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Cost-effectiveness of Family Based Pediatric Obesity Treatment

This study has been completed.
Sponsor:
Collaborator:
Healthnow
Information provided by (Responsible Party):
Leonard Epstein, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00717132
First received: July 10, 2008
Last updated: August 16, 2016
Last verified: August 2016
  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
Weight Change
Quality of Life
Behavioral: Individual Behavior Modification
Behavioral: Family-based 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:


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 ]

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: Individual Behavioral Modification
Individual behavioral weight control treatment; parent and child are treated separately for 15 total sessions.
Behavioral: Individual Behavior Modification
Individual behavioral treatment for obesity. Children and parents meeting individually for 15 total behavioral modification intervention sessions.
Active Comparator: Family-based Behavioral Modification
Family-based behavioral weight control treatment; parent and child are treated together for 15 total sessions.
Behavioral: Family-based behavior modification
Family-base behavior treatment for obesity. Children and parents meeting together for 15 total behavioral modification intervention sessions.

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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Leonard Epstein, Leonard H. Epstein, Ph.D., State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT00717132     History of Changes
Other Study ID Numbers: Cost-effectiveness  A-45270 
Study First Received: July 10, 2008
Last Updated: August 16, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data will be submitted

Keywords provided by State University of New York at Buffalo:
weight
cost effectiveness
obesity
family based behavioral treatment

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Body Weight Changes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on December 02, 2016