NCT00717132

Brief Summary

To determine the cost effectiveness of treating the child alone and parent alone to traditional family-based method of obesity treatment. It is hypothesized that a family-based approach will be more cost effective, and will support the savings and effectiveness of treating multiple family members together.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

May 16, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

July 10, 2008

Last Update Submit

May 11, 2022

Conditions

Keywords

weightcost effectivenessobesityfamily based behavioral treatment

Outcome Measures

Primary Outcomes (1)

  • Change in Standardized BMI

    The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. Children's BMI also accounts for age and sex.

    baseline, 6 months, 12 months

Secondary Outcomes (1)

  • change in quality adjusted life years (QALY)

    baseline, 6 months, 12 months

Study Arms (2)

Individual Behavioral Modification

EXPERIMENTAL

Individual behavioral weight control treatment; parent and child are treated separately for 15 total sessions.

Behavioral: Individual Behavior Modification

Family-based Behavioral Modification

ACTIVE COMPARATOR

Family-based behavioral weight control treatment; parent and child are treated together for 15 total sessions.

Behavioral: Family-based behavior modification

Interventions

Individual behavioral treatment for obesity. Children and parents meeting individually for 15 total behavioral modification intervention sessions.

Individual Behavioral Modification

Family-base behavior treatment for obesity. Children and parents meeting together for 15 total behavioral modification intervention sessions.

Family-based Behavioral Modification

Eligibility Criteria

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

You may qualify if:

  • Overweight child and parent in each family

You may not qualify if:

  • The parent and child must have no dietary or activity limitations that would preclude making the requested behavior changes; no current psychiatric problems and no history of eating disorders, including anorexia nervosa, bulimia nervosa or binge eating disorder. Families with a first degree relative with any of the mentioned eating disorders will also be excluded. The participating child must be able to read at a 3rd grade level and demonstrate the ability to maintain diet and activity records in a simulated recording interview. Both parent and child must be able to read the English language well enough to understand the consent and assent forms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY @ Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Body Weight ChangesBody WeightObesity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Leonard H Epstein, PhD

    SUNY @ Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Leonard H. Epstein, Ph.D.

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 16, 2008

Study Start

October 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

May 16, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Data will be submitted

Locations