Obesity
Conditions
Brief summary
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
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
Interventions
DEVICEsmartcare
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.
OTHERfinancial incentives
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)
Sponsors
Korea Health Industry Development Institute
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. male students aged between 19 to 45; 2. body mass index ≥ 27; 3. smartphone user (either Android or iPhone); 4. able and willing to attend a four pre-specified visit during the study period.
Exclusion criteria
1. any treatment involving pharmacotherapy, procedure, or surgery; 2. use of any activity tracker device during the last three months. 3. Those who answered positively to any Physical Activity Readiness Questionnaire (PAR-Q) question were also excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the amount of weight loss (kg) | 12 weeks | Body weight change from the baseline body weight at each visit (4, 8, 12 week) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the level of physical activity (METs*hour/week) | 12 weeks | 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) |
Outcome results
None listed