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

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

Tracking Information
First Submitted Date  ICMJE December 19, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE March 1, 2012
Actual Primary Completion Date February 28, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lose 2 Win A Novel Method to Motivate Weight Loss Maintenance Among College Students
Official Title  ICMJE "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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Overweight
  • Obese
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2013)
144
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2014
Actual Primary Completion Date February 28, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 24 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021383
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janet L Thomas, PhD University of Minnesota
PRS Account University of Minnesota
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP