NCT05069155

The STEP 4Life Trial

Completed NA Results posted Last updated 28 November 2023

What this trial tests

NA trial testing Gamification in Alzheimer Disease, At Risk in 240 participants. Completed in 2 January 2023.

Timeline

1 November 2021

Primary endpoint
21 November 2022

2 January 2023

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	health services research
Enrollment	240
Start date	1 November 2021
Primary completion	21 November 2022
Estimated completion	2 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Gamification

Conditions studied

• Alzheimer Disease, At Risk — all drugs for Alzheimer Disease, At Risk →
• Alzheimer Disease, Protection Against — all drugs for Alzheimer Disease, Protection Against →
• Dementia — all drugs for Dementia →

Sponsor

University of Pennsylvania

Who can join

Adults 55 to 75, any sex, with Alzheimer Disease, At Risk or Alzheimer Disease, Protection Against. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period. Primary · Baseline to 12 week intervention period (Weeks 1 - 12)

The primary outcome of the study is the change in mean daily steps from the baseline period to the end of the 12 week intervention period collected by Fitbit Inspire device.

Group	Value	95% CI
Control	735	± 1306
Gamification	2422	± 1460

Change in Mean Daily Step Counts During the 6 Week Follow-up Period After the End of the Intervention Period Tracked by Fitbit Inspire Device. Secondary · 6 week follow-up period (Weeks 13 - 18)

The secondary outcome will examine the change in mean daily step counts during the 6 week follow-up period after the end of the 12 week intervention period.

Group	Value	95% CI
Control	705	± 1916
Gamification	1983	± 1478

Change in Moderate-vigorous Physical Activity Minutes (MVPA) During the Start of the Intervention Period Compared to Baseline Period. Secondary · Baseline to 12 week intervention period (Weeks 1-2)

MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day.

Group	Value	95% CI
Control	4.2	± 6.4
Gamification	9.1	± 10.4

Change in Moderate-vigorous Physical Activity (MVPA) Minutes During the Baseline and Follow-up Period (Weeks 13-18). Secondary · Baseline and 6 week follow-up period (Weeks 13 - 18)

MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day.

Group	Value	95% CI
Control	3.8	± 11.5
Gamification	8	± 11.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 12-week intervention and 6-week follow-up. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control

Serious: 0/50 (0%)

Deaths: 0/50

Gamification

Serious: 0/44 (0%)

Deaths: 0/44

Other adverse events (1 terms — click to expand)

Reaction	System	Control	Gamification
Skin rash	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT05069155 adverse events section.

Sponsor's own description

The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with social incentives) targeting daily step counts to prevent or delay the development of Alzheimer's Disease and Related Dementias (ADRD).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of gamification with a support partner to increase physical activity in older adults at risk for Alzheimer's disease: The STEP 4Life randomized clinical trial.
   Greysen SR, Oon AL, Harkins K, Rareshide C, et al · · 2024 · cited 3× · PMID 38962958 · DOI 10.1002/alz.14058