Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives

Obesity Clinical Trial

— EPAWROSFI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02548182
• Other study ID #: 1-2-1-002-12
• Status: Active, not recruiting
• Phase: N/A
• First received: September 7, 2015
• Last updated: September 11, 2015
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Device:
• smartcare
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.

Other:
• financial 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Korea Health Industry Development Institute

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the amount of weight loss (kg)	Body weight change from the baseline body weight at each visit (4, 8, 12 week)	12 weeks	No
Secondary	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	No