Early Phase 1
N=46
Companion: Sensor-based Two-way Communication for Physical Activity in Older Adults
Exercise · Physical Activity
Bottom Line
View on ClinicalTrials.gov: NCT04827212 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline — 1.3; 1.6 h/day — p=0.037
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Companion (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Northeastern University
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline |
1.3; 1.6 | 0.037 sig |
| PRIMARY Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months |
1.5; 1.5 | 0.78 |
| PRIMARY Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months |
1.5; 1.5 | 0.56 |
| PRIMARY Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline |
10.6; 10.2 | 0.4 |
| PRIMARY Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months |
10.4; 9.6 | 0.18 |
| PRIMARY Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months |
10.3; 10.2 | 0.86 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04827212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.