CClinicalTrials.gg
CompletedNCT04315363DASHUpdated Feb 29, 2024Results posted

Daily Activity Study of Health: Increasing Physical Activity in Aging

An interventional study of Motivational MRI and Behavioral Intervention and Control MRI and Behavioral Intervention in Aging, sponsored by Northeastern University. Completed at 1 site in United States. Open to participants aged 60 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.

Sponsored by Northeastern University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
60 Years to 95 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Aging

Keywords

  • motivation
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In context

Lead sponsor

Northeastern University is the lead sponsor of 55 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 95 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Intervention

    Brain MRI and Motivational Behavioral Intervention

    Behavioral: Motivational MRI and Behavioral Intervention

  • Active comparator
    Active control

    Brain MRI and Control Behavioral Intervention

    Behavioral: Control MRI and Behavioral Intervention

Interventions

  • BehavioralMotivational MRI and Behavioral Intervention

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

  • BehavioralControl MRI and Behavioral Intervention

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline; 6-week

Secondary outcomes

  1. 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.

    Time frame: Baseline; 6-week

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Results

Posted Feb 29, 2024
Limitations and caveats
Given that the trial was conducted during lockdowns due to the COVID-19 pandemic, the original brain imaging MRI outcomes were modified. Intervention delivery was remote due to in-person data collection restrictions.

Participant flow

Participant flow — Overall Study
MilestoneInterventionActive Control
Started2119
Completed2117
Not completed02

Outcome measures

PrimaryChange 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.

Time frame:
Baseline; 6-week
Reported as:
Mean · Change in average daily hours
Change in Sedentary Behavior (Average Hour/Day)
Change in average daily hoursInterventionActive Control
Change in Sedentary Behavior (Average Hour/Day)-0.11 ± 1.620.05 ± 1.61
Statistical analysis
  • Intervention vs Active Control · ANOVA · p = 0.8
SecondaryChange 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.

Time frame:
Baseline; 6-week
Reported as:
Mean · Change in minutes daily
Change in Moderate-to-Vigorous Physical Activity
Change in minutes dailyInterventionActive Control
Change in Moderate-to-Vigorous Physical Activity-0.17 ± 1.090.14 ± 0.41
Statistical analysis
  • Intervention vs Active Control · ANOVA · p = 0.35

Adverse events

Collected over Duration of the study (6-week intervention and baseline visit). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention0/21 (0%)0/21 (0%)0/21 (0%)
Active Control0/19 (0%)0/19 (0%)0/19 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)InterventionActive ControlTotal
Mean70.0 ± 5.468.4 ± 5.068.7 ± 5.2
Sex: Female, Male
Sex: Female, Male(Participants)InterventionActive ControlTotal
Female151833
Male617
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)InterventionActive ControlTotal
Black/African American707
White/Caucasian121729
Asian/Pacific Islander213
Other011
Region of Enrollment
Region of Enrollment(participants)InterventionActive ControlTotal
United States211940
education
education(years)InterventionActive ControlTotal
Mean16.6 ± 3.616.0 ± 3.616.3 ± 3.5
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Study locations

1 site
  • Northeastern University
    Boston, Massachusetts 02120, United States
09

References and documents

Publications

  • 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. PubMed 33945886 ↗

Study documents

  • Study protocol · Dec 17, 2019
  • Statistical analysis plan · Mar 6, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04315363
Lead sponsor
Northeastern University
Collaborators
National Institute on Aging (NIA)
Responsible party
Maiya Geddes (Affiliate Associate Professor, Northeastern University) — Principal investigator
First posted
Mar 19, 2020
Start date
Nov 13, 2020
Primary completion
Oct 1, 2022
Completion
Sep 30, 2023
Results posted
Feb 29, 2024
Last update
Feb 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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