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

Not Applicable

Completed

Interventions: Behavioral: Incentives for weight loss
Behavioral: Incentives for dietary self-monitoring and weight loss
Behavioral: Incentives for dietary self-monitoring

Brief Summary: 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: In this two-site, randomized, single-masked, 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.

Recruitment & Eligibility

Inclusion Criteria

BMI ≥30 kg/m2
Desire to lose weight
Agrees to attend outcome visits per protocol
Available for class times
Transportation and ability to attend in-person study visits at baseline (screening), 26, 52, and 78 weeks
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
Have or willing to create a Gmail address
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 enrolled 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
History of ascites requiring paracentesis
Pain, fainting or other conditions that prohibit mild/moderate exercise

Arm && Interventions

Group	Intervention	Description
Weight loss	Incentives for weight loss	Weekly incentives for weight loss
Combined	Incentives for dietary self-monitoring and weight loss	Weekly incentives for dietary self-monitoring and weight loss
Dietary self-monitoring	Incentives for dietary self-monitoring	Weekly incentives for dietary self-monitoring

Primary Outcome Measures

Name	Time	Method
Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 26 weeks	26 weeks	Measured on a calibrated, digital scale to the nearest 0.1 kg

Secondary Outcome Measures

Name	Time	Method
Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 78 weeks	78 weeks	Measured on a calibrated, digital scale to the nearest 0.1 kg
Change in diastolic blood pressure from baseline to 26, 52, and 78 weeks	Baseline, 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.
Change in dose equivalents of cardiovascular medications from baseline to 78 weeks	Baseline, 78 weeks	Dose equivalents for antihypertensive, antilipemic, and type 2 diabetes medications
Change in systolic blood pressure from baseline to 26, 52, and 78 weeks	Baseline, 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.
Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 52 weeks	52 weeks	Measured on a calibrated, digital scale to the nearest 0.1 kg

Locations (2): University of Wisconsin-Madison
🇺🇸
Madison, Wisconsin, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States