- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04770909
Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University Medical Center
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin-Madison
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Combined
Weekly incentives for dietary self-monitoring and weight loss
|
Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring and weight loss
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|
Experimental: Dietary self-monitoring
Weekly incentives for dietary self-monitoring
|
Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring
|
|
Experimental: Weight loss
Weekly incentives for weight loss
|
Participants can earn up to $300 during the trial for achieving weight loss
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What is the study measuring?
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
Time Frame: 26 weeks
|
Measured on a calibrated, digital scale to the nearest 0.1 kg
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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
Time Frame: 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
Time Frame: 78 weeks
|
Measured on a calibrated, digital scale to the nearest 0.1 kg
|
78 weeks
|
|
Change in Use of Cardiovascular Medications From Baseline to 78 Weeks for All Participants
Time Frame: Baseline, 78 weeks
|
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.
|
Baseline, 78 weeks
|
|
Change in Use of Cardiovascular Medications From Participants Who Took 1 or More Medications From Baseline to 78 Weeks
Time Frame: Baseline, 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.
|
Baseline, 78 weeks
|
|
Diastolic Blood Pressure
Time Frame: 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.
Data are model estimated means, baseline values are the same for all groups.
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baseline, 26, 52, and 78 weeks
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Systolic Blood Pressure
Time Frame: 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.
Data are model estimated means, baseline values are the same for all groups.
|
26, 52, and 78 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intrinsic Motivation for Weight Loss as Assessed by Modified Treatment Self-Regulation Questionnaire
Time Frame: 26 weeks
|
Association of intrinsic motivation for weight loss with proportion of patients who achieve clinically significant weight loss of at least 5 percent of baseline weight at 26 weeks will be measured with modified version of Treatment Self-Regulation Questionnaire.
Intrinsic motivation will be calculated as mean of items 2, 4, 6, 8, 11, 14, 16, 17.
Each item can be answered from '1 - not at all true' to '6 - very true'.
Lower scores correspond to lower intrinsic motivation for weight loss
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26 weeks
|
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Extrinsic Motivation for Weight Loss as Assessed by Modified Treatment Self-Regulation Questionnaire
Time Frame: 26 weeks
|
Association of extrinsic motivation for weight loss with proportion of patients who achieve clinically significant weight loss of at least 5 percent of baseline weight at 26 weeks will be measured with modified version of Treatment Self-Regulation Questionnaire. Extrinsic motivation will be calculated as mean of items 1, 3, 5, 7, 9, 10, 12, 13, 15, 18. Each item can be answered from '1 - not at all true' to '6 - very true'. Lower scores correspond to lower extrinsic motivation for weight loss |
26 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa Cadmus-Bertram, PhD, University of Wisconsin, Madison
- Principal Investigator: Corrine Voils, PhD, University of Utah Department of Internal Medicine
Publications and helpful links
General Publications
- Shaw RJ, Miller H, Barnes C, Davenport C, Morton-Oswald S, Jackson S, Bean M, Cohen J, Griffin C, Pendergast J, Olsen M, Gierisch J, Voils C. Development, Challenges, and Evolution of the Log2Lose Intervention for Weight Management: Randomized Controlled Digital Health Trial. JMIR Form Res. 2025 Nov 17;9:e70842. doi: 10.2196/70842.
- Voils CI, Gierisch JM, Pendergast JF, Davenport CA, Olsen MK, Barnes C, Bean M, Cadmus-Bertram L, Colon J, Elwert F, Garza K, Gavin KL, Jackson S, Miller H, Morton-Oswald S, Pabich S, Reed SD, Yancy WS Jr, Shaw RJ. Study protocol for Log2Lose: A randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity. Contemp Clin Trials. 2025 Sep;156:108042. doi: 10.1016/j.cct.2025.108042. Epub 2025 Aug 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-1693
- A539722 (Other Identifier: UW Madison)
- SMPH/SURGERY (Other Identifier: UW Madison)
- UG3HL150558-01 (U.S. NIH Grant/Contract)
- Protocol Version 1/3/2025 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
- The data will be used for research or implementation purposes and not to identify individual participants
- The data must be secured using the appropriate computer technology
- The data must be destroyed or returned after analyses are complete
- The authors of any manuscript resulting from the Log2Lose data must acknowledge the source of the data upon which their manuscript is based.
- Any analyses for the purpose of presentation, abstracts, and/or publications must be coordinated with the Log2Lose leadership team, so there can be some coordination of analyses to ensure that redundant analyses are not being performed independently
- All coauthors must be given an opportunity for review and approval of a draft manuscript prior to submission for publication.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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