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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
Show all 9Show fewer
- 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
Show all 12Show fewer
- 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
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.
- Conditions
- Cognitive Decline
- 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 group | Role | What they receive |
|---|---|---|
| Multicomponent Intervention | Experimental | The 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.
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)
Mini-mental state exam
The Mini-mental state exam is a dementia screening tool.
Measured: 3 months
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
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
Auditory Verbal Learning Test
A delayed recall test will be used to assess cognitive function.
Measured: 3 months
Cultural Consensus Modeling
A multi-method approach to identify shared cultural beliefs around a specific subject.
Measured: 3 months
Mediterranean diet screener
This 14-item questionnaire assesses adherence to the Mediterranean diet.
Measured: 3 months
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
Physical Activity Readiness Questionnaire
The PAR-Q+ is a seven-question pre-participation screening tools for physical activity.
Measured: 3 months
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
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
Height
Height will be measured using a standard stadiometer.
Measured: 3 months
Weight
Weight will be measured using a standard stadiometer and scale.
Measured: 3 months
Blood Pressure
Blood pressure will be measured by trained staff using electronic and/or manual blood pressure machine.
Measured: 3 months
Health Related Quality of Life
The HRQL measures health related quality of life.
Measured: 3 months
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
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
Lubben Social Network Scale
The questionnaire screens for social isolation through assessment of social networks and social supports.
Measured: 3 months
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.
- First posted13 Jun 2025
- Study start22 Apr 2025
- Primary completion22 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert L. Newton, Jr., Pennington Biomedical Research Center
- Investigators
- Robert L Newton, Jr, PhD, Principal investigator, Pennington Biomedical Research Center
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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Program for Addressing Cognition in Rural Communities
- ClinicalTrials.gov ID
- NCT07018830
- Acronym / sponsor ID
- MPAAC-R / 2022-63-pbrc
- Conditions
- Cognitive Decline
- Keywords
- dementia risk, rural, african american, lifestyle behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 22 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Intervention | Experimental | Behavioral: Behavioral TreatmentThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- > 60 years of age
- reside in a rural city
- not cognitively impaired
- physically capable of exercise
- willing to attend group sessions
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Behavioral TreatmentParticipants 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. | Behavioural | Multicomponent Intervention |
Primary outcome
Study feasibility
Time frame: 3 months
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.
18 secondary outcomes
Mini-mental state exam
Time frame: 3 months
Everyday Cognition Scale
Time frame: 3 months
Wide Range Achievement Test - Reading Subtest
Time frame: 3 months
Auditory Verbal Learning Test
Time frame: 3 months
Cultural Consensus Modeling
Time frame: 3 months
Mediterranean diet screener
Time frame: 3 months
Perceived Sleep Quality Index
Time frame: 3 months
Physical Activity Readiness Questionnaire
Time frame: 3 months
Short Physical Performance Battery
Time frame: 3 months
Community Healthy Activities Model Program for Seniors
Time frame: 3 months
Height
Time frame: 3 months
Weight
Time frame: 3 months
Blood Pressure
Time frame: 3 months
Health Related Quality of Life
Time frame: 3 months
Geriatric Depression Scale
Time frame: 3 months
The Food Noise Questionnaire
Time frame: 3 months
Lubben Social Network Scale
Time frame: 3 months
Treatment satisfaction
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Yes. Participant data can be shared upon request.
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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.
Robert L Newton, Jr, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
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.