NCT04770909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
706

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 13, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 20, 2026

Completed
Last Updated

May 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

February 22, 2021

Results QC Date

March 30, 2026

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    26 weeks

Secondary Outcomes (6)

  • Percent of Participants Who Achieve Clinically Significant Weight Loss of at Least 5 Percent of Baseline Weight at 52 Weeks

    52 weeks

  • Percent of Participants Who Achieve Clinically Significant Weight Loss of at Least 5 Percent of Baseline Weight at 78 Weeks

    78 weeks

  • Change in Use of Cardiovascular Medications From Baseline to 78 Weeks for All Participants

    Baseline, 78 weeks

  • Change in Use of Cardiovascular Medications From Participants Who Took 1 or More Medications From Baseline to 78 Weeks

    Baseline, 78 weeks

  • Diastolic Blood Pressure

    baseline, 26, 52, and 78 weeks

  • +1 more secondary outcomes

Other Outcomes (2)

  • Intrinsic Motivation for Weight Loss as Assessed by Modified Treatment Self-Regulation Questionnaire

    26 weeks

  • Extrinsic Motivation for Weight Loss as Assessed by Modified Treatment Self-Regulation Questionnaire

    26 weeks

Study Arms (4)

Combined

EXPERIMENTAL

Weekly incentives for dietary self-monitoring and weight loss

Behavioral: Incentives for dietary self-monitoring and weight loss

Dietary self-monitoring

EXPERIMENTAL

Weekly incentives for dietary self-monitoring

Behavioral: Incentives for dietary self-monitoring

Weight loss

EXPERIMENTAL

Weekly incentives for weight loss

Behavioral: Incentives for weight loss

Control

NO INTERVENTION

Interventions

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

Combined

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

Dietary self-monitoring

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

Weight loss

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Corrine I. Voils, PhD
Organization
University of Utah Department of Internal Medicine

Study Officials

  • Lisa Cadmus-Bertram, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR
  • Corrine Voils, PhD

    University of Utah Department of Internal Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 2 (incentives for dietary self-monitoring: yes vs. no) x 2 (incentives for weight loss: yes vs. no)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

May 13, 2021

Primary Completion

April 8, 2024

Study Completion

April 10, 2025

Last Updated

May 20, 2026

Results First Posted

May 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

First, investigators will strip all data of personal identifiers (i.e., personal health information (PHI)) in accordance with the HIPAA privacy rule. Each consented and enrolled participant will be assigned a unique study ID, which will be the only participant-level identifier. Time information starting at baseline will be coded in units of study time, with baseline = '0' and termination of 18 months or dropout for all participants, regardless of the calendar date of their baseline visit. Proprietary software code will be shared in accordance with institutional policies and consent of the creators.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Study data will be made available for use by investigators not associated with the proposed study within three years after the primary results have been published.
Access Criteria
1. The data will be used for research or implementation purposes and not to identify individual participants 2. The data must be secured using the appropriate computer technology 3. The data must be destroyed or returned after analyses are complete 4. The authors of any manuscript resulting from the Log2Lose data must acknowledge the source of the data upon which their manuscript is based. 5. 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 6. All coauthors must be given an opportunity for review and approval of a draft manuscript prior to submission for publication.

Locations