Choosing Healthy Options in College Environments and Settings

NCT01134783 | Completed Results DMC

• 2 other identifiers: 0908S715211U01HL096767
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index (BMI)

  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.

  Baseline to 24 Months

Secondary Outcomes (5)

• Prevalence of Overweight/Obese

  Baseline to 24 Months

• Change in BMI From Baseline to 4 Months

  Baseline to 4 Months

• Change in Weight From Baseline to 4 Months

  Baseline to 4 Months

• Change in BMI From Baseline to 12 Months

  Baseline to 12 Months

• Change in Weight From Baseline to 12 Months

  Baseline to 12 Months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: CHOICES Intervention

Control Group

NO INTERVENTION

Control group (serving as a comparison group)

Interventions

CHOICES Intervention BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-35 years
• Intending to be available for a 24 month intervention

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Anoka Ramsey Community College

Coon Rapids, Minnesota, 55433, United States

Location

Inver Hills Community College

Inver Grove Heights, Minnesota, 55076, United States

Location

Saint Paul College

Saint Paul, Minnesota, 55102, United States

Location

Related Publications (2)

• 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.

  PMID: 27939237 DERIVED

• 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.

  PMID: 27283096 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Because of sample size constraints we combined overweight and obese participants into one category. Additional insights might be gleaned from examining intervention impact and transitions between three categories of weight status.

Results Point of Contact

• Title: Dr. Leslie A. Lytle
• Organization: University of North Carolina, Chapel Hill

llytle@email.unc.edu

919-843-8171

Study Officials

• Melissa N. Laska, PhD, RD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: March 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 17, 2016
• Results First Posted: June 17, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)