Companion: Sensor-based Two-way Communication for Physical Activity in Older Adults

An Integrated Two-Way Communication and Near-Real-Time Sensing System to Detect and Modify Daily Inactivity Among Adults Over Age 60

This pilot study is a small sample (N=46) 16-week clinical trial with a follow-up after 24-weeks among sedentary adults >60 y with a BMI >25 kg/m2 to tests the impact of a hybrid artificial intelligence behavior change system (Companion) on physical activity. Participants will be randomized to a control and intervention group. All participants will engage in a proven supervised exercise program from week 1 to 16. Only the intervention group will receive Companion from week 1 to 16.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Exercise
• Intervention / Treatment: Behavioral: Companion

Detailed Description

This is a single site randomized clinical trial to test if if Companion improves and sustains free-living physical activity and sedentary behaviors in adults >60 y and improves health outcomes. Forty-six sedentary adults >60 y with a BMI >25 kg/m2 will be randomized to a control and intervention group. Both groups will undergo a 16-week supervised training program involving supervised training sessions 45-60 min, twice a week. The intervention group will additionally receive the two-way communication-based Companion meta intervention. Two-way communication during weeks 1 to 4, will focus on gathering information on the adult's motivations, preferences, habits, contexts, and usual behavior patterns to build typical individual behavior models. The model will be used to develop an adaptive physical active and sedentary behavior intervention prescription. Primary outcomes from Aim 1 and exploratory outcomes from Aim 2 will be measured at baseline and then after 16 and 24 weeks.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Northeastern Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 60 years and above- This intervention study focusses on this population demographic.
• Participants have a body mass index greater than 25 kg/m2- This threshold for BMI is used to classify an adult as overweight or obese
• No conditions preventing participation in physical activity lasting 10 to 30 min- Such conditions will limit prescription of physical activity/exercise components of the training program and that promoted using Companion.
• Have a smart phone- The absence of a smart phone will limit the ability of remote communication with the study participant using Companion.

Exclusion Criteria:

• Engage in structured physical activity for more than 2 days/week lasting 30 min/session- Physically active participants will not be representative of typical adults >60 y. Being active prior to study participation may mask the effects of the intervention.
• Regularly use any assistive device for walking- Use of an assistive device would limit the ability to engage in prescribed physical activity. Future work can be tailored for sub-groups in the demographic being studied.
• Likely to alter medications pertaining to cardiovascular or metabolic health- Altering medications during the study will influence change in selected outcome measures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks
Experimental: Treatment; Treatment group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks. In addition, the Companion will be deployed in the treatment group only.	Behavioral: Companion; Companion integrates wearable sensing with the smartphone to develop a behavior-aware, virtual system that uses a "human-in-the-loop" approach to enable meaningful two-way communication. Companion builds rich models of typical behavior using sensors and context sensitive ecological momentary assessment to deliver intervention components and behavior change strategies using socially engaging, contextually salient, and tailored text-message conversations in near-real-time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline	Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.	Baseline
Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months	Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.	4 months
Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months	Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.	6 months
Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline	Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.	Baseline
Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months	Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.	4 months
Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months	Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Body Fat Measured Via Bioelectrical Impedance at Baseline	This is an exploratory outcome. The amount of fat in the body will be computed as a percentage	Baseline
Percent Body Fat Measured Via Bioelectrical Impedance After 4 Months	This is an exploratory outcome. The amount of fat in the body will be computed as a percentage	4 months
Percent Body Fat Measured Via Bioelectrical Impedance After 6 Months	This is an exploratory outcome. The amount of fat in the body will be computed as a percentage	6 months
Attention and Executive Function Measured Using the NIH Tool Box Measured at Baseline	This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.	Baseline
Attention and Executive Function Measured Using the NIH Tool Box After 4 Months	This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.	4 months
Attention and Executive Function Measured Using the NIH Tool Box	This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.	6 months
Working Memory Measured Using the NIH Tool Box at Baseline	This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged accross participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.	Baseline
Working Memory Measured Using the NIH Tool Box After 4 Months	This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.	4 months
Working Memory Measured Using the NIH Tool Box After 6 Months	This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.	6 months
Relative Processing Speed Measured Using the NIH Tool Box at Baseline	Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.	Baseline
Relative Processing Speed Measured Using the NIH Tool Box Measured After 4 Months	This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged accross participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.	4 months
Relative Processing Speed Measured Using the NIH Tool Box Measured After 6 Months	This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.	6 months
Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline	This is an exploratory outcome.	Baseline
Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months	This is an exploratory outcome.	4 months
Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 6 Months	This is an exploratory outcome.	6 months
Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline	This is an exploratory outcome.	Baseline
Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months	This is an exploratory outcome.	4 months
Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Were Measured After 6 Months	This is an exploratory outcome.	6 months

Collaborators and Investigators

• Sponsor: Northeastern University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Dinesh John, PhD, Northeastern University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 29, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20-01-15; P30AG048785 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No