Clinical trial NCT04315363: Daily Activity Study of Health: Increasing Physical Activity in Aging
Official title: Changing and Understanding Motivation to Increase Physical Activity Among Sedentary Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: motivation
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Sedentary Behavior (Average Hour/Day)
timeFrame: Baseline; 6-week
Secondary outcomes:
measure: Change in Moderate-to-Vigorous Physical Activity
timeFrame: Baseline; 6-week
Other outcomes:
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
References:
citation: Ai M, Morris TP, Ordway C, Quinonez E, D'Agostino F, Whitfield-Gabrieli S, Hillman CH, Pindus DM, McAuley E, Mayo N, de la Colina AN, Phillips S, Kramer AF, Geddes M. The Daily Activity Study of Health (DASH): A pilot randomized controlled trial to enhance physical activity in sedentary older adults. Contemp Clin Trials. 2021 Jul;106:106405. doi: 10.1016/j.cct.2021.106405. Epub 2021 May 1.