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

NCT04827212 | Completed Early Phase 1 Results

• 2 other identifiers: 20-01-15P30AG048785
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise; Physical Activity

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (18)

• Percent Body Fat Measured Via Bioelectrical Impedance at Baseline

  Baseline

• Percent Body Fat Measured Via Bioelectrical Impedance After 4 Months

  4 months

• Percent Body Fat Measured Via Bioelectrical Impedance After 6 Months

  6 months

Study Arms (2)

Control

NO INTERVENTION

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

Treatment

EXPERIMENTAL

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

Interventions

Companion 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.

Treatment

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northeastern University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Northeastern Univeristy

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Dinesh John
• Organization: Northeastern University

d.john@northeastern.edu

(801) 230-6320

Study Officials

• Dinesh John, PhD

  Northeastern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 1, 2021
• Study Start: March 16, 2021
• Primary Completion: November 2, 2022
• Study Completion: December 13, 2022
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Locations

US (1)