ExerciseEarly Phase 1NCT04827212

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

A Early Phase 1 study testing Companion in people with Exercise and Physical Activity, run by Northeastern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Exercise, Physical Activity
What is being tested?: Companion
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 16 Mar 2021to 13 Dec 2022
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northeastern Univeristy
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Exercise, Physical Activity
Being tested: Companion
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CompanionBehavioural
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.

Study groups in NCT04827212
Study group	Role	What they receive
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. Receives: Behavioral: Companion

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 202113 Dec 2022

First posted1 Apr 2021
Study start16 Mar 2021
Primary completion2 Nov 2022
Study completion13 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ExerciseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04827212
Sponsor's protocol ID: 20-01-15
Other IDs: P30AG048785
Status last verified: Jun 2024
First submitted: 23 Mar 2021
Last updated: 3 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Exercise trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Integrated Two-Way Communication and Near-Real-Time Sensing System to Detect and Modify Daily Inactivity Among Adults Over Age 60
ClinicalTrials.gov ID: NCT04827212
Acronym / sponsor ID: 20-01-15
Conditions: Exercise, Physical Activity
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Northeastern UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 16 Mar 2021 (actual)
Primary completion: 2 Nov 2022 (actual)
Study completion: 13 Dec 2022 (actual)
First posted: 1 Apr 2021 (actual)
Results: Posted 3 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Control group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks
Treatment	Experimental	Behavioral: CompanionTreatment 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.

Who may qualify

Ages: 60 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CompanionCompanion 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.	Behavioural	Treatment

Primary outcome

Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline
Time frame: 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.
Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months
Time frame: 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.
Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months
Time frame: 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.
Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline
Time frame: 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.
Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months
Time frame: 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.
Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months
Time frame: 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.

Results and safety

Results posted to the registry on 3 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	23	21
Treatment	23	21

Primary outcome: Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: h/day

Measure	Control n = 22	Treatment n = 23
Value	1.3 (0.5)	1.6 (0.5)

Control vs Treatment: Mean Difference (Final Values): 0.31, p = 0.037, Mixed Models Analysis

Population analysed: Accelerometer data were missing for 1 participant in the control group.This results in a discrepancy with overall participant flow table which represents the number of participants with any available data.

Primary outcome: Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months

Time frame: 4 months. Mean (Standard Deviation). Unit: h/day

Measure	Control n = 20	Treatment n = 21
Value	1.5 (0.2)	1.5 (0.2)

Control vs Treatment: Mean Difference (Final Values): -0.02, p = 0.78, Mixed Models Analysis

Population analysed: There were 2 participants lost to followup in both groups and 1 participant was missing accelerometer data in the control group. This results in a discrepancy with overall participant flow table which represents the number of participants with any available data.

Primary outcome: Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months

Time frame: 6 months. Mean (Standard Deviation). Unit: h/day

Measure	Control n = 17	Treatment n = 16
Value	1.5 (0.24)	1.5 (0.24)

Control vs Treatment: Mean Difference (Final Values): 0.05, p = 0.56, Mixed Models Analysis

Population analysed: 5 and 6 participants were lost to followup and additionally, accelerometer data were missing for 1 participant each in the control and treatment groups respectively. This results in a discrepancy with overall participant flow table which represents the number of participants with any available data.

Primary outcome: Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: h/day

Measure	Control n = 22	Treatment n = 23
Value	10.6 (2.0)	10.2 (2.0)

Control vs Treatment: Mean Difference (Final Values): -0.49, p = 0.4, Mixed Models Analysis

Adverse events

Time frame: Baseline, during face-to-face interactions, and after 4 and 16 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Treatment	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dinesh John, PhD principal investigator

Northeastern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Companion in people with Exercise and Physical Activity, run by Northeastern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04827212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.