ObesitySTEPUPNCT03311230
Social Incentives To Encourage Physical Activity and Understand Predictors
A study testing Supportive social incentive, Competitive social incentive and Collaborative social incentive in people with Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study tests the effectiveness of three social incentive-based gamification interventions to increase physical activity using a 24-week intervention period with a 12-week follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Supportive social incentive, Competitive social incentive and Collaborative social incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 18 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- ability to read and provide informed consent to participate in the study;
- Self-reported body mass index (BMI) of 25 or greater.
- Smartphone or tablet compatible with application for the wearable activity tracking device.
Who cannot join
- Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English;
- conditions that would make participation unsafe such as pregnancy or being told by a physician not to exercise;
- already enrolled in another study targeting physical activity;
- any other medical conditions or reasons he or she is unable to participate in a physical activity study for 36 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study tests the effectiveness of three social incentive-based gamification interventions to increase physical activity using a 24-week intervention period with a 12-week follow-up.
Read the detailed description
This is a four-arm randomized, controlled trial with a 24-week intervention period and 12-week follow-up period. Participants are considered ready to be randomized once they have completed all surveys, established a baseline step count, and selected a step goal increase.Participants in the control arm will receive no other interventions during the 24-week intervention period or the 12-week follow-up period. Participants randomized to the one of the three intervention arms will have a 4-week ramp up towards their step goal. The participant will then be asked to maintain their goal during the 20-week "maintenance period" and the 12-week "follow-up period." Participants in arms 2-4 will be entered into an intervention approach that has points and levels designed to incorporate insights from behavioral economics. Participants in the supportive social incentive arm will be asked to identify a family member or friend to be their support sponsor. This sponsor will be encouraged to support the participant in their progress during the study. Participants in the competitive social incentive arm will be in a group of three total participants.At the end of each week the participants will receive notification that ranks them on their cumulative points in the study thus far and also displays their level.This feedback may help to induce participants to compete for the top spot among the group. Participants in the collaborative social incentive arm will be in a group of three total participants as a team. Each day one of the members of the group will be randomly selected to represent their team for that day. In this design, each person is accountable to the others on the team and this may induce a collaborative effort to meet their daily goals.
- Conditions
- Obesity
- Being tested
- Supportive social incentive, Competitive social incentive, Collaborative social incentive
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive social incentiveBehavioural
A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
Competitive social incentiveBehavioural
Participants in this intervention will be competing against each other in the game.
Collaborative social incentiveBehavioural
Participants in this intervention will be working with each other in the game.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this arm will receive no other interventions during the 9 month study period |
| Supportive social incentive | Experimental | Participants will identify a family member or friend to support them during a gamification intervention. Receives: Behavioral: Supportive social incentive |
| Competitive social incentive | Experimental | Participants will compete in a gamification intervention in groups of three. Receives: Behavioral: Competitive social incentive |
| Collaborative social incentive | Experimental | Participants will collaborate in groups of three in a gamification intervention Receives: Behavioral: Collaborative social incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Daily Steps
Change in mean daily steps from baseline to main intervention period
Measured: weeks 5 to 24 of the intervention
Secondary outcomes (3)
Change in Mean Daily Steps
Change in mean daily steps from baseline through the follow-up period
Measured: Weeks 25 to 36 of the follow-up period
Proportion of Participant-days That Step Goals Are Achieved
proportion of days participants meet their step goal
Measured: Weeks 5 to 24 of the main intervention period.
Proportion of Participant-days That Step Goals Are Achieved
proportion of days participants meet their step goal
Measured: Weeks 25 to 36 of the follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start30 Oct 2017
- Primary completion7 Jan 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Deloitte
- Responsible party
- Principal investigator, Mitesh Patel, University of Pennsylvania
- Investigators
- Mitesh Patel, MD, MBA, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311230
- Sponsor's protocol ID
- 827508
- Acronym
- STEPUP
- Status last verified
- Feb 2020
- First submitted
- 11 Oct 2017
- Last updated
- 2 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lewey J, Murphy S, Zhang D, Putt ME, Elovitz MA, Riis V, Patel MS, Levine LD. Effectiveness of a Text-Based Gamification Intervention to Improve Physical Activity Among Postpartum Individuals With Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial. JAMA Cardiol. 2022 Jun 1;7(6):591-599. doi: 10.1001/jamacardio.2022.0553.
PubMed 35442393Rewley J, Guszcza J, Dierst-Davies R, Steier D, Szwartz G, Patel M. Loss Aversion Explains Physical Activity Changes in a Behavioral Gamification Trial. Games Health J. 2021 Dec;10(6):430-436. doi: 10.1089/g4h.2021.0130.
PubMed 34860130Patel MS, Small DS, Harrison JD, Fortunato MP, Oon AL, Rareshide CAL, Reh G, Szwartz G, Guszcza J, Steier D, Kalra P, Hilbert V. Effectiveness of Behaviorally Designed Gamification Interventions With Social Incentives for Increasing Physical Activity Among Overweight and Obese Adults Across the United States: The STEP UP Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1624-1632. doi: 10.1001/jamainternmed.2019.3505.
PubMed 31498375Harrison JD, Jones JM, Small DS, Rareshide CAL, Szwartz G, Steier D, Guszcza J, Kalra P, Torio B, Reh G, Hilbert V, Patel MS. Social incentives to encourage physical activity and understand predictors (STEP UP): Design and rationale of a randomized trial among overweight and obese adults across the United States. Contemp Clin Trials. 2019 May;80:55-60. doi: 10.1016/j.cct.2019.04.001. Epub 2019 Apr 4.
PubMed 30954675
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Incentives To Encourage Physical Activity and Understand Predictors
- ClinicalTrials.gov ID
- NCT03311230
- Acronym / sponsor ID
- STEPUP / 827508
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Deloitte
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Posted 12 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the effectiveness of three social incentive-based gamification interventions to increase physical activity using a 24-week intervention period with a 12-week follow-up.
Detailed description
This is a four-arm randomized, controlled trial with a 24-week intervention period and 12-week follow-up period. Participants are considered ready to be randomized once they have completed all surveys, established a baseline step count, and selected a step goal increase.Participants in the control arm will receive no other interventions during the 24-week intervention period or the 12-week follow-up period. Participants randomized to the one of the three intervention arms will have a 4-week ramp up towards their step goal. The participant will then be asked to maintain their goal during the 20-week "maintenance period" and the 12-week "follow-up period." Participants in arms 2-4 will be entered into an intervention approach that has points and levels designed to incorporate insights from behavioral economics. Participants in the supportive social incentive arm will be asked to identify a family member or friend to be their support sponsor. This sponsor will be encouraged to support the participant in their progress during the study. Participants in the competitive social incentive arm will be in a group of three total participants.At the end of each week the participants will receive notification that ranks them on their cumulative points in the study thus far and also displays their level.This feedback may help to induce participants to compete for the top spot among the group. Participants in the collaborative social incentive arm will be in a group of three total participants as a team. Each day one of the members of the group will be randomly selected to represent their team for that day. In this design, each person is accountable to the others on the team and this may induce a collaborative effort to meet their daily goals.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this arm will receive no other interventions during the 9 month study period |
| Supportive social incentive | Experimental | Behavioral: Supportive social incentiveParticipants will identify a family member or friend to support them during a gamification intervention. |
| Competitive social incentive | Experimental | Behavioral: Competitive social incentiveParticipants will compete in a gamification intervention in groups of three. |
| Collaborative social incentive | Experimental | Behavioral: Collaborative social incentiveParticipants will collaborate in groups of three in a gamification intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older;
- ability to read and provide informed consent to participate in the study;
- Self-reported body mass index (BMI) of 25 or greater.
- Smartphone or tablet compatible with application for the wearable activity tracking device.
Key exclusion criteria (4 listed)
- Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English;
- conditions that would make participation unsafe such as pregnancy or being told by a physician not to exercise;
- already enrolled in another study targeting physical activity;
- any other medical conditions or reasons he or she is unable to participate in a physical activity study for 36 weeks.
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 |
|---|---|---|
| Supportive social incentiveA family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress. | Behavioural | Supportive social incentive |
| Competitive social incentiveParticipants in this intervention will be competing against each other in the game. | Behavioural | Competitive social incentive |
| Collaborative social incentiveParticipants in this intervention will be working with each other in the game. | Behavioural | Collaborative social incentive |
Primary outcome
Change in Mean Daily Steps
Time frame: weeks 5 to 24 of the intervention
Change in mean daily steps from baseline to main intervention period
3 secondary outcomes
Change in Mean Daily Steps
Time frame: Weeks 25 to 36 of the follow-up period
Proportion of Participant-days That Step Goals Are Achieved
Time frame: Weeks 5 to 24 of the main intervention period.
Proportion of Participant-days That Step Goals Are Achieved
Time frame: Weeks 25 to 36 of the follow-up period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35442393Lewey J, Murphy S, Zhang D, Putt ME, Elovitz MA, Riis V, Patel MS, Levine LD. Effectiveness of a Text-Based Gamification Intervention to Improve Physical Activity Among Postpartum Individuals With Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial. JAMA Cardiol. 2022 Jun 1;7(6):591-599. doi: 10.1001/jamacardio.2022.0553.
- Derived from this study: PubMed 34860130Rewley J, Guszcza J, Dierst-Davies R, Steier D, Szwartz G, Patel M. Loss Aversion Explains Physical Activity Changes in a Behavioral Gamification Trial. Games Health J. 2021 Dec;10(6):430-436. doi: 10.1089/g4h.2021.0130.
- Derived from this study: PubMed 31498375Patel MS, Small DS, Harrison JD, Fortunato MP, Oon AL, Rareshide CAL, Reh G, Szwartz G, Guszcza J, Steier D, Kalra P, Hilbert V. Effectiveness of Behaviorally Designed Gamification Interventions With Social Incentives for Increasing Physical Activity Among Overweight and Obese Adults Across the United States: The STEP UP Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1624-1632. doi: 10.1001/jamainternmed.2019.3505.
- Derived from this study: PubMed 30954675Harrison JD, Jones JM, Small DS, Rareshide CAL, Szwartz G, Steier D, Guszcza J, Kalra P, Torio B, Reh G, Hilbert V, Patel MS. Social incentives to encourage physical activity and understand predictors (STEP UP): Design and rationale of a randomized trial among overweight and obese adults across the United States. Contemp Clin Trials. 2019 May;80:55-60. doi: 10.1016/j.cct.2019.04.001. Epub 2019 Apr 4.
- 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 study testing Supportive social incentive, Competitive social incentive and Collaborative social incentive in people with Obesity, 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 4 inclusion and 4 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 2 Mar 2020. 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?
Yes. Results are posted in the registry (first posted 12 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mean Daily Steps (time frame: weeks 5 to 24 of the 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 NCT03311230, which also lists 4 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 2 Mar 2020.