NCT03311230

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 12, 2020

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

October 11, 2017

Results QC Date

November 14, 2019

Last Update Submit

February 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Daily Steps

    Change in mean daily steps from baseline to main intervention period

    weeks 5 to 24 of the intervention

Secondary Outcomes (3)

  • Change in Mean Daily Steps

    Weeks 25 to 36 of the follow-up period

  • Proportion of Participant-days That Step Goals Are Achieved

    Weeks 5 to 24 of the main intervention period.

  • Proportion of Participant-days That Step Goals Are Achieved

    Weeks 25 to 36 of the follow-up period.

Study Arms (4)

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.

Behavioral: Supportive social incentive

Competitive social incentive

EXPERIMENTAL

Participants will compete in a gamification intervention in groups of three.

Behavioral: Competitive social incentive

Collaborative social incentive

EXPERIMENTAL

Participants will collaborate in groups of three in a gamification intervention

Behavioral: Collaborative social incentive

Interventions

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.

Supportive social incentive

Participants in this intervention will be competing against each other in the game.

Competitive social incentive

Participants in this intervention will be working with each other in the game.

Collaborative social incentive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Joseph Harrison
Organization
University of Pennsylvania

Study Officials

  • Mitesh Patel, MD, MBA, MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mitesh S. Patel, Director, Penn Medicine Nudge Unit

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 17, 2017

Study Start

October 30, 2017

Primary Completion

January 7, 2019

Study Completion

March 18, 2019

Last Updated

March 2, 2020

Results First Posted

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations