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

Northwell Health

Status and phase: Completed; Phase 1

Conditions: Sedentary Behavior

Treatments: Behavioral: Behavioral Change Techniques

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04967313

1P30AG063786-01 (U.S. NIH Grant/Contract)

20-1166

Details and patient eligibility

About

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.

Full 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at least 80% adherence of Fitbit wear and text responsiveness during the two weeks of the baseline period will be withdrawn from the study.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.

Enrollment: 60 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Behavioral Change Techniques to Increase Walking

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Change Techniques