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Completed

NCT Number: NCT04827212

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

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.

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Key information

Conditions

Exercise Behavior Motor Activity Physical Activity

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Northeastern Univeristy

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. Percent Body Fat Measured Via Bioelectrical Impedance at Baseline

    Time frame: Baseline

    This is an exploratory outcome. The amount of fat in the body will be computed as a percentage

  2. Percent Body Fat Measured Via Bioelectrical Impedance After 4 Months

    Time frame: 4 months

    This is an exploratory outcome. The amount of fat in the body will be computed as a percentage

  3. Percent Body Fat Measured Via Bioelectrical Impedance After 6 Months

    Time frame: 6 months

    This is an exploratory outcome. The amount of fat in the body will be computed as a percentage

  4. Attention and Executive Function Measured Using the NIH Tool Box Measured at Baseline

    Time frame: Baseline

    This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

  5. Attention and Executive Function Measured Using the NIH Tool Box After 4 Months

    Time frame: 4 months

    This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

  6. Attention and Executive Function Measured Using the NIH Tool Box

    Time frame: 6 months

    This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

  7. Working Memory Measured Using the NIH Tool Box at Baseline

    Time frame: Baseline

    This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged accross participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

  8. Working Memory Measured Using the NIH Tool Box After 4 Months

    Time frame: 4 months

    This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

  9. Working Memory Measured Using the NIH Tool Box After 6 Months

    Time frame: 6 months

    This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

  10. Relative Processing Speed Measured Using the NIH Tool Box at Baseline

    Time frame: Baseline

    Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

  11. Relative Processing Speed Measured Using the NIH Tool Box Measured After 4 Months

    Time frame: 4 months

    This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged accross participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

  12. Relative Processing Speed Measured Using the NIH Tool Box Measured After 6 Months

    Time frame: 6 months

    This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

  13. Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline

    Time frame: Baseline

    This is an exploratory outcome.

  14. Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months

    Time frame: 4 months

    This is an exploratory outcome.

  15. Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 6 Months

    Time frame: 6 months

    This is an exploratory outcome.

  16. Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline

    Time frame: Baseline

    This is an exploratory outcome.

  17. Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months

    Time frame: 4 months

    This is an exploratory outcome.

  18. Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Were Measured After 6 Months

    Time frame: 6 months

    This is an exploratory outcome.

Sponsors and collaborators

Lead sponsor

Northeastern University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

An Integrated Two-Way Communication and Near-Real-Time Sensing System to Detect and Modify Daily Inactivity Among Adults Over Age 60

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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