Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 706
- 试验地点
- 2
- 主要终点
- Percent of Participants Who Achieve Clinically Significant Weight Loss of at Least 5 Percent of Baseline Weight at 26 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
Weight loss
Weekly incentives for weight loss
干预措施: Incentives for weight loss (Behavioral)
Combined
Weekly incentives for dietary self-monitoring and weight loss
干预措施: Incentives for dietary self-monitoring and weight loss (Behavioral)
Dietary self-monitoring
Weekly incentives for dietary self-monitoring
干预措施: Incentives for dietary self-monitoring (Behavioral)
结局指标
主要结局
Percent of Participants Who Achieve Clinically Significant Weight Loss of at Least 5 Percent of Baseline Weight at 26 Weeks
时间窗: 26 weeks
Measured on a calibrated, digital scale to the nearest 0.1 kg
次要结局
- 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)
- Systolic Blood Pressure(26, 52, and 78 weeks)