Unveiling the Digital Phenotype of PA Behavior (MIADP)

October 17, 2023 updated by: PXL University College

Unveiling the Digital Phenotype: A Protocol for a Prospective Study on Physical Activity Behavior in Community-dwelling Older Adults

Observational data from healthy adults aged 65+ will be collected through cross-sectional and longitudinal methods to analyze physical activity patterns, identifying digital phenotypes. Measurements include self-reports, clinical assessments, and EMA, with statistical analysis using multivariate regression and time series analysis, and a neural network if needed to find digital phenotypes related to physical activity in older adults.

Study Overview

Detailed Description

Observational data will be collected in healthy older adults aged 65 or above combining both cross-sectional and longitudinal data collection methods to analyze patterns of PA behavior and identify prognostic factors affecting PA outcomes in order to identify digital phenotypes related to PA.

The measurements are based on the Behavioral Change Wheel and include self-reporting assessments, clinical assessments for cross-sectional data collection and ecological momentary assessment (EMA) as well as time series data collection for longitudinal data. The statistical analysis will involve multivariate regression analysis and time series analysis, with a Bonferroni correction to account for multiple comparisons. A machine learning algorithm is used due to the complexity of the data. If no suitable model is found, a neural network will be used to determine digital phenotypes related to PA behavior in older adults.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Healthy Community Dwelling older adults aged 65 years or more

Description

Inclusion Criteria:

  • Participants are 65 years of older
  • Participants are competent to give informed consent
  • Participants are able to actively participate in the study
  • Participants are community-dwelling (living independent at home or in a service apartment)
  • Without a severe illness
  • Dutch language proficiency as native speaker

Exclusion Criteria:

  • Current neurological disorder such as Parkinson's disease, multiple sclerosis, cerebrovascular accident, …
  • Current cardiovascular disorder such as stroke, acute myocardial infarct, coronary artery bypass grafting, percutaneous coronary intervention less than 5 years ago
  • Current respiratory disorder, such as chronic obstructive pulmonary disease, pneumonia, pulmonary fibrosis, asthma, …
  • Current severe metabolic disorder, such as diabetes type 1 and 2, severe osteoporosis, …
  • Current severe cognitive disorders, such as Alzheimer's disease, vascular dementia, Lewy Body dementia, frontotemporal dementia,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Community Dwellling Healthy Older Adults
  • 65 years or older
  • able to give informed consent
  • community dwelling
  • no severe illness (neurological, cardiovascular, respiratory, metabolic, cognitive disorder)
  • dutch language profiency

An observational study will be conducted to gather data on multiple levels aiming to identify diverse digital phenotypes related to PA behavior among community-dwelling older adults.

A hybrid approach will be employed, combining both cross-sectional and longitudinal data collection methods. The overall aim is to employ data analysis to identify patterns of PA - behavior (referred to as phenotypes) and to pinpoint prognostic factors that affect PA outcomes.

This integrated strategy will be complemented by four distinct measurement approaches, ensuring a comprehensive assessment of the research objectives. These measurement approaches include:self-reporting, clinical, ecological momentary and time series assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digital phenotypes of PA
Time Frame: 14 days
Patterns of physical activity behavior
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Kim Daniels, MS, PXL University College of Applied Sciences and Arts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2024

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • MIADP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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