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临床试验/NCT04973072
NCT04973072Unknown不适用

The Effect of Small Wins on Body Fat Loss

Noah Lim1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年9月13日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
1
主要终点
Whether maintaining what has achieved in the post-treatment period

研究概览

简要总结

This 24-week-long study compares the effectiveness of two finance incentive structures for weight loss: 1) smaller rewards for achieving intermediate goals vs 2) large reward for achieving an overall goal. Target participants are male Singaporeans or Permanent Residents who are overweight and 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: smaller rewards for achieving intermediate goals vs. a large reward for achieving an overall goal - on weight loss. Male Singaporeans or Permanent Residents between the ages of 25 and 60 will be recruited. Participants must be healthy and have a body mass index (BMI) of between 23 and 27.5, and own and use a smartphone or tablet. Participants will be given an individual-tailored percentage body fat (PBF) goal and will be blinded from the presence of different treatment conditions and randomly assigned to one of the three conditions for 12 weeks:

  1. Control group. Participants will receive only participation fees.
  2. One large reward treatment. Participants will be awarded S$X for reaching the PBF goal at the end of 12 weeks.
  3. Small wins treatment. Participants in the Small wins treatment condition will also be given 3 triweekly intermediate goals (IGs). Specifically, given the PBF goal, the PBF Loss Target (LT) is the difference between the initial PBF measured at the first visit and the goal, i.e., LT = initial PBF - PBF goal. Then, the IG1 is to achieve 25% of the LT, the IG2 is to achieve 50% of the LT, and the IG3 is to achieve 75% of the LT. The cash rewards that participants will receive are capped by S$X and depend on which IGs participants achieve and whether participants maintain their progress at the end of the 12 weeks.

All participants will be given an individual-tailored 12-week percentage body fat (PBF) goal. The formula for this goal will be set 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
Male
接受健康志愿者

入选标准

  • Singaporeans or PRs
  • Between the ages of 25 and 60
  • Body mass index (BMI) of between 23 and 27.5
  • Own and use a smartphone or tablet

排除标准

  • Currently participating in any other research program focused on physical activity or weight loss. Note: exercise or education programs (e.g. gym membership, diabetes education class) do not count as research programs.
  • Have any reasons why they would not be able to complete a 24-week research program focused on improving health (e.g., plan to move to another country)
  • Have a serious medical condition, including one or more of the following conditions: High blood pressure (hypertension), High cholesterol (Hyperlipidaemia), Heart attack (Myocardial infarction), Heart failure, Stroke (Cerebrovascular disease), Chronic obstructive pulmonary disease (COPD), Kidney disease, and Diabetes (Type 2).

结局指标

主要结局

Whether maintaining what has achieved in the post-treatment period

时间窗: At the end of the 24 weeks

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

Whether reaching the prescribed PBF goal

时间窗: At the end of the 12 weeks

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

Achievement Percentage

时间窗: At the end of the 12 weeks

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

Weekly Achievement Percentage

时间窗: Through the study completion (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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