Cardiovascular DiseasesNCT00024830
Peer-Based Skills Training to Enhance Teen Weight Loss
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To evaluate the efficacy of peer-based skills training to enhance weight control and improve psychosocial functioning in overweight adolescents. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1999to Aug 2002
- Phase
- Observational
- 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
No eligibility criteria
About this study
To evaluate the efficacy of peer-based skills training to enhance weight control and improve psychosocial functioning in overweight adolescents.
Read the detailed description
BACKGROUND:
The prevalence of obesity in children, adolescents, and adults has increased significantly over the last two decades. Adolescents who are obese are at great risk for remaining obese into adulthood. Given the difficulty of treating adult obesity, intervening with adolescents before they reach adulthood is critical. Decreasing obesity during adolescence provides an opportunity to prevent the continuance of pediatric onset obesity into adulthood. There are well-established weight control interventions for children between 8 and 12 years of age. However, treatment findings with overweight adolescents are not as robust and are difficult to replicate. One potential limitation of existing weight control interventions for adolescents is the minimal attention given to the peer group as an active component of treatment.
The study was in response to an initiative issued by the National Institute of Diabetes and Digestive and Kidney Diseases and entitled "Innovative Approaches to the Prevention of Obesity". The resulting grant was later reassigned to the National Heart, Lung, and Blood Institute.
DESIGN NARRATIVE:
A total of 119 adolescents between the ages of 13 and 16 years and between 20 and 80% overweight were randomized to one of three treatment conditions: (1) cognitive-behavioral treatment (CBT); (2) cognitive-behavioral treatment with the addition of peer-based skills training (CBT + PBST); or 3) standard care (SC). The cognitive-behavioral intervention consisted of 16 weekly sessions followed by four monthly maintenance sessions. Adolescents randomized to CBT + PBST received the cognitive-behavioral treatment as well as an intensive 32 session peer-based intervention. The peer-based intervention combined problem-solving therapy with principles from Outward Bound to address self-reliance, social competence and physical self-worth. One way analyses of variance was conducted at the end of treatment and at 6-months after the end of treatment to compare the three groups on initial reduction in percent overweight and maintenance of decreases in percent overweight at follow-up. Analysis of variance was also used to compare the three groups on measures of social functioning, self-esteem, physical activity level, and physical self-worth.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2001 (estimated)
- Study startSep 1999
- Study completionAug 2002
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 Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)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
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Elissa Jelalian, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024830
- Sponsor's protocol ID
- 987
- Other IDs
- R01HL065132
- Status last verified
- Oct 2005
- First submitted
- 28 Sep 2001
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Jelalian E, Mehlenbeck R, Lloyd-Richardson EE, Birmaher V, Wing RR. 'Adventure therapy' combined with cognitive-behavioral treatment for overweight adolescents. Int J Obes (Lond). 2006 Jan;30(1):31-9. doi: 10.1038/sj.ijo.0803069.
PubMed 16158087Rancourt 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 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Based Skills Training to Enhance Teen Weight Loss
- ClinicalTrials.gov ID
- NCT00024830
- Acronym / sponsor ID
- 987
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1999
- Study completion
- Aug 2002 (actual)
- First posted
- 28 Sep 2001 (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 evaluate the efficacy of peer-based skills training to enhance weight control and improve psychosocial functioning in overweight adolescents.
Detailed description
BACKGROUND:
The prevalence of obesity in children, adolescents, and adults has increased significantly over the last two decades. Adolescents who are obese are at great risk for remaining obese into adulthood. Given the difficulty of treating adult obesity, intervening with adolescents before they reach adulthood is critical. Decreasing obesity during adolescence provides an opportunity to prevent the continuance of pediatric onset obesity into adulthood. There are well-established weight control interventions for children between 8 and 12 years of age. However, treatment findings with overweight adolescents are not as robust and are difficult to replicate. One potential limitation of existing weight control interventions for adolescents is the minimal attention given to the peer group as an active component of treatment.
The study was in response to an initiative issued by the National Institute of Diabetes and Digestive and Kidney Diseases and entitled "Innovative Approaches to the Prevention of Obesity". The resulting grant was later reassigned to the National Heart, Lung, and Blood Institute.
DESIGN NARRATIVE:
A total of 119 adolescents between the ages of 13 and 16 years and between 20 and 80% overweight were randomized to one of three treatment conditions: (1) cognitive-behavioral treatment (CBT); (2) cognitive-behavioral treatment with the addition of peer-based skills training (CBT + PBST); or 3) standard care (SC). The cognitive-behavioral intervention consisted of 16 weekly sessions followed by four monthly maintenance sessions. Adolescents randomized to CBT + PBST received the cognitive-behavioral treatment as well as an intensive 32 session peer-based intervention. The peer-based intervention combined problem-solving therapy with principles from Outward Bound to address self-reliance, social competence and physical self-worth. One way analyses of variance was conducted at the end of treatment and at 6-months after the end of treatment to compare the three groups on initial reduction in percent overweight and maintenance of decreases in percent overweight at follow-up. Analysis of variance was also used to compare the three groups on measures of social functioning, self-esteem, physical activity level, and physical self-worth.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 Mar 2016.
- Background: PubMed 16158087Jelalian E, Mehlenbeck R, Lloyd-Richardson EE, Birmaher V, Wing RR. 'Adventure therapy' combined with cognitive-behavioral treatment for overweight adolescents. Int J Obes (Lond). 2006 Jan;30(1):31-9. doi: 10.1038/sj.ijo.0803069.
- 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 Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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
The Miriam Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Mar 2016. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00024830, 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 16 Mar 2016.