosis, psychiatric symptomatology sufficiently severe to require immediate treatment.
  • Genetic obesity syndrome as determined by the study physician.
  • Currently receiving obesity treatment and/or participating in a weight management program.
  • Inability to engage in moderate exercise defined as 30 minutes of vigorous activity on most days of the week.
  • Acute or severe medical conditions that require aggressive weight management intervention (e.g., diabetes pseudotumor cerebri, or hypoventilation).
  • Regular use of a medication that affects body weight such as oral steroids or antipsychotic medications.
  • Taking stimulant or antidepressant medication for a period \< four months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behavior

Study Officials

  • Marsha D. Marcus, Ph.D.

    Western Psychiatric Insitute & Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

July 1, 2001

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

February 18, 2008

Record last verified: 2008-02