Clinical trial NCT00717132: Cost-effectiveness of Family Based Pediatric Obesity Treatment
Official title: Cost-effectiveness of Family Based Pediatric Obesity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Change
Quality of Life
Keywords: weight
cost effectiveness
obesity
family based behavioral treatment
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Healthnow
First posted: 2008-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Change in Standardized BMI
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: change in quality adjusted life years (QALY)
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: SUNY @ Buffalo
state: New York
Study officials:
affiliation: SUNY @ Buffalo
name: Leonard H Epstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: