Choosing Healthy Options in College Environments and Settings (CHOICES)
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|ClinicalTrials.gov Identifier: NCT01134783|
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : June 17, 2016
Last Update Posted : June 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: CHOICES Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||441 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating Innovative Weight Reduction Strategies for College Students|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: Intervention Group
The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website
Behavioral: CHOICES Intervention
Academic course on healthy weight behaviors followed by participation in a social networking and social support website.
No Intervention: Control Group
Control group (serving as a comparison group)
- Change in Body Mass Index (BMI) [ Time Frame: Baseline to 24 Months ]The primary aim of this study is to examine the effectiveness of a 24-month 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 post treatment as compared to students randomized to the control condition.
- Prevalence of Overweight/Obese [ Time Frame: Baseline to 24 Months ]The prevalence of overweight/obese between intervention and control students
- Change in BMI From Baseline to 4 Months [ Time Frame: Baseline to 4 Months ]Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 4 months
- Change in Weight From Baseline to 4 Months [ Time Frame: Baseline to 4 Months ]Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 4 months
- Change in BMI From Baseline to 12 Months [ Time Frame: Baseline to 12 Months ]Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 12 months
- Change in Weight From Baseline to 12 Months [ Time Frame: Baseline to 12 Months ]Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134783
|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|