Multicomponent Program for Addressing Cognition in Rural Communities

NCT07018830 | Completed

• 1 other identifier: 2022-63-pbrc
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Decline

Keywords

dementia risk; rural; african american; lifestyle behavior

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (18)

• Mini-mental state exam

  3 months

• Everyday Cognition Scale

  3 months

• Wide Range Achievement Test - Reading Subtest

  3 months

• Auditory Verbal Learning Test

  3 months

• Cultural Consensus Modeling

  3 months

Study Arms (1)

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.

Behavioral: Behavioral Treatment

Interventions

Behavioral Treatment BEHAVIORAL

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.

Multicomponent Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robert L Newton, Jr, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 13, 2025
• Study Start: April 22, 2025
• Primary Completion: June 22, 2025
• Study Completion: June 30, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available June 2026
• Access Criteria: All study data will be available. Request from the investigative team.

Locations

US (1)