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

NCT ID: NCT04770909

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

706 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-13

Study Completion Date

2025-04-10

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2 (incentives for dietary self-monitoring: yes vs. no) x 2 (incentives for weight loss: yes vs. no)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Combined

Weekly incentives for dietary self-monitoring and weight loss

Group Type EXPERIMENTAL

Incentives for dietary self-monitoring and weight loss

Intervention Type BEHAVIORAL

Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring and weight loss

Dietary self-monitoring

Weekly incentives for dietary self-monitoring

Group Type EXPERIMENTAL

Incentives for dietary self-monitoring

Intervention Type BEHAVIORAL

Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring

Weight loss

Weekly incentives for weight loss

Group Type EXPERIMENTAL

Incentives for weight loss

Intervention Type BEHAVIORAL

Participants can earn up to $300 during the trial for achieving weight loss

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Incentives for dietary self-monitoring

Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring

Intervention Type BEHAVIORAL

Incentives for weight loss

Participants can earn up to $300 during the trial for achieving weight loss

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Cadmus-Bertram, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Corrine Voils, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah Department of Internal Medicine

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40774423 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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A539722

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/SURGERY

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 1/3/2025

Identifier Type: OTHER

Identifier Source: secondary_id

UG3HL150558-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-1693

Identifier Type: -

Identifier Source: org_study_id

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