Physical ActivityNCT03566277
Project Step: Evaluating Deposit Contracts and Daily Feedback to Promote Walking in Overweight and Obese Adults
A study testing Self-monitoring, Incentives and Feedback in people with Physical Activity and Sedentary Lifestyle, run by Drexel University.
Trial summary
The purpose of this study is to test whether deposit contracts, wherein individuals invest their own money with the study to serve as the incentive, with or without daily feedback about progress help individuals to increase step counts and more often meet a step goal compared to self-monitoring only. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Lifestyle, Obesity
- What is being tested?
- Self-monitoring, Incentives and Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 8 Aug 2017
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25 kg/m2 ≤ BMI ≤ 45 kg/m2
- Age 18-70
- Currently inactive (engages in less than 6,000 steps/day on at least 4 of 7 days per week, confirmed by FitBit at baseline)
- Able to engage in moderate amount of walking
- Able to receive email/text messages from study staff
Who cannot join
- medical or psychiatric conditions that would make it difficult to comply with study protocols
About this study
The purpose of this study is to test whether deposit contracts, wherein individuals invest their own money with the study to serve as the incentive, with or without daily feedback about progress help individuals to increase step counts and more often meet a step goal compared to self-monitoring only.
Read the detailed description
Approximately 68% of adults are overweight or obese, which is associated with increased risk for health conditions, including cardiovascular disease, type 2 diabetes, and cancer. These individuals are more often sedentary than the general population, which compounds the risk for these same conditions. While the benefits of engaging in physical activity are well-established, few individuals are able to successfully increase activity to recommended levels. Existing intervention programs, often derived from theories such as social cognitive theory or related theories, have had limited success. Behavioral economics offers a promising alternative, suggesting that engagement in any behavior is based on the maximizing utility and happiness. Interventions based on this theory aim to increase the immediate benefit of engaging in physical activity, often using a financial incentive.
This study will last for 16 weeks. Each participant will invest $42 with the study, and be exposed to to each of three interventions. All participants will have the use of a FitBit for ongoing self-monitoring and a step-count goal of 10,000 steps per day. In one condition, these will be the only interventions you receive. In one condition, you will receive a monetary consequence for meeting or not meeting the goal. Each day during the incentive conditions, you will be eligible to lose $0.75 of your own money for not meeting the goal, or to earn back $0.75 of your money plus $0.75 from the study (i.e., a total of $1.50) for meeting the goal. In the third condition, you will have daily feedback mid-afternoon about your distance from the goal and the money you stand to gain or lose. You will be made aware of what condition you are in.
- Conditions
- Physical Activity, Sedentary Lifestyle, Obesity, Overweight
- Being tested
- Self-monitoring, Incentives, Feedback
- Medical subject headings
- Motor Activity, Sedentary Behavior, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-monitoringBehavioural
Participants will have access to a wrist-worn activity monitor and have a daily step goal
IncentivesBehavioural
Participants will have a deposit contract, wherein they will lose money if a goal is not reached, or double their money if a goal is reached
FeedbackBehavioural
Participants will receive text message feedback each day about progress towards their goal
| Study group | Role | What they receive |
|---|---|---|
| Single-arm trial | Experimental | All participants will undergo each of three conditions during the study. Receives: Behavioral: Self-monitoring; Behavioral: Incentives; Behavioral: Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step counts
Daily number of steps taken
Measured: Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)
Goal attainment
Proportion of days step goal was met
Measured: Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 Dec 2016
- Primary completion1 Aug 2017
- Study completion8 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- Psi Chi, Qualtrics, American College of Sports Medicine
- Responsible party
- Principal investigator, Stephanie Kerrigan, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566277
- Sponsor's protocol ID
- 1601004185-1
- Status last verified
- Jun 2018
- First submitted
- 12 Jun 2018
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kerrigan SG, Forman EM, Patel M, Williams D, Zhang F, Crosby RD, Butryn ML. Evaluating the Feasibility, Acceptability, and Effects of Deposit Contracts With and Without Daily Feedback to Promote Physical Activity. J Phys Act Health. 2020 Jan 1;17(1):29-36. doi: 10.1123/jpah.2018-0589.
PubMed 31698334
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Step: Evaluating Deposit Contracts and Daily Feedback to Promote Walking in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT03566277
- Acronym / sponsor ID
- 1601004185-1
- Conditions
- Physical Activity, Sedentary Lifestyle, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Psi Chi, Qualtrics, American College of Sports Medicine
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether deposit contracts, wherein individuals invest their own money with the study to serve as the incentive, with or without daily feedback about progress help individuals to increase step counts and more often meet a step goal compared to self-monitoring only.
Detailed description
Approximately 68% of adults are overweight or obese, which is associated with increased risk for health conditions, including cardiovascular disease, type 2 diabetes, and cancer. These individuals are more often sedentary than the general population, which compounds the risk for these same conditions. While the benefits of engaging in physical activity are well-established, few individuals are able to successfully increase activity to recommended levels. Existing intervention programs, often derived from theories such as social cognitive theory or related theories, have had limited success. Behavioral economics offers a promising alternative, suggesting that engagement in any behavior is based on the maximizing utility and happiness. Interventions based on this theory aim to increase the immediate benefit of engaging in physical activity, often using a financial incentive.
This study will last for 16 weeks. Each participant will invest $42 with the study, and be exposed to to each of three interventions. All participants will have the use of a FitBit for ongoing self-monitoring and a step-count goal of 10,000 steps per day. In one condition, these will be the only interventions you receive. In one condition, you will receive a monetary consequence for meeting or not meeting the goal. Each day during the incentive conditions, you will be eligible to lose $0.75 of your own money for not meeting the goal, or to earn back $0.75 of your money plus $0.75 from the study (i.e., a total of $1.50) for meeting the goal. In the third condition, you will have daily feedback mid-afternoon about your distance from the goal and the money you stand to gain or lose. You will be made aware of what condition you are in.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm trial | Experimental | Behavioral: Self-monitoring, Behavioral: Incentives, Behavioral: FeedbackAll participants will undergo each of three conditions during the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 25 kg/m2 ≤ BMI ≤ 45 kg/m2
- Age 18-70
- Currently inactive (engages in less than 6,000 steps/day on at least 4 of 7 days per week, confirmed by FitBit at baseline)
- Able to engage in moderate amount of walking
- Able to receive email/text messages from study staff
Key exclusion criteria (1 listed)
- medical or psychiatric conditions that would make it difficult to comply with study protocols
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-monitoringParticipants will have access to a wrist-worn activity monitor and have a daily step goal | Behavioural | Single-arm trial |
| IncentivesParticipants will have a deposit contract, wherein they will lose money if a goal is not reached, or double their money if a goal is reached | Behavioural | Single-arm trial |
| FeedbackParticipants will receive text message feedback each day about progress towards their goal | Behavioural | Single-arm trial |
Primary outcome
Step counts
Time frame: Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)
Daily number of steps taken
Goal attainment
Time frame: Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)
Proportion of days step goal was met
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Derived from this study: PubMed 31698334Kerrigan SG, Forman EM, Patel M, Williams D, Zhang F, Crosby RD, Butryn ML. Evaluating the Feasibility, Acceptability, and Effects of Deposit Contracts With and Without Daily Feedback to Promote Physical Activity. J Phys Act Health. 2020 Jan 1;17(1):29-36. doi: 10.1123/jpah.2018-0589.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Self-monitoring, Incentives and Feedback in people with Physical Activity and Sedentary Lifestyle, run by Drexel University.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 25 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Step counts (time frame: Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)). The study lists 2 primary outcomes in all. 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 NCT03566277, which also lists 1 linked publication.
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 25 Jun 2018.