Clinical trial NCT01043614: Peer Education, Exercising and Eating Right - Obesity Prevention in Freshmen Women
Official title: Project PEER: Peer Education, Exercising and Eating Right
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Obesity Prevention
Freshman women
Freshman 15 weight gain
Self efficacy
Activity and nutrition intervention
Peer education
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Anthropometric measures (eg; weight, hip/ waist dimensions)
timeFrame: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
Secondary outcomes:
measure: Self-efficacy measures for physical activity, nutrition
timeFrame: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: Uiversity of Illinois at Urbana- Champaign
name: Ellen M Evans, PhD
role: PRINCIPAL_INVESTIGATOR
References: