Body Weight ChangesREWARD TeensNCT01857791
Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program
A study testing multidisciplinary, behavior modification in people with Body Weight Changes, run by University of Vermont at 1 site in United States.
Trial summary
Childhood obesity has more than tripled in the past 30 years. From 1980 to 2008, the prevalence of obesity among adolescents aged 12 to 18 years, increased from 5.0% to 18.1%.1 Although several pediatric weight management programs are available, access to these programs may not always be possible. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- multidisciplinary, behavior modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2016
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Phone screening
- Approval to participate in a weight management program from the child's pediatrician
- Children between the ages of 12 and 18 years
- Children overweight (>85th-<95th BMI percentile) or obese (>95th BMI percentile)
Who cannot join
- Children with evidence of significant cardiovascular disease or cardiac arrhythmias
- Children with liver disease
- Children on chronic use of medications including diuretics, steroids and adrenergic-stimulating agents
- Children with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions
- Children with evidence of family and/or medical neglect or physical, mental or sexual child abuse
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Vermont
Burlington, Vermont, 05405
Connie Tompkins, PhD, 802-656-3817, Connie.Tompkins@uvm.edu
Connie Tompkins, PhD
About this study
Childhood obesity has more than tripled in the past 30 years. From 1980 to 2008, the prevalence of obesity among adolescents aged 12 to 18 years, increased from 5.0% to 18.1%.1 Although several pediatric weight management programs are available, access to these programs may not always be possible.
The proposed study will be an ongoing research program with approximately 40 children ages 12-18 years enrolled into the study over a year. All study participants will participate in a baseline evaluation which will include body composition measures, aerobic testing, as well as nutrition and physical activity questionnaires. Study participants will be assigned to the clinic-based group. The clinic- based group will participate in a 12-week multi-disciplinary weight management program. All study participants will then participate in a 12-week follow-up evaluation similar to the baseline visit. New participants will be enrolled every 12 weeks. Every 12 weeks, active participants (those that have completed a minimum of 12 weeks) will have the option to continue in the program or, discontinue their active participation in the program and enroll into the maintenance phase which will consist of measures only every 12 weeks.
The objective of the proposed study includes examining the efficacy of the clinic-based, multi-disciplinary, pediatric weight management program.
- Conditions
- Body Weight Changes
- Being tested
- multidisciplinary, behavior modification
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary, behavior modificationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| multidisciplinary, behavior modification | Experimental | Not described Receives: Behavioral: multidisciplinary, behavior modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Body weight will be measured at baseline and at 12-weeks. Mean percentage weight change will be assessed following the 12-week intervention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Connie Tompkins, PhD, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857791
- Sponsor's protocol ID
- M11-083
- Acronym
- REWARD Teens
- Status last verified
- Sep 2015
- First submitted
- 15 May 2013
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program
- ClinicalTrials.gov ID
- NCT01857791
- Acronym / sponsor ID
- REWARD Teens / M11-083
- Conditions
- Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (estimated)
- First posted
- 20 May 2013 (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.
Childhood obesity has more than tripled in the past 30 years. From 1980 to 2008, the prevalence of obesity among adolescents aged 12 to 18 years, increased from 5.0% to 18.1%.1 Although several pediatric weight management programs are available, access to these programs may not always be possible.
The proposed study will be an ongoing research program with approximately 40 children ages 12-18 years enrolled into the study over a year. All study participants will participate in a baseline evaluation which will include body composition measures, aerobic testing, as well as nutrition and physical activity questionnaires. Study participants will be assigned to the clinic-based group. The clinic- based group will participate in a 12-week multi-disciplinary weight management program. All study participants will then participate in a 12-week follow-up evaluation similar to the baseline visit. New participants will be enrolled every 12 weeks. Every 12 weeks, active participants (those that have completed a minimum of 12 weeks) will have the option to continue in the program or, discontinue their active participation in the program and enroll into the maintenance phase which will consist of measures only every 12 weeks.
The objective of the proposed study includes examining the efficacy of the clinic-based, multi-disciplinary, pediatric weight management program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multidisciplinary, behavior modification | Experimental | Behavioral: multidisciplinary, behavior modification |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Phone screening
- Approval to participate in a weight management program from the child's pediatrician
- Children between the ages of 12 and 18 years
- Children overweight (>85th-<95th BMI percentile) or obese (>95th BMI percentile)
Key exclusion criteria (5 listed)
- Children with evidence of significant cardiovascular disease or cardiac arrhythmias
- Children with liver disease
- Children on chronic use of medications including diuretics, steroids and adrenergic-stimulating agents
- Children with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions
- Children with evidence of family and/or medical neglect or physical, mental or sexual child abuse
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 |
|---|---|---|
| multidisciplinary, behavior modification | Behavioural | multidisciplinary, behavior modification |
Primary outcome
weight loss
Time frame: 12 weeks
Body weight will be measured at baseline and at 12-weeks. Mean percentage weight change will be assessed following the 12-week intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary, behavior modification in people with Body Weight Changes, run by University of Vermont 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Sep 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Connie Tompkins, PhD (8026563817, Connie.Tompkins@uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 12 weeks). 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 10 Sep 2015.