Physical ActivityNCT03574519
Project Step II: The Effects of Incentives and Feedback on Promoting Walking Within Overweight and Obese Adults
A study testing Non-contingent incentives, Contingent incentives and Weekly feedback in people with Physical Activity and Sedentary Lifestyle, run by Drexel University at 1 site in United States.
Trial summary
This study will evaluate the main effects of daily vs. weekly feedback and contingent vs. non-contingent incentives for increasing walking behavior among overweight and obese adults. 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, Overweight and Obesity
- What is being tested?
- Non-contingent incentives, Contingent incentives and Weekly feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 30 Jan 2018
- 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 OR engaged in less than 10,000 steps /day on at least 5/7 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
- Psychiatric conditions that would make it difficult to comply
- Medical conditions that would make it difficult to comply
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the main effects of daily vs. weekly feedback and contingent vs. non-contingent incentives for increasing walking behavior among overweight and obese adults.
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 (i.e., weighing the cost and benefit of the behavior). 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 8 weeks. All participants will have the use of a FitBit for ongoing self-monitoring and a personalized step-count goal designed to help increase daily steps. Participants will receive feedback on reaching their goals either daily or weekly.
- Being tested
- Non-contingent incentives, Contingent incentives, Weekly feedback, Daily feedback
- Medical subject headings
- Motor Activity, Sedentary Behavior, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contingent incentivesBehavioural
Incentives are provided for participation
Contingent incentivesBehavioural
Incentives are provided for attaining daily goals
Weekly feedbackBehavioural
Text message feedback is delivered weekly summarizing the past week's progress
Daily feedbackBehavioural
Text message feedback is delivered daily summarizing the current day's progress
| Study group | Role | What they receive |
|---|---|---|
| Non-contingent incentives and weekly feedback | Experimental | Participants will receive payment for participating in the study (regardless of goal attainment) and will receive weekly updates about their performance. Receives: Behavioral: Non-contingent incentives; Behavioral: Weekly feedback |
| Non-contingent incentives and daily feedback | Experimental | Participants will receive payment for participating in the study (regardless of goal attainment) and will receive daily updates about their performance. Receives: Behavioral: Non-contingent incentives; Behavioral: Daily feedback |
| Contingent incentives and weekly feedback | Experimental | Participants will receive payment for meeting their daily goals and will receive weekly updates about their performance. Receives: Behavioral: Contingent incentives; Behavioral: Weekly feedback |
| Contingent incentives and daily feedback | Experimental | Participants will receive payment for meeting their daily goals and will receive daily updates about their performance. Receives: Behavioral: Contingent incentives; Behavioral: Daily feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step counts
Average daily step counts
Measured: Change from baseline to end of 6-week intervention
Secondary outcomes (2)
Step counts
Average daily step counts
Measured: Change from end of intervention to end of 2-week follow-up
Step counts
Measured: Daily change during 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Jun 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 61 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
- NCT03574519
- Sponsor's protocol ID
- 1601004185-2
- Status last verified
- Jun 2018
- First submitted
- 12 Jun 2018
- Last updated
- 3 Jul 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, Williams D, Patel M, Loyka C, Zhang F, Crosby RD, Butryn ML. Project Step: A Randomized Controlled Trial Investigating the Effects of Frequent Feedback and Contingent Incentives on Physical Activity. J Phys Act Health. 2021 Mar 1;18(3):247-253. doi: 10.1123/jpah.2020-0198. Epub 2021 Feb 17.
PubMed 33601334
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Step II: The Effects of Incentives and Feedback on Promoting Walking Within Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT03574519
- Acronym / sponsor ID
- 1601004185-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Psi Chi, Qualtrics, American College of Sports Medicine
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 2 Jul 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.
This study will evaluate the main effects of daily vs. weekly feedback and contingent vs. non-contingent incentives for increasing walking behavior among overweight and obese adults.
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 (i.e., weighing the cost and benefit of the behavior). 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 8 weeks. All participants will have the use of a FitBit for ongoing self-monitoring and a personalized step-count goal designed to help increase daily steps. Participants will receive feedback on reaching their goals either daily or weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-contingent incentives and weekly feedback | Experimental | Behavioral: Non-contingent incentives, Behavioral: Weekly feedbackParticipants will receive payment for participating in the study (regardless of goal attainment) and will receive weekly updates about their performance. |
| Non-contingent incentives and daily feedback | Experimental | Behavioral: Non-contingent incentives, Behavioral: Daily feedbackParticipants will receive payment for participating in the study (regardless of goal attainment) and will receive daily updates about their performance. |
| Contingent incentives and weekly feedback | Experimental | Behavioral: Contingent incentives, Behavioral: Weekly feedbackParticipants will receive payment for meeting their daily goals and will receive weekly updates about their performance. |
| Contingent incentives and daily feedback | Experimental | Behavioral: Contingent incentives, Behavioral: Daily feedbackParticipants will receive payment for meeting their daily goals and will receive daily updates about their performance. |
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 OR engaged in less than 10,000 steps /day on at least 5/7 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 (2 listed)
- Psychiatric conditions that would make it difficult to comply
- Medical conditions that would make it difficult to comply
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 |
|---|---|---|
| Non-contingent incentivesIncentives are provided for participation | Behavioural | Non-contingent incentives and daily feedback, Non-contingent incentives and weekly feedback |
| Contingent incentivesIncentives are provided for attaining daily goals | Behavioural | Contingent incentives and daily feedback, Contingent incentives and weekly feedback |
| Weekly feedbackText message feedback is delivered weekly summarizing the past week's progress | Behavioural | Contingent incentives and weekly feedback, Non-contingent incentives and weekly feedback |
| Daily feedbackText message feedback is delivered daily summarizing the current day's progress | Behavioural | Contingent incentives and daily feedback, Non-contingent incentives and daily feedback |
Primary outcome
Step counts
Time frame: Change from baseline to end of 6-week intervention
Average daily step counts
2 secondary outcomes
Step counts
Time frame: Change from end of intervention to end of 2-week follow-up
Step counts
Time frame: Daily change during 6-week intervention
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 3 Jul 2018.
- Derived from this study: PubMed 33601334Kerrigan SG, Forman EM, Williams D, Patel M, Loyka C, Zhang F, Crosby RD, Butryn ML. Project Step: A Randomized Controlled Trial Investigating the Effects of Frequent Feedback and Contingent Incentives on Physical Activity. J Phys Act Health. 2021 Mar 1;18(3):247-253. doi: 10.1123/jpah.2020-0198. Epub 2021 Feb 17.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-contingent incentives, Contingent incentives and Weekly feedback in people with Physical Activity and Sedentary Lifestyle, run by Drexel University at 1 site in United States.
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 2 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 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Change from baseline to end of 6-week intervention). 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 NCT03574519, 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 3 Jul 2018.