Obesity & Overweight
Conditions
Keywords
behavioral intervention, obesity, financial incentives, reinforcement learning, artificial intelligence
Brief summary
The purpose of this study is to determine the feasibility of providing personalized incentives for dietary self-monitoring and/or interim weight loss to people enrolled in a weight-loss program
Detailed description
In this study, community outpatients will participate in a clinician-facilitated, group-based behavioral weight-loss program for 24 weeks. Dietary self-monitoring data (input by patients via a mobile phone dietary application) and weight data (input by patients via cellular scale) will be collected by a software platform. A reinforcement learning algorithm will use data collected during the trial to predict which participants will respond to a financial incentive. Incentives will be provided to participants predicted to respond, and they will be notified of incentives via text messaging.
Interventions
BEHAVIORALpersonalized financial incentives
Every week, a reinforcement learning algorithm will process data on weight loss, calorie logging, and incentives earned to predict that their weight loss is positively influenced by incentives.
Sponsors
University of Utah
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Willing to attend virtual baseline and follow-up data collection visits 2. At least 18 years of age 3. Verified obesity as defined as a BMI ≥30 kg/m2 4. Agree to attend 13 biweekly group classes (virtual) delivered by a registered dietitian 5. Agree to review study materials between classes 6. Regular access to an unshared smart phone 7. Reliable access to internet 8. Able to speak and read English 9. Desire to lose weight 10. Able to connect to a video conference call using a smartphone, tablet or computer with a webcam and microphone 11. Ability to download and use Fitbit app daily 12. Have or be willing to create a Gmail address 13. Physical ability to stand on a scale without support
Exclusion criteria
1. Weight loss of at least 10lbs in the month prior to screening 2. Weight \> 380lbs 3. Currently enrolled or enrolled in the previous month in a clinical, research, or community program focusing on lifestyle change that could affect weight 4. New user of weight loss medication 5. Pregnant, lactating or planning on becoming pregnant during the study 6. History of bariatric procedure or planning to have bariatric procedure in the study timeframe 7. Residing in a nursing home, skilled nursing facility or assisted living facility 8. Impaired hearing 9. Significant dementia, drug or alcohol abuse, or unstable psychiatric illness (e.g., schizophrenia, psychosis) 10. Current treatment for cancer or being treated for cancer (besides basal cell carcinoma or squamous cell) in the last 6 months 11. Use of insulin, sulfonylureas, or meglitinides due to increased risk for hypoglycemia 12. Diuretic medication doses higher than hydrochlorothiazide or chlorthalidone 25 mg daily, furosemide 40 mg daily, torsemide 20 mg daily, bumetanide 1 mg daily, or any use of metolazone; use of potassium-sparing diuretics is acceptable 13. Unstable heart disease in the 6 months prior to screening 14. Chronic kidney disease at stage 4 or higher 15. Exertional chest pain 16. Pain, fainting, or other conditions that prohibit mild/moderate exercise 17. History of ascites requiring paracentesis 18. Inducing vomiting to prevent weight gain or counteract the effects of eating an average of 1 time per week or more in the past 3 months\* 19. Not suitable for study participation due to other reasons at the discretion of the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening-to-enrollment ratio | Week 0 | number of potential participants screened for the study/ number of participants who provide a baseline weight for the intervention |
| Retention for outcomes | 25 weeks | number of participants who provide a weight at 25 weeks/number of participants who provide a baseline weight for the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to calorie logging | 24 weeks | Proportion of weeks participants achieve adequate calorie logging (5 days per week) |
| Adherence to self-weighing | 24 weeks | Proportion of weeks participants weigh at least twice per week on a study-provided cellular scale |
| Body weight | baseline to 25 weeks | Changes in body weight from baseline to week 25, measured by study-provided cellular scales |
Countries
United States
Outcome results
None listed