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Cost-effectiveness of Family Based Pediatric Obesity Treatment

Primary Purpose

Weight Change, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individual Behavior Modification
Family-based behavior modification
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Change focused on measuring weight, cost effectiveness, obesity, family based behavioral treatment

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • SUNY @ Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individual Behavioral Modification

Family-based Behavioral Modification

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

change in quality adjusted life years (QALY)
The quality-adjusted life-year (QALY) is a measure of the value of health outcomes. Health is calculated by length of life and quality of life. QALY takes the value of years living and the quality into a single index number. The QALY calculation is the change in utility value resulting from the treatment multiplied by the duration of the treatment effect to provide the number of QALYs. QALYs can then be incorporated with medical costs to arrive at a final common denominator of cost/QALY.

Full Information

First Posted
July 10, 2008
Last Updated
May 11, 2022
Sponsor
State University of New York at Buffalo
Collaborators
Healthnow
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1. Study Identification

Unique Protocol Identification Number
NCT00717132
Brief Title
Cost-effectiveness of Family Based Pediatric Obesity Treatment
Official Title
Cost-effectiveness of Family Based Pediatric Obesity Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
Healthnow

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Change, Quality of Life
Keywords
weight, cost effectiveness, obesity, family based behavioral treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual Behavioral Modification
Arm Type
Experimental
Arm Description
Individual behavioral weight control treatment; parent and child are treated separately for 15 total sessions.
Arm Title
Family-based Behavioral Modification
Arm Type
Active Comparator
Arm Description
Family-based behavioral weight control treatment; parent and child are treated together for 15 total sessions.
Intervention Type
Behavioral
Intervention Name(s)
Individual Behavior Modification
Intervention Description
Individual behavioral treatment for obesity. Children and parents meeting individually for 15 total behavioral modification intervention sessions.
Intervention Type
Behavioral
Intervention Name(s)
Family-based behavior modification
Intervention Description
Family-base behavior treatment for obesity. Children and parents meeting together for 15 total behavioral modification intervention sessions.
Primary Outcome Measure Information:
Title
Change in Standardized BMI
Description
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.
Time Frame
baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
change in quality adjusted life years (QALY)
Description
The quality-adjusted life-year (QALY) is a measure of the value of health outcomes. Health is calculated by length of life and quality of life. QALY takes the value of years living and the quality into a single index number. The QALY calculation is the change in utility value resulting from the treatment multiplied by the duration of the treatment effect to provide the number of QALYs. QALYs can then be incorporated with medical costs to arrive at a final common denominator of cost/QALY.
Time Frame
baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard H Epstein, PhD
Organizational Affiliation
SUNY @ Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY @ Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be submitted

Learn more about this trial

Cost-effectiveness of Family Based Pediatric Obesity Treatment

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