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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04827212
• Other study ID #: 20-01-15
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: March 16, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2022
• Source: Northeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: April 30, 2023
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
United States	Northeastern Univeristy	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent body fat measured via bioelectrical impedance	This is an exploratory outcome. The amount of fat in the body will be computed as a percentage	Baseline
Other	Percent body fat measured via bioelectrical impedance	This is an exploratory outcome. The amount of fat in the body will be computed as a percentage	4 months
Other	Percent body fat measured via bioelectrical impedance	This is an exploratory outcome. The amount of fat in the body will be computed as a percentage	6 months
Other	Attention and executive function measured using the NIH tool box	This is an exploratory outcome. This construct will be measured using the Flanker Inhibitory Control and Attention Test in the NIH tool box	Baseline
Other	Attention and executive function measured using the NIH tool box	This is an exploratory outcome. This construct will be measured using the Flanker Inhibitory Control and Attention Test in the NIH tool box.	4 months
Other	Attention and executive function measured using the NIH tool box	This is an exploratory outcome. This construct will be measured using the Flanker Inhibitory Control and Attention Test in the NIH tool box.	6 months
Other	Working memory measured using the NIH tool box.	This is an exploratory outcome. This construct will be measured using the list sorting task in the NIH tool box.	Baseline
Other	Working memory measured using the NIH tool box.	This is an exploratory outcome. This construct will be measured using the list sorting task in the NIH tool box.	4 months
Other	Working memory measured using the NIH tool box.	This is an exploratory outcome. This construct will be measured using the list sorting task in the NIH tool box.	6 months
Other	Processing Speed measured using the NIH tool box.	This is an exploratory outcome. This construct will be measured using the pattern comparison task in the NIH tool box.	Baseline
Other	Processing Speed measured using the NIH tool box.	This is an exploratory outcome. This construct will be measured using the pattern comparison task in the NIH tool box.	4 months
Other	Processing Speed measured using the NIH tool box.	This is an exploratory outcome. This construct will be measured using the pattern comparison task in the NIH tool box.	6 months
Other	Blood glucose measured using a cardiocheck fingerstick blood sample	This is an exploratory outcome.	Baseline
Other	Blood glucose measured using a cardiocheck fingerstick blood sample	This is an exploratory outcome.	4 months
Other	Blood glucose measured using a cardiocheck fingerstick blood sample	This is an exploratory outcome.	6 months
Other	Total cholesterol measured using a cardiocheck fingerstick blood sample	This is an exploratory outcome.	Baseline
Other	Total cholesterol measured using a cardiocheck fingerstick blood sample	This is an exploratory outcome.	4 months
Other	Total cholesterol measured using a cardiocheck fingerstick blood sample	This is an exploratory outcome.	6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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