Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives

Not Applicable

• Conditions: Obesity
• Interventions: Device: smartcare; Other: financial incentives

• Registration Number: NCT02548182
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Study Start: 2015-03
• Status Verified: 2015-08
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-11
• Last Update Submitted: 2015-09-11
• Study First Posted: 2015-09-14
• Last Update Posted: 2015-09-14
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 105

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
smartcare plus financial incentives	financial incentives	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.
smartcare plus financial incentives	smartcare	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.
smartcare	smartcare	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.

Primary Outcome Measures

Name	Time	Method
the amount of weight loss (kg)	12 weeks	Body weight change from the baseline body weight at each visit (4, 8, 12 week)

Secondary Outcome Measures

Name	Time	Method
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)