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ObesityEPAWROSFINCT02548182

Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives

A study testing smartcare and financial incentives in people with Obesity, run by Seoul National University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 19 to 45 years, men only
Conditions the study is for
Obesity
What is being tested?
smartcare and financial incentives
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
No sites listed yet
Study dates
Mar 2015to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • male students aged between 19 to 45;
  • body mass index ≥ 27;
  • smartphone user (either Android or iPhone);
  • able and willing to attend a four pre-specified visit during the study period.

Who cannot join

  • any treatment involving pharmacotherapy, procedure, or surgery;
  • use of any activity tracker device during the last three months.
  • Those who answered positively to any Physical Activity Readiness Questionnaire (PAR-Q) question were also excluded.

About this study

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

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.

Read the 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
Conditions
Obesity
Being tested
smartcare, financial incentives
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • smartcareDevice

    Also called Fit.life™ wireless physical activity tracker

    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.

  • financial incentivesOther

    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)

Study groups in NCT02548182
Study groupRoleWhat they receive
controlNo interventionA 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.
smartcareActive comparatorParticipants 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.
Receives: Device: smartcare
smartcare plus financial incentivesActive comparatorParticipants 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.
Receives: Device: smartcare; Other: financial incentives

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the amount of weight loss (kg)

    Body weight change from the baseline body weight at each visit (4, 8, 12 week)

    Measured: 12 weeks

Secondary outcomes (1)

  1. 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)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionNov 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02548182
Sponsor's protocol ID
1-2-1-002-12
Acronym
EPAWROSFI
Status last verified
Aug 2015
First submitted
7 Sep 2015
Last updated
14 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19066383

  • 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.

    PubMed 25970009

  • 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.

    PubMed 17848854

  • 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.

    PubMed 24618584

  • 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.

    PubMed 28063226

Questions about this trial

What is this clinical trial studying?

A study testing smartcare and financial incentives in people with Obesity, run by Seoul National University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the amount of weight loss (kg) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02548182, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2015.

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