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Choosing Healthy Options in College Environments and Settings (CHOICES)

10 maggio 2016 aggiornato da: University of Minnesota

Evaluating Innovative Weight Reduction Strategies for College Students

Examine the effectiveness of a weight gain prevention intervention to positively affect body mass index in 2-year college students

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

The goal of this research is to develop and test innovative strategies to help prevent unhealthy weight gain in college students attending 2-year community or technical colleges. The intervention we propose for Phase 2, and will refine through our formative experiences in Phase 1, will be based on social ecological and social networks models with students randomized to conditions. Students (n=440) with BMIs between 20.0 and 34.9 will be recruited to participate in an intervention trial that lasts 24 months. After the initial screening and consent procedures, students will complete baseline measures that include: assessment of body composition; blood pressure and a blood draw; a behavioral and psychosocial survey; medical and weight history and two 24-hour online dietary recalls. After the completion of baseline assessments, students will be randomized into treatment or control conditions. Students randomized into the intervention condition will participate in a 1-credit course offered through their 2-year college that focuses on eating, activity, sleep and stress management as ways to help maintain or achieve a healthy weight; three course sections will be offered to accommodate students' scheduling needs and learning preferences. A web-based social network and support component will be introduced as part of this course and will continue as the intervention channel for 20 months following the 1-credit course. This supported intervention phase will use a study-designed website to reinforce, inform and encourage exchange and support between all intervention participants. Students will be asked to track their weight and weight-control behaviors on the website and intervention staff will interact with participants electronically or through phone calls offering encouragement and helping with problem solving. Control students will receive their health assessments and usual care including existing public health information on maintaining a healthy weight and information regarding health services offered on their school's campus. The effectiveness and sustainability of the intervention approaches will be evaluated.

The primary aim is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect BMI in 2-year college students. Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment, as compared to students randomized to the control condition.

The secondary aims of this study are to: 1) Examine the effectiveness of a weight gain prevention intervention to positively affect weight in 2-year college students' and 2) compare the effects of the intervention and control groups with regard to change in BMI and weight from baseline to four months and from baseline to 12 months.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

441

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Minnesota
      • Coon Rapids, Minnesota, Stati Uniti, 55433
        • Anoka Ramsey Community College
      • Inver Grove Heights, Minnesota, Stati Uniti, 55076
        • Inver Hills Community College
      • St. Paul, Minnesota, Stati Uniti, 55102
        • Saint Paul College

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 35 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Age 18-35 years
  • Intending to be available for a 24 month intervention

Exclusion Criteria:

  • Unable to provide informed consent
  • BMI < 18.5 kg/m2, >/=35 kg/m2
  • Household member on study staff
  • Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); current or planned enrollment in another diet/physical activity/weight loss intervention study
  • Regular use of systemic steroids, prescription weight loss drugs, and/or diabetes medications (oral or injected). "Regular use" is defined as "taking this medication most days of the week for the previous month"
  • Current treatment for an eating disorder
  • Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months
  • Current treatment for malignancy (other than non-melanoma skin cancer)
  • Investigator discretion
  • Currently pregnant or gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, actively planning pregnancy within the next 24 months.
  • Systolic BP at screening >/= 160 mmHg or diastolic BP >/= 100 mmHg. If BP exceeds this level, participants can return for re-screening after being evaluated and treated for hypertension.
  • Weight loss of more than 15 lbs over the past three months
  • Trying to gain weight.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention Group
The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website
Academic course on healthy weight behaviors followed by participation in a social networking and social support website.
Nessun intervento: Control Group
Control group (serving as a comparison group)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Mass Index (BMI)
Lasso di tempo: Baseline to 24 Months
The primary aim of this study is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect body mass index (BMI) in 2-year college students. Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment as compared to students randomized to the control condition.
Baseline to 24 Months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of Overweight/Obese
Lasso di tempo: Baseline to 24 Months
The prevalence of overweight/obese between intervention and control students
Baseline to 24 Months
Change in BMI From Baseline to 4 Months
Lasso di tempo: Baseline to 4 Months
Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 4 months
Baseline to 4 Months
Change in Weight From Baseline to 4 Months
Lasso di tempo: Baseline to 4 Months
Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 4 months
Baseline to 4 Months
Change in BMI From Baseline to 12 Months
Lasso di tempo: Baseline to 12 Months
Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 12 months
Baseline to 12 Months
Change in Weight From Baseline to 12 Months
Lasso di tempo: Baseline to 12 Months
Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 12 months
Baseline to 12 Months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Melissa N. Laska, PhD, RD, University of Minnesota

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2011

Completamento primario (Effettivo)

1 maggio 2014

Completamento dello studio (Effettivo)

1 maggio 2014

Date di iscrizione allo studio

Primo inviato

28 maggio 2010

Primo inviato che soddisfa i criteri di controllo qualità

28 maggio 2010

Primo Inserito (Stima)

2 giugno 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

17 giugno 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 maggio 2016

Ultimo verificato

1 maggio 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 0908S71521
  • 1U01HL096767 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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 .

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