Weight ReductionNCT03534336

Behavioral Economics-Based Online Lifestyle Balance Program

A study testing Incentive for Education and Incentive for Weight Loss in people with Weight Reduction and Health Knowledge, Attitudes, Practice, run by National University of Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Weight Reduction, Health Knowledge, Attitudes, Practice
What is being tested?: Incentive for Education and Incentive for Weight Loss
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 710 participants
Where: 1 siteSingapore
Study dates: 12 Oct 2015to 22 Jun 2016
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 40 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

BMI between 23 and 33
Age between 40 and 60 years old

Who cannot join

History of diabetes
History of significant cardiovascular disease
Family history of atherosclerosis
High blood pressure
Significant lung disease

Trial locations and contacts

1 site in 1 country.

Singapore1 site

National University of Singapore
Singapore, 119077

Other trials in Singapore

About this study

The objective of this project is to design a Behavioral Economics Based Online Lifestyle Balance Program that employs behavioral economics to engage and motivate adherence to an Internet-based program. The investigators compare the effects of two financial incentives on inducing weight loss: a direct financial incentive for weight loss and a financial incentive for health literacy.

Read the detailed description

This project investigates whether participants in an online weight loss program can be induced to achieve weight loss using financial incentives. The study is a 3-arm randomized controlled trial (RCT) stratified by gender. The goal is to examine how overweight individuals respond to two different types of financial incentives. The first type of incentive, incentive for weight loss (IW), is a cash award of approximately $150 given for achieving 5% weight loss over 12 weeks. The second type of incentive, incentive for education (IE), is a $150 award for passing quizzes that test the participants' health literacy about weight loss and the techniques required for maintaining a healthy lifestyle. The investigators compare the effectiveness of IW to IE in promoting weight loss in overweight individuals and investigate whether the two incentives work equally well for men and women.

Conditions: Weight Reduction, Health Knowledge, Attitudes, Practice
Being tested: Incentive for Education, Incentive for Weight Loss
Keywords: Weight Reduction, Health Literacy, Financial Incentives, Lifestyle Change
Medical subject headings: Weight Loss, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Incentive for EducationBehavioural
A $150 "Incentive for Education" is given to the participants for passing at least nine quizzes by the end of the program
Incentive for Weight LossBehavioural
A $150 "Incentive for Weight Loss" is given to the participants for losing at least 5% of baseline weight by the end of the program

Study groups in NCT03534336
Study group	Role	What they receive
Control	No intervention	Participants are enrolled in a 12-week, self-administered online weight loss program. The program is delivered through 12 weekly sessions; each includes educational videos and a health literacy quiz. Each quiz contains 10 questions, and a quiz is considered "passed" when at least 7 questions are answered correctly. All participants are encouraged to follow the program, take the quizzes, and lose 5% of their baseline body weight by the end of the program. No financial incentives are given for losing weight or passing quizzes.
Incentive for Education	Experimental	Same 12-week, self-administered online weight loss program as in the Control arm. Each participant is also given a $150 "Incentive for Education" for passing at least nine quizzes by the end of the program. Receives: Behavioral: Incentive for Education
Incentive for Weight Loss	Experimental	Same 12-week, self-administered online weight loss program as in the Control arm. Each participant is also given a $150 "Incentive for Weight Loss" for losing 5% of their baseline body weight. Receives: Behavioral: Incentive for Weight Loss

What is being measured

The primary outcome is the main question the study is designed to answer.

Weight Loss at the end of the weight loss program (at Week 13)
Weight measured at the Week 13 weigh-in session. Weight measurements are taken by trained research assistants using digital scales.
Measured: At week 13 of the RCT.

Secondary outcomes (1)

Weight Loss at the end of the post-intervention period (Week 25)
Weight measured at the Week 25 weigh-in session. Weight measurements are taken by trained research assistants using digital scales.
Measured: At week 25 of the RCT.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 201522 Jun 2016

First posted23 May 2018
Study start12 Oct 2015
Primary completion22 Jun 2016
Study completion22 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Weight ReductionStudies 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: Treatment
Allocation: Randomised
Intervention model: Factorial
Model description: 3-arm RCT (Control, Incentive for Weight Loss, Incentive for Education) stratified by Gender.
Masking: Single blind
Who is masked: Participant
Enrolment: 710 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03534336
Sponsor's protocol ID: A-14-071
Status last verified: Aug 2018
First submitted: 11 May 2018
Last updated: 22 Aug 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in the research, after de-identification (text, tables, figures, and appendices).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
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All Weight Reduction trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral Economics-Based Online Lifestyle Balance Program
ClinicalTrials.gov ID: NCT03534336
Acronym / sponsor ID: A-14-071
Conditions: Weight Reduction, Health Knowledge, Attitudes, Practice
Keywords: Weight Reduction, Health Literacy, Financial Incentives, Lifestyle Change
Study type: Interventional
Recruitment status: Completed
Enrolment: 710 participants (actual)
Lead sponsor: National University of SingaporeUniversity, hospital or other
Study start: 12 Oct 2015 (actual)
Primary completion: 22 Jun 2016 (actual)
Study completion: 22 Jun 2016 (actual)
First posted: 23 May 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 3
Model description: 3-arm RCT (Control, Incentive for Weight Loss, Incentive for Education) stratified by Gender.

Arm	Type	Receives
Control	No intervention	–Participants are enrolled in a 12-week, self-administered online weight loss program. The program is delivered through 12 weekly sessions; each includes educational videos and a health literacy quiz. Each quiz contains 10 questions, and a quiz is considered "passed" when at least 7 questions are answered correctly. All participants are encouraged to follow the program, take the quizzes, and lose 5% of their baseline body weight by the end of the program. No financial incentives are given for losing weight or passing quizzes.
Incentive for Education	Experimental	Behavioral: Incentive for EducationSame 12-week, self-administered online weight loss program as in the Control arm. Each participant is also given a $150 "Incentive for Education" for passing at least nine quizzes by the end of the program.
Incentive for Weight Loss	Experimental	Behavioral: Incentive for Weight LossSame 12-week, self-administered online weight loss program as in the Control arm. Each participant is also given a $150 "Incentive for Weight Loss" for losing 5% of their baseline body weight.

Who may qualify

Ages: 40 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

BMI between 23 and 33
Age between 40 and 60 years old

Key exclusion criteria (5 listed)

History of diabetes
History of significant cardiovascular disease
Family history of atherosclerosis
High blood pressure
Significant lung disease

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
Incentive for EducationA $150 "Incentive for Education" is given to the participants for passing at least nine quizzes by the end of the program	Behavioural	Incentive for Education
Incentive for Weight LossA $150 "Incentive for Weight Loss" is given to the participants for losing at least 5% of baseline weight by the end of the program	Behavioural	Incentive for Weight Loss

Primary outcome

Weight Loss at the end of the weight loss program (at Week 13)
Time frame: At week 13 of the RCT.
Weight measured at the Week 13 weigh-in session. Weight measurements are taken by trained research assistants using digital scales.

1 secondary outcome

Weight Loss at the end of the post-intervention period (Week 25)
Time frame: At week 25 of the RCT.

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 22 Aug 2018.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the research, after de-identification (text, tables, figures, and appendices).

Related trials for Weight Reduction

Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingPhase 1/2
Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer, Cancer-Associated Weight Loss
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
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Not yet recruitingPhase 3
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
Obesity

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 5 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 22 Aug 2018. 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 Loss at the end of the weight loss program (at Week 13) (time frame: At week 13 of the RCT.). 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 NCT03534336.

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 22 Aug 2018.