- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01043614
Peer Education, Exercising and Eating Right - Obesity Prevention in Freshmen Women (ProjectPEER)
Project PEER: Peer Education, Exercising and Eating Right
Project PEER utilizes a randomized controlled study design to investigate the combined effects of an exercise and nutrition intervention that is based on self-efficacy principles and delivered primarily by peer educators to reduce the risk for obesity in female college freshman over one academic year (N = 300). The control group will receive minimal interaction from the research team, paralleling the typical freshman experience on the UIUC campus. Recruitment will take place in two waves (consecutive fall terms with n = 150).
During the final year (Fall 2010) of the project, a General Education course will be offered that targets weight management. Importantly, the discussion groups for this course will be taught by peer educators trained using the peer resources further refined during the PEER project. In addition to conventional measures of content knowledge assessed in the college classroom when obtaining class credit, personal physical activity and nutrition behaviors along with behavioral determinants (self-efficacy, self-regulatory skills and outcome expectations) will also be assessed.
Primary Aim 1: To determine the effectiveness of a peer-delivered self efficacy-based behavioral intervention to enhance nutrition and physical activity behaviors and subsequently weight management success in female university freshman over one academic year. We hypothesize that freshmen randomized to the intervention group will be more successful in losing or maintaining weight than the control group through a combination of diet and physical activity strategies.
Primary Aim 2: To examine the role played by social cognitive factors in changing nutrition and physical activity behaviors across one academic year. We hypothesize that self-efficacy will have both a direct influence on behavior and an indirect effect through its influence on self-regulatory skills and outcome expectations.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Illinois
-
Urbana, Illinois, Forente stater, 61801
- University of Illinois at Urbana-Champaign
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Female
- In first year on campus, enrolled full-time, and in residence on the UIUC campus
- Aged 17-19 yrs (minors will be required to obtain parental signature on the IRB form)
- Free from any chronic disease/condition that would alter ability to exercise or preclude diet manipulation such as diabetes, hypertension or pregnancy.
- Free from an eating disorder as assessed using the Eating Disorder Inventory
- Free from any medications that would alter adiposity or psychological outcomes
- Sedentary or participation in non-professional recreational activity
- Non-smoking
- Body mass index (BMI) between the 50th and 95th BMI-for-age percentile
Exclusion Criteria:
- Male
- Status other than freshman or enrolled for entire year
- Not living on campus
- Smoking
- Pregnant
- Competitive athlete
- Chronic condition that would alter ability to exercise or preclude diet manipulation such as diabetes, hypertension
- Eating disorder as assessed using the Eating Disorder Inventory
- Taking medications that would alter adiposity or psychological outcomes
- Participation in competitive athletics
- BMI outside parameters
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Peer group education
Small groups of female college freshmen facilitated by peer educators
|
An exercise and nutrition intervention that is based on self-efficacy principles and delivered primarily by peer educators to reduce the risk for obesity in female college freshman over one academic year
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Anthropometric measures (eg; weight, hip/ waist dimensions)
Tidsramme: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Self-efficacy measures for physical activity, nutrition
Tidsramme: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Ellen M Evans, PhD, Uiversity of Illinois at Urbana- Champaign
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2007-04574
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