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| Name | Class |
|---|---|
| Korea Health Industry Development Institute | OTHER_GOV |
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The investigators are planning to conduct a pilot RCT of young obese population to evaluate the effect of smartcare with or without financial incentives for 12 weeks. Participants will be randomly assigned to a three-arm of control, smartcare, and smartcare plus financial incentives group.
To test the feasibility and potential impact of smartcare with or without financial incentives, the study employed a three-arm, open label randomized controlled trial design: control, smartcare, and smartcare plus financial incentives. The investigators hypothesized that the 'smartcare + financial incentive' arm will show the greatest change in outcomes, followed by the 'smartcare' only arm, and lastly the control arm. Specific aims of the study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | A standardized education material on diet, exercise, and behavior modification were provided to all participants, and each participant received a one-to-one education on diet and exercise from a trained nurse for 5 minutes each session. | |
| smartcare | Active Comparator | Participants allocated to a smartcare arms received the Fit.lifeā¢ wireless physical activity tracker (Fit.lifeā¢, Suwon, Korea) that measures daily and weekly physical activity. It is convenient for data upload via Bluetooth on participant mobile phone or wirelessly via a personal computer, and has been validated for measurement of free-living physical activity in adults [REF]. Participants allocated to a smartcare arms were also provided a standardized education material on diet, exercise, and behavior modification. |
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| smartcare plus financial incentives | Active Comparator | Participants in the 'smartcare plus financial incentive' arms were told that they are entitled to receive financial incentives depending on their achievement of the physical activity and weight target, and the amount they ca expect .The investigators provide financial incentives classified as process-based incentive and outcome-based incentive in addition to smartcare group intervention. A smartphone application was customized for the use of the investigators' intervention, different for the 'smart care' group and 'smartcare plus financial incentive' group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smartcare | Device | Fit.lifeā¢ wireless physical activity tracker can measure daily physical activity including activity strength and time. It was chosen for its small size, accuracy in the measurement of physical activity, and convenient data upload via Bluetooth on participant mobile phone or wirelessly via a personal computer. Fit.lifeā¢ wireless physical activity tracker has been validated for measurement of free-living physical activity in adults [REF]. A smartphone application was customized for the use of the investigators' intervention, different for the 'smart care' group and 'smartcare plus financial incentive' group. The version for the latter group included the feature for the monitoring and feedback of financial incentives. |
| Measure | Description | Time Frame |
|---|---|---|
| the amount of weight loss (kg) | Body weight change from the baseline body weight at each visit (4, 8, 12 week) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the level of physical activity (METs*hour/week) | Average weekly physical activity(METs*hour/week) calculated by the IPAQ(International Physical Activity Questionnaire) at visit 4 (12 week), Physical activity change (METs*hour/week) from the baseline body weight at visit 4 (12 week) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Belong Cho, MD, MPH, PhD | Depart. of Family Medicine/Center for Health Promotion and Optimal Aging, Seoul National University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19066383 | Background | Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804. | |
| 25970009 | Background | Halpern SD, French B, Small DS, Saulsgiver K, Harhay MO, Audrain-McGovern J, Loewenstein G, Brennan TA, Asch DA, Volpp KG. Randomized trial of four financial-incentive programs for smoking cessation. N Engl J Med. 2015 May 28;372(22):2108-17. doi: 10.1056/NEJMoa1414293. Epub 2015 May 13. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| financial incentives | Other | Financial incentives are provided in the form of process-based and outcome-based incentive.(maximum 320,000KRW) Process-based incentives were based on daily physical activity level. Participants in the 'smart care plus financial incentive' arms could earn incentives of up to 10,000 KRW per week according to the following schedule: 1,000 KRW if a participant reached target amount of physical activity in a day / An additional 3,000 KRW if a participant reached target amount of physical activity every day in a week. Outcome-based incentives were based on achievement of weight loss target at each visit. 50,000 KRW if a participant reached weight loss target of 3% from the baseline body weight at visit 2 (4 week)/ 50,000 KRW in weight loss target of 5% from the baseline body weight at visit 3 (8 week) / 100,000 KRW in weight loss target of 7% from the baseline body weight at final visit 4 (12 week) |
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| 17848854 | Background | Finkelstein EA, Linnan LA, Tate DF, Birken BE. A pilot study testing the effect of different levels of financial incentives on weight loss among overweight employees. J Occup Environ Med. 2007 Sep;49(9):981-9. doi: 10.1097/JOM.0b013e31813c6dcb. |
| 24618584 | Background | Giles EL, Robalino S, McColl E, Sniehotta FF, Adams J. The effectiveness of financial incentives for health behaviour change: systematic review and meta-analysis. PLoS One. 2014 Mar 11;9(3):e90347. doi: 10.1371/journal.pone.0090347. eCollection 2014. |
| 28063226 | Derived | Shin DW, Yun JM, Shin JH, Kwon H, Min HY, Joh HK, Chung WJ, Park JH, Jung KT, Cho B. Enhancing physical activity and reducing obesity through smartcare and financial incentives: A pilot randomized trial. Obesity (Silver Spring). 2017 Feb;25(2):302-310. doi: 10.1002/oby.21731. Epub 2017 Jan 7. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |