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

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ClinicalTrials.gov Identifier: NCT04770909
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : October 12, 2022
Sponsor:
Collaborators:
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Incentives for dietary self-monitoring and weight loss Behavioral: Incentives for dietary self-monitoring Behavioral: Incentives for weight loss Not Applicable

Detailed Description:

In this two-site, randomized, single-blinded, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2 (incentives for dietary self-monitoring: yes vs. no) x 2 (incentives for weight loss: yes vs. no)
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity
Actual Study Start Date : May 13, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined
Weekly incentives for dietary self-monitoring and weight loss
Behavioral: 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

Experimental: Dietary self-monitoring
Weekly incentives for dietary self-monitoring
Behavioral: 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
Behavioral: Incentives for weight loss
Participants can earn up to $300 during the trial for achieving weight loss

No Intervention: Control



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change in dose equivalents of cardiovascular medications from baseline to 78 weeks [ Time Frame: Baseline, 78 weeks ]
    Dose equivalents for antihypertensive, antilipemic, and type 2 diabetes medications

  4. Change in diastolic blood pressure from baseline to 26, 52, and 78 weeks [ 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.

  5. Change in systolic blood pressure from baseline to 26, 52, and 78 weeks [ 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.


Other Outcome Measures:
  1. 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

  2. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥30 kg/m2
  • Desire to lose weight
  • Agrees to attend visits per protocol
  • Access to telephone
  • Transportation and ability to attend in-person study visits at 0, 6, 12 and 18 months
  • 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
  • E-mail address
  • Reliable access to internet
  • 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 5 lbs in the month prior to screening
  • Currently enrolled or enrollment 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 or dyspnea
  • History of ascites requiring paracentesis
  • Pain, fainting or other condition that prohibits mild/moderate exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770909


Contacts
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Contact: Kara Gavin, PhD 608-265-8758 log2lose@surgery.wisc.edu
Contact: Jennie Embree 608-265-8758 log2lose@surgery.wisc.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Megan Oakes, MS    919-668-0966    megan.oakes@duke.edu   
Contact: Shauna Malone    919-668-1263    shauna.malone@duke.edu   
Principal Investigator: Jennifer Gierisch, PhD         
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Kara Gavin, PhD       log2lose@surgery.wisc.edu   
Contact: Jennie Embree       log2lose@surgery.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Corrine I Voils, PhD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04770909    
Other Study ID Numbers: 2020-1693
A539722 ( Other Identifier: UW Madison )
SMPH/SURGERY ( Other Identifier: UW Madison )
Protocol Version 3/25/2022 ( Other Identifier: UW Madison )
UG3HL150558-01 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Body Weight Changes