Clinical trial NCT05472831: Optimizing Cognition Via Exercise and Nutrition
Official title: Optimizing Cognition Via Exercise and Nutrition
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Function 1, Social
Keywords: Physical activity
Diet
Health disparities
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: National Institute on Aging (NIA)
First posted: 2022-07-25
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators propose to test the preliminary efficacy of the refined BAILAMOS™ Latin dance program plus a culturally tailored MIND diet (Mediterranean-DASH diet intervention for neurodegenerative delay) program on cognitive function among older Latinos (ages 50+) at risk of cognitive decline. This project will test whether participants randomized to the BAILAMOS™ Latin dance plus MIND diet experience better cognitive outcomes than participants randomized to the BAILAMOS™ Latin dance plus a health education program.

Detailed description: By 2060, the prevalence of Alzheimer's disease (AD) in Latinos is projected to increase by 832%. There is an urgent need to create non-pharmacological interventions to reduce the risk of AD among Latinos. Physical activity (PA) and diet interventions (e.g. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND)) have been shown to decrease the incidence of AD. Behavioral interventions that concomitantly target physical activity (PA) and diet have shown an improvement in cognitive function; however, these studies have not been conducted in older Latinos nor have they included culturally appropriate interventions. The need to test culturally appropriate PA and diet interventions that have the potential to reduce the loss of cognitive function in older Latinos, a group at elevated risk of health disparities, is of high public health importance. OCEAN (Optimizing Cognition via Exercise and Nutrition) is a 6-month multidomain (Latin dance plus MIND DIET) intervention delivered virtually to middle-aged and older Latinos. The investigators propose a pilot randomized controlled trial to test the preliminary efficacy of the refined BAILAMOS™ Latin dance program plus MIND (Mediterranean-DASH diet intervention for neurodegenerative delay)- a new program tailored for the protection of the brain. The impact of the combined program (intervention group (IG)) will be compared to a BAILAMOS™ plus health education (control group (CG)) on cognitive performance among middle-aged to older Latinos at risk of cognitive decline.

Eligibility criteria: Inclusion Criteria:

1. age 50 years and older
2. self-identification as Latino/Hispanic
3. ability to understand Spanish
4. score of \>21 on the Telephone Interview of Cognitive Status (TICs-m)
5. \<3 days or \<90 minutes of moderate-to-vigorous physical activity per week
6. self-report having a cardiovascular disease (CVD) OR at least one CVD risk factor (i.e., hypertension, hyperlipidemia, diabetes, obesity, current smoker, or family history of CVD) OR family history of Alzheimer's disease
7. administer EASY questionnaire-yes to any question means they will need medical clearance)
8. Suboptimal diet assessment \<8
9. must be able to attend a one-hour orientation before the start of the intervention
10. have access to a tablet or computer with internet access.

Exclusion Criteria:

1. significant physical illness or medical condition that would preclude participation in a dance program
2. current or past history of a significant psychiatric condition that would interfere with participation in the study
3. presence of self-reported uncontrolled cardiovascular disease or uncontrolled diabetes mellitus
4. severe chronic obstructive pulmonary disease
5. recent healing or unhealed fracture(s)
6. had recurrent falls in the past 12 months
7. hip or knee replacement
8. participated in a structured dance program for 2 or more days in the past month
9. Sub-optimal diet assessment \>8
10. Cannot attend a one-hour orientation before the start of the intervention
11. Travel for more than 2-weeks throughout course of intervention and do not have access to internet

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Change in scores from baseline to post-intervention 6 months
measure: WMS-R: Wechsler Memory Scale-Logical Memory I & II
timeFrame: Change in score from baseline to post-intervention 6 months
measure: Stroop Neuropsychological Screening Test (Trennerry et al., 1989)
timeFrame: Change in score from baseline to post-intervention 6 months
measure: Digit Span Test (Wechsler, 1987)
timeFrame: Change in score from baseline to post-intervention 6 months
measure: Word fluency Test (Welsh et al., 1994)
timeFrame: Change in score from baseline to post-intervention 6 months
measure: Digit Ordering Test (Cooper at al., 1991)
timeFrame: Change in score from baseline to post-intervention 6 months
Secondary outcomes:
measure: Minutes per day of light and moderate-to-vigorous physical activity via GT3x Actigraph Accelerometer
timeFrame: Change in minutes per day of light and moderate-to-vigorous physical activity from baseline to post-intervention 6 months
measure: Godin-Shephard leisure-time physical activity questionnaire (GLTEQ)
timeFrame: Change in activity score from baseline to post-intervention 6 months
measure: MIND diet adherence
timeFrame: Change in MIND diet adherence from baseline to post-intervention 6 months
measure: National Institutes of Health (NIH) Toolbox: Perceived Stress Fixed Form Age 18+ v2.0
timeFrame: Change in scores from baseline to post-intervention 6 months
measure: National Institutes of Health (NIH) Toolbox General Life Satisfaction Fixed Form A Age 18+ v2.0
timeFrame: Change in scores from baseline to post-intervention 6 months
measure: National Institutes of Health (NIH) Tool Box: Sadness Fixed Form Age 18+ v2.0
timeFrame: Change in scores from baseline to post-intervention 6 months
measure: National Institues of Health (NIH) Toolbox Loneliness Fixed Form Age 18+ v2.0
timeFrame: Change in scores from baseline to post-intervention 6 months
measure: Spectroscopy-Based Veggie Meter®
timeFrame: Change in scores from baseline to post-intervention 6 months
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Susan Hughes, PhD
role: PRINCIPAL_INVESTIGATOR
References: