Daily Activity Study of Health: Increasing Physical Activity in Aging

Aging Clinical Trial

— DASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315363
• Other study ID #: 19-06-05
• Secondary ID: P30AG048785
• Status: Completed
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: Northeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Motivational MRI and Behavioral Intervention
Motivational messaging delivered during a functional brain MRI scan and with daily messaging
• Control MRI and Behavioral Intervention
Control messaging delivered during a functional brain MRI scan and with daily messaging

Locations

Country	Name	City	State
United States	Northeastern University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Northeastern University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sedentary Behavior (Average Hour/Day)	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.	Baseline; 6-week
Secondary	Change in Moderate-to-Vigorous Physical Activity	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.	Baseline; 6-week