- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00285558
Peer-enhanced Intervention to Support Teen Weight Loss
Peer-Enhanced Intervention to Support Teen Weight Loss
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Rhode Island
-
Providence, Rhode Island, Stati Uniti, 02903
- Bradley Hasbro Children's Research Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: CBT with peer-enhanced activities
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.
|
|
|
Comparatore attivo: CBT with supervised aerobic exercise
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Change in Adolescent Body Mass Index (BMI)
Lasso di tempo: 12 and 24 months
|
12 and 24 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Self concept
Lasso di tempo: 12 and 24 months
|
Self- Perception Profile for Adolescents and the Physical Self-Worth Scale
|
12 and 24 months
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Elissa Jelalian, PhD, Brown University Medical School; Lifespan Corporation
Pubblicazioni e link utili
Pubblicazioni generali
- Rancourt 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DK62916 (completed)
- R01DK062916 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .