Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To quantify the effectiveness of a 'smartcare' intervention to promote physical activity and reduce weight over a 12 week period. To quantify the incremental effectiveness of adding financial incentives to 'smartcare' intervention

Official Title
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Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives: A Pilot Randomized Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Device: smartcare
* Other: financial incentives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male students aged between 19 to 45; body mass index ≥ 27; smartphone user (either Android or iPhone); able and willing to attend a four pre-specified visit during the study period. Exclusion Criteria: any treatment involving pharmacotherapy, procedure, or surgery; use of any activity tracker device during the last three months. Those who answered positively to any Physical Activity Readiness Questionnaire (PAR-Q) question were also excluded.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>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. | |
| Active Comparator: smartcare<br>Participants allocated to a smartcare arms received the Fit.life™ wireless physical activity tracker (Fit.life™, 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. | Device: smartcare<br>* Fit.life™ 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.life™ 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.<br>* Other names: Fit.life™ wireless physical activity tracker;|
| Active Comparator: smartcare plus financial incentives<br>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. | Device: smartcare<br>* Fit.life™ 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.life™ 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.<br>* Other names: Fit.life™ wireless physical activity tracker;Other: financial incentives<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |