ObesityNCT01533454
A Randomized Incentive-Based Weight Loss Trial in Singapore
A study testing Financial Incentives in people with Obesity and Incentives, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
The purpose of this study is to test the extent to which incentives, when combined with an existing evidence-based weight loss program, improve weight loss and weight loss maintenance. It will also compare the cost-effectiveness of the incentive-based weight loss programs to the basic program without incentives. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Incentives
- What is being tested?
- Financial Incentives
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2012to Oct 2015
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Age 21+
- BMI 25+
- Willing to be randomized into 1 of the 2 study arms
- Willing to pay the $399 entry fee
- Stated willingness to commit to participating in all assessments regardless of weight change or study arm
Who cannot join
- Current pregnancy/lactation (women who become pregnant during the study will be withdrawn)
- Type 1 diabetes
- Type 2 diabetes on medication other than Metformin
- End-stage Renal Disease
- Ischemic Heart Disease requiring intervention in the past 6 months
- Thyroid disease that has yet to stabilize
Show all 19Show fewer
- Changes in weight of greater than 3% in the past 6 months
- Use of weight loss medication in the past 6 months
- Malignancy requiring chemotherapy/radiation in the past 5 years
- Acute medical problems requiring 3+ days of missed work during previous 4 week period
- Any serious hospitalization or surgery in the past 6 months
- Use of corticosteroids in the past 6 months
- Answer 'YES' to any of the PAR-Q questions
- Unable to obtain MD consent from a physician giving permission to participate in the study
- Evidence of clinical depression (as assessed by the Beck Depression Inventory)
- Currently on medications for a mental health or substance abuse condition
- Evidence of binge eating based on the Binge Eating Disorders Scale (BEDS)
- Unable to communicate in English
- Additional concerns in which the clinical investigator deems problematic for participation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test the extent to which incentives, when combined with an existing evidence-based weight loss program, improve weight loss and weight loss maintenance. It will also compare the cost-effectiveness of the incentive-based weight loss programs to the basic program without incentives.
Read the detailed description
Globally, the rise in obesity rates has reached epidemic proportions, and in Singapore 53% of adults have a body mass index (BMI) great than 23.0 kg/m2, a level that increases risk for chronic disease among Asians. This study aims to test the extent to which traditional or behavioural economic incentives, when combined with an existing evidence-based weight loss program, improve weight loss and weight loss maintenance. Data will be collected through a two-arm (basic weight loss program, basic program plus traditional or behavioural economic incentives) randomized controlled trial (RCT) where key outcome variables are defined as weight loss (kilograms) at 8 months when the incentive program concludes, and at 12 months, after a 4 month period in which no additional incentives are provided. We hypothesize that at both 8 and 12 months, weight loss will be greater in the incentive arm than in the arm without incentives. The growing obesity epidemic, the high costs of obesity to employers, insurers and governments across Asia, and the fact that the incentive program is designed to be close to cost neutral, suggest that this research has high potential to have a significant public health impact, both in Singapore and the region.
- Conditions
- Obesity, Incentives
- Being tested
- Financial Incentives
- Keywords
- Obesity, Weight loss, Incentives, Motivation
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentivesOther
Incentive arm participants will be able to earn incentives for meeting specified weight loss targets or step goals. They will be offered a choice between traditional (payments with certainty) and behavioral(payments paid via lottery) incentives.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control participants will attend a 4-month structured weight-loss program and attend subsequent follow-ups at 4-month intervals upon completion of the program. |
| Incentives | Experimental | Incentive arm participants will be offered an additional program (in addition to the COMM program) where they can earn incentives for meeting specified weight loss targets or step goals. They will be offered a choice between traditional (payments with certainty) and behavioral(payments paid via lottery) incentives. Receives: Other: Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Measured: Baseline, 4 months, 8 months and 12 months
Secondary outcomes (7)
Percent body fat
Measured: Baseline, 4 months, 8 months, 12 months
Self-reported physical activity
Measured: Baseline, 4 months, 8 months, 12 months
Steps, aerobic steps and minutes of physical activity
Measured: Monthly through month 8 (in incentive arms)
Intrinsic and Extrinsic motivation
Measured: Baseline
Sociodemographics
Measured: Baseline
Health-related quality of life
Measured: Baseline, 4 months, 8 months, 12 months
Intervention costs
Measured: Baseline through month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2015
- Study completionOct 2015
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 ObesityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Principal investigator, Eric A. Finkelstein, Duke-NUS Graduate Medical School
- Investigators
- Eric A. Finkelstein, PhD, MHA, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533454
- Sponsor's protocol ID
- 0742_001
- Status last verified
- Jan 2016
- First submitted
- 12 Feb 2012
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Finkelstein EA, Tham KW, Haaland BA, Sahasranaman A. Applying economic incentives to increase effectiveness of an outpatient weight loss program (TRIO) - A randomized controlled trial. Soc Sci Med. 2017 Jul;185:63-70. doi: 10.1016/j.socscimed.2017.05.030. Epub 2017 May 15.
PubMed 28554160
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Incentive-Based Weight Loss Trial in Singapore
- ClinicalTrials.gov ID
- NCT01533454
- Acronym / sponsor ID
- 0742_001
- Conditions
- Obesity, Incentives
- Keywords
- Obesity, Weight loss, Incentives, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- Sep 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Feb 2012 (estimated)
- 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.
The purpose of this study is to test the extent to which incentives, when combined with an existing evidence-based weight loss program, improve weight loss and weight loss maintenance. It will also compare the cost-effectiveness of the incentive-based weight loss programs to the basic program without incentives.
Detailed description
Globally, the rise in obesity rates has reached epidemic proportions, and in Singapore 53% of adults have a body mass index (BMI) great than 23.0 kg/m2, a level that increases risk for chronic disease among Asians. This study aims to test the extent to which traditional or behavioural economic incentives, when combined with an existing evidence-based weight loss program, improve weight loss and weight loss maintenance. Data will be collected through a two-arm (basic weight loss program, basic program plus traditional or behavioural economic incentives) randomized controlled trial (RCT) where key outcome variables are defined as weight loss (kilograms) at 8 months when the incentive program concludes, and at 12 months, after a 4 month period in which no additional incentives are provided. We hypothesize that at both 8 and 12 months, weight loss will be greater in the incentive arm than in the arm without incentives. The growing obesity epidemic, the high costs of obesity to employers, insurers and governments across Asia, and the fact that the incentive program is designed to be close to cost neutral, suggest that this research has high potential to have a significant public health impact, both in Singapore and the region.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control participants will attend a 4-month structured weight-loss program and attend subsequent follow-ups at 4-month intervals upon completion of the program. |
| Incentives | Experimental | Other: Financial IncentivesIncentive arm participants will be offered an additional program (in addition to the COMM program) where they can earn incentives for meeting specified weight loss targets or step goals. They will be offered a choice between traditional (payments with certainty) and behavioral(payments paid via lottery) incentives. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Age 21+
- BMI 25+
- Willing to be randomized into 1 of the 2 study arms
- Willing to pay the $399 entry fee
Key exclusion criteria (19 listed)
- Current pregnancy/lactation (women who become pregnant during the study will be withdrawn)
- Type 1 diabetes
- Type 2 diabetes on medication other than Metformin
- End-stage Renal Disease
- Ischemic Heart Disease requiring intervention in the past 6 months
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 |
|---|---|---|
| Financial IncentivesIncentive arm participants will be able to earn incentives for meeting specified weight loss targets or step goals. They will be offered a choice between traditional (payments with certainty) and behavioral(payments paid via lottery) incentives. | Other | Incentives |
Primary outcome
Weight change
Time frame: Baseline, 4 months, 8 months and 12 months
7 secondary outcomes
Percent body fat
Time frame: Baseline, 4 months, 8 months, 12 months
Self-reported physical activity
Time frame: Baseline, 4 months, 8 months, 12 months
Steps, aerobic steps and minutes of physical activity
Time frame: Monthly through month 8 (in incentive arms)
Intrinsic and Extrinsic motivation
Time frame: Baseline
Sociodemographics
Time frame: Baseline
Health-related quality of life
Time frame: Baseline, 4 months, 8 months, 12 months
Intervention costs
Time frame: Baseline through month 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Derived from this study: PubMed 28554160Finkelstein EA, Tham KW, Haaland BA, Sahasranaman A. Applying economic incentives to increase effectiveness of an outpatient weight loss program (TRIO) - A randomized controlled trial. Soc Sci Med. 2017 Jul;185:63-70. doi: 10.1016/j.socscimed.2017.05.030. Epub 2017 May 15.
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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.
Eric A. Finkelstein, PhD, MHA principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentives in people with Obesity and Incentives, run by Duke-NUS Graduate Medical School 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 19 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: finished, as of the sponsor's last update on 5 Jan 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: Baseline, 4 months, 8 months and 12 months). 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 NCT01533454, 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 5 Jan 2016.