Helping Employees Lose Pounds (HELP)
|ClinicalTrials.gov Identifier: NCT02853877|
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : April 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss||Behavioral: Weekly Incentive||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Translating Insights From Behavioral Economics and Self-Determination Theory to Promote Sustained Weight Loss Among Obese Employees|
|Actual Study Start Date :||August 2, 2016|
|Actual Primary Completion Date :||January 4, 2017|
|Actual Study Completion Date :||April 7, 2017|
Experimental: Weekly Incentive
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
The tailored incentives intervention aims to assess the impact of tailored messaging and financial incentives on weight loss among obese employees.
No Intervention: Weekly Weigh-In
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.
- Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire [ Time Frame: 12 weeks ]
- Change in weight as measured by participant weight measurements using Withings scales [ Time Frame: 12 weeks and 24 weeks ]
- Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire [ Time Frame: 24 weeks ]
- Change in physical activity as measured by the short form of the International Physical Activity Questionnaire [ Time Frame: 12 weeks and 24 weeks ]
- Change in eating behaviors as measured by the Three Factor Eating Questionnaire [ Time Frame: 12 weeks and 24 weeks ]
- 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?" [ Time Frame: 12 weeks and 24 weeks ]
- Change in self-efficacy to lose weight as measured by the Perceived Competence Scale [ Time Frame: 12 weeks and 24 weeks ]
- 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?" [ Time Frame: 12 and 24 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853877
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Jeffrey T Kullgren, MD,MS,MPH||University of Michigan|