Clinical trial NCT04770909: Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity
Official title: Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Duke University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-02-25
Enrollment: 706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 (incentives for dietary self-monitoring: yes vs. no) x 2 (incentives for weight loss: yes vs. no)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 26 weeks
timeFrame: 26 weeks
Secondary outcomes:
measure: Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 52 weeks
timeFrame: 52 weeks
measure: Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 78 weeks
timeFrame: 78 weeks
measure: Change in dose equivalents of cardiovascular medications from baseline to 78 weeks
timeFrame: Baseline, 78 weeks
measure: Change in diastolic blood pressure from baseline to 26, 52, and 78 weeks
timeFrame: Baseline, 26, 52, and 78 weeks
measure: Change in systolic blood pressure from baseline to 26, 52, and 78 weeks
timeFrame: Baseline, 26, 52, and 78 weeks
Other outcomes:
measure: Intrinsic motivation for weight loss as assessed by modified Treatment Self-Regulation Questionnaire
timeFrame: 26 weeks
measure: Extrinsic motivation for weight loss as assessed by modified Treatment Self-Regulation Questionnaire
timeFrame: 26 weeks
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Lisa Cadmus-Bertram, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah Department of Internal Medicine
name: Corrine Voils, PhD
role: PRINCIPAL_INVESTIGATOR
References: