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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
706
Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring and weight loss
Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring
Participants can earn up to $300 during the trial for achieving weight loss
Duke University Medical Center
Durham, North Carolina, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
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
Time frame: 26 weeks
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
Time frame: 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
Time frame: 78 weeks
Change in Use of Cardiovascular Medications From Baseline to 78 Weeks for All Participants
Antihypertensive, antilipemic, and type 2 diabetes medications use reported here descriptively as the count of participants who decreased medications, increased medications, or where medications stayed the same.
Time frame: Baseline, 78 weeks
Change in Use of Cardiovascular Medications From Participants Who Took 1 or More Medications From Baseline to 78 Weeks
Antihypertensive, antilipemic, and type 2 diabetes medication use, reported here descriptively as the count of participants with any medications who decreased medications, increased medications, or where medications stayed the same.
Time frame: Baseline, 78 weeks
Diastolic Blood Pressure
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. Data are model estimated means, baseline values are the same for all groups.
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Time frame: baseline, 26, 52, and 78 weeks
Systolic Blood Pressure
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. Data are model estimated means, baseline values are the same for all groups.
Time frame: 26, 52, and 78 weeks