Clinical trial NCT01134783: Choosing Healthy Options in College Environments and Settings
Official title: Evaluating Innovative Weight Reduction Strategies for College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-06-02
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline to 24 Months
Secondary outcomes:
measure: Prevalence of Overweight/Obese
timeFrame: Baseline to 24 Months
measure: Change in BMI From Baseline to 4 Months
timeFrame: Baseline to 4 Months
measure: Change in Weight From Baseline to 4 Months
timeFrame: Baseline to 4 Months
measure: Change in BMI From Baseline to 12 Months
timeFrame: Baseline to 12 Months
measure: Change in Weight From Baseline to 12 Months
timeFrame: Baseline to 12 Months
Other outcomes:
Locations:
city: Coon Rapids
country: United States
facility: Anoka Ramsey Community College
state: Minnesota
city: Inver Grove Heights
country: United States
facility: Inver Hills Community College
state: Minnesota
city: St. Paul
country: United States
facility: Saint Paul College
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Melissa N. Laska, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.