Choosing Healthy Options in College Environments and Settings

Not Applicable

Completed

Conditions: Obesity

Interventions: Behavioral: CHOICES Intervention

Registration Number: NCT01134783

Lead Sponsor: University of Minnesota

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 441

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention Group	CHOICES Intervention	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

Primary Outcome Measures

Name	Time	Method
Change in Body Mass Index (BMI)	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of Overweight/Obese	Baseline to 24 Months	The prevalence of overweight/obese between intervention and control students
Change in BMI From Baseline to 4 Months	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 12 Months	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
Change in Weight From Baseline to 4 Months	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	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

Trial Locations

Locations (3): Saint Paul College
🇺🇸
St. Paul, Minnesota, United States
Inver Hills Community College
🇺🇸
Inver Grove Heights, Minnesota, United States
Anoka Ramsey Community College
🇺🇸
Coon Rapids, Minnesota, United States