- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03534336
Behavioral Economics-Based Online Lifestyle Balance Program
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 119077
- National University of Singapore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI between 23 and 33
- Age between 40 and 60 years old
Exclusion Criteria:
- History of diabetes
- History of significant cardiovascular disease
- Family history of atherosclerosis
- High blood pressure
- Significant lung disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
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. |
|
EXPERIMENTAL: Incentive for Education
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. |
A $150 "Incentive for Education" is given to the participants for passing at least nine quizzes by the end of the program
|
EXPERIMENTAL: Incentive for Weight Loss
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. |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At week 13 of the RCT.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Loss at the end of the post-intervention period (Week 25)
Time Frame: At week 25 of the RCT.
|
Weight measured at the Week 25 weigh-in session.
Weight measurements are taken by trained research assistants using digital scales.
|
At week 25 of the RCT.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-14-071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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