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| Name | Class |
|---|---|
| Deloitte | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Competitive social incentive | Experimental | Participants will compete in a gamification intervention in groups of three. |
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| Collaborative social incentive | Experimental | Participants will collaborate in groups of three in a gamification intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportive social incentive | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Daily Steps | Change in mean daily steps from baseline to main intervention period | weeks 5 to 24 of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Daily Steps | Change in mean daily steps from baseline through the follow-up period | Weeks 25 to 36 of the follow-up period |
| Proportion of Participant-days That Step Goals Are Achieved |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitesh Patel, MD, MBA, MS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35442393 | Derived | 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. | |
| 34860130 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants in this arm will receive no other interventions during the 9 month study period |
| FG001 | Supportive Social Incentive | Participants will identify a family member or friend to support them during a gamification intervention. Supportive social incentive: 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. |
| FG002 | Competitive Social Incentive | Participants will compete in a gamification intervention in groups of three. Competitive social incentive: Participants in this intervention will be competing against each other in the game. |
| FG003 | Collaborative Social Incentive | Participants will collaborate in groups of three in a gamification intervention Collaborative social incentive: Participants in this intervention will be working with each other in the game. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants in this arm will receive no other interventions during the 9 month study period |
| BG001 | Supportive Social Incentive | Participants will identify a family member or friend to support them during a gamification intervention. Supportive social incentive: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Daily Steps | Change in mean daily steps from baseline to main intervention period | Posted | Mean | Standard Deviation | Steps/Day | weeks 5 to 24 of the intervention |
|
Adverse event data was collected when participants were started in the study through the maintenance and follow-up periods (9 months, or 252 days).
Mortality was not a risk associated with participation in our study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants in this arm will receive no other interventions during the 9 month study period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broken foot | Injury, poisoning and procedural complications | Non-systematic Assessment | The participant suffered a broken foot and required surgery to repair. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Harrison | University of Pennsylvania | 2157461249 | joseph.harrison@uphs.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2017 | Nov 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Competitive social incentive | Behavioral | Participants in this intervention will be competing against each other in the game. |
|
| Collaborative social incentive | Behavioral | Participants in this intervention will be working with each other in the game. |
|
proportion of days participants meet their step goal
| 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 | Weeks 25 to 36 of the follow-up period. |
| Rewley 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. |
| 31498375 | Derived | Patel 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. |
| 30954675 | Derived | Harrison 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. |
| Unrelated injury |
|
| BG002 | Competitive Social Incentive | Participants will compete in a gamification intervention in groups of three. Competitive social incentive: Participants in this intervention will be competing against each other in the game. |
| BG003 | Collaborative Social Incentive | Participants will collaborate in groups of three in a gamification intervention Collaborative social incentive: Participants in this intervention will be working with each other in the game. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education level | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Annual household income | Count of Participants | Participants |
|
| Self-reported measures, health status | Count of Participants | Participants |
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| Prior wearable device use | Count of Participants | Participants |
|
| BMI, Mean (SD) | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Smoking actively | Count of Participants | Participants |
|
| Baseline step count, Mean (SD) | Mean | Standard Deviation | steps/day |
|
| Step goal selection, No. (%) | Count of Participants | Participants |
|
| Step goal increase from baseline, mean (SD) | Mean | Standard Deviation | steps/day |
|
| OG002 |
| Competitive Social Incentive |
Participants will compete in a gamification intervention in groups of three. Competitive social incentive: Participants in this intervention will be competing against each other in the game. |
| OG003 | Collaborative Social Incentive | Participants will collaborate in groups of three in a gamification intervention Collaborative social incentive: Participants in this intervention will be working with each other in the game. |
|
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| Secondary | Change in Mean Daily Steps | Change in mean daily steps from baseline through the follow-up period | Posted | Mean | Standard Deviation | Steps/Day | Weeks 25 to 36 of the follow-up period |
|
|
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| Secondary | Proportion of Participant-days That Step Goals Are Achieved | proportion of days participants meet their step goal | Posted | Number | Proportion of participant-days | Weeks 5 to 24 of the main intervention period. |
|
|
|
| Secondary | Proportion of Participant-days That Step Goals Are Achieved | proportion of days participants meet their step goal | Posted | Number | Proportion of participant-days | Weeks 25 to 36 of the follow-up period. |
|
|
|
| 0 |
| 151 |
| 0 |
| 151 |
| 0 |
| 151 |
| EG001 | Supportive Social Incentive | Participants will identify a family member or friend to support them during a gamification intervention. Supportive social incentive: 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. | 0 | 151 | 0 | 151 | 1 | 151 |
| EG002 | Competitive Social Incentive | Participants will compete in a gamification intervention in groups of three. Competitive social incentive: Participants in this intervention will be competing against each other in the game. | 0 | 150 | 0 | 150 | 0 | 150 |
| EG003 | Collaborative Social Incentive | Participants will collaborate in groups of three in a gamification intervention Collaborative social incentive: Participants in this intervention will be working with each other in the game. | 0 | 150 | 0 | 150 | 0 | 150 |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |