Clinical trial NCT04827212: Companion: Sensor-based Two-way Communication for Physical Activity in Older Adults
Official title: An Integrated Two-Way Communication and Near-Real-Time Sensing System to Detect and Modify Daily Inactivity Among Adults Over Age 60
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Exercise
Physical Activity
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-04-01
Enrollment: 51
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline
timeFrame: Baseline
measure: Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months
timeFrame: 4 months
measure: Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months
timeFrame: 6 months
measure: Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline
timeFrame: Baseline
measure: Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months
timeFrame: 4 months
measure: Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Percent Body Fat Measured Via Bioelectrical Impedance at Baseline
timeFrame: Baseline
measure: Percent Body Fat Measured Via Bioelectrical Impedance After 4 Months
timeFrame: 4 months
measure: Percent Body Fat Measured Via Bioelectrical Impedance After 6 Months
timeFrame: 6 months
measure: Attention and Executive Function Measured Using the NIH Tool Box Measured at Baseline
timeFrame: Baseline
measure: Attention and Executive Function Measured Using the NIH Tool Box After 4 Months
timeFrame: 4 months
measure: Attention and Executive Function Measured Using the NIH Tool Box
timeFrame: 6 months
measure: Working Memory Measured Using the NIH Tool Box at Baseline
timeFrame: Baseline
measure: Working Memory Measured Using the NIH Tool Box After 4 Months
timeFrame: 4 months
measure: Working Memory Measured Using the NIH Tool Box After 6 Months
timeFrame: 6 months
measure: Relative Processing Speed Measured Using the NIH Tool Box at Baseline
timeFrame: Baseline
measure: Relative Processing Speed Measured Using the NIH Tool Box Measured After 4 Months
timeFrame: 4 months
measure: Relative Processing Speed Measured Using the NIH Tool Box Measured After 6 Months
timeFrame: 6 months
measure: Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline
timeFrame: Baseline
measure: Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months
timeFrame: 4 months
measure: Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 6 Months
timeFrame: 6 months
measure: Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline
timeFrame: Baseline
measure: Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months
timeFrame: 4 months
measure: Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Were Measured After 6 Months
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: Northeastern Univeristy
state: Massachusetts
Study officials:
affiliation: Northeastern University
name: Dinesh John, PhD
role: PRINCIPAL_INVESTIGATOR
References: