DASH: Changing and Understanding Motivation to Increase Physical Activity Among Sedentary Older Adults: Daily Activity Study of Health

Sponsor
Northeastern University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04315363
Collaborator
(none)
40
1
2
18.8
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational MRI and Behavioral Intervention
  • Behavioral: Control MRI and Behavioral Intervention
Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Changing and Understanding Motivation to Increase Physical Activity Among Sedentary Older Adults
Actual Study Start Date :
Nov 6, 2020
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Brain MRI and Motivational Behavioral Intervention

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

Active Comparator: Active control

Brain MRI and Control Behavioral Intervention

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

Outcome Measures

Primary Outcome Measures

  1. Total step count (average steps/day) [Baseline; 6-week; 3-month follow-up]

    This metric quantifies the change in the average number of steps taken each day, from the baseline period to the 6-week and 3-month followup periods. It is a marker of change in habitual ambulatory activity.

  2. Sedentary behavior (average min/day) [Baseline; 6-week; 3-month follow-up]

    This metric quantifies the change in the average amount of time spent sedentary each day, from the baseline period to the 6-week and 3-month follow-up periods. It is a marker of time spent inactive.

Secondary Outcome Measures

  1. Cognitive functioning [Baseline; 6-week; 3-month follow-up]

    Executive function, complex attention and processing speed

  2. Affective processing [Baseline; 6-week; 3-month follow-up]

    Measure of affect and mood (i.e., geriatric depression scale)

  3. Structural and functional imaging [Baseline; 6-week; 3-month follow-up]

    Structural brain imaging will be used to measure brain morphology including cortical thickness, hippocampal subfields, and white matter structure. Functional brain imaging will be used to measure changes in brain activity at rest.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northeastern University Boston Massachusetts United States 02120

Sponsors and Collaborators

  • Northeastern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maiya Geddes, Affiliate Associate Professor, Northeastern University
ClinicalTrials.gov Identifier:
NCT04315363
Other Study ID Numbers:
  • 19-06-05
First Posted:
Mar 19, 2020
Last Update Posted:
Mar 3, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maiya Geddes, Affiliate Associate Professor, Northeastern University

Study Results

No Results Posted as of Mar 3, 2022