NCT02853877

Brief Summary

This study will evaluate the effectiveness of financial incentives and messaging tailored to individual goals and aspirations to promote and sustain weight loss. This is a 2-arm randomized controlled trial that will recruit eligible employees at a large university to participate in a 3-month weight loss program, followed by a 3-month follow-up period. The primary outcome will be change in autonomous motivation for weight loss. The study hypothesis is that intervention group participants will have a greater increase in autonomous motivation for weight loss than participants in the control group at 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 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

First Submitted

Initial submission to the registry

July 27, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

August 2, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2017

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

July 27, 2016

Last Update Submit

April 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire

    12 weeks

Secondary Outcomes (1)

  • Change in weight as measured by participant weight measurements using Withings scales

    12 weeks and 24 weeks

Other Outcomes (6)

  • Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire

    24 weeks

  • Change in physical activity as measured by the short form of the International Physical Activity Questionnaire

    12 weeks and 24 weeks

  • Change in eating behaviors as measured by the Three Factor Eating Questionnaire

    12 weeks and 24 weeks

  • +3 more other outcomes

Study Arms (2)

Weekly Incentive

EXPERIMENTAL

Participants in the Weekly Incentive arm will be asked to weigh in each week during a 12 week intervention period. They will receive tailored messages and have an opportunity to win a financial reward each week they meet their weight loss goal. Participants will be asked to complete a final weight measurement at week 24.

Behavioral: Weekly Incentive

Weekly Weigh-In

NO INTERVENTION

Participants in the Weekly Weigh-In arm will be asked to weigh in each week during a 12 week intervention period. Participants will be asked to complete a final weight measurement at week 24.

Interventions

The tailored incentives intervention aims to assess the impact of tailored messaging and financial incentives on weight loss among obese employees.

Weekly Incentive

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Interested in losing weight
  • Body Mass Index between 30 and 40 kg/m2
  • Have wireless internet at home
  • Have Android or iOS smart device
  • Willing to record themselves weighing in on a scale or let a family member record them weighing in on a scale

You may not qualify if:

  • Pregnant or lactating, or intending to become pregnant in the next 6 months
  • Taking medication (other than metformin) for diabetes to control blood sugar
  • Having a serious psychiatric diagnosis, unstable medical conditions or experienced a heart attack or stroke in the past 6 months
  • Having a history of drug or alcohol abuse or addiction to prescription medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey T Kullgren, MD,MS,MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 3, 2016

Study Start

August 2, 2016

Primary Completion

January 4, 2017

Study Completion

April 7, 2017

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations