Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 主要终点
- the amount of weight loss (kg)
研究概览
简要总结
The investigators are planning to conduct a pilot RCT of young obese population to evaluate the effect of smartcare with or without financial incentives for 12 weeks. Participants will be randomly assigned to a three-arm of control, smartcare, and smartcare plus financial incentives group.
详细描述
To test the feasibility and potential impact of smartcare with or without financial incentives, the study employed a three-arm, open label randomized controlled trial design: control, smartcare, and smartcare plus financial incentives. The investigators hypothesized that the 'smartcare + financial incentive' arm will show the greatest change in outcomes, followed by the 'smartcare' only arm, and lastly the control arm. Specific aims of the study are as follows:
- To quantify the effectiveness of a 'smartcare' intervention to promote physical activity and reduce weight over a 12 week period.
- To quantify the incremental effectiveness of adding financial incentives to 'smartcare' intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male students aged between 19 to 45;
- •body mass index ≥ 27;
- •smartphone user (either Android or iPhone);
- •able and willing to attend a four pre-specified visit during the study period.
排除标准
- •any treatment involving pharmacotherapy, procedure, or surgery;
- •use of any activity tracker device during the last three months.
- •Those who answered positively to any Physical Activity Readiness Questionnaire (PAR-Q) question were also excluded.
研究组 & 干预措施
control
A standardized education material on diet, exercise, and behavior modification were provided to all participants, and each participant received a one-to-one education on diet and exercise from a trained nurse for 5 minutes each session.
smartcare
Participants allocated to a smartcare arms received the Fit.life™ wireless physical activity tracker (Fit.life™, Suwon, Korea) that measures daily and weekly physical activity. It is convenient for data upload via Bluetooth on participant mobile phone or wirelessly via a personal computer, and has been validated for measurement of free-living physical activity in adults [REF]. Participants allocated to a smartcare arms were also provided a standardized education material on diet, exercise, and behavior modification.
干预措施: smartcare (Device)
smartcare plus financial incentives
Participants in the 'smartcare plus financial incentive' arms were told that they are entitled to receive financial incentives depending on their achievement of the physical activity and weight target, and the amount they ca expect .The investigators provide financial incentives classified as process-based incentive and outcome-based incentive in addition to smartcare group intervention. A smartphone application was customized for the use of the investigators' intervention, different for the 'smart care' group and 'smartcare plus financial incentive' group.
干预措施: financial incentives (Other)
smartcare plus financial incentives
Participants in the 'smartcare plus financial incentive' arms were told that they are entitled to receive financial incentives depending on their achievement of the physical activity and weight target, and the amount they ca expect .The investigators provide financial incentives classified as process-based incentive and outcome-based incentive in addition to smartcare group intervention. A smartphone application was customized for the use of the investigators' intervention, different for the 'smart care' group and 'smartcare plus financial incentive' group.
干预措施: smartcare (Device)
结局指标
主要结局
the amount of weight loss (kg)
时间窗: 12 weeks
Body weight change from the baseline body weight at each visit (4, 8, 12 week)
次要结局
- the level of physical activity (METs*hour/week)(12 weeks)