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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04770909
• Other study ID #: 2020-1693
• Secondary ID: A539722SMPH/SURG
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 13, 2021
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: April 2025
• Est. primary completion date: April 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 10 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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Duke University, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intrinsic motivation for weight loss as assessed by modified Treatment Self-Regulation Questionnaire	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	26 weeks
Other	Extrinsic motivation for weight loss as assessed by modified Treatment Self-Regulation Questionnaire	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
Primary	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	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	52 weeks
Secondary	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	78 weeks
Secondary	Change in dose equivalents of cardiovascular medications from baseline to 78 weeks	Dose equivalents for antihypertensive, antilipemic, and type 2 diabetes medications	Baseline, 78 weeks
Secondary	Change in diastolic blood pressure from baseline to 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.	Baseline, 26, 52, and 78 weeks
Secondary	Change in systolic blood pressure from baseline to 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.	Baseline, 26, 52, and 78 weeks