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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-16

Study Completion Date

2022-12-13

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.

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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.

Conditions

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Exercise Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Control group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Companion

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes