Weight Loss Clinical Trial
— HELPOfficial title:
Translating Insights From Behavioral Economics and Self-Determination Theory to Promote Sustained Weight Loss Among Obese Employees
| Verified date | April 2017 |
| Source | University of Michigan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan | Ann Arbor | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| University of Michigan |
United States,
| 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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