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出境医 / 临床实验 / Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults

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

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Sedentary Behavior Behavioral: Behavioral Change Techniques Phase 1

Detailed 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/five days per week using four behavior change techniques (BCTs), provided in random order, and shown to have been effective in changing physical activity. This pilot will help determine if a personalized, virtual trial design can have widespread use in future research and clinical practice. The investigators will randomize 60 participants. Participants will complete a two-week baseline period during which they will be asked to wear a Fitbit device all day and night, even while they are sleeping, and to acknowledge receipt of a daily text message that is not an activity prompt. Baseline participants will be instructed to sync their Fitbit device by opening the Fitbit app on their phone at least every two days. After completion of the baseline period, a clinical research coordinator will review individual adherence to Fitbit wear and to survey responses. Adherence to Fitbit wear will be defined as recorded activity of greater than 10 hours a day. Text message adherence will be defined as responding to a given text message. Baseline participants that do not achieve at least 80% adherence of Fitbit wear and text responsiveness during the two weeks of the baseline period will be withdrawn from the study. Those that maintain at least 80% adherence will be randomized to one of their selected behavior change techniques to begin their pilot personalized trial. Participants who are randomized to receive intervention sequences will receive email confirmation including their protocol timeline. Enrollment will continue until up to 60 participants have been randomized. Individuals in the intervention period will receive four BCTs: goal setting, action planning, self-monitoring of behavior, and feedback on behavior. BCTs will be delivered individually to participants over the course of eight weeks in four two-week blocks. The order of BCT administration will be randomized by the study statistician. Participants may receive additional text messages to those outlined above with important reminders to sync their data as needed. Upon completion, participants in the personalized trials phase will receive an individual report that demonstrates their walking responses in relation to their selected BCTs. After receiving the report, clinical research coordinators will contact participants to respond to questions and to obtain feedback about their personalized trials experience.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The order of administration for the 4 Behavioral Change Techniques (BCTs) will be randomized by the study statistician.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized, Controlled Trial to Test Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults
Actual Study Start Date : October 5, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : April 1, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Behavioral Change Techniques to Increase Walking
Individuals will receive daily text messages with the goal of increasing daily walking by 2,000 more steps five days per week. Participants will be enrolled for a baseline period lasting two 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 receive daily text messages of behavior change techniques (BCTs) for eight weeks. The four BCTs utilized in this study are: goal setting, action planning, self-monitoring of behavior, and feedback on behavior. Each BCT will be delivered to participants daily for a two-week block. Four blocks (one BCT per block) will be delivered to the participant. The order in which the BCT interventions are presented to participants will be randomized by the study statistician. The goal of the BCT text messages will be to encourage walking behavior.
 Behavioral: Behavioral Change Techniques

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.
Outcome Measures
Primary Outcome Measures :
  1. Within-person change in Daily Steps. [ Time Frame: 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.

  2. Participant Satisfaction with Personalized Trial Components. [ Time Frame: 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 "Not at all satisfied" to "Very satisfied". Means and standard deviations will be reported for each element of satisfaction.


Secondary Outcome Measures :
  1. Self-Efficacy for Walking [ Time Frame: Assessed at baseline, week 2, week 4, week 6, week 8, and week 10. ]
    This will be assessed using the Self-Efficacy for Walking (SE-W) scale,[1] an 10-item measure assessing patient's capabilities to walk for durations of 5 to 50 minutes. Items are scored from 0 to 100%, with scores of 0% indicating participants are "not at all confident" they could walk for that duration and scores of 100% indicating the participants are "highly confident" they could walk that duration. Items are average to create a total score, with higher scores indicating higher levels of beliefs about capabilities/self-efficacy.

  2. Participant Attitudes and Opinions towards Personalized Trials. [ Time Frame: Assessed once after completion of the study at 10 weeks. ]
    Participants will be asked via survey about their attitudes and opinions regarding the personalized trial implementation (e.g., Did the trial feel burdensome?). Participants will rate items on a 7-point Likert scale with responses ranging from "Strongly Disagree" to "Strongly Agree". Scores on each item will be reported with means and standard deviations.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
Contacts and Locations

Contacts
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Contact: Joan Duer-Hefele, RN, MA 6467667153 jduerhefele@northwell.edu
Contact: Karina Davidson, PhD, MASc

Locations
Layout table for location information
United States, New York
Center for Personalized Health Recruiting
New York, New York, United States, 10022
Contact: Joan Duer-Hefele, RN    646-766-7153    jduerhefele@northwell.edu   
Sponsors and Collaborators
Northwell Health
National Institute on Aging (NIA)
Columbia University
Investigators
Layout table for investigator information
Principal Investigator: Karina Davidson, PhD, MASc Northwell Health
Tracking Information
First Submitted Date  ICMJE July 2, 2021
First Posted Date  ICMJE July 19, 2021
Last Update Posted Date November 3, 2021
Actual Study Start Date  ICMJE October 5, 2021
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2021)
  • Within-person change in Daily Steps. [ Time Frame: 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.
  • Participant Satisfaction with Personalized Trial Components. [ Time Frame: 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 "Not at all satisfied" to "Very satisfied". Means and standard deviations will be reported for each element of satisfaction.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2021)
  • Self-Efficacy for Walking [ Time Frame: Assessed at baseline, week 2, week 4, week 6, week 8, and week 10. ]
    This will be assessed using the Self-Efficacy for Walking (SE-W) scale,[1] an 10-item measure assessing patient's capabilities to walk for durations of 5 to 50 minutes. Items are scored from 0 to 100%, with scores of 0% indicating participants are "not at all confident" they could walk for that duration and scores of 100% indicating the participants are "highly confident" they could walk that duration. Items are average to create a total score, with higher scores indicating higher levels of beliefs about capabilities/self-efficacy.
  • Participant Attitudes and Opinions towards Personalized Trials. [ Time Frame: Assessed once after completion of the study at 10 weeks. ]
    Participants will be asked via survey about their attitudes and opinions regarding the personalized trial implementation (e.g., Did the trial feel burdensome?). Participants will rate items on a 7-point Likert scale with responses ranging from "Strongly Disagree" to "Strongly Agree". Scores on each item will be reported with means and standard deviations.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults
Official Title  ICMJE A Randomized, Controlled Trial to Test Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults
Brief 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.
Detailed 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/five days per week using four behavior change techniques (BCTs), provided in random order, and shown to have been effective in changing physical activity. This pilot will help determine if a personalized, virtual trial design can have widespread use in future research and clinical practice. The investigators will randomize 60 participants. Participants will complete a two-week baseline period during which they will be asked to wear a Fitbit device all day and night, even while they are sleeping, and to acknowledge receipt of a daily text message that is not an activity prompt. Baseline participants will be instructed to sync their Fitbit device by opening the Fitbit app on their phone at least every two days. After completion of the baseline period, a clinical research coordinator will review individual adherence to Fitbit wear and to survey responses. Adherence to Fitbit wear will be defined as recorded activity of greater than 10 hours a day. Text message adherence will be defined as responding to a given text message. Baseline participants that do not achieve at least 80% adherence of Fitbit wear and text responsiveness during the two weeks of the baseline period will be withdrawn from the study. Those that maintain at least 80% adherence will be randomized to one of their selected behavior change techniques to begin their pilot personalized trial. Participants who are randomized to receive intervention sequences will receive email confirmation including their protocol timeline. Enrollment will continue until up to 60 participants have been randomized. Individuals in the intervention period will receive four BCTs: goal setting, action planning, self-monitoring of behavior, and feedback on behavior. BCTs will be delivered individually to participants over the course of eight weeks in four two-week blocks. The order of BCT administration will be randomized by the study statistician. Participants may receive additional text messages to those outlined above with important reminders to sync their data as needed. Upon completion, participants in the personalized trials phase will receive an individual report that demonstrates their walking responses in relation to their selected BCTs. After receiving the report, clinical research coordinators will contact participants to respond to questions and to obtain feedback about their personalized trials experience.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
The order of administration for the 4 Behavioral Change Techniques (BCTs) will be randomized by the study statistician.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Sedentary Behavior
Intervention  ICMJE Behavioral: Behavioral Change Techniques

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.
Study Arms  ICMJE Experimental: Behavioral Change Techniques to Increase Walking
Individuals will receive daily text messages with the goal of increasing daily walking by 2,000 more steps five days per week. Participants will be enrolled for a baseline period lasting two 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 receive daily text messages of behavior change techniques (BCTs) for eight weeks. The four BCTs utilized in this study are: goal setting, action planning, self-monitoring of behavior, and feedback on behavior. Each BCT will be delivered to participants daily for a two-week block. Four blocks (one BCT per block) will be delivered to the participant. The order in which the BCT interventions are presented to participants will be randomized by the study statistician. The goal of the BCT text messages will be to encourage walking behavior.
Intervention: Behavioral: Behavioral Change Techniques
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2021) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2022
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Joan Duer-Hefele, RN, MA 6467667153 jduerhefele@northwell.edu
Contact: Karina Davidson, PhD, MASc
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04967313
Other Study ID Numbers  ICMJE 20-1166
1P30AG063786-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary. Pooling personalized trials together is a more efficient approach for deriving population-level estimates than conventional randomized controlled trials.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent form following completion of recruitment but prior to publication of any data from the current study. De-identified, pooled individual participant data will be made available within a year of final participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely.
Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.
Responsible Party Karina Davidson, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • Columbia University
Investigators  ICMJE
Principal Investigator: Karina Davidson, PhD, MASc Northwell Health
PRS Account Northwell Health
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP