Lose 2 Win A Novel Method to Motivate Weight Loss Maintenance Among College Students (L2W)

• ClinicalTrials.gov Identifier: NCT02021383
• Recruitment Status: Completed
• First Posted: December 27, 2013
• Last Update Posted: May 13, 2019
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Tracking Information

• First Submitted Date: December 19, 2013
• First Posted Date: December 27, 2013
• Last Update Posted Date: May 13, 2019
• Actual Study Start Date: March 1, 2012
• Actual Primary Completion Date: February 28, 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 19, 2013): Maintenance of the weight lost from Baseline to Week 10 (Phase 1) measured ten months (week 52) after end of treatment (week 10). [ Time Frame: Baseline, Week 10, Week 24, Week 52 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 19, 2013)

• Change in physical activity from baseline on the Physical Activity Questionnaire at week 24 [ Time Frame: Baseline, Week 24 ]
• Change in physical activity from baseline on the Physical Activity Questionnaire at week 52 [ Time Frame: Baseline, Week 52 ]
• Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 24 [ Time Frame: Baseline, Week 24 ]
• Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 52 [ Time Frame: Baseline, Week 52 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lose 2 Win A Novel Method to Motivate Weight Loss Maintenance Among College Students
• Official Title: "Lose 2 Win" Contests: A Novel Method to Motivate Weight Loss Maintenance Among College Students
• Brief Summary: Investigators are conducting a randomized controlled trial with overweight and obese college students on the University of Minnesota campus. The primary outcome will be weight loss measured 12 months after study enrollment (corresponds to 10 months after the end of treatment).

Detailed Description

Approximately 30% of college students are overweight or obese. Intervening on excess weight early may eliminate obesity-related morbidity. Evidence supports use of monetary incentives to encourage weight-loss; questions remain about the efficacy of contingency management on weight loss maintenance.

"Lose 2 Win" contests in which participants who achieve weight-loss goals are eligible for cash prizes, appear well-suited for implementation on campuses. Our objective in this two-phase trial is to evaluate the feasibility, acceptability and efficacy of Lose 2 Win for weight-loss maintenance among college students.

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

Condition

• Overweight
• Obese

Intervention

• Behavioral: Bi-weekly in person meetings with a Registered Dietician

  Participants in the Contest Plus group had the opportunity to receive 5 in person meetings with a Registered Dietician. These meetings took place bi-weekly and gave the participants a chance to discuss food consumption, physical activity, meal planning and assessed the participant's weight at each visit.

  Participants in the Contest only and Control group were not eligible to receive these meetings.

• Behavioral: Financial incentives for weight loss maintenance
  Participants in the Contest Plus and Contest Only groups were eligible for a lottery based financial incentive for maintaining their weight lost during phase 1 (Baseline to week 10) of the trial. There were three, month-long follow up assessments (weeks 16, 20 and 24) that participants were eligible for. The lottery prize was contingent upon the length of time they maintained their weight loss.

Study Arms

• Experimental: Contest Plus
  The Contest Plus group were eligible to receive the financial incentives for weight loss maintenance at three monthly follow ups; weeks 16, 20 and 24. Eligible participants completed online surveys and in person weigh ins verifying weight maintenance. In addition to the financial incentives, participants in this group had bi-weekly in person meetings with a Registered Dietician during phase 2 (week 16-24) of the trial. They also received an in home scale to monitor weight daily.
  Interventions:

  • Behavioral: Bi-weekly in person meetings with a Registered Dietician
  • Behavioral: Financial incentives for weight loss maintenance
• No Intervention: Control
  The Control condition did not receive any intervention and were not eligible to win the lottery based incentive. Participants completed follow surveys (weeks 16, 20 and 24) and received remuneration for completing surveys and in person weigh in.
• Experimental: Contest Only
  The Contest only group were eligible to receive the financial incentives for weight loss maintenance for maintaining weight lost at three monthly follow ups; weeks 16, 20 and 24. Eligible participants completed online surveys and in person weigh ins verifying weight maintenance.
  Intervention: Behavioral: Financial incentives for weight loss maintenance

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2013): 144
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 28, 2014
• Actual Primary Completion Date: February 28, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 18-24 years of age
• University of Minnesota Freshman, Sophomore, or Junior
• Plan on enrolling at the U of Minnesota through Spring 2013
• BMI greater than or equal to 26 and less than or equal to 35.5
• Have working internet and phone access
• Ability to read/write English
• Ability to safely engage in exercise

Exclusion Criteria:

• Currently pregnant or breastfeeding
• Prior or planned weight loss surgery
• Having a special diet or being a member of an "organized weight loss program"
• Diagnosis of Diabetes
• Have had Binge Eating Disorder
• Have lost greater than or equal to 10 pounds in the last 3 months

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 24 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: NCT02021383
• Other Study ID Numbers: 1207S16661; 20807 ( Other Grant/Funding Number: UMN - Clinical and Translational Science Institute )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Minnesota
• Study Sponsor: University of Minnesota
• Collaborators: Not Provided

Investigators

• Principal Investigator: Janet L Thomas, PhD; University of Minnesota

• PRS Account: University of Minnesota
• Verification Date: May 2019