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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02853877
Other study ID # HUM00107647
Secondary ID
Status Completed
Phase N/A
First received July 27, 2016
Last updated April 14, 2017
Start date August 2, 2016
Est. completion date April 7, 2017

Study information

Verified date April 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date April 7, 2017
Est. primary completion date January 4, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire 24 weeks
Other Change in physical activity as measured by the short form of the International Physical Activity Questionnaire 12 weeks and 24 weeks
Other Change in eating behaviors as measured by the Three Factor Eating Questionnaire 12 weeks and 24 weeks
Other Change in participation in weight-related wellness programs as measured by responses to the question "In the past 3 months, have you participated in any health and wellness programs?" 12 weeks and 24 weeks
Other Change in self-efficacy to lose weight as measured by the Perceived Competence Scale 12 weeks and 24 weeks
Other Change in stage of change for weight loss as measured by responses to the questions "Are you currently trying to lose weight?" and "Do you intend to try to lose weight in the near future?" 12 and 24 weeks
Primary Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire 12 weeks
Secondary Change in weight as measured by participant weight measurements using Withings scales 12 weeks and 24 weeks
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