Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity

Study Overview
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Brief Summary
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This study involves an evaluation of whether providing small incentives weekly for dietary self-monitoring and/or weight loss improves short- and long-term weight loss. Participants can expect to be on study for 18 months.

Detailed Description
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In this two-site, randomized, single-blinded, longitudinal 2x2 factorial study, called Log2Lose, adults with obesity from Madison, WI and Durham, NC will be offered a 78 week, evidence-based behavioral weight management program comprising an incentivized weight loss intervention for 26 weeks (Phase I), an incentivized weight loss maintenance intervention for 26 weeks (Phase II), and a non-incentivized weight maintenance intervention for 26 weeks (Phase III). Participants will be randomized in a 2x2 design to receive adjunctive incentives for either weekly weight loss or dietary self-monitoring, both, or neither. The investigators will assess the proportion of participants achieving clinically significant weight loss of greater than or equal to 5 percent at the end of each phase. All participants will participate in an 18-month weight management program delivered via videoconference.

Official Title
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Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Incentives for dietary self-monitoring and weight loss
* Behavioral: Incentives for dietary self-monitoring
* Behavioral: Incentives for weight loss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥30 kg/m2 Desire to lose weight Agrees to attend visits per protocol Access to telephone Transportation and ability to attend in-person study visits at 0, 6, 12 and 18 months Able to stand for weight measurements without assistance Able to speak and read English Able to download and use the MyFitnessPal and Fitbit apps daily Possess smart phone with data and texting plan E-mail address Reliable access to internet Able to connect to a video conference call using a smartphone, tablet or computer with a webcam and microphone Score of at least 4 out of 6 on a validated cognitive screener Exclusion Criteria: Weight >380 lb Weight loss of at least 10 lbs in the month prior to screening Currently enrolled or enrollment in previous month in a clinical, research, or community program focusing on lifestyle change that could affect weight Current use of weight loss medication History of bariatric surgery or planning to have bariatric surgery in the study timeframe Residing in a nursing home or receiving home health care Impaired hearing Significant dementia, drug or alcohol misuse, or unstable psychiatric illness (e.g., schizophrenia, psychosis) Current treatment for cancer or being treated for cancer (besides basal cell carcinoma or squamous cell) in the last 6 months Use of insulin, sulfonylureas, or meglitinides due to increased risk for hypoglycemia Pregnant, breastfeeding, or planning to become pregnant within the study timeframe Diuretic medication doses higher than hydrochlorothiazide 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 Chronic kidney disease at stage 4 or 5 Unstable heart disease in the 6 months prior to screening Exertional chest pain or dyspnea History of ascites requiring paracentesis Pain, fainting or other condition that prohibits mild/moderate exercise

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2 (incentives for dietary self-monitoring: yes vs. no) x 2 (incentives for weight loss: yes vs. no)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined<br>Weekly incentives for dietary self-monitoring and weight loss | Behavioral: Incentives for dietary self-monitoring and weight loss<br>* Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring and weight loss<br>|
| Experimental: Dietary self-monitoring<br>Weekly incentives for dietary self-monitoring | Behavioral: Incentives for dietary self-monitoring<br>* Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring<br>|
| Experimental: Weight loss<br>Weekly incentives for weight loss | Behavioral: Incentives for weight loss<br>* Participants can earn up to $300 during the trial for achieving weight loss<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 26 weeks | Measured on a calibrated, digital scale to the nearest 0.1 kg | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 52 weeks | Measured on a calibrated, digital scale to the nearest 0.1 kg | 52 weeks | 
| Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 78 weeks | Measured on a calibrated, digital scale to the nearest 0.1 kg | 78 weeks | 
| Change in dose equivalents of cardiovascular medications from baseline to 78 weeks | Dose equivalents for antihypertensive, antilipemic, and type 2 diabetes medications | Baseline, 78 weeks | 
| Change in diastolic blood pressure from baseline to 26, 52, and 78 weeks | Average of two sequential measurements measured on a digital blood pressure monitor. A second reading will be taken one minute after the first. If the difference between the systolic measurements is greater than 15mmHg, then a third reading will be taken, one minute after the second reading. | Baseline, 26, 52, and 78 weeks | 
| Change in systolic blood pressure from baseline to 26, 52, and 78 weeks | Average of two sequential measurements measured on a digital blood pressure monitor. A second reading will be taken one minute after the first. If the difference between the systolic measurements is greater than 15mmHg, then a third reading will be taken, one minute after the second reading. | Baseline, 26, 52, and 78 weeks |