A Randomized Incentive-Based Weight Loss Trial in Singapore
| Tracking Information | |||||
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| First Received Date ICMJE | February 12, 2012 | ||||
| Last Updated Date | May 13, 2013 | ||||
| Start Date ICMJE | September 2012 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Weight change [ Time Frame: Baseline, 4 months, 8 months and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01533454 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Randomized Incentive-Based Weight Loss Trial in Singapore | ||||
| Official Title ICMJE | A Randomized Incentive-Based Weight Loss Trial in Singapore | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Individuals aged 21 and above with a BMI greater than 25. |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Financial Incentives
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. |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 188 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Singapore | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01533454 | ||||
| Other Study ID Numbers ICMJE | 0742_001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Eric A. Finkelstein, Duke-NUS Graduate Medical School | ||||
| Study Sponsor ICMJE | Duke-NUS Graduate Medical School | ||||
| Collaborators ICMJE | Singapore General Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Duke-NUS Graduate Medical School | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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