Aging
Conditions
Keywords
motivation
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.
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.
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
Sponsors
National Institute on Aging (NIA)
Northeastern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to 95 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sedentary Behavior (Average Hour/Day) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Moderate-to-Vigorous Physical Activity | Baseline; 6-week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Brain MRI and Motivational Behavioral Intervention
Behavioral Intervention: Motivational messaging (self affirmation on highest ranked value and positively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional | 21 |
| Active Control Brain MRI and Control Behavioral Intervention
Control Behavioral Intervention: Control motivational messaging (self affirmation on lowest ranked value and negatively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional | 19 |
| Total | 40 |
Baseline characteristics
| Characteristic | Intervention | Active Control | Total |
|---|---|---|---|
| Age, Continuous | 70.0 years STANDARD_DEVIATION 5.4 | 68.4 years STANDARD_DEVIATION 5 | 68.7 years STANDARD_DEVIATION 5.2 |
| education | 16.6 years STANDARD_DEVIATION 3.6 | 16.0 years STANDARD_DEVIATION 3.6 | 16.3 years STANDARD_DEVIATION 3.5 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black/African American | 7 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 12 Participants | 17 Participants | 29 Participants |
| Region of Enrollment United States | 21 participants | 19 participants | 40 participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 6 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 19 |
| other Total, other adverse events | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
Primary
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
Population: The number of average daily hours spent sedentary after the intervention compared to the pre-intervention baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Sedentary Behavior (Average Hour/Day) | -0.11 Change in average daily hours | Standard Deviation 1.62 |
| Active Control | Change in Sedentary Behavior (Average Hour/Day) | 0.05 Change in average daily hours | Standard Deviation 1.61 |
p-value: 0.8ANOVA
Secondary
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
Population: The change in average number of daily minutes spent in moderate-to-vigorous physical activity after the intervention compared to the pre-intervention baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Moderate-to-Vigorous Physical Activity | -0.17 Change in minutes daily | Standard Deviation 1.09 |
| Active Control | Change in Moderate-to-Vigorous Physical Activity | 0.14 Change in minutes daily | Standard Deviation 0.41 |
p-value: 0.35ANOVA