Obesity
Conditions
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.
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.
Interventions
BEHAVIORALIncentives 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
BEHAVIORALIncentives for dietary self-monitoring
Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring
BEHAVIORALIncentives for weight loss
Participants can earn up to $300 during the trial for achieving weight loss
Sponsors
University of Wisconsin, Madison
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
2 (incentives for dietary self-monitoring: yes vs. no) x 2 (incentives for weight loss: yes vs. no)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Achieve Clinically Significant Weight Loss of at Least 5 Percent of Baseline Weight at 26 Weeks | 26 weeks | Measured on a calibrated, digital scale to the nearest 0.1 kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Achieve Clinically Significant Weight Loss of at Least 5 Percent of Baseline Weight at 52 Weeks | 52 weeks | Measured on a calibrated, digital scale to the nearest 0.1 kg |
| Percent of Participants Who Achieve Clinically Significant Weight Loss of at Least 5 Percent of Baseline Weight at 78 Weeks | 78 weeks | Measured on a calibrated, digital scale to the nearest 0.1 kg |
| Change in Use of Cardiovascular Medications From Baseline to 78 Weeks for All Participants | 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. |
| Change in Use of Cardiovascular Medications From Participants Who Took 1 or More Medications From Baseline to 78 Weeks | 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. |
| Diastolic Blood Pressure | 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. |
| Systolic Blood Pressure | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLisa Cadmus-Bertram, PhD
University of Wisconsin, Madison
PRINCIPAL_INVESTIGATORCorrine Voils, PhD
University of Utah Department of Internal Medicine
Participant flow
Pre-assignment details
3306 unique people completed an online screening survey. 1646 people were deemed eligible for a phone screening survey. 897 people completed phone screening and were eligible for in-person visit. 727 people completed in person visits and were eligible for group classes. Per protocol, participants were randomized to a condition but only considered enrolled if they provided a baseline weight. 706 people provided baseline weight and attended group classes were randomization status was disclosed.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 163 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 32 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 496 Participants |
| Region of Enrollment United States | 177 participants |
| Sex: Female, Male Female | 138 Participants |
| Sex: Female, Male Male | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 175 | 1 / 177 | 1 / 181 | 0 / 173 |
| other Total, other adverse events | 44 / 175 | 39 / 177 | 37 / 181 | 44 / 173 |
| serious Total, serious adverse events | 9 / 175 | 14 / 177 | 7 / 181 | 8 / 173 |
Outcome results
None listed