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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Exercise, Physical Activity

Intervention / Treatment
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* Behavioral: Companion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks | |
| Experimental: Treatment<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity measured using a body-worn accelerometer | 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:min) will be averaged to obtain a representative estimate of daily habitual behavior. | Baseline | 
| Physical activity measured using a body-worn accelerometer | 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:min) will be averaged to obtain a representative estimate of daily habitual behavior. | 4 months | 
| Physical activity measured using a body-worn accelerometer | 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:min) will be averaged to obtain a representative estimate of daily habitual behavior. | 6 months | 
| Sedentary behavior measured using a body-worn accelerometer | Total time spent sitting and lying down will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours:min) will be averaged to obtain a representative estimate of daily habitual behavior. | Baseline | 
| Sedentary behavior measured using a body-worn accelerometer | Total time spent sitting and lying down will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours:min) will be averaged to obtain a representative estimate of daily habitual behavior. | 4 months | 
| Sedentary behavior measured using a body-worn accelerometer | Total time spent sitting and lying down will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours:min) will be averaged to obtain a representative estimate of daily habitual behavior. | 6 months |