NCT04869644

A Trial of Habit Formation Theory for Exercise in Older Adults

Completed Phase 1 Results posted Last updated 30 November 2022

What this trial tests

Phase 1 trial testing Goal setting in Sedentary Behavior in 49 participants. Completed in 31 May 2022.

Timeline

26 March 2021

Primary endpoint
1 February 2022

31 May 2022

Quick facts

Lead sponsor	Northwell Health
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	49
Start date	26 March 2021
Primary completion	1 February 2022
Estimated completion	31 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Goal setting
• Action Planning
• Self-monitoring of behavior
• Behavioral Practice/Rehearsal
• Habit Formation

Conditions studied

• Sedentary Behavior — all drugs for Sedentary Behavior →
• Aging — all drugs for Aging →
• Activity, Motor — all drugs for Activity, Motor →
• Behavior, Health — all drugs for Behavior, Health →

Sponsor

Northwell Health — full company profile →

Who can join

Adults 45 to 75, any sex, with Sedentary Behavior or Aging. 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 Automaticity Score. Primary · Assessed daily via online survey for participants across the duration of the 10-week intervention. Daily assessments will be aggregated by week to generate weekly means for automaticity.

Automaticity of behavior is assessed by a 4-item questionnaire asking about the automaticity of participant's walking behavior using a 4-point Likert scale with responses ranging from "Strongly Disagree" to "Strongly Agree". Items are summed together to form a total score ranging from 0 to 12, with higher scores indicating that participant's new walking behaviors have become more habitual and automatic. Change in daily automaticity levels over the course of the intervention period will be examined until scores level out and reach a score of 8 or more on 7 consecutive days. Participants will be

Group	Value	95% CI
Intervention: Behavioral Change Techniques to Encourage Habit Formation	17

Participant Satisfaction With Personalized Trial Components. Primary · Assessed once after completion of the study at 12 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.

"Please rate your overall satisfaction with the BCT text messages"

Group	Value	95% CI
Intervention: Behavioral Change Techniques to Encourage Habit Formation	2.53	± 0.78

"Please rate your satisfaction with the ease of using the BCT text messages"

Group	Value	95% CI
Intervention: Behavioral Change Techniques to Encourage Habit Formation	2.97	± 0.18

"Please rate your satisfaction with the overall effectiveness of the BCT text messages"

Group	Value	95% CI
Intervention: Behavioral Change Techniques to Encourage Habit Formation	2.50	± 0.82

"Video explanations and demonstrations of study devices and procedures"

Group	Value	95% CI
Intervention: Behavioral Change Techniques to Encourage Habit Formation	2.38	± 0.67

"Text messaging for reminders (e.g. synch your Fitbit)"

Group	Value	95% CI
Intervention: Behavioral Change Techniques to Encourage Habit Formation	2.76	± 0.54

"Text messaging for data collection (i.e. surveys)"

Group	Value	95% CI
Intervention: Behavioral Change Techniques to Encourage Habit Formation	2.65	± 0.67

"Use of the Fitbit device to track your activity and sleep"

Group	Value	95% CI
Intervention: Behavioral Change Techniques to Encourage Habit Formation	2.60	± 0.60

"Study communications"

Group	Value	95% CI
Intervention: Behavioral Change Techniques to Encourage Habit Formation	2.67	± 0.58

Adverse events — posted to ClinicalTrials.gov

Time frame: Data for adverse events were collected for each participant over 12 weeks (2-week baseline and 10-week intervention).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention: Behavioral Change Techniques to Encourage Habit Formation

Serious: 0/44 (0%)

Deaths: 0/44

Other adverse events (1 terms — click to expand)

Reaction	System	Intervention: Behavioral C…
Rash	Product Issues	—

Data from ClinicalTrials.gov NCT04869644 adverse events section.

Sponsor's own description

This personalized trial will evaluate the effects of five behavioral change techniques (BCTs) described in Habit Formation Theory (Goal setting, Action Planning, Self-Monitoring, Behavioral Practice/Rehearsal and Habit Formation) delivered by text message to enhance low-intensity walking by 2,000 more steps per day/5 days per week in healthy Northwell employees aged 45-75 years old.

Publications & conference data

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

1. Protocol of a feasibility study of a virtual personalized (N-of-1) trial for increasing low-intensity physical activity in older adults via habit formation.
   Suls J, Friel CP, Butler M, Duer-Hefele J, et al · · 2023 · cited 1× · PMID 37333978 · DOI 10.1016/j.conctc.2023.101135
2. 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