OverweightNCT04954547
The Effect of Activities-based Subsidy on Body Fat Loss
A study testing Subsidy Treatment and Cash Treatment in people with Overweight, run by Noah Lim at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Overweight
- What is being tested?
- Subsidy Treatment and Cash Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Aug 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University of Singapore
Singapore
Ta-Cheng Huang
About this study
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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Subsidy Treatment, Cash Treatment
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subsidy TreatmentBehavioural
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).
Cash TreatmentBehavioural
Participants will be awarded $350 for reaching the PBF goal at the end of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Subsidy Arm | Experimental | Participants in the arm will receive $$50 if they reach the PBF goal and will be subsidized on approved health-improving expenses. Receives: Behavioral: Subsidy Treatment |
| Cash Arm | Experimental | Participants in the arm will receive S$350 if they reach the PBF goal. Receives: Behavioral: Cash Treatment |
| Control | No intervention | Other than the participation fees, no additional incentives will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether reaching the prescribed PBF goal
This is binary variable, which is 1 if the participant reaches the prescribed PBF goal, and 0 otherwise
Measured: At the end of the 12 weeks
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.
Measured: At the end of the 24 weeks
Achievement Percentage
A percentage of the change in PBF from the predetermined change in PBF
Measured: At the end of the 24 weeks
Weekly Achievement Percentage
A percentage of the change in PBF from the predetermined change in PBF
Measured: Through study completion (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start23 Aug 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noah Lim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noah Lim, National University of Singapore
- Investigators
- Noah Lim, PhD, Study director, The Global Asia Institute, The National University of SingaporeAndrea Chung, PhD, Principal investigator, Booz Allen HamiltonTa-Cheng Huang, PhD, Principal investigator, The Global Asia Institute, The National University of SingaporeKegon Tan, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954547
- Sponsor's protocol ID
- NUS-IRB-2020-643
- Status last verified
- Apr 2022
- First submitted
- 21 Jun 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17075583
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Activities-based Subsidy on Body Fat Loss
- ClinicalTrials.gov ID
- NCT04954547
- Acronym / sponsor ID
- NUS-IRB-2020-643
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Noah LimUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subsidy Arm | Experimental | Behavioral: Subsidy TreatmentParticipants in the arm will receive $$50 if they reach the PBF goal and will be subsidized on approved health-improving expenses. |
| Cash Arm | Experimental | Behavioral: Cash TreatmentParticipants in the arm will receive S$350 if they reach the PBF goal. |
| Control | No intervention | –Other than the participation fees, no additional incentives will be provided. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subsidy TreatmentParticipants 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). | Behavioural | Subsidy Arm |
| Cash TreatmentParticipants will be awarded $350 for reaching the PBF goal at the end of 12 weeks. | Behavioural | Cash Arm |
Primary outcome
Whether reaching the prescribed PBF goal
Time frame: 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
Time frame: 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
Time frame: At the end of the 24 weeks
A percentage of the change in PBF from the predetermined change in PBF
Weekly Achievement Percentage
Time frame: Through study completion (24 weeks)
A percentage of the change in PBF from the predetermined change in PBF
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Background: PubMed 17075583Chaston 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Lim, PhD study director
The Global Asia Institute, The National University of Singapore
Andrea Chung, PhD principal investigator
Booz Allen Hamilton
Ta-Cheng Huang, PhD principal investigator
The Global Asia Institute, The National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subsidy Treatment and Cash Treatment in people with Overweight, run by Noah Lim at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ta-Cheng Huang, PhD (+6566012086, tchuang@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether reaching the prescribed PBF goal (time frame: At the end of the 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04954547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.