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Cognitive DeclineMPAAC-RNCT07018830

Multicomponent Program for Addressing Cognition in Rural Communities

A study testing Behavioral Treatment in people with Cognitive Decline, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is designed to develop and evaluate a multicomponent intervention program among older rural-residing and African American residents with a long-term goal of reducing risk factors for Alzheimer's disease. The motivation for this study is that previous non-pharmacological (e.g. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Cognitive Decline
What is being tested?
Behavioral Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
22 Apr 2025to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • > 60 years of age
  • reside in a rural city
  • not cognitively impaired
  • physically capable of exercise
  • willing to attend group sessions
  • plan to live in the study area for the next 6 months
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  • willing to allow researchers to use data for research purposes after study participation is completed
  • free of conditions that would make regular exercise unsafe as deemed by the medical investigator
  • report at least two of the following: a) no regular physical activity, b) not consuming the Mediterranean diet, 3) sleep < 6 hours per night, 4) current diagnosis of hypertension, diabetes, or obesity (by physician diagnosis or medication), 5) high school education or less, 6) history of depression.

Who cannot join

  • unable or unwilling to give informed consent
  • are cognitively impaired (MMSE score of ≤ 18)
  • have sleep apnea
  • have uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg).
  • have had a hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
  • have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months
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  • are undergoing cardiopulmonary rehabilitation
  • are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
  • have another member of the household that is a participant in the study
  • have plans to relocate out of the study area within the next 6 months
  • have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
  • have other medical, psychiatric, or behavioral factors that in the judgment of the Principal or Medical Investigator may interfere with study participation or the ability to follow the intervention protocol

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808-4124

Other trials in United States

About this study

The study is designed to develop and evaluate a multicomponent intervention program among older rural-residing and African American residents with a long-term goal of reducing risk factors for Alzheimer's disease. The motivation for this study is that previous non-pharmacological (e.g. exercise diet, social engagement) interventions have improved cognitive function in older adults with and without cognitive impairments, but these studies were largely conducted without substantial representation from residents living in rural communities or African Americans. Due to geographic, sociocultural, and environmental differences between rural residents, African Americans and other populations, it is unclear whether positive findings from previous interventions will translate to rural residents or African American individuals.

Read the detailed description

It is estimated that just over 5 million Americans are currently living with Alzheimer's Disease (AD) , and that number will rise to approximately 9 million by 2050. Rural areas were shown to have 1.4 - 1.7 times higher risk of developing dementia compared to urban areas and risk was shown to be increasing in comparison to urban areas. Risk factors in rural populations include age, lower levels of education, less access to health care, and higher rates of chronic disease. The prevalence of AD among African Americans is also elevated as it is approximately double that of non-Hispanic white Americans and older African Americans may be as much as 64% more likely to develop AD compared to non-Hispanic white Americans. Some contributors to AD are similar across rural residence and African Americans, including limited health care access, lower levels of trust in physicians, limited transportation, and built environmental issues. However, to date, there are few studies that have engaged in intervention work to address reduction of AD risk factors in older adults residing in rural communities. This is particularly true for older African Americans who may face increased barriers. Therefore, there is a need to conduct more AD prevention interventions in rural communities and especially those with large proportions of African Americans.

A large literature suggests that modifiable lifestyle behaviors are associated with the risk of developing AD. For example, both cross-sectional and longitudinal studies show that lower levels of physical activity and poorer dietary intake are associated with higher risk of developing AD. African Americans have low levels of physical activity and poor dietary quality compared to corresponding non-Hispanic white Americans. Studies in cohorts with predominantly low African American representation have shown that increasing physical activity, improving dietary intake, and engaging in cognitive training, individually, have all increased cognitive test scores across multiple domains. In addition, recent data (again from predominantly white cohorts) suggests that simultaneously changing multiple of these lifestyle behaviors at the same time may engage multiple, possibly synergistic neuroprotective mechanisms and thereby maximize neuroprotective benefits.

Multicomponent interventions, or non-pharmacological interventions that address several behaviors simultaneously (e.g. physical activity, diet, cognitive training, sleep) have been shown to be effective in improving cognitive function in older adults. Recently, the two-year Finnish Geriatric Intervention study to Prevent Cognitive Impairment and Disability (FINGER) trial intervened on physical activity, diet, cognitive training, and cardiometabolic health management simultaneously; those in the intervention had significant improvements in global cognitive function, executive functioning, and processing speed, compared to a group receiving usual health care. The FINGER results were so impressive that a worldwide network of FINGER replication studies have been engaged, including the POINTER study in the United States. However, to our knowledge, none of these multicomponent studies have included a large number of rural residents or African Americans.

We will develop a multicomponent intervention specifically tailored to older adults living in rural communities, and recruit at least 20, with a maximum of 40, adults into it. The 12 session intervention will consist of group-based lifestyle change sessions at a facility determined by the community. Cognitive functioning will be assessed to determine the brain effects of the intervention in this understudied population.

Specific Aim 1: To determine if a multicomponent intervention is feasible to deliver in older rural-residing adults. Hypothesis 1: We hypothesize that the intervention will be feasible to deliver. Feasibility will be assessed through recruitment, retention, attendance, and satisfaction ratings.

Specific Aim 2: To determine if a multicomponent intervention in older rural residing adults improves cognition in the following domains: attention, processing speed, memory, and executive function. Hypothesis 2: We hypothesize that changes in all cognitive domains will improve in the interventions compared to baseline. Change over the course of the intervention will be assessed in key AD related cognitive domains (attention, processing speed, memory, and executive function).

Collecting this data sets the stage for the definitive study of the benefits of a multicomponent intervention in rural, diverse (e.g. 50% African American) residents. This will involve collecting measures of amyloid, tau, inflammation, brain metabolism, comparing findings to a control group, and assessing other AD-relevant pathways in older rural, diverse (e.g. 50% African American) adults, which could in turn increase understanding of neurobiological mechanisms and optimal physical activity recommendations for older adults residing in rural communities.

Being tested
Behavioral Treatment
Keywords
dementia risk, rural, african american, lifestyle behavior
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral TreatmentBehavioural

    Participants will be provided 11, 60 - 90 minute group sessions. They will receive behavioral strategies to address each of the lifestyle behaviors. These strategies are based on the Social Cognitive Theory and Self Determination Theory. Topics will include, but are not limited to, self-monitoring, goal setting, social support, cues, problem solving, and relapse prevention. Groups may occur both in-person and virtually.

Study groups in NCT07018830
Study groupRoleWhat they receive
Multicomponent InterventionExperimentalThe multicomponent program will provide a package of altering several lifestyle behaviors simultaneously. The components will include physical activity, dietary intake, cognitive training, sleep, social engagement, and chronic disease management. The goals are to increase physical activity to the current guidelines, adhere to the Mediterranean diet, engage in cognitive training of memory, increase sleep to recommended levels, engage in social activities, and effectively manage chronic diseases.
Receives: Behavioral: Behavioral Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study feasibility

    Feasibility measures the likelihood of success of the study. It will be measured by a composite of 1) recruitment, 2) attendance, 3) retention, and 4) satisfaction.

    Measured: 3 months

Secondary outcomes (18)
  1. Mini-mental state exam

    The Mini-mental state exam is a dementia screening tool.

    Measured: 3 months

  2. Everyday Cognition Scale

    A self- and study partner-rated questionnaire will be used to measure cognitive change over time in overall functional ability.

    Measured: 3 months

  3. Wide Range Achievement Test - Reading Subtest

    Reading level will be assessed using a test of irregular word reading that assesses participant's ability to recognize and pronounce words in isolation

    Measured: 3 months

  4. Auditory Verbal Learning Test

    A delayed recall test will be used to assess cognitive function.

    Measured: 3 months

  5. Cultural Consensus Modeling

    A multi-method approach to identify shared cultural beliefs around a specific subject.

    Measured: 3 months

  6. Mediterranean diet screener

    This 14-item questionnaire assesses adherence to the Mediterranean diet.

    Measured: 3 months

  7. Perceived Sleep Quality Index

    The PSQI is a measure of subjective sleep duration and quality over a 4-week period. It is the most widely used validated sleep questionnaire in the field.

    Measured: 3 months

  8. Physical Activity Readiness Questionnaire

    The PAR-Q+ is a seven-question pre-participation screening tools for physical activity.

    Measured: 3 months

  9. Short Physical Performance Battery

    The SPPB is a brief performance battery based on timed short distance walk, repeated chair stands and balance test.

    Measured: 3 months

  10. Community Healthy Activities Model Program for Seniors

    The questionnaire assesses the weekly frequency and duration of various physical activities typically undertaken by older adults.

    Measured: 3 months

  11. Height

    Height will be measured using a standard stadiometer.

    Measured: 3 months

  12. Weight

    Weight will be measured using a standard stadiometer and scale.

    Measured: 3 months

  13. Blood Pressure

    Blood pressure will be measured by trained staff using electronic and/or manual blood pressure machine.

    Measured: 3 months

  14. Health Related Quality of Life

    The HRQL measures health related quality of life.

    Measured: 3 months

  15. Geriatric Depression Scale

    The GDS is a measure of depression that is able to discriminate the pattern of depressive symptoms from the general characteristics of the elderly population.

    Measured: 3 months

  16. The Food Noise Questionnaire

    The Food Noise Questionnaire (FNQ) provides a brief 5-item practical tool for researchers and clinicians to measure food noise.

    Measured: 3 months

  17. Lubben Social Network Scale

    The questionnaire screens for social isolation through assessment of social networks and social supports.

    Measured: 3 months

  18. Treatment satisfaction

    Participants will complete a satisfaction questionnaire adapted from the investigators' previous study.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start22 Apr 2025
  3. Primary completion22 Jun 2025
  4. Study completion30 Jun 2025

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07018830
Sponsor's protocol ID
2022-63-pbrc
Acronym
MPAAC-R
Status last verified
Jun 2025
First submitted
27 May 2025
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Participant data can be shared upon request.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Treatment in people with Cognitive Decline, run by Pennington Biomedical Research Center 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 28 Aug 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Study feasibility (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 Aug 2025.

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