BehaviorNCT00177229
KidQuest Family-Based Weight Control
A study testing Family-based treatment in people with Behavior, run by University of Pittsburgh.
Trial summary
The purpose of this study is to determine if a family based diet and exercise program is helpful for extremely overweight children aged 8-12, and to compare this approach to standard medical management of severe pediatric obesity. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Behavior
- What is being tested?
- Family-based treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to May 2006
- 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
- No healthy volunteers
- Child
Who may be able to join
- Be >150% of ideal body weight for height and age based on norms of the World Health Organization.
- Have at least one parent or guardian who will participate in the treatment program with child.
Who cannot join
- Mental retardation, pervasive developmental disorder or psychosis, psychiatric symptomatology sufficiently severe to require immediate treatment.
- Genetic obesity syndrome as determined by the study physician.
- Currently receiving obesity treatment and/or participating in a weight management program.
- Inability to engage in moderate exercise defined as 30 minutes of vigorous activity on most days of the week.
- Acute or severe medical conditions that require aggressive weight management intervention (e.g., diabetes pseudotumor cerebri, or hypoventilation).
- Regular use of a medication that affects body weight such as oral steroids or antipsychotic medications.
- Taking stimulant or antidepressant medication for a period < four months.
About this study
Official title: Family-Based Treatment of Severe Pediatric Obesity
The purpose of this study is to determine if a family based diet and exercise program is helpful for extremely overweight children aged 8-12, and to compare this approach to standard medical management of severe pediatric obesity.
Read the detailed description
The prevalence of pediatric obesity has increased significantly, and approximately 11% of American children and adolescents are obese. Of particular concern, the greatest increase in prevalence has occured among the heaviest children. Severe pediatric obesity (defined as > 150% of ideal body weight for height) is associated with higher rates of medical and psychosocial morbidity than milder obesity is. Moreover, severely obese children are likelier than less severely obese children are to become obese adults and suffer the long-term health consequences of obesity. Although the efficacy of family-based behavioral weight control programs in the treatment of moderate pediatric obesity is well established, few studies have focused on the treatment of severe obesity. Thus in this application, we propose a randomized controlled trial to evaluate the efficacy of a family-based behavioral weight control program in the management of severe pediatric obesity.
Two hundred children aged 8-12 will be randomized to a six-month family-based program or usual care, and will complete assessments at pre- and post- treatment and 6-month and 12-month follow-ups. We hypothesized that: 1) Children who participate in the family-based program, when compared to children who receive usual care, will show favorable changes in body mass index, body composition, food intake, activity level, and cardiovascular risk factors. 2) Children who participate in the family-based program, when compared to children who receive usual care, will report higher levels of self-esteem, social competence and health-related quality of life, and report fewer psychiatric symptoms. A secondary aim of the the proposed investigation is to examine the relationships among gender, race, compliance to diet and exercise. level of parent adherence and treatment outcome. The proposed investigation is significant as the first effort to systematically evaluate a treatment program for severely obese children. It will provide data about a serious public health problem and establish a foundation for programmatic research to develop effective treatments for an underserved population.
- Conditions
- Behavior
- Being tested
- Family-based treatment
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based treatmentBehavioural
20 weekly group contacts with individual coaching over first 6 months, brief monthly contacts over next 6 months, no contacts over last 6 months. Medical monitoring throughout study period.
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Enhanced usual care: 2 free, individual consultations with a nutritionist over first 6 months. Medical monitoring throughout study period. |
| B | Experimental | Not described Receives: Behavioral: Family-based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI and cardiovascular risk factors
Measured: 0,6,12,18
Secondary outcomes (1)
Eating, activity, and psychosocial functioning
Measured: 0,6,12,18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2001
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Marsha D. Marcus, Ph.D., Principal investigator, Western Psychiatric Insitute & Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177229
- Sponsor's protocol ID
- 0405048
- Status last verified
- Feb 2008
- First submitted
- 12 Sep 2005
- Last updated
- 18 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Treatment of Severe Pediatric Obesity
- ClinicalTrials.gov ID
- NCT00177229
- Acronym / sponsor ID
- 0405048
- Conditions
- Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2001
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 15 Sep 2005 (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.
The purpose of this study is to determine if a family based diet and exercise program is helpful for extremely overweight children aged 8-12, and to compare this approach to standard medical management of severe pediatric obesity.
Detailed description
The prevalence of pediatric obesity has increased significantly, and approximately 11% of American children and adolescents are obese. Of particular concern, the greatest increase in prevalence has occured among the heaviest children. Severe pediatric obesity (defined as > 150% of ideal body weight for height) is associated with higher rates of medical and psychosocial morbidity than milder obesity is. Moreover, severely obese children are likelier than less severely obese children are to become obese adults and suffer the long-term health consequences of obesity. Although the efficacy of family-based behavioral weight control programs in the treatment of moderate pediatric obesity is well established, few studies have focused on the treatment of severe obesity. Thus in this application, we propose a randomized controlled trial to evaluate the efficacy of a family-based behavioral weight control program in the management of severe pediatric obesity.
Two hundred children aged 8-12 will be randomized to a six-month family-based program or usual care, and will complete assessments at pre- and post- treatment and 6-month and 12-month follow-ups. We hypothesized that: 1) Children who participate in the family-based program, when compared to children who receive usual care, will show favorable changes in body mass index, body composition, food intake, activity level, and cardiovascular risk factors. 2) Children who participate in the family-based program, when compared to children who receive usual care, will report higher levels of self-esteem, social competence and health-related quality of life, and report fewer psychiatric symptoms. A secondary aim of the the proposed investigation is to examine the relationships among gender, race, compliance to diet and exercise. level of parent adherence and treatment outcome. The proposed investigation is significant as the first effort to systematically evaluate a treatment program for severely obese children. It will provide data about a serious public health problem and establish a foundation for programmatic research to develop effective treatments for an underserved population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Enhanced usual care: 2 free, individual consultations with a nutritionist over first 6 months. Medical monitoring throughout study period. |
| B | Experimental | Behavioral: Family-based treatment |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Be >150% of ideal body weight for height and age based on norms of the World Health Organization.
- Have at least one parent or guardian who will participate in the treatment program with child.
Key exclusion criteria (7 listed)
- Mental retardation, pervasive developmental disorder or psychosis, psychiatric symptomatology sufficiently severe to require immediate treatment.
- Genetic obesity syndrome as determined by the study physician.
- Currently receiving obesity treatment and/or participating in a weight management program.
- Inability to engage in moderate exercise defined as 30 minutes of vigorous activity on most days of the week.
- Acute or severe medical conditions that require aggressive weight management intervention (e.g., diabetes pseudotumor cerebri, or hypoventilation).
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 |
|---|---|---|
| Family-based treatment20 weekly group contacts with individual coaching over first 6 months, brief monthly contacts over next 6 months, no contacts over last 6 months. Medical monitoring throughout study period. | Behavioural | B |
Primary outcome
BMI and cardiovascular risk factors
Time frame: 0,6,12,18
1 secondary outcome
Eating, activity, and psychosocial functioning
Time frame: 0,6,12,18
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 18 Feb 2008.
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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.
Marsha D. Marcus, Ph.D. principal investigator
Western Psychiatric Insitute & Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Family-based treatment in people with Behavior, run by University of Pittsburgh.
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 2 inclusion and 7 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 18 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
BMI and cardiovascular risk factors (time frame: 0,6,12,18). 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 18 Feb 2008.