Daily Activity Study of Health: Increasing Physical Activity in Aging

NCT ID: NCT04315363

Last Updated: 2024-02-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-13

Study Completion Date

2023-09-30

Brief Summary

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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

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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

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Brain MRI and Motivational Behavioral Intervention

Group Type EXPERIMENTAL

Motivational MRI and Behavioral Intervention

Intervention Type BEHAVIORAL

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

Active control

Brain MRI and Control Behavioral Intervention

Group Type ACTIVE_COMPARATOR

Control MRI and Behavioral Intervention

Intervention Type BEHAVIORAL

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

Interventions

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Motivational MRI and Behavioral Intervention

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

Intervention Type BEHAVIORAL

Control MRI and Behavioral Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Northeastern University

OTHER

Sponsor Role lead

Responsible Party

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Maiya Geddes

Affiliate Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northeastern University

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 33945886 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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P30AG048785

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-06-05

Identifier Type: -

Identifier Source: org_study_id

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