Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04869644
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2021-04-18
Brief Title:
A Trial of Habit Formation Theory for Exercise in Older Adults
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
A Personalized Trial Pilot to Test Habit Formation Theory for Low Intensity Physical Exercise in Older Adults
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 PracticeRehearsal and Habit Formation delivered by text message to enhance low-intensity walking by 2000 more steps per day5 days per week in healthy Northwell employees aged 45-75 years old
Detailed Description:
This pilot study uses a virtual single-arm personalized design to evaluate the effects of the five behavioral change techniques BCTs described in Habit Formation Theory Goal Setting Action Planning Self-Monitoring Behavioral PracticeRehearsal and Habit Formation delivered by text message to enhance low-intensity walking by 2000 more steps per day5 days per week in healthy Northwell employees aged 45-75 years old Up to sixty participants will complete a 12-week personalized trial of their walking behavior and assess all five behavioral change techniques described in habit formation theory Prior to beginning the trial participants will be sent a Fitbit activity tracking watch that monitors number of steps per day Participants will be instructed to wear the Fitbit device all day and night even when they are sleeping The single-arm personalized trial will be comprised of a 2-week baselinescreening phase and a 10-week intervention phase During the baseline phase participants baseline levels of physical activity operationalized as average steps per day measured using the Fitbit device and adherence to the trial protocol operationalized as wearing the Fitbit device for a minimum of 10 hours per day and completing daily survey measure will be assessed Participants who are adherent to the study protocol defined as adherence to Fitbit use and survey measures on 80 or more days during baseline will proceed to the intervention phase At the beginning of the intervention participants will develop a walking plan with the goal of walking 2000 more steps per day than their average levels of baseline activity eg if you walked an average of 6000 steps per day during baseline the new goal would be 8000 The walking plan will include details about the day time and location of walking behavior Participants will commit to walking according to this plan 5 days per week eg walking 8000 steps per day on 5 planned days A time-sensitive text of all 5 BCTs will delivered to the participant when the context eg day of week time of day that they pre-selected is encountered Participants will later receive a text message with a link to a secure survey in which they will note whether they engaged with the five behavioral change techniques which were prompted The goal of the intervention is to help participants make their walking behavior habitual and automatic Participants will be assessed in terms of their satisfaction with the personalized trial design their Fitbit-measured daily steps adherence to their walking plan and the automaticity of their walking behavior After completion of the intervention phase participants will be allowed to keep the Fitbit device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30AG063786-01 | NIH | None | httpsreporternihgovquickSearchP30AG063786-01 |