Weight ChangeNCT00717132
Cost-effectiveness of Family Based Pediatric Obesity Treatment
A study testing Individual Behavior Modification and Family-based behavior modification in people with Weight Change and Quality of Life, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Change, Quality of Life
- What is being tested?
- Individual Behavior Modification and Family-based behavior modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Overweight child and parent in each family
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Weight Change, Quality of Life
- Being tested
- Individual Behavior Modification, Family-based behavior modification
- Keywords
- weight, cost effectiveness, obesity, family based behavioral treatment
- Medical subject headings
- Body Weight Changes, Body Weight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Behavior ModificationBehavioural
Individual behavioral treatment for obesity. Children and parents meeting individually for 15 total behavioral modification intervention sessions.
Family-based behavior modificationBehavioural
Family-base behavior treatment for obesity. Children and parents meeting together for 15 total behavioral modification intervention sessions.
| Study group | Role | What they receive |
|---|---|---|
| Individual Behavioral Modification | Experimental | Individual behavioral weight control treatment; parent and child are treated separately for 15 total sessions. Receives: 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. Receives: Behavioral: Family-based behavior modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 months, 12 months
Secondary outcomes (1)
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.
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ChangeStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Healthnow
- Responsible party
- Principal investigator, Leonard Epstein, State University of New York at Buffalo
- Investigators
- Leonard H Epstein, PhD, Principal investigator, SUNY @ Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717132
- Sponsor's protocol ID
- Cost-effectiveness
- Other IDs
- A-45270
- Status last verified
- Apr 2022
- First submitted
- 10 Jul 2008
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be submitted
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Family Based Pediatric Obesity Treatment
- ClinicalTrials.gov ID
- NCT00717132
- Acronym / sponsor ID
- Cost-effectiveness
- Conditions
- Weight Change, Quality of Life
- Keywords
- weight, cost effectiveness, obesity, family based behavioral treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Healthnow
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Behavioral Modification | Experimental | Behavioral: Individual Behavior ModificationIndividual behavioral weight control treatment; parent and child are treated separately for 15 total sessions. |
| Family-based Behavioral Modification | Active comparator | Behavioral: Family-based behavior modificationFamily-based behavioral weight control treatment; parent and child are treated together for 15 total sessions. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Overweight child and parent in each family
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Behavior ModificationIndividual behavioral treatment for obesity. Children and parents meeting individually for 15 total behavioral modification intervention sessions. | Behavioural | Individual Behavioral Modification |
| Family-based behavior modificationFamily-base behavior treatment for obesity. Children and parents meeting together for 15 total behavioral modification intervention sessions. | Behavioural | Family-based Behavioral Modification |
Primary outcome
Change in Standardized BMI
Time frame: baseline, 6 months, 12 months
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.
1 secondary outcome
change in quality adjusted life years (QALY)
Time frame: baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Individual participant dataSharing planned: Yes. Data will be submitted
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard H Epstein, PhD principal investigator
SUNY @ Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Behavior Modification and Family-based behavior modification in people with Weight Change and Quality of Life, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Standardized BMI (time frame: baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.