Clinical trial NCT02548182: Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives
Official title: Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2015-09-14
Enrollment: 105
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: the amount of weight loss (kg)
timeFrame: 12 weeks
Secondary outcomes:
measure: the level of physical activity (METs*hour/week)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Depart. of Family Medicine/Center for Health Promotion and Optimal Aging, Seoul National University Hospital
name: Belong Cho, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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. doi: 10.1097/JOM.0b013e31813c6dcb.
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.
citation: Shin DW, Yun JM, Shin JH, Kwon H, Min HY, Joh HK, Chung WJ, Park JH, Jung KT, Cho B. Enhancing physical activity and reducing obesity through smartcare and financial incentives: A pilot randomized trial. Obesity (Silver Spring). 2017 Feb;25(2):302-310. doi: 10.1002/oby.21731. Epub 2017 Jan 7.