Cognitive Function 1, Social Clinical Trial
— OCEANOfficial title:
Optimizing Cognition Via Exercise and Nutrition
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 30, 2024 |
Est. primary completion date | January 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Urbana-Champaign | Urbana | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign | National Institute on Aging (NIA), University of Illinois at Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montreal Cognitive Assessment (MoCA) | MoCA version 8.1 Blind will be used to assess global cognition. The MoCA-BLIND assesses different cognitive domains such as attention and concentration, memory, language, conceptual thinking, calculations, and orientation. It contains the same items as the original MoCA except those requiring visual abilities have been removed as this is administered over the phone. Time to administer the MoCA- BLIND is approximately 5-10 minutes. The total possible score is 22 points; a score of 19 or above is considered normal. | Change in scores from baseline to post-intervention 6 months | |
Primary | WMS-R: Wechsler Memory Scale-Logical Memory I & II | Logical Memory I & II will be used to assess episodic memory. A brief story will be read to the participant who will then asked to retell it immediately (I) and after a 10- min delay filled with other activities (II). The score is the number of the 25 story units recalled immediately (I) and after the delay (II). | Change in score from baseline to post-intervention 6 months | |
Primary | Stroop Neuropsychological Screening Test (Trennerry et al., 1989) | Stroop Test will be used to assess executive function. In Stroop C, participants are shown a list of colors printed in conflicting color ink and are asked to read words (names of colors). The second part of this task is Stroop CW in which participants are shown a list of colors printed in conflicting color ink and are asked to say the color of the ink the word is printed. The scores are the number of words named correctly in 30 seconds and the number of colors named correctly in 30 seconds subtracting the number of errors. respectively. | Change in score from baseline to post-intervention 6 months | |
Primary | Digit Span Test (Wechsler, 1987) | Digit Span Forward & Backward will be used to assess working memory. Digit strings of increasing length will be read, and the participant is asked to repeat each string forward (Digit Span Forward) or backward (Digit Span Backward). The score is the number of correctly retrieved strings in each part. | Change in score from baseline to post-intervention 6 months | |
Primary | Word fluency Test (Welsh et al., 1994) | Word Fluency will be used to assess executive function. The Word Fluency Test asks participants to name as many animals (part 1) or fruits and vegetables (part 2) as possible in 60 seconds. The score is the sum of the number of animals and the number of fruits and vegetables named. | Change in score from baseline to post-intervention 6 months | |
Primary | Digit Ordering Test (Cooper at al., 1991) | Digit ordering test will be used to assess working memory. For Digit Ordering, digit strings of increasing length will be read and the participant is asked to reorder the digits and say them in ascending order. The score is the number of correctly reordered strings. | Change in score from baseline to post-intervention 6 months | |
Secondary | Minutes per day of light and moderate-to-vigorous physical activity via GT3x Actigraph Accelerometer | Device-assessed physical activity via GT3x Actigraph accelerometers will be used to assess minutes per day spent in light physical activity and moderate-to-vigorous physical activity. | Change in minutes per day of light and moderate-to-vigorous physical activity from baseline to post-intervention 6 months | |
Secondary | Godin-Shephard leisure-time physical activity questionnaire (GLTEQ) | The GLTEQ is a 3-item questionnaire that assesses the number of times in the past week an individual participates in strenuous (eg, jogging), moderate (eg, brisk walking), and mild (eg, easy walking) exercise of more than 15 minutes in duration. Frequencies from the strenuous and moderate items are multiplied by 9 and 5 metabolic equivalents, respectively, and summed to calculate a moderate-to-vigorous activity score in accordance with the GLTEQ scoring protocol. | Change in activity score from baseline to post-intervention 6 months | |
Secondary | MIND diet adherence | Block 2005 Food Frequency Questionnaire will be used to compute MIND diet scores. Frequency of consumption for food items was assigned a score of 0, 0.5, or 1, where scores ranged from 0 (lowest adherence) to 15 (highest adherence). | Change in MIND diet adherence from baseline to post-intervention 6 months | |
Secondary | National Institutes of Health (NIH) Toolbox: Perceived Stress Fixed Form Age 18+ v2.0 | NIH Tool box measure of perceived stress is a self-reported measure that assesses how unpredictable, uncontrollable, and overloaded respondents find their lives. 10 items are administered using a 5-point scale, with options ranging from "never" to "very often". Higher scores are indicative of higher perceived stress. | Change in scores from baseline to post-intervention 6 months | |
Secondary | National Institutes of Health (NIH) Toolbox General Life Satisfaction Fixed Form A Age 18+ v2.0 | NIH Tool box measure of general life satisfaction assesses global feelings and attitudes about one's life. 5 items are administered using a 5 and 7-point scale, ranging from "strongly disagree" to "strongly agree". Higher scores are indicative of higher general life satisfaction. | Change in scores from baseline to post-intervention 6 months | |
Secondary | National Institutes of Health (NIH) Tool Box: Sadness Fixed Form Age 18+ v2.0 | NIH Toolbox measure of depression/sadness assesses negative mood, negative views of self, and negative social cognition. 8 items are administered using a 5-point scale ranging from "never" to "always". Higher scores are indicative of more sadness. | Change in scores from baseline to post-intervention 6 months | |
Secondary | National Institues of Health (NIH) Toolbox Loneliness Fixed Form Age 18+ v2.0 | NIH Toolbox measure of loneliness assesses perceptions of loneliness using 5 items, responses from a 5-point scale ranging from "never" to "always". Higher scores are indicative of more loneliness. | Change in scores from baseline to post-intervention 6 months | |
Secondary | Spectroscopy-Based Veggie Meter® | The Veggie Meter (VM; Longevity Link Inc., Salt Lake City, UT, USA) is a commercially available device that uses reflection spectroscopy to measure the level of carotenoid pigments in a person's skin by scanning the tip of the finger. Scores range from 0-800. | Change in scores from baseline to post-intervention 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02875301 -
Investigating Gains in Neurocognition in an Intervention Trial of Exercise
|
Phase 3 | |
Recruiting |
NCT02917928 -
The Potential of Carnosine Supplementation in Optimising Cardiometabolic Health
|
Phase 2 | |
Completed |
NCT00647478 -
System-IGF-1 Pathway and Alzheimer's Disease
|
||
Completed |
NCT03123900 -
Effects of Physical and Cognitive Training in Neuroplasticity, Health and Cognition. Movement Project
|
N/A | |
Completed |
NCT02489747 -
Effects of Wheat Bran Extract on Cognitive and Memory Function
|
N/A | |
Completed |
NCT02922400 -
Social Cognition Assessment in Young Adults
|
N/A | |
Completed |
NCT03286725 -
Physical Exercise for Education ('Fit to Study')
|
N/A | |
Recruiting |
NCT03524495 -
Well-being of Shelter Guests in Vancouver
|
N/A | |
Not yet recruiting |
NCT05781126 -
The Effect of Listening Effort, Cognition and Anxiety-depression in Listening Satisfaction by Hearing Aid Users
|
||
Completed |
NCT04396015 -
Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
|
N/A | |
Completed |
NCT03878394 -
Comparison of the Effectiveness of Different Home Exercise Programs
|
N/A | |
Not yet recruiting |
NCT04898439 -
GReen And Healthy Schools
|
N/A | |
Terminated |
NCT03968081 -
Exploration of Theory of Mind in a Situation of Social Rejection in Borderline Personality Disorder
|
N/A | |
Completed |
NCT03342924 -
Associations of Cognition, Fitness, and Body Composition Among Ethnic Minority Youth
|
N/A | |
Recruiting |
NCT06139705 -
Weather Sensitivity and the Effects of Walking in Nature on Stress Response of Individuals With Coronary Artery Disease
|
N/A | |
Completed |
NCT04494737 -
Wellbeing, Stress Reduction and Social Cognition
|
N/A | |
Completed |
NCT04243642 -
PJ-011726 IntelliSpace Cognition MCI Study
|
||
Completed |
NCT04046289 -
Effects of Probiotics and Calcium Supplementation on Growth, Development, and Metabolic Parameters
|
||
Completed |
NCT03182621 -
Comprehensive Versus Traditional Lifestyle Program
|
N/A | |
Completed |
NCT02399020 -
Social Cognition and Interaction Training for Adults With Psychotic Disorders: An Open Pilot Study in Finland
|
N/A |