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

NCT04967313 | Completed Phase 1 Results DMC

• 2 other identifiers: 20-11661P30AG063786-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Behavior

Keywords

Physical Activity; Sedentary Behavior; Behavior Change; Behavior Change Techniques; Virtual; Personalized Trial; Personalized; Feasibility

Outcome Measures

Primary Outcomes (2)

• Within-person Change in Daily Steps.

  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. Changes in daily steps between intervention and baseline will be represented using a regression parameter.

  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 Satisfaction With Personalized Trial Components.

  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.

  Assessed once after completion of the study at 10 weeks.

Secondary Outcomes (2)

• Self-Efficacy for Walking

  Assessed at baseline, week 2, week 4, week 6, week 8, and week 10.

• Participant Attitudes and Opinions Towards Personalized Trials.

  Assessed once after completion of the study at 10 weeks.

Study Arms (1)

Behavioral Change Techniques to Increase Walking

EXPERIMENTAL

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

Interventions

Behavioral Change Techniques BEHAVIORAL

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.

Behavioral Change Techniques to Increase Walking

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Northwell Health: lead
• National Institute on Aging (NIA): collaborator
• Columbia University: collaborator

Study Sites (1)

Center for Personalized Health

New York, New York, 10022, United States

Location

Related Publications (1)

• Friel CP, Robles PL, Butler M, Pahlevan-Ibrekic C, Duer-Hefele J, Vicari F, Chandereng T, Cheung K, Suls J, Davidson KW. Testing Behavior Change Techniques to Increase Physical Activity in Middle-Aged and Older Adults: Protocol for a Randomized Personalized Trial Series. JMIR Res Protoc. 2023 Jun 14;12:e43418. doi: 10.2196/43418.

  PMID: 37314839 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Joan Duer-Hefele, RN, MA
• Organization: Northwell Health

jduerhefele@northwell.edu

646-766-7153

Study Officials

• Karina Davidson, PhD, MASc

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Vice President, Research & Dean of Academic Affairs

Model Details: The order of administration for the 4 Behavioral Change Techniques (BCTs) will be randomized by the study statistician.

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 19, 2021
• Study Start: October 5, 2021
• Primary Completion: May 4, 2022
• Study Completion: May 31, 2022
• Last Updated: February 1, 2023
• Results First Posted: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)