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NCT04967313

Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults

Completed Phase 1 Results posted Last updated 1 February 2023
What this trial tests

Phase 1 trial testing Behavioral Change Techniques in Sedentary Behavior in 60 participants. Completed in 31 May 2022.

Timeline
5 October 2021
Primary endpoint
4 May 2022
31 May 2022

Quick facts

Lead sponsorNorthwell Health
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment60
Start date5 October 2021
Primary completion4 May 2022
Estimated completion31 May 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Northwell Health — full company profile →

Who can join

Adults 45 to 75, any sex, with Sedentary Behavior. 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.

Within-person Change in Daily Steps. Primary · Steps will be assessed continuously via worn activity tracker. Step counts will be aggregated and analyzed at the daily level. This will yield 70 daily measurements of physical activity over the course of the 10-week study.

Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by baseline and intervention phases to generate average daily steps in each phase. Changes in daily steps between baseline and intervention phases will be compared using Generalized Linear Mixed Model analyses. Changes in daily steps between intervention and baseline will be represented using a regression parameter.

Increase in Daily Steps Due to Intervention
GroupValue95% CI
Behavioral Change Techniques to Increase Walking120.85
Standard Error for Regression of Intervention on Daily Steps
GroupValue95% CI
Behavioral Change Techniques to Increase Walking257.42
Participant Satisfaction With Personalized Trial Components. Primary · Assessed once after completion of the study at 10 weeks.

Participants will rate their satisfaction with the Personalized Trial overall and with individual elements of the trial in a satisfaction survey developed for this trial. Participants will rate 9 items assessing satisfaction with methods and process of the trial on a 4-point Likert scale with responses ranging from "0 - Not at all satisfied" to "3 - Very satisfied". Higher scores indicate greater levels of satisfaction. Means and standard deviations will be reported for each element of satisfaction.

The behavior change techniques (BCTs) assigned to you
GroupValue95% CI
Behavioral Change Techniques to Increase Walking2.10± 0.92
The frequency that each BCT was delivered to you (daily)
GroupValue95% CI
Behavioral Change Techniques to Increase Walking2.38± 0.81
Video explanations and demonstrations of study devices and procedures
GroupValue95% CI
Behavioral Change Techniques to Increase Walking2.06± 1.00
Text messaging for delivery of study interventions (BCTs)
GroupValue95% CI
Behavioral Change Techniques to Increase Walking2.42± 0.84
Text messaging for reminders (e.g. sync your Fitbit)
GroupValue95% CI
Behavioral Change Techniques to Increase Walking2.59± 0.73
Text messaging for data collection (i.e. surveys)
GroupValue95% CI
Behavioral Change Techniques to Increase Walking2.60± 0.70
Use of the fitbit device to track your activity and sleep
GroupValue95% CI
Behavioral Change Techniques to Increase Walking2.71± 0.56
Study communications
GroupValue95% CI
Behavioral Change Techniques to Increase Walking2.52± 0.73

Sponsor's own description

The purpose of this pilot study is to determine the feasibility of using personalized trial methods in a virtual research study with Northwell employees aged 45-75 years old to increase low-intensity walking by 2,000 steps per day/5 days per week using four behavior change techniques (BCTs), provided in random order, and shown to have been effective in changing physical activity. The study will include a two-week baseline period during which levels of physical activity and adherence to the trial protocol will be evaluated. Individuals meeting adherence criteria will be randomized to the eight-week BCT intervention.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Testing Behavior Change Techniques to Increase Physical Activity in Middle-Aged and Older Adults: Protocol for a Randomized Personalized Trial Series.
    Friel CP, Robles PL, Butler M, Pahlevan-Ibrekic C, et al · · 2023 · cited 4× · PMID 37314839 · DOI 10.2196/43418
  2. Feasibility Test of Personalized (N-of-1) Trials for Increasing Middle-Aged and Older Adults' Physical Activity.
    Friel CP, Goodwin AM, Robles PL, Butler MJ, et al · · 2025 · cited 1× · PMID 39231913 · DOI 10.1007/s12529-024-10319-w
  3. Digital, Personalized Clinical Trials Among Older Adults, Lessons Learned From the COVID-19 Pandemic, and Directions for the Future: Aggregated Feasibility Data From Three Trials Among Older Adults.
    Arader L, Miller D, Perrin A, Vicari F, et al · · 2025 · PMID 40239192 · DOI 10.2196/54629

Verify or expand the search:

Other recruiting trials for Sedentary Behavior

Currently open trials in the same condition.

Other Northwell Health trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04967313.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing