NCT01043614

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2009

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

January 7, 2010

Status Verified

January 1, 2010

Enrollment Period

1.7 years

First QC Date

December 10, 2009

Last Update Submit

January 6, 2010

Conditions

Keywords

ObesityObesity PreventionFreshman womenFreshman 15 weight gainSelf efficacyActivity and nutrition interventionPeer education

Outcome Measures

Primary Outcomes (1)

  • Anthropometric measures (eg; weight, hip/ waist dimensions)

    Baseline, 3 mo, 8 mo, 1 y and 2 y follow up

Secondary Outcomes (1)

  • Self-efficacy measures for physical activity, nutrition

    Baseline, 3 mo, 8 mo, 1 y and 2 y follow up

Study Arms (1)

Peer group education

EXPERIMENTAL

Small groups of female college freshmen facilitated by peer educators

Behavioral: PEER group intervention

Interventions

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

Peer group education

Eligibility Criteria

Age17 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Ellen M Evans, PhD

    Uiversity of Illinois at Urbana- Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2009

First Posted

January 7, 2010

Study Start

August 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

January 7, 2010

Record last verified: 2010-01

Locations