Choosing Healthy Options in College Environments and Settings (CHOICES)

• ClinicalTrials.gov Identifier: NCT01134783
• Recruitment Status: Completed
• First Posted: June 2, 2010
• Results First Posted: June 17, 2016
• Last Update Posted: June 17, 2016
• Sponsor: University of Minnesota
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): University of Minnesota

Tracking Information

• First Submitted Date: May 28, 2010
• First Posted Date: June 2, 2010
• Results First Submitted Date: August 24, 2015
• Results First Posted Date: June 17, 2016
• Last Update Posted Date: June 17, 2016
• Study Start Date: March 2011
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 10, 2016)

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.

Original Primary Outcome Measures (submitted: May 28, 2010)

BMI [ Time Frame: 24 months ]

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.

Current Secondary Outcome Measures (submitted: May 10, 2016)

• 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

Original Secondary Outcome Measures (submitted: May 28, 2010)

Environmental behavioral and mental health outcomes between conditions [ Time Frame: 24 months ]

To examine differences across the measurement periods between students randomized to intervention and control conditions on environmental, behavioral and mental health outcomes.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Choosing Healthy Options in College Environments and Settings
• Official Title: Evaluating Innovative Weight Reduction Strategies for College Students
• Brief Summary: Examine the effectiveness of a weight gain prevention intervention to positively affect body mass index in 2-year college students

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Obesity

Intervention

Behavioral: CHOICES Intervention

Academic course on healthy weight behaviors followed by participation in a social networking and social support website.

Study Arms

• 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
  Intervention: Behavioral: CHOICES Intervention
• No Intervention: Control Group
  Control group (serving as a comparison group)

Publications *

• Lytle LA, Laska MN, Linde JA, Moe SG, Nanney MS, Hannan PJ, Erickson DJ. Weight-Gain Reduction Among 2-Year College Students: The CHOICES RCT. Am J Prev Med. 2017 Feb;52(2):183-191. doi: 10.1016/j.amepre.2016.10.012. Epub 2016 Dec 6.
• Laska MN, Lytle LA, Nanney MS, Moe SG, Linde JA, Hannan PJ. Results of a 2-year randomized, controlled obesity prevention trial: Effects on diet, activity and sleep behaviors in an at-risk young adult population. Prev Med. 2016 Aug;89:230-236. doi: 10.1016/j.ypmed.2016.06.001. Epub 2016 Jun 7.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 12, 2012): 441
• Original Estimated Enrollment (submitted: May 28, 2010): 600
• Actual Study Completion Date: May 2014
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01134783
• Other Study ID Numbers: 0908S71521; 1U01HL096767 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Minnesota
• Original Responsible Party: Dr. Leslie Lytle, University of Minnesota
• Current Study Sponsor: University of Minnesota
• Original Study Sponsor: Same as current
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Melissa N. Laska, PhD, RD; University of Minnesota

• PRS Account: University of Minnesota
• Verification Date: May 2016