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

Primary Purpose

Overweight, Obese

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bi-weekly in person meetings with a Registered Dietician

Financial incentives for weight loss maintenance

About this trial

This is an interventional prevention trial for Overweight focused on measuring Weight loss, Weight maintenance, Contingency Management, College students, Financial incentives

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Contest Plus

Control

Contest Only

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Maintenance of the weight lost from Baseline to Week 10 (Phase 1) measured ten months (week 52) after end of treatment (week 10).

Secondary Outcome Measures

Change in physical activity from baseline on the Physical Activity Questionnaire at week 24

Change in physical activity from baseline on the Physical Activity Questionnaire at week 52

Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 24

Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 52

Full Information

NCT ID

NCT02021383

First Posted

December 19, 2013

Last Updated

May 10, 2019

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT02021383

Brief Title

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

Acronym

L2W

Official Title

"Lose 2 Win" Contests: A Novel Method to Motivate Weight Loss Maintenance Among College Students

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

March 1, 2012 (Actual)

Primary Completion Date

February 28, 2014 (Actual)

Study Completion Date

February 28, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obese

Keywords

Weight loss, Weight maintenance, Contingency Management, College students, Financial incentives

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Contest Plus

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Arm Title

Contest Only

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Bi-weekly in person meetings with a Registered Dietician

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Financial incentives for weight loss maintenance

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Change in physical activity from baseline on the Physical Activity Questionnaire at week 24

Time Frame

Baseline, Week 24

Title

Change in physical activity from baseline on the Physical Activity Questionnaire at week 52

Time Frame

Baseline, Week 52

Title

Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 24

Time Frame

Baseline, Week 24

Title

Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 52

Time Frame

Baseline, Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janet L Thomas, PhD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55414

Country

United States

12. IPD Sharing Statement

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