NCT04315363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

November 13, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 29, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

1.9 years

First QC Date

February 26, 2020

Results QC Date

October 16, 2023

Last Update Submit

February 27, 2024

Conditions

Keywords

motivation

Outcome Measures

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.

    Baseline; 6-week

Secondary Outcomes (1)

  • Change in Moderate-to-Vigorous Physical Activity

    Baseline; 6-week

Study Arms (2)

Intervention

EXPERIMENTAL

Brain MRI and Motivational Behavioral Intervention

Behavioral: Motivational MRI and Behavioral Intervention

Active control

ACTIVE COMPARATOR

Brain MRI and Control Behavioral Intervention

Behavioral: Control MRI and Behavioral Intervention

Interventions

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

Intervention

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

Active control

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02120, United States

Location

Related 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.

    PMID: 33945886BACKGROUND

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

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.

Results Point of Contact

Title
Meishan Ai
Organization
Northeastern University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliate Associate Professor

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 19, 2020

Study Start

November 13, 2020

Primary Completion

October 1, 2022

Study Completion

September 30, 2023

Last Updated

February 29, 2024

Results First Posted

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations