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Completed

NCT Number: NCT04315363

Daily Activity Study of Health: Increasing Physical Activity in Aging

In this six-week behavioral intervention, sedentary older adults will receive daily health messaging via their smart phone to better understand their daily activities and emotions. Participants undergo structural and functional brain imaging before and after the intervention along with measures of their behavioral, emotional and thinking functions.

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Key information

Conditions

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeastern University

Boston, Massachusetts, 02120, United States

About this study

This project will obtain data on the effects of a six week intervention designed to increase subjects' motivation to increase their physical activity. Subjects will be randomized into two different conditions to examine the efficacy of self-affirmation + positive messaging versus a control group that receives negative messaging only on changes in physical activity.

We will also examine whether any differential physical activity or structured exercise engendered in the two groups is maintained at 3 months post-intervention.

Secondary outcome measures will include a battery of cognitive, psychosocial, and neuroimaging measures that are designed to explicate the mechanisms that underlie motivation effects for physical activity in sedentary older adults.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age range 60-95
  • Not exercising more than 150 minutes of moderate/vigorous intensity per week AND sitting more than 8 hours per day
  • No contraindications to MRI (if opting for MRI)
  • Being able to speak English fluently
  • Body Mass Index (BMI) between 20 and 40
  • Normal or corrected-normal vision based on the minimal 20/20 standard
  • Ambulatory without severe pain or the assistance of walking devices
  • No diagnosis of a neurological disease
  • Regular access to a computer with internet or smartphone

Exclusion criteria

  • Primary care physician does not approve additional physical activity
  • Inability to ambulate without assistive device
  • Any unstable medical condition
  • Current diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Axis I or II disorder including Major Depression
  • History of major psychiatric illness including schizophrenia (not including general anxiety disorder or depression)
  • Current treatment for cancer - except non-melanoma skin
  • Neurological condition (multiple sclerosis, Parkinson's disease, dementia, mild cognitive impairment) or brain injury (traumatic or stroke)
  • Current alcohol or substance abuse
  • Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep vein thrombosis or other cardiovascular event
  • Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year
  • Not passing the Telephone Interview of Cognitive Status (TICS) as normal
  • Use of any anti-psychotic, anti-depressant, anti-anxiety, and attention deficit disorder (ADD/ADHD) medications.

Treatment and study plan

Motivational MRI and Behavioral Intervention

Behavioral

Motivational messaging delivered during a functional brain MRI scan and with daily messaging

Control MRI and Behavioral Intervention

Behavioral

Control messaging delivered during a functional brain MRI scan and with daily messaging

Primary outcomes

  1. Change in Sedentary Behavior (Average Hour/Day)

    Time frame: Baseline; 6-week

    This metric quantifies the change in the average amount of time spent sedentary each day in hours, from the baseline period to the 6-week follow-up period. It is a marker of time spent inactive.

Secondary outcomes

  1. Change in Moderate-to-Vigorous Physical Activity

    Time frame: Baseline; 6-week

    This measure focuses on the change in average moderate-to-vigorous physical activity (MVPA) daily minutes after the intervention compared to the pre-intervention average MVPA baseline.

Sponsors and collaborators

Lead sponsor

Northeastern University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Changing and Understanding Motivation to Increase Physical Activity Among Sedentary Older Adults

Acronym: DASH

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 19, 2020
Registry last updated
Feb 29, 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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