Choosing Healthy Options in College Environments and Settings (CHOICES)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leslie Lytle, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01134783
First received: May 28, 2010
Last updated: December 12, 2012
Last verified: December 2012

May 28, 2010
December 12, 2012
March 2011
April 2014   (final data collection date for primary outcome measure)
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.
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 interim, post treatment and at follow-up as compared to students randomized to the control condition.
Complete list of historical versions of study NCT01134783 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Choosing Healthy Options in College Environments and Settings
Evaluating Innovative Weight Reduction Strategies for College Students

Examine the effectiveness of a weight gain prevention intervention to positively affect body mass index in 2-year college students

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 29.9 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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
  • Behavioral: Web-Only Curriculum
    15 week web-only course teaching college students healthy eating, exercise, sleep and stress management strategies
  • 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.
  • Behavioral: Web-Enhanced
    This intervention arm will be a combination of the web-only version and the personal, face-to-face version
  • 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
    Intervention: Behavioral: Web-Only Curriculum
  • 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.
    Intervention: Behavioral: Face-to-Face, In-Person Class
  • Experimental: Web-Enhanced
    This intervention arm is a combination of the web-only curriculum arm and the face-to-face, in-person class arm.
    Intervention: Behavioral: Web-Enhanced
  • No Intervention: Control Group
    control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
441
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01134783
0908S71521, 1U01HL096767
Yes
Leslie Lytle, University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Melissa N. Laska, PhD, RD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP