ObesityEarly Phase 1NCT00537160
Diet and Exercise in Overweight Children Postburn
A Early Phase 1 study testing Behavior modification, Nutrition Education, Exercise in people with Obesity and Burns, run by Shriners Hospitals for Children.
Trial summary
Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- What is being tested?
- Behavior modification, Nutrition Education, Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Oct 2012
- Phase
- Early Phase 1
- 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 10 to 18 years
- All sexes
- Child, Adult
Who may be able to join
- 10-18 years old
- BMI > or = 95th percentile
- > 1 year postburn and out of pressure garments
- Live within 100 minle radius of SHC
- Informed consent and HIPPA form signed
- Parent/guardia willing to make time commitment
Who cannot join
- Undergone major surgery in the 4 months prior to start of program or have any major surgery planned in 2 year time frame
- Physical/health condition that precludes regular exercise
- Significant mental health diagnosis
- Advised by MD not to exercise
- Thyroid disease, routine steroid use,pregnancy
- Unable to understand the instructions/content of program
About this study
Official title: The Impact of a Diet and Exercise Program in Overweight Pediatric Patients During Burn Rehabilitation
Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.
- Being tested
- Behavior modification, Nutrition Education, Exercise
- Keywords
- Pediatrics
- Medical subject headings
- Obesity, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior modification, Nutrition Education, ExerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: 12 and 24 months following intervention
Secondary outcomes (1)
fitness level
Measured: 12 and 24 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startApr 2006
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Gottschlich, Shriners Hospitals for Children
- Investigators
- Michele M Gottschlich, PhD, RD, CNSD, Principal investigator, Shriners Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537160
- Sponsor's protocol ID
- 06-04-26-01
- Status last verified
- Oct 2012
- First submitted
- 27 Sep 2007
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Diet and Exercise Program in Overweight Pediatric Patients During Burn Rehabilitation
- ClinicalTrials.gov ID
- NCT00537160
- Acronym / sponsor ID
- 06-04-26-01
- Keywords
- Pediatrics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Sep 2007 (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.
Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 10-18 years old
- BMI > or = 95th percentile
- > 1 year postburn and out of pressure garments
- Live within 100 minle radius of SHC
- Informed consent and HIPPA form signed
Key exclusion criteria (6 listed)
- Undergone major surgery in the 4 months prior to start of program or have any major surgery planned in 2 year time frame
- Physical/health condition that precludes regular exercise
- Significant mental health diagnosis
- Advised by MD not to exercise
- Thyroid disease, routine steroid use,pregnancy
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 |
|---|---|---|
| Behavior modification, Nutrition Education, Exercise | Behavioural | – |
Primary outcome
BMI
Time frame: 12 and 24 months following intervention
1 secondary outcome
fitness level
Time frame: 12 and 24 months following intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
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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.
Michele M Gottschlich, PhD, RD, CNSD principal investigator
Shriners Hospital for Children
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Behavior modification, Nutrition Education, Exercise in people with Obesity and Burns, run by Shriners Hospitals for Children.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 Oct 2012. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 (time frame: 12 and 24 months following intervention). 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 29 Oct 2012.