ObesityNCT00285558
Peer-enhanced Intervention to Support Teen Weight Loss
A study testing CBT with peer-enhanced activities and CBT with supervised aerobic exercise in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether adding a peer-based intervention based on an outward bound model is more effective than a standard behavioral weight intervention for helping adolescents lose weight. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Obesity
- What is being tested?
- CBT with peer-enhanced activities and CBT with supervised aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to May 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 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents 13-16 years old
- 20-90% overweight with reference gender and age
- At least 1 parent who can participate
- English speaking
- Agree to study participation and random assignment
- Be available for long-term follow-up
Who cannot join
- Current involvement in another weight loss program
- Unable to adhere to prescribed dietary plan and physical activity due to medical condition
- Unable to understand intervention materials
- In treatment for or diagnosed with psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Bradley Hasbro Children's Research Center
Providence, Rhode Island, 02903
About this study
Official title: Peer-Enhanced Intervention to Support Teen Weight Loss
The purpose of this study is to determine whether adding a peer-based intervention based on an outward bound model is more effective than a standard behavioral weight intervention for helping adolescents lose weight.
Read the detailed description
The prevalence of overweight in children and adolescents has increased significantly during the last two decades. While there are empirically supported weight management interventions for school age children, treatment findings with overweight adolescents are not as consistent. A potential limitation of weight control interventions for adolescents is the minimal attention given to the peer group as an active component of treatment. We have promising findings from a pilot study that involves adding an innovative peer-based intervention (peer-based skills training; PBST) to cognitive- behavioral weight management treatment for adolescents. The purpose of the proposed study is to expand the pilot by: 1) increasing our sample size, 2) assessing weight loss over a longer time period, and 3) evaluating the role of psychosocial variables, as well as physical activity and diet, in mediating treatment outcome. It is hypothesized that overweight adolescents randomized to cognitive-behavioral treatment with peer enhancement will demonstrate greater weight loss at long term follow-up than adolescents randomized to cognitive-behavioral treatment with exercise.
One hundred and fifty adolescents between the ages of 13 and 16 years and 20% and 90% overweight will be randomized to one of two treatment conditions: 1) Cognitive-Behavioral Weight Loss Treatment with Peer-Based Skills Training (CBT+PBST) or 2) Cognitive-Behavioral Weight Loss Treatment with Exercise (CBT+EXER). Measures of height, weight, physical activity, diet, and psychosocial functioning will be obtained at baseline, end of treatment, 12 months, and 24 months after randomization. A between-groups t-test will be conducted to evaluate group differences in change in percent overweight between baseline and 24-month follow-up. Hierarchical linear modeling will be used to assess the pattern of weight loss for the two treatment groups across four time points: baseline, end of treatment, 12 month, and 24 month follow-up. Effects of treatment on psychosocial measures will be analyzed using mixed analysis of variance with treatment condition as the between subjects factor and a within subject factor of time. Finally, a series of regression analyses will be conducted to evaluate the role of psychosocial variables, physical activity, and diet, as mediators of treatment outcome.
- Conditions
- Obesity
- Being tested
- CBT with peer-enhanced activities, CBT with supervised aerobic exercise
- Keywords
- obesity, adolescent, weight loss, body mass index, evaluation studies, peer group, behavior therapy, diet, exercise, self efficacy, parents
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT with peer-enhanced activitiesBehavioural
CBT with supervised aerobic exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CBT with peer-enhanced activities | Experimental | Cognitive behavioral treatment (CBT) with peer-enhanced adventure therapy. The peer intervention, ''adventure therapy,'' is based on the principles of Outward Bound and was expected to affect weight status through a positive effect on self-concept. Receives: Behavioral: CBT with peer-enhanced activities |
| CBT with supervised aerobic exercise | Active comparator | Cognitive behavioral treatment (CBT) with supervised aerobic exercise. Activities for the supervised exercise intervention included use of treadmills, stationary bicycles, and other aerobic activities selected by participants, including dance videos and brisk walking within the clinic setting. Receives: Behavioral: CBT with supervised aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adolescent Body Mass Index (BMI)
Measured: 12 and 24 months
Secondary outcomes (1)
Self concept
Self- Perception Profile for Adolescents and the Physical Self-Worth Scale
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startAug 2003
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- 118 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elissa Jelalian, PhD, Principal investigator, Brown University Medical School; Lifespan Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285558
- Sponsor's protocol ID
- DK62916 (completed)
- Other IDs
- R01DK062916
- Status last verified
- Oct 2017
- First submitted
- 31 Jan 2006
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Jelalian E, Lloyd-Richardson EE, Mehlenbeck RS, Hart CN, Flynn-O'Brien K, Kaplan J, Neill M, Wing RR. Behavioral weight control treatment with supervised exercise or peer-enhanced adventure for overweight adolescents. J Pediatr. 2010 Dec;157(6):923-928.e1. doi: 10.1016/j.jpeds.2010.05.047. Epub 2010 Jul 23.
PubMed 20655544Rancourt D, Barker DH, Jelalian E. Sex as a Moderator of Adolescents' Weight Loss Treatment Outcomes. J Adolesc Health. 2018 May;62(5):591-597. doi: 10.1016/j.jadohealth.2017.12.002. Epub 2018 Mar 7.
PubMed 29525290
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Enhanced Intervention to Support Teen Weight Loss
- ClinicalTrials.gov ID
- NCT00285558
- Acronym / sponsor ID
- DK62916 (completed)
- Conditions
- Obesity
- Keywords
- obesity, adolescent, weight loss, body mass index, evaluation studies, peer group, behavior therapy, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Aug 2003 (actual)
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 2 Feb 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.
The purpose of this study is to determine whether adding a peer-based intervention based on an outward bound model is more effective than a standard behavioral weight intervention for helping adolescents lose weight.
Detailed description
The prevalence of overweight in children and adolescents has increased significantly during the last two decades. While there are empirically supported weight management interventions for school age children, treatment findings with overweight adolescents are not as consistent. A potential limitation of weight control interventions for adolescents is the minimal attention given to the peer group as an active component of treatment. We have promising findings from a pilot study that involves adding an innovative peer-based intervention (peer-based skills training; PBST) to cognitive- behavioral weight management treatment for adolescents. The purpose of the proposed study is to expand the pilot by: 1) increasing our sample size, 2) assessing weight loss over a longer time period, and 3) evaluating the role of psychosocial variables, as well as physical activity and diet, in mediating treatment outcome. It is hypothesized that overweight adolescents randomized to cognitive-behavioral treatment with peer enhancement will demonstrate greater weight loss at long term follow-up than adolescents randomized to cognitive-behavioral treatment with exercise.
One hundred and fifty adolescents between the ages of 13 and 16 years and 20% and 90% overweight will be randomized to one of two treatment conditions: 1) Cognitive-Behavioral Weight Loss Treatment with Peer-Based Skills Training (CBT+PBST) or 2) Cognitive-Behavioral Weight Loss Treatment with Exercise (CBT+EXER). Measures of height, weight, physical activity, diet, and psychosocial functioning will be obtained at baseline, end of treatment, 12 months, and 24 months after randomization. A between-groups t-test will be conducted to evaluate group differences in change in percent overweight between baseline and 24-month follow-up. Hierarchical linear modeling will be used to assess the pattern of weight loss for the two treatment groups across four time points: baseline, end of treatment, 12 month, and 24 month follow-up. Effects of treatment on psychosocial measures will be analyzed using mixed analysis of variance with treatment condition as the between subjects factor and a within subject factor of time. Finally, a series of regression analyses will be conducted to evaluate the role of psychosocial variables, physical activity, and diet, as mediators of treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT with peer-enhanced activities | Experimental | Behavioral: CBT with peer-enhanced activitiesCognitive behavioral treatment (CBT) with peer-enhanced adventure therapy. The peer intervention, ''adventure therapy,'' is based on the principles of Outward Bound and was expected to affect weight status through a positive effect on self-concept. |
| CBT with supervised aerobic exercise | Active comparator | Behavioral: CBT with supervised aerobic exerciseCognitive behavioral treatment (CBT) with supervised aerobic exercise. Activities for the supervised exercise intervention included use of treadmills, stationary bicycles, and other aerobic activities selected by participants, including dance videos and brisk walking within the clinic setting. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Adolescents 13-16 years old
- 20-90% overweight with reference gender and age
- At least 1 parent who can participate
- English speaking
- Agree to study participation and random assignment
Key exclusion criteria (4 listed)
- Current involvement in another weight loss program
- Unable to adhere to prescribed dietary plan and physical activity due to medical condition
- Unable to understand intervention materials
- In treatment for or diagnosed with psychiatric disorder
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 |
|---|---|---|
| CBT with peer-enhanced activities | Behavioural | CBT with peer-enhanced activities |
| CBT with supervised aerobic exercise | Behavioural | CBT with supervised aerobic exercise |
Primary outcome
Change in Adolescent Body Mass Index (BMI)
Time frame: 12 and 24 months
1 secondary outcome
Self concept
Time frame: 12 and 24 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 6 Oct 2017.
- Results publication: PubMed 20655544Jelalian E, Lloyd-Richardson EE, Mehlenbeck RS, Hart CN, Flynn-O'Brien K, Kaplan J, Neill M, Wing RR. Behavioral weight control treatment with supervised exercise or peer-enhanced adventure for overweight adolescents. J Pediatr. 2010 Dec;157(6):923-928.e1. doi: 10.1016/j.jpeds.2010.05.047. Epub 2010 Jul 23.
- Derived from this study: PubMed 29525290Rancourt D, Barker DH, Jelalian E. Sex as a Moderator of Adolescents' Weight Loss Treatment Outcomes. J Adolesc Health. 2018 May;62(5):591-597. doi: 10.1016/j.jadohealth.2017.12.002. Epub 2018 Mar 7.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Elissa Jelalian, PhD principal investigator
Brown University Medical School; Lifespan Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT with peer-enhanced activities and CBT with supervised aerobic exercise in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 6 inclusion and 4 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 6 Oct 2017. 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 Adolescent Body Mass Index (BMI) (time frame: 12 and 24 months). 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 NCT00285558, which also lists 2 linked publications.
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 6 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.