CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Behavioral Change Techniquesbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04967313
NCT04967313Phase 1Completed

A Randomized, Controlled Trial to Test Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults

Northwell Health·interventional·Posted Jul 19, 2021·Updated Feb 1, 2023

In Brief

A Phase 1 clinical trial evaluating Behavioral Change Techniques for Sedentary Behavior. Completed, enrolled 60 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedJul 19, 2021
Enrollment StartOct 5, 2021
Primary CompletionMay 4, 2022
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.0 years ago

Interventions

Behavioral Change Techniquesbehavioral

Four behavioral changes techniques (BCTs) will be administered to participants in random order. The BCTs are defined as follows: 1. Goal setting: set or agree on a goal defined in terms of behavior to be achieved. Example: Set the goal of walking 2,000 steps more per day. 2. Action planning: prompt detailed planning of performance of behavior (must include a setting \[walking to the mailbox\], frequency, duration, and intensity. Example: Develop a plan to walk today. 3. Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit. Example: Did you check your Fitbit and record daily total number of steps? 4. Feedback on behavior: Monitor and provide informative or evaluative feedback on performance of the behavior (e.g. form, frequency, duration, intensity). Example: You walked 6,000 steps today. This is 1,000 steps above your baseline.