A Randomized Incentive-Based Weight Loss Trial in Singapore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Weight change
研究概览
简要总结
The purpose of this study is to test the extent to which incentives, when combined with an existing evidence-based weight loss program, improve weight loss and weight loss maintenance. It will also compare the cost-effectiveness of the incentive-based weight loss programs to the basic program without incentives.
详细描述
Globally, the rise in obesity rates has reached epidemic proportions, and in Singapore 53% of adults have a body mass index (BMI) great than 23.0 kg/m2, a level that increases risk for chronic disease among Asians. This study aims to test the extent to which traditional or behavioural economic incentives, when combined with an existing evidence-based weight loss program, improve weight loss and weight loss maintenance. Data will be collected through a two-arm (basic weight loss program, basic program plus traditional or behavioural economic incentives) randomized controlled trial (RCT) where key outcome variables are defined as weight loss (kilograms) at 8 months when the incentive program concludes, and at 12 months, after a 4 month period in which no additional incentives are provided. We hypothesize that at both 8 and 12 months, weight loss will be greater in the incentive arm than in the arm without incentives. The growing obesity epidemic, the high costs of obesity to employers, insurers and governments across Asia, and the fact that the incentive program is designed to be close to cost neutral, suggest that this research has high potential to have a significant public health impact, both in Singapore and the region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Willing to be randomized into 1 of the 2 study arms
- •Willing to pay the $399 entry fee
- •Stated willingness to commit to participating in all assessments regardless of weight change or study arm
排除标准
- •Current pregnancy/lactation (women who become pregnant during the study will be withdrawn)
- •Type 1 diabetes
- •Type 2 diabetes on medication other than Metformin
- •End-stage Renal Disease
- •Ischemic Heart Disease requiring intervention in the past 6 months
- •Thyroid disease that has yet to stabilize
- •Changes in weight of greater than 3% in the past 6 months
- •Use of weight loss medication in the past 6 months
- •Malignancy requiring chemotherapy/radiation in the past 5 years
- •Acute medical problems requiring 3+ days of missed work during previous 4 week period
- •Any serious hospitalization or surgery in the past 6 months
- •Use of corticosteroids in the past 6 months
- •Answer 'YES' to any of the PAR-Q questions
- •Unable to obtain MD consent from a physician giving permission to participate in the study
- •Evidence of clinical depression (as assessed by the Beck Depression Inventory)
- •Currently on medications for a mental health or substance abuse condition
- •Evidence of binge eating based on the Binge Eating Disorders Scale (BEDS)
- •Unable to communicate in English
- •Additional concerns in which the clinical investigator deems problematic for participation
结局指标
主要结局
Weight change
时间窗: Baseline, 4 months, 8 months and 12 months
次要结局
- Steps, aerobic steps and minutes of physical activity(Monthly through month 8 (in incentive arms))
- Sociodemographics(Baseline)
- Health-related quality of life(Baseline, 4 months, 8 months, 12 months)
- Intervention costs(Baseline through month 8)
- Self-reported physical activity(Baseline, 4 months, 8 months, 12 months)
- Intrinsic and Extrinsic motivation(Baseline)
- Percent body fat(Baseline, 4 months, 8 months, 12 months)
研究者
Eric A. Finkelstein
Professor
Duke-NUS Graduate Medical School