Clinical trial NCT02853877: Helping Employees Lose Pounds
Official title: Translating Insights From Behavioral Economics and Self-Determination Theory to Promote Sustained Weight Loss Among Obese Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in weight as measured by participant weight measurements using Withings scales
timeFrame: 12 weeks and 24 weeks
Other outcomes:
measure: Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire
timeFrame: 24 weeks
measure: Change in physical activity as measured by the short form of the International Physical Activity Questionnaire
timeFrame: 12 weeks and 24 weeks
measure: Change in eating behaviors as measured by the Three Factor Eating Questionnaire
timeFrame: 12 weeks and 24 weeks
measure: 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?"
timeFrame: 12 weeks and 24 weeks
measure: Change in self-efficacy to lose weight as measured by the Perceived Competence Scale
timeFrame: 12 weeks and 24 weeks
measure: 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?"
timeFrame: 12 and 24 weeks
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey T Kullgren, MD,MS,MPH
role: PRINCIPAL_INVESTIGATOR
References: