Pediatric ObesityNCT00409422
Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
A study testing weight management program in people with Pediatric Obesity and Insulin Resistance, run by Yale University at 1 site in United States.
Trial summary
To compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Pediatric Obesity, Insulin Resistance, Hyperinsulinemia
- What is being tested?
- weight management program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Feb 2007
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 8-16 years old
- BMI >95th percentile for age/gender based on CDC
- Both primary caregiver/parent and child must agree to participate in the nutrition classes
Who cannot join
- endocrinopathies, including hypothyroidism and diabetes
- Psychiatric disorders that will interfere with ability to complete follow-up and adherence to protocol
- Any behavioral or psychosocial issue that will interfere with subject's completion of program, including eating disorder.
- Any use of medication (steroids, for ex.) that contributes to excess adiposity.
- Any use of pharmacological intervention for weight management, including prescription medications, over-the-counter medications, or herbal supplements.
- Any concurrent membership in a weight management program.
- Inability or unwillingness of parent to accompany the child to nutrition classes.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
To compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits.
Read the detailed description
Patients are randomized (2:1) to either the intensive or standard treatment (control). Those who get randomized into the intensive group go to a family-based weight management program, including exercise, nutrition, behavior modification, and parenting classes. The intensive group is further randomized into a diet or non-dieting class to compare the outcomes of two different nutrition intervention methods. These classes meet twice per week (exercise twice per week and nutrition/behavior modification once per week)for first six months and then only twice per month during last six months. An exercise physiologist supervises the exercise component, which involves 45 minutes of aerobic activity (targeted at 65 to 80 percent of the subject's estimated maximum heart rate. A registered dietitian facilitates the nutrition and behavior component. A social worker facilitates parent classes when the children have a behavior modification topic in their class (parents only attend nutrition sessions). Those who get randomized into the control group go to clinic visits every 6 months. Intervention subjects go to clinic, as well, every 6 months to obtain the same measurements as the controls (weight, BMI, % fat, fasting insulin, fasting glucose, lipids, blood pressure).
- Conditions
- Pediatric Obesity, Insulin Resistance, Hyperinsulinemia
- Being tested
- weight management program
- Keywords
- pediatric obesity, overweight, insulin resistance, hyperinsulinemia, weight management program, family-based
- Medical subject headings
- Pediatric Obesity, Insulin Resistance, Hyperinsulinism, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight management programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Measured: 6 months and 1 year
body mass index
Measured: 6 months and 1 year
% body fat
Measured: 6 months and 1 year
lipids
Measured: 6 months and 1 year
blood pressure
Measured: 6 months and 1 year
glucose
Measured: 6 months and 1 year
insulin
Measured: 6 months and 1 year
HOMA index
Measured: 6 months and 1 year
Secondary outcomes (1)
planned to compare dieting with non-dieting approach in weight management group
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startMay 2002
- Primary completionOct 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 200 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Sonia Caprio, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409422
- Sponsor's protocol ID
- HIC 15994
- Status last verified
- Jun 2008
- First submitted
- 6 Dec 2006
- Last updated
- 24 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Savoye M, Shaw M, Dziura J, Tamborlane WV, Rose P, Guandalini C, Goldberg-Gell R, Burgert TS, Cali AM, Weiss R, Caprio S. Effects of a weight management program on body composition and metabolic parameters in overweight children: a randomized controlled trial. JAMA. 2007 Jun 27;297(24):2697-704. doi: 10.1001/jama.297.24.2697.
PubMed 17595270
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
- ClinicalTrials.gov ID
- NCT00409422
- Acronym / sponsor ID
- HIC 15994
- Conditions
- Pediatric Obesity, Insulin Resistance, Hyperinsulinemia
- Keywords
- pediatric obesity, overweight, insulin resistance, hyperinsulinemia, weight management program, family-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2002
- Primary completion
- Oct 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 8 Dec 2006 (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 compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits.
Detailed description
Patients are randomized (2:1) to either the intensive or standard treatment (control). Those who get randomized into the intensive group go to a family-based weight management program, including exercise, nutrition, behavior modification, and parenting classes. The intensive group is further randomized into a diet or non-dieting class to compare the outcomes of two different nutrition intervention methods. These classes meet twice per week (exercise twice per week and nutrition/behavior modification once per week)for first six months and then only twice per month during last six months. An exercise physiologist supervises the exercise component, which involves 45 minutes of aerobic activity (targeted at 65 to 80 percent of the subject's estimated maximum heart rate. A registered dietitian facilitates the nutrition and behavior component. A social worker facilitates parent classes when the children have a behavior modification topic in their class (parents only attend nutrition sessions). Those who get randomized into the control group go to clinic visits every 6 months. Intervention subjects go to clinic, as well, every 6 months to obtain the same measurements as the controls (weight, BMI, % fat, fasting insulin, fasting glucose, lipids, blood pressure).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 8-16 years old
- BMI >95th percentile for age/gender based on CDC
- Both primary caregiver/parent and child must agree to participate in the nutrition classes
Key exclusion criteria (8 listed)
- endocrinopathies, including hypothyroidism and diabetes
- Psychiatric disorders that will interfere with ability to complete follow-up and adherence to protocol
- Any behavioral or psychosocial issue that will interfere with subject's completion of program, including eating disorder.
- Any use of medication (steroids, for ex.) that contributes to excess adiposity.
- Any use of pharmacological intervention for weight management, including prescription medications, over-the-counter medications, or herbal supplements.
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 |
|---|---|---|
| weight management program | Behavioural | – |
Primary outcome
weight
Time frame: 6 months and 1 year
body mass index
Time frame: 6 months and 1 year
% body fat
Time frame: 6 months and 1 year
lipids
Time frame: 6 months and 1 year
blood pressure
Time frame: 6 months and 1 year
glucose
Time frame: 6 months and 1 year
insulin
Time frame: 6 months and 1 year
HOMA index
Time frame: 6 months and 1 year
1 secondary outcome
planned to compare dieting with non-dieting approach in weight management group
Time frame: 6 months and 1 year
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 24 Jun 2008.
- Derived from this study: PubMed 17595270Savoye M, Shaw M, Dziura J, Tamborlane WV, Rose P, Guandalini C, Goldberg-Gell R, Burgert TS, Cali AM, Weiss R, Caprio S. Effects of a weight management program on body composition and metabolic parameters in overweight children: a randomized controlled trial. JAMA. 2007 Jun 27;297(24):2697-704. doi: 10.1001/jama.297.24.2697.
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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.
Sonia Caprio, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight management program in people with Pediatric Obesity and Insulin Resistance, run by Yale University 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 3 inclusion and 8 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 24 Jun 2008. 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?
weight (time frame: 6 months and 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00409422, which also lists 1 linked publication.
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 24 Jun 2008.