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

University of Wisconsin (UW)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Incentives for dietary self-monitoring; Behavioral: Incentives for weight loss; Behavioral: Incentives for dietary self-monitoring and weight loss

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04770909

A539722 (Other Identifier)

UG3HL150558-01 (U.S. NIH Grant/Contract)

SMPH/SURGERY (Other Identifier)

Protocol Version 1/3/2025 (Other Identifier)

2020-1693

Details and patient eligibility

About

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.

Full 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.

Enrollment: 706 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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706 participants in 4 patient groups

Combined

Experimental group

Description:

Weekly incentives for dietary self-monitoring and weight loss

Treatment:

Behavioral: Incentives for dietary self-monitoring and weight loss

Dietary self-monitoring

Experimental group

Description:

Weekly incentives for dietary self-monitoring

Treatment:

Behavioral: Incentives for dietary self-monitoring

Weight loss

Experimental group

Description:

Weekly incentives for weight loss

Treatment:

Behavioral: Incentives for weight loss

Control

No Intervention group