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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Ta-Cheng Huang, PhD contact

+6566012086

tchuang@nus.edu.sg

Singapore1 site, 1 recruiting
  • National University of Singapore

    Singapore

    Ta-Cheng Huang

    Recruiting

Other trials in Singapore

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:

  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.

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 groups in NCT04954547
Study groupRoleWhat they receive
Subsidy ArmExperimentalParticipants 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 ArmExperimentalParticipants in the arm will receive S$350 if they reach the PBF goal.
Receives: Behavioral: Cash Treatment
ControlNo interventionOther 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.

  1. 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

  2. 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

  3. Achievement Percentage

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

    Measured: At the end of the 24 weeks

  4. 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.

  1. First posted8 Jul 2021
  2. Study start23 Aug 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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)
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

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.

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