A Trial of Habit Formation Theory for Exercise in Older Adults

NCT ID: NCT04869644

Last Updated: 2022-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-26

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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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 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. 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 FitbitĀ® 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 baseline/screening phase and a 10-week intervention phase. During the baseline phase, participant's 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 2,000 more steps per day than their average levels of baseline activity (e.g., if you walked an average of 6,000 steps per day during baseline, the new goal would be 8,000). 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 (e.g., walking 8,000 steps per day on 5 planned days. A time-sensitive text of all 5 BCTs will delivered to the participant when the context (e.g., 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.

Conditions

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Sedentary Behavior Aging Activity, Motor Behavior, Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention: Behavioral Change Techniques to encourage Habit Formation

Individuals will receive daily text messages with the goal of increasing daily walking by 2,000 more steps 5 days per week. Participants will be enrolled for a baseline period lasting 2 weeks where their average daily activity level will be assessed using a Fitbit device to generate an average daily step counts. Following completion of baseline, participants will be asked to generate a walking plan with the goal of walking an additional 2,000 steps above their baseline activity level on 5 days per week. This walking plan will include details about day of the week, time of day, and location of walking. Once participants have completed their walking plan, they will receive daily texts based on the 5 identified BCTs for the duration of the 10-week intervention. All BCTs will be delivered daily. The goal of the text messages will be to encourage habit formation for walking behavior.

Group Type EXPERIMENTAL

Goal setting

Intervention Type BEHAVIORAL

Goal setting: set or agree on a goal defined in terms of behavior to be achieved.

Action Planning

Intervention Type BEHAVIORAL

Action planning: prompt detailed planning of performance of behavior (must include a setting \[walking to the mailbox\], frequency, duration, and intensity.

Self-monitoring of behavior

Intervention Type BEHAVIORAL

Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit.

Behavioral Practice/Rehearsal

Intervention Type BEHAVIORAL

Behavioral rehearsal: prompt practice or rehearsal of walking one or more times in a context when the performance may not be necessary, in order to increase habit and skill.

Habit Formation

Intervention Type BEHAVIORAL

Prompt rehearsal \& repetition of walking 2,000 steps or more in the same context repeatedly so that the context elicits the behavior.

Interventions

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Goal setting

Goal setting: set or agree on a goal defined in terms of behavior to be achieved.

Intervention Type BEHAVIORAL

Action Planning

Action planning: prompt detailed planning of performance of behavior (must include a setting \[walking to the mailbox\], frequency, duration, and intensity.

Intervention Type BEHAVIORAL

Self-monitoring of behavior

Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit.

Intervention Type BEHAVIORAL

Behavioral Practice/Rehearsal

Behavioral rehearsal: prompt practice or rehearsal of walking one or more times in a context when the performance may not be necessary, in order to increase habit and skill.

Intervention Type BEHAVIORAL

Habit Formation

Prompt rehearsal \& repetition of walking 2,000 steps or more in the same context repeatedly so that the context elicits the behavior.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Men and women who:

* Age 45 - 75 years old of age
* Fluent in English
* Employed in the Northwell Health system
* Community-dwelling
* Report they are in good general health, walk regularly and have never been informed by a clinician that it was not advisable/safe to participate in a low-intensity walking program
* Owns and can regularly access a smartphone capable of receiving text messages
* Owns and can regularly access an e-mail account

Exclusion Criteria

* \< 45 years old or \> 75 years old
* Unable to speak/comprehend English
* Not employed in Northwell Health system
* Have self-reported poor health, limited mobility and/or have been advised by a clinician not to increase their low-intensity walking
* Pregnancy
* Previous diagnosis of a serious mental health condition or psychiatric disorder, such as bipolar disorder
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Karina Davidson

Senior Vice President, Research & Dean of Academic Affairs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karina W Davidson

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

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Center for Personalized Health

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P30AG063786-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-1182

Identifier Type: -

Identifier Source: org_study_id

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