Cost-effectiveness of Family Based Pediatric Obesity Treatment - Full Text View

Sponsor:	State University of New York at Buffalo
Collaborator:	Healthnow
Information provided by:	State University of New York at Buffalo
ClinicalTrials.gov Identifier:	NCT00717132

Purpose

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.

Condition	Intervention
Body Mass Index Quality of Life	Behavioral: Behavior Modification

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Cost-effectiveness of Family Based Pediatric Obesity Treatment

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:

Standardized BMI [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

quality adjusted life years [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2007
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Individual weight control behavioral treatment; parent and child are treated separately	Behavioral: Behavior Modification Individual child and parent behavioral treatment
Active Comparator: 2 Traditional family-based weight control behavioral treatment; parent and child are treated together as a family	Behavioral: Behavior Modification Family-based behavioral treatment

Detailed Description:

Research has shown that family-based treatment programs produce significant short and long-term decreases in weight relative to height. Reductions in relative weight are observed for both parents and their children, with a significant relationship between parent and child relative weight changes.

Usual care for families with obesity is for the parent and child to be treated separately by their individual physicians, often with different types of treatment plans. This may be less efficacious for the parent and child than a family-based intervention in which the parent and child are treated together. The separate treatments may also be more expensive than concurrent treatment following the same treatment plan.

There are many reasons to hypothesize that a family-based treatment will be more efficacious and more cost effective than other formats for treating families with multiple generations of obesity. If family members are treated together, they have the same treatment goals. They can learn to support each other, model positive behaviors, work together to change behaviors and modify the shared family environment. The simultaneous treatment of parents and children in a group format, which is how family-based treatments are administered, reduces the time therapists provide treatment in comparison to the usual format in which each parent and child would be seen individually.

An important challenge for obesity treatment is to develop efficacious and cost-effective interventions to treat pediatric obesity. The goal of this study is to evaluate the efficacy and cost effectiveness over 12 month follow-up for 50 families with overweight parents and children randomized to family-based behavioral treatment in comparison to the treatment of the parents and children separately, by different therapists, which represent usual care for families with obese parents and children.

Eligibility

Ages Eligible for Study:	8 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Overweight child and parent in each family

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717132

Locations

United States, New York
SUNY @ Buffalo
Buffalo, New York, United States, 14214

Sponsors and Collaborators

State University of New York at Buffalo

Healthnow

Investigators

Principal Investigator:

Leonard H Epstein, PhD

SUNY @ Buffalo

More Information

No publications provided

Responsible Party:	Leonard H. Epstein, Ph.D, SUNY @ Buffalo
ClinicalTrials.gov Identifier:	NCT00717132 History of Changes
Other Study ID Numbers:	Cost-effectiveness, #RF A-45270
Study First Received:	July 10, 2008
Last Updated:	September 23, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:

Body mass index
cost effectiveness
obesity
family based behavioral treatment

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012