Physical ActivityPhase 3NCT02629601
Evaluating Incentive Designs to Increase Physical Activity Goal Adherence in a Wellness Program
A Phase 3 study testing Active Rewards, Lottery 1 and Lottery 2 in people with Physical Activity, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a 4-week, five-arm, randomized, controlled trial to compare a standard wellness incentive program for physical activity to four other designs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Active Rewards, Lottery 1 and Lottery 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Sep 2016
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Vitality member that has activated "active rewards" program
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This is a 4-week, five-arm, randomized, controlled trial to compare a standard wellness incentive program for physical activity to four other designs.
Read the detailed description
Increased physical activity is associated with numerous health benefits including lower risk of cardiovascular disease. However, many individuals do not achieve physical activity goals. Vitality is a wellness program in South Africa that uses a program called "Active Rewards" to incentives achievement of weekly physical activity goals. In this study, the investigators will compare the standard active rewards program to doubling the magnitude or adding lottery designs with and without broadcasting the # of winners.
- Conditions
- Physical Activity
- Being tested
- Active Rewards, Lottery 1, Lottery 2, Broadcasting winners, Active Rewards Doubled
- Keywords
- physical activity, financial incentives, behavioral economics
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active RewardsBehavioural
Vitality standard active rewards wellness program for physical activity promotion
Lottery 1Behavioural
Participants have 1 in 3 chance of winning 3 times the reward and 1 in 100 chance of winning 40 times the reward
Lottery 2Behavioural
Participants have 1 in 2 chance of winning 2 times the reward and 1 in 200 chance of winning 80 times the reward
Broadcasting winnersBehavioural
Participants are told how many individuals won the lottery during that week.
Active Rewards DoubledBehavioural
Vitality standard active rewards wellness program for physical activity promotion with double the magnitude of incentives
| Study group | Role | What they receive |
|---|---|---|
| Active Rewards | Experimental | Participant will receive the standard active rewards incentives. Receives: Behavioral: Active Rewards |
| Active Rewards Doubled | Active comparator | Participant will receive the standard active rewards doubled in magnitude. Receives: Behavioral: Active Rewards Doubled |
| Active Rewards & Lottery 1 | Active comparator | Participant will receive the standard active rewards incentives plus a lottery 1 with a 1 in 3 chance of winning 3 times the reward and 1 in 100 chance of winning 40 times the reward. Receives: Behavioral: Active Rewards; Behavioral: Lottery 1 |
| Active Rewards & Lottery 1 & Broadcast | Active comparator | Participant will receive the standard active rewards incentives plus a lottery 1 with a 1 in 3 chance of winning 3 times the reward and 1 in 100 chance of winning 40 times the reward. Includes broadcasting winners (number) each week. Receives: Behavioral: Active Rewards; Behavioral: Lottery 1; Behavioral: Broadcasting winners |
| Active Rewards & Lottery 2 & Broadcast | Active comparator | Participant will receive the standard active rewards incentives plus a lottery 2 with a 1 in 2 chance of winning 2 times the reward and 1 in 200 chance of winning 80 times the reward. Includes broadcasting winners (number) each week. Receives: Behavioral: Active Rewards; Behavioral: Lottery 2; Behavioral: Broadcasting winners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants that acheived their weekly physical activity goal
Binary outcome
Measured: 4 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Change plans and no longer testing these interventions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Discovery Vitality
- Responsible party
- Sponsor
- Investigators
- Mitesh Patel, MD, MBA, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629601
- Sponsor's protocol ID
- 823617
- Status last verified
- Sep 2016
- First submitted
- 7 Dec 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Incentive Designs to Increase Physical Activity Goal Adherence in a Wellness Program
- ClinicalTrials.gov ID
- NCT02629601
- Acronym / sponsor ID
- 823617
- Conditions
- Physical Activity
- Keywords
- physical activity, financial incentives, behavioral economics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change plans and no longer testing these interventions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Discovery Vitality
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Dec 2015 (estimated)
- 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 is a 4-week, five-arm, randomized, controlled trial to compare a standard wellness incentive program for physical activity to four other designs.
Detailed description
Increased physical activity is associated with numerous health benefits including lower risk of cardiovascular disease. However, many individuals do not achieve physical activity goals. Vitality is a wellness program in South Africa that uses a program called "Active Rewards" to incentives achievement of weekly physical activity goals. In this study, the investigators will compare the standard active rewards program to doubling the magnitude or adding lottery designs with and without broadcasting the # of winners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Active Rewards | Experimental | Behavioral: Active RewardsParticipant will receive the standard active rewards incentives. |
| Active Rewards Doubled | Active comparator | Behavioral: Active Rewards DoubledParticipant will receive the standard active rewards doubled in magnitude. |
| Active Rewards & Lottery 1 | Active comparator | Behavioral: Active Rewards, Behavioral: Lottery 1Participant will receive the standard active rewards incentives plus a lottery 1 with a 1 in 3 chance of winning 3 times the reward and 1 in 100 chance of winning 40 times the reward. |
| Active Rewards & Lottery 1 & Broadcast | Active comparator | Behavioral: Active Rewards, Behavioral: Lottery 1, Behavioral: Broadcasting winnersParticipant will receive the standard active rewards incentives plus a lottery 1 with a 1 in 3 chance of winning 3 times the reward and 1 in 100 chance of winning 40 times the reward. Includes broadcasting winners (number) each week. |
| Active Rewards & Lottery 2 & Broadcast | Active comparator | Behavioral: Active Rewards, Behavioral: Lottery 2, Behavioral: Broadcasting winnersParticipant will receive the standard active rewards incentives plus a lottery 2 with a 1 in 2 chance of winning 2 times the reward and 1 in 200 chance of winning 80 times the reward. Includes broadcasting winners (number) each week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Vitality member that has activated "active rewards" program
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Active RewardsVitality standard active rewards wellness program for physical activity promotion | Behavioural | Active Rewards, Active Rewards & Lottery 1, Active Rewards & Lottery 1 & Broadcast, Active Rewards & Lottery 2 & Broadcast |
| Lottery 1Participants have 1 in 3 chance of winning 3 times the reward and 1 in 100 chance of winning 40 times the reward | Behavioural | Active Rewards & Lottery 1, Active Rewards & Lottery 1 & Broadcast |
| Lottery 2Participants have 1 in 2 chance of winning 2 times the reward and 1 in 200 chance of winning 80 times the reward | Behavioural | Active Rewards & Lottery 2 & Broadcast |
| Broadcasting winnersParticipants are told how many individuals won the lottery during that week. | Behavioural | Active Rewards & Lottery 1 & Broadcast, Active Rewards & Lottery 2 & Broadcast |
| Active Rewards DoubledVitality standard active rewards wellness program for physical activity promotion with double the magnitude of incentives | Behavioural | Active Rewards Doubled |
Primary outcome
Proportion of participants that acheived their weekly physical activity goal
Time frame: 4 week intervention period
Binary outcome
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- 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.
Mitesh Patel, MD, MBA, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active Rewards, Lottery 1 and Lottery 2 in people with Physical Activity, run by University of Pennsylvania 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 1 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: withdrawn, as of the sponsor's last update on 29 Sep 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of participants that acheived their weekly physical activity goal (time frame: 4 week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2016.