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Choosing Healthy Options in College Environments and Settings (CHOICES)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01134783
First received: May 28, 2010
Last updated: June 30, 2014
Last verified: June 2014
  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

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Study Completion Date: May 2014
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
Criteria

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/physical activity/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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134783

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
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Melissa N. Laska, PhD, RD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
No publications provided

Responsible Party: 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 30, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014