Companion: Sensor-based Two-way Communication for Physical Activity in Older Adults
- Conditions
- Physical ActivityExercise
- Interventions
- Behavioral: Companion
- Registration Number
- NCT04827212
- Lead Sponsor
- Northeastern University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Companion 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.
- Primary Outcome Measures
Name Time Method Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months 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.
Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline 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 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.
Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Northeastern Univeristy
šŗšøBoston, Massachusetts, United States