Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives (EPAWROSFI)

Seoul National University

Status: Unknown

Conditions: Obesity

Treatments: Device: smartcare; Other: financial incentives

Study type: Interventional

Funder types: Other

Identifiers

NCT02548182

1-2-1-002-12

Details and patient eligibility

About

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.

Full 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

Enrollment: 105 estimated patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: smartcare

smartcare plus financial incentives

Active Comparator group

Description:

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.

Treatment:

Other: financial incentives

Device: smartcare