ObesityProjectPEERNCT01043614
Peer Education, Exercising and Eating Right - Obesity Prevention in Freshmen Women
A study testing PEER group intervention in people with Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 17 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- PEER group intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- Sedentary or participation in non-professional recreational activity
- Non-smoking
- Body mass index (BMI) between the 50th and 95th BMI-for-age percentile
Who cannot join
- Male
- Status other than freshman or enrolled for entire year
- Not living on campus
- Smoking
- Pregnant
- Competitive athlete
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: 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.
Read more
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.
- Conditions
- Obesity
- Being tested
- PEER group intervention
- Keywords
- Obesity, Obesity Prevention, Freshman women, Freshman 15 weight gain, Self efficacy, Activity and nutrition intervention, Peer education
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEER group interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Peer group education | Experimental | Small groups of female college freshmen facilitated by peer educators Receives: Behavioral: PEER group intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measures (eg; weight, hip/ waist dimensions)
Measured: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
Secondary outcomes (1)
Self-efficacy measures for physical activity, nutrition
Measured: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startAug 2008
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Investigators
- Ellen M Evans, PhD, Principal investigator, Uiversity of Illinois at Urbana- Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043614
- Sponsor's protocol ID
- 2007-04574
- Acronym
- ProjectPEER
- Status last verified
- Jan 2010
- First submitted
- 10 Dec 2009
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project PEER: Peer Education, Exercising and Eating Right
- ClinicalTrials.gov ID
- NCT01043614
- Acronym / sponsor ID
- ProjectPEER / 2007-04574
- Conditions
- Obesity
- Keywords
- Obesity, Obesity Prevention, Freshman women, Freshman 15 weight gain, Self efficacy, Activity and nutrition intervention, Peer education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer group education | Experimental | Behavioral: PEER group interventionSmall groups of female college freshmen facilitated by peer educators |
Who may qualify
- Ages
- 17 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- Male
- Status other than freshman or enrolled for entire year
- Not living on campus
- Smoking
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEER group interventionAn 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 | Behavioural | Peer group education |
Primary outcome
Anthropometric measures (eg; weight, hip/ waist dimensions)
Time frame: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
1 secondary outcome
Self-efficacy measures for physical activity, nutrition
Time frame: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen M Evans, PhD principal investigator
Uiversity of Illinois at Urbana- Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEER group intervention in people with Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measures (eg; weight, hip/ waist dimensions) (time frame: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2010.