Clinical trial NCT04967313: Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults
Official title: A Randomized, Controlled Trial to Test Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sedentary Behavior
Keywords: Physical Activity
Sedentary Behavior
Behavior Change
Behavior Change Techniques
Virtual
Personalized Trial
Personalized
Feasibility
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Columbia University
First posted: 2021-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The order of administration for the 4 Behavioral Change Techniques (BCTs) will be randomized by the study statistician.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Within-person Change in Daily Steps.
timeFrame: 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.
measure: Participant Satisfaction With Personalized Trial Components.
timeFrame: Assessed once after completion of the study at 10 weeks.
Secondary outcomes:
measure: Self-Efficacy for Walking
timeFrame: Assessed at baseline, week 2, week 4, week 6, week 8, and week 10.
measure: Participant Attitudes and Opinions Towards Personalized Trials.
timeFrame: Assessed once after completion of the study at 10 weeks.
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Personalized Health
state: New York
Study officials:
affiliation: Northwell Health
name: Karina Davidson, PhD, MASc
role: PRINCIPAL_INVESTIGATOR
References: