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The Effect of Activities-based Subsidy on Body Fat Loss

Primary Purpose

Overweight

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Subsidy Treatment
Cash Treatment
Sponsored by
Noah Lim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Singaporeans or Permanent Residents
  • Female
  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • National University of SingaporeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Subsidy Arm

Cash Arm

Control

Arm Description

Participants in the arm will receive $$50 if they reach the PBF goal and will be subsidized on approved health-improving expenses.

Participants in the arm will receive S$350 if they reach the PBF goal.

Other than the participation fees, no additional incentives will be provided.

Outcomes

Primary Outcome Measures

Whether reaching the prescribed PBF goal
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
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
A percentage of the change in PBF from the predetermined change in PBF
Weekly Achievement Percentage
A percentage of the change in PBF from the predetermined change in PBF

Secondary Outcome Measures

Full Information

First Posted
June 21, 2021
Last Updated
April 24, 2022
Sponsor
Noah Lim
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1. Study Identification

Unique Protocol Identification Number
NCT04954547
Brief Title
The Effect of Activities-based Subsidy on Body Fat Loss
Official Title
The Effect of Activities-based Subsidy on Body Fat Loss
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Noah Lim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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: 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. Cash treatment group (CTG). Participants will be awarded $(X+Y) for reaching the PBF goal at the end of 12 weeks. 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. Because P and W differ between most persons, our formula tailors a different goal to each research subject. Our formula is meant to be flexible toward each participant's baseline weight and body fat percent. Leveraging the 5% weight loss target, the investigators determined the expected percentage of this weight that is lost as fat, knowing that weight loss includes not only fat loss but also other components such as water loss. In previous studies, for 1 kg loss in weight, on average, 78.8% came from body fat. Hence, the investigators have targeted 80% of weight loss from our participants to come from body fat. To examine changes in health, objective measurements will be made during scheduled participant visits on Weeks 1, 12, and 24. Measures include height, weight, waist circumference, and PBF. Each participant will also be given a free digital scale for personal use from home. Their weight and PBF data from the scale will be synchronized to a mobile application, which we will retrieve with the participant's consent, to examine changes throughout the study's duration. There are a total of 3 scheduled visits. The first in Week 1 allows us to determine the baseline measures. The second visit in Week 12 marks the end of the treatment and allows us to investigate treatment effects. The last visit in Week 24 checks for post-treatment effects. During all 3 visits, the participants will also complete a Health Risk Assessment Survey. This survey should take no longer than 10 minutes to complete, and the research team will be physically present to assist them with it if so required. Due to the uncertainty of the pandemic, the investigators may hold the second and/or the third research visits virtually (or at least provide an online option) to avoid large gatherings if necessary. For each virtual research visit, the research team will contact the participants through a video call, during which they will step on the weighing scales and show the readings to the team. If a research visit is held online, the participation fee/rewards will be sent electronically. The research team will still hold physical meetings for those who experience technical difficulties. To let participants track their PBF progress, every participant would be given a digital scale for their keeping even after the research has concluded. The scale, named 'Lite Mould Body Composition Smart Scale', priced at US$13 (before shipping) is commercially available and will be supplied by the manufacturer 'Yolanda'. It comes with a free mobile application to let them track their progress. The app is publicly available on the Apple and Google Play stores for free under the name 'Feelfit' by Shenzhen QingNiu Software Co. Ltd. Referring to the Health Products Act (HPA), this scale would not be defined as a "medical device". The digital scale serves simply, as would a conventional scale, to inform the user on some bodily metric. It does not attempt to make any medical judgment or recommendation for the user. The research team has done testing on the digital scale and is satisfied with the precision of the device. The participants are expected to weigh-in on the scales weekly from home at their convenience. In the middle of each of the 12 weeks (e.g. Wednesday or Thursday), an automated email will be sent to the participants reminding them to do so by the end of the week (Sunday). Non-compliance will not be penalized, but participants are strongly encouraged to weigh-in. The following is the complete list of data that the participants will have access to from the scale's mobile application. The researchers, with the participants' consent, will also retrieve this data for analysis: 1. Basal metabolism rate; 2. BMI; 3. Bone mass; 4. Metabolic age; 5. Muscle mass; 6. PBF; 7. Skeletal muscle weight ratio; 8. Subcutaneous fat; 9. Total body water; 10. Visceral fat; 11. Weight The study will be split into two waves of 300 participants. The investigators will start the first wave when they successfully recruit 300 eligible participants in the first recruitment phase and the second wave with another 300 eligible participants in the second recruitment phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subsidy Arm
Arm Type
Experimental
Arm Description
Participants in the arm will receive $$50 if they reach the PBF goal and will be subsidized on approved health-improving expenses.
Arm Title
Cash Arm
Arm Type
Experimental
Arm Description
Participants in the arm will receive S$350 if they reach the PBF goal.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Other than the participation fees, no additional incentives will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Subsidy Treatment
Intervention Description
Participants will be awarded $50 for reaching the PBF goal at the end of 12 weeks. Regardless of goal-attainment, participants will be reimbursed 50% of approved health-improving expenses up to a cap of $300 in the 12 weeks. The subsidy is voluntary and flexible, with no direct intervention from researchers - participants will submit receipts and simply be reimbursed at the end of the experiment (subject to approval from the research team).
Intervention Type
Behavioral
Intervention Name(s)
Cash Treatment
Intervention Description
Participants will be awarded $350 for reaching the PBF goal at the end of 12 weeks.
Primary Outcome Measure Information:
Title
Whether reaching the prescribed PBF goal
Description
This is binary variable, which is 1 if the participant reaches the prescribed PBF goal, and 0 otherwise
Time Frame
At the end of the 12 weeks
Title
Whether maintaining what has achieved in the post-treatment period
Description
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.
Time Frame
At the end of the 24 weeks
Title
Achievement Percentage
Description
A percentage of the change in PBF from the predetermined change in PBF
Time Frame
At the end of the 24 weeks
Title
Weekly Achievement Percentage
Description
A percentage of the change in PBF from the predetermined change in PBF
Time Frame
Through study completion (24 weeks)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Singaporeans or Permanent Residents Female 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ta-Cheng Huang, PhD
Phone
+6566012086
Email
tchuang@nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Lim, PhD
Organizational Affiliation
The Global Asia Institute, The National University of Singapore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrea Chung, PhD
Organizational Affiliation
Booz Allen Hamilton
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ta-Cheng Huang, PhD
Organizational Affiliation
The Global Asia Institute, The National University of Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kegon Tan, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Singapore
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ta-Cheng Huang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17075583
Citation
Chaston TB, Dixon JB, O'Brien PE. Changes in fat-free mass during significant weight loss: a systematic review. Int J Obes (Lond). 2007 May;31(5):743-50. doi: 10.1038/sj.ijo.0803483. Epub 2006 Oct 31.
Results Reference
background

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The Effect of Activities-based Subsidy on Body Fat Loss

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