AgingDASHNCT04315363
Daily Activity Study of Health: Increasing Physical Activity in Aging
A study testing Motivational MRI and Behavioral Intervention in people with Aging, run by Northeastern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Motivational MRI and Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeastern University
Boston, Massachusetts, 02120
About this study
Official title: Changing and Understanding Motivation to Increase Physical Activity Among Sedentary Older Adults
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.
- Conditions
- Aging
- Being tested
- Motivational MRI and Behavioral Intervention, Control MRI and Behavioral Intervention
- Keywords
- motivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational MRI and Behavioral InterventionBehavioural
Motivational messaging delivered during a functional brain MRI scan and with daily messaging
Control MRI and Behavioral InterventionBehavioural
Control messaging delivered during a functional brain MRI scan and with daily messaging
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Brain MRI and Motivational Behavioral Intervention Receives: Behavioral: Motivational MRI and Behavioral Intervention |
| Active control | Active comparator | Brain MRI and Control Behavioral Intervention Receives: Behavioral: Control MRI and Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline; 6-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start13 Nov 2020
- Primary completion1 Oct 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Maiya Geddes, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315363
- Sponsor's protocol ID
- 19-06-05
- Other IDs
- P30AG048785
- Acronym
- DASH
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2020
- Last updated
- 29 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing and Understanding Motivation to Increase Physical Activity Among Sedentary Older Adults
- ClinicalTrials.gov ID
- NCT04315363
- Acronym / sponsor ID
- DASH / 19-06-05
- Conditions
- Aging
- Keywords
- motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Posted 29 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivational MRI and Behavioral InterventionBrain MRI and Motivational Behavioral Intervention |
| Active control | Active comparator | Behavioral: Control MRI and Behavioral InterventionBrain MRI and Control Behavioral Intervention |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational MRI and Behavioral InterventionMotivational messaging delivered during a functional brain MRI scan and with daily messaging | Behavioural | Intervention |
| Control MRI and Behavioral InterventionControl messaging delivered during a functional brain MRI scan and with daily messaging | Behavioural | Active control |
Primary outcome
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.
1 secondary outcome
Change in Moderate-to-Vigorous Physical Activity
Time frame: Baseline; 6-week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33945886Ai 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.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational MRI and Behavioral Intervention in people with Aging, run by Northeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sedentary Behavior (Average Hour/Day) (time frame: Baseline; 6-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.