Choosing Healthy Options in College Environments and Settings (CHOICES)
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Purpose
Examine the effectiveness of a weight gain prevention intervention to positively affect body mass index in 2-year college students
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Behavioral: Web-Only Curriculum Behavioral: Face-to-Face, In-Person Class Behavioral: Web-Enhanced |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluating Innovative Weight Reduction Strategies for College Students |
- BMI [ Time Frame: 24 months ] [ Designated as safety issue: No ]The primary aim is to examine the effectiveness of a 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 at post treatment as compared to students randomized to the control condition.
- Environmental behavioral and mental health outcomes between conditions [ Time Frame: 24 months ] [ Designated as safety issue: No ]To examine differences across the measurement periods between students randomized to intervention and control conditions on environmental, behavioral and mental health outcomes.
| Enrollment: | 441 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Web-Only Curriculum
We are offering a semester long web based curriculum course to provide students with information on healthy sleeping, eating and activity
|
Behavioral: Web-Only Curriculum
15 week web-only course teaching college students healthy eating, exercise, sleep and stress management strategies
|
|
Experimental: Face-to-Face, In-Person Class
This face-to-face, in-person class includes strategies to assist in healthy eating, life skills training, enlisting positive role models and social support and changing the structure of the home to make healthier food and activity choices the easy choices.
|
Behavioral: Face-to-Face, In-Person Class
Face-to-face group sessions led by study intervention staff to increase healthful behaviors in the categories of diet, physical activity, stress management and sleep.
|
|
Experimental: Web-Enhanced
This intervention arm is a combination of the web-only curriculum arm and the face-to-face, in-person class arm.
|
Behavioral: Web-Enhanced
This intervention arm will be a combination of the web-only version and the personal, face-to-face version
|
|
No Intervention: Control Group
control group
|
Detailed Description:
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.
We will also conduct exploratory analyses examining how diet, activity and screen time differ between control and intervention groups.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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/PA/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.
Contacts and Locations| United States, Minnesota | |
| Anoka Ramsey Community College | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Inver Hills Community College | |
| Inver Grove Heights, Minnesota, United States, 55076 | |
| Saint Paul College | |
| St. Paul, Minnesota, United States, 55102 | |
| Principal Investigator: | Melissa N. Laska, PhD, RD | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | Leslie Lytle, Professor, University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT01134783 History of Changes |
| Other Study ID Numbers: | 0908S71521, 1U01HL096767 |
| Study First Received: | May 28, 2010 |
| Last Updated: | June 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013