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临床试验/NCT04954547
NCT04954547Unknown不适用

The Effect of Activities-based Subsidy on Body Fat Loss

Noah Lim1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2021年8月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
800
试验地点
1
主要终点
Weekly Achievement Percentage

研究概览

简要总结

This 24-week-long study compares the effectiveness of two types of incentives for weight loss: 1) conditional subsidy 2) financial goal reward. Target participants are overweight female Singaporeans or Permanent Residents who are otherwise healthy.

详细描述

This study, which spans 24 weeks (12 treatment, 12 post-treatment), aims to compare the effectiveness of 2 financial incentive structures - a conditional subsidy versus a goal reward - on fat loss. 600 overweight but otherwise healthy female Singaporeans or Permanent Residents will be recruited via 2 recruitment phases, 2 months apart from each other. Participants will be given an individual-tailored percentage body fat (PBF) goal and assigned to one of three interventions:

  1. Subsidy treatment group (STG) - Participants will be awarded $X for reaching the PBF goal at the end of 12 weeks. Regardless of goal attainment, participants will also be reimbursed 50% of approved health-improving expenses up to a cap of $Y in the 12 weeks. The subsidy is voluntary and flexible, with no direct intervention from researchers - participants will submit receipts to the program website and simply be reimbursed at the end of the experiment. To prevent cheating, all receipts must bear the participants' full name or be justifiably traceable to them. When submitting the receipt to the program website, they must also specify the purpose of the expense - this serves as a psychological reminder to utilize the expense more meaningfully, while allowing us to discern better to approve or reject the reimbursement claim.
  2. Cash treatment group (CTG). Participants will be awarded $(X+Y) for reaching the PBF goal at the end of 12 weeks.
  3. Control. Other than the participation fees, no additional incentives will be provided.

All participants will be given an individual-tailored 12-week PBF goal. The formula for this goal will be set following the approval of the IRB, in consultation with medical and fitness professionals (including certified doctors and fitness trainers) to ensure that it is safe, challenging, and achievable. The base formula, which assumes a 5% weight loss as is often defined to be the medically significant level, is:

(P*W-x*5%*W)/(95%*W)

where P is PBF at baseline (week 1), W is body mass in kg at baseline, P×W is their body fat mass at baseline, and x, ranging between 0% and 100%, is the parameter that is set in consultation with professionals. At 100%, it implies that all 5% in weight loss is from fat, vice versa.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singaporeans or Permanent Residents
  • Overweight (BMI: 23 to 27.5)
  • Participants need to own a smartphone or tablet
  • Must be able to commit to a 24-week research program focused on improving health
  • Own a smartphone or tablet

排除标准

  • Chronically diseased (e.g. hypertension, hyperglycemia, hyperlipidemia), or is suffering or suffered from medical conditions (e.g. stroke, heart attack).
  • Currently pregnant or breastfeeding or intending to become pregnant over the next year
  • Currently participating in any other research program focused on physical activity or weight loss
  • Currently taking any prescribed medications.

结局指标

主要结局

Weekly Achievement Percentage

时间窗: Through study completion (24 weeks)

A percentage of the change in PBF from the predetermined change in PBF

Whether reaching the prescribed PBF goal

时间窗: At the end of the 12 weeks

This is binary variable, which is 1 if the participant reaches the prescribed PBF goal, and 0 otherwise

Whether maintaining what has achieved in the post-treatment period

时间窗: At the end of the 24 weeks

This is binary variable, which is 1 if the participant loses more fat in the post-treatment period than in the intervention period, and 0 otherwise.

Achievement Percentage

时间窗: At the end of the 24 weeks

A percentage of the change in PBF from the predetermined change in PBF

次要结局

未报告次要终点

研究者

发起方
Noah Lim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Noah Lim

Professor

National University of Singapore

研究点 (1)

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