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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02021383
Other study ID # 1207S16661
Secondary ID 20807
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2012
Est. completion date February 28, 2014

Study information

Verified date May 2019
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date February 28, 2014
Est. primary completion date February 28, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maintenance of the weight lost from Baseline to Week 10 (Phase 1) measured ten months (week 52) after end of treatment (week 10). Baseline, Week 10, Week 24, Week 52
Secondary Change in physical activity from baseline on the Physical Activity Questionnaire at week 24 Baseline, Week 24
Secondary Change in physical activity from baseline on the Physical Activity Questionnaire at week 52 Baseline, Week 52
Secondary Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 24 Baseline, Week 24
Secondary Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 52 Baseline, Week 52
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