Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Choosing Healthy Options in College Environments and Settings (CHOICES)

10. mai 2016 oppdatert av: 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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

441

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 35 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Ingen inngripen: Control Group
Control group (serving as a comparison group)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Body Mass Index (BMI)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of Overweight/Obese
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2011

Primær fullføring (Faktiske)

1. mai 2014

Studiet fullført (Faktiske)

1. mai 2014

Datoer for studieregistrering

Først innsendt

28. mai 2010

Først innsendt som oppfylte QC-kriteriene

28. mai 2010

Først lagt ut (Anslag)

2. juni 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. juni 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. mai 2016

Sist bekreftet

1. mai 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 0908S71521
  • 1U01HL096767 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere