NCT02021383

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2014

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

December 19, 2013

Last Update Submit

May 10, 2019

Conditions

Keywords

Weight lossWeight maintenanceContingency ManagementCollege studentsFinancial incentives

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    Baseline, Week 24

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

    Baseline, Week 52

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

    Baseline, Week 24

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

    Baseline, Week 52

Study Arms (3)

Contest Plus

EXPERIMENTAL

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.

Behavioral: Bi-weekly in person meetings with a Registered DieticianBehavioral: Financial incentives for weight loss maintenance

Control

NO INTERVENTION

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.

Contest Only

EXPERIMENTAL

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.

Behavioral: Financial incentives for weight loss maintenance

Interventions

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.

Contest Plus

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.

Contest OnlyContest Plus

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Janet L Thomas, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 27, 2013

Study Start

March 1, 2012

Primary Completion

February 28, 2014

Study Completion

February 28, 2014

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations