Cognitive Function 1, SocialOCEANNCT05472831
Optimizing Cognition Via Exercise and Nutrition
A study testing BAILAMOS dance program plus MIND diet and BAILAMOS dance program plus Health Education in people with Cognitive Function 1, Social, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function 1, Social
- What is being tested?
- BAILAMOS dance program plus MIND diet and BAILAMOS dance program plus Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 19 Oct 2024
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 50 years and older
- self-identification as Latino/Hispanic
- ability to understand Spanish
- score of >21 on the Telephone Interview of Cognitive Status (TICs-m)
- <3 days or <90 minutes of moderate-to-vigorous physical activity per week
- 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
Show all 10Show fewer
- administer EASY questionnaire-yes to any question means they will need medical clearance)
- Suboptimal diet assessment <8
- must be able to attend a one-hour orientation before the start of the intervention
- have access to a tablet or computer with internet access.
Who cannot join
- significant physical illness or medical condition that would preclude participation in a dance program
- current or past history of a significant psychiatric condition that would interfere with participation in the study
- presence of self-reported uncontrolled cardiovascular disease or uncontrolled diabetes mellitus
- severe chronic obstructive pulmonary disease
- recent healing or unhealed fracture(s)
- had recurrent falls in the past 12 months
Show all 11Show fewer
- hip or knee replacement
- participated in a structured dance program for 2 or more days in the past month
- Sub-optimal diet assessment >8
- Cannot attend a one-hour orientation before the start of the intervention
- Travel for more than 2-weeks throughout course of intervention and do not have access to internet
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
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.
Read the 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.
- Conditions
- Cognitive Function 1, Social
- Being tested
- BAILAMOS dance program plus MIND diet, BAILAMOS dance program plus Health Education
- Keywords
- Physical activity, Diet, Health disparities
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAILAMOS dance program plus MIND dietBehavioural
The refined BAILAMOS program is a Latin dance, Spanish-language intervention that encompasses six dance styles (Merengue, Cha Cha Cha, Bachata, Salsa, Cumbia and Samba). The program meets twice weekly for 60 minutes per session during 6-months via Zoom. The experimental group will also receive one, 60 minute MIND diet session per week.
BAILAMOS dance program plus Health EducationBehavioural
The refined BAILAMOS program is a Latin dance, Spanish-language intervention that encompasses six dance styles (Merengue, Cha Cha Cha, Bachata, Salsa, Cumbia and Samba). The program meets twice weekly for 60 minutes per session during 6-months via Zoom. The experimental group will also receive one, 60 minute Health Education session per week.
| Study group | Role | What they receive |
|---|---|---|
| BAILAMOS dance program plus MIND diet | Experimental | BAILAMOS dance program plus MIND diet: Includes a 6-month, twice a week x 60 minutes/session, virtually delivered Latin dance program plus a 60 minute MIND diet session per week. Receives: Behavioral: BAILAMOS dance program plus MIND diet |
| BAILAMOS dance program plus Health Education | Experimental | BAILAMOS dance program plus Health Education: Includes a 6-month, twice a week x 60 minutes/session, virtually delivered Latin dance program plus a 60 minute health education session per week. Receives: Behavioral: BAILAMOS dance program plus Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in scores from baseline to post-intervention 6 months
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).
Measured: Change in score from baseline to post-intervention 6 months
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.
Measured: Change in score from baseline to post-intervention 6 months
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.
Measured: Change in score from baseline to post-intervention 6 months
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.
Measured: Change in score from baseline to post-intervention 6 months
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.
Measured: Change in score from baseline to post-intervention 6 months
Secondary outcomes (8)
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.
Measured: Change in minutes per day of light and moderate-to-vigorous physical activity from baseline to post-intervention 6 months
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.
Measured: Change in activity score from baseline to post-intervention 6 months
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).
Measured: Change in MIND diet adherence from baseline to post-intervention 6 months
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.
Measured: Change in scores from baseline to post-intervention 6 months
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.
Measured: Change in scores from baseline to post-intervention 6 months
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.
Measured: Change in scores from baseline to post-intervention 6 months
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.
Measured: Change in scores from baseline to post-intervention 6 months
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.
Measured: Change in scores from baseline to post-intervention 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start15 Aug 2022
- Primary completion19 Oct 2024
- Study completion19 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function 1, SocialStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Chicago, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Susan Hughes, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472831
- Sponsor's protocol ID
- 5P30AG022849-18
- Other IDs
- 5P30AG022849-18
- Acronym
- OCEAN
- Status last verified
- Aug 2025
- First submitted
- 17 Dec 2021
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cognition Via Exercise and Nutrition
- ClinicalTrials.gov ID
- NCT05472831
- Acronym / sponsor ID
- OCEAN / 5P30AG022849-18
- Conditions
- Cognitive Function 1, Social
- Keywords
- Physical activity, Diet, Health disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- University of Illinois at Chicago, National Institute on Aging (NIA)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 19 Oct 2024 (actual)
- Study completion
- 19 Oct 2024 (actual)
- First posted
- 25 Jul 2022 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAILAMOS dance program plus MIND diet | Experimental | Behavioral: BAILAMOS dance program plus MIND dietBAILAMOS dance program plus MIND diet: Includes a 6-month, twice a week x 60 minutes/session, virtually delivered Latin dance program plus a 60 minute MIND diet session per week. |
| BAILAMOS dance program plus Health Education | Experimental | Behavioral: BAILAMOS dance program plus Health EducationBAILAMOS dance program plus Health Education: Includes a 6-month, twice a week x 60 minutes/session, virtually delivered Latin dance program plus a 60 minute health education session per week. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age 50 years and older
- self-identification as Latino/Hispanic
- ability to understand Spanish
- score of >21 on the Telephone Interview of Cognitive Status (TICs-m)
- <3 days or <90 minutes of moderate-to-vigorous physical activity per week
Key exclusion criteria (11 listed)
- significant physical illness or medical condition that would preclude participation in a dance program
- current or past history of a significant psychiatric condition that would interfere with participation in the study
- presence of self-reported uncontrolled cardiovascular disease or uncontrolled diabetes mellitus
- severe chronic obstructive pulmonary disease
- recent healing or unhealed fracture(s)
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 |
|---|---|---|
| BAILAMOS dance program plus MIND dietThe refined BAILAMOS program is a Latin dance, Spanish-language intervention that encompasses six dance styles (Merengue, Cha Cha Cha, Bachata, Salsa, Cumbia and Samba). The program meets twice weekly for 60 minutes per session during 6-months via Zoom. The experimental group will also receive one, 60 minute MIND diet session per week. | Behavioural | BAILAMOS dance program plus MIND diet |
| BAILAMOS dance program plus Health EducationThe refined BAILAMOS program is a Latin dance, Spanish-language intervention that encompasses six dance styles (Merengue, Cha Cha Cha, Bachata, Salsa, Cumbia and Samba). The program meets twice weekly for 60 minutes per session during 6-months via Zoom. The experimental group will also receive one, 60 minute Health Education session per week. | Behavioural | BAILAMOS dance program plus Health Education |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: Change in scores from baseline to post-intervention 6 months
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.
WMS-R: Wechsler Memory Scale-Logical Memory I & II
Time frame: Change in score from baseline to post-intervention 6 months
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).
Stroop Neuropsychological Screening Test (Trennerry et al., 1989)
Time frame: Change in score from baseline to post-intervention 6 months
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.
Digit Span Test (Wechsler, 1987)
Time frame: Change in score from baseline to post-intervention 6 months
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.
Word fluency Test (Welsh et al., 1994)
Time frame: Change in score from baseline to post-intervention 6 months
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.
Digit Ordering Test (Cooper at al., 1991)
Time frame: Change in score from baseline to post-intervention 6 months
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.
8 secondary outcomes
Minutes per day of light and moderate-to-vigorous physical activity via GT3x Actigraph Accelerometer
Time frame: Change in minutes per day of light and moderate-to-vigorous physical activity from baseline to post-intervention 6 months
Godin-Shephard leisure-time physical activity questionnaire (GLTEQ)
Time frame: Change in activity score from baseline to post-intervention 6 months
MIND diet adherence
Time frame: Change in MIND diet adherence from baseline to post-intervention 6 months
National Institutes of Health (NIH) Toolbox: Perceived Stress Fixed Form Age 18+ v2.0
Time frame: Change in scores from baseline to post-intervention 6 months
National Institutes of Health (NIH) Toolbox General Life Satisfaction Fixed Form A Age 18+ v2.0
Time frame: Change in scores from baseline to post-intervention 6 months
National Institutes of Health (NIH) Tool Box: Sadness Fixed Form Age 18+ v2.0
Time frame: Change in scores from baseline to post-intervention 6 months
National Institues of Health (NIH) Toolbox Loneliness Fixed Form Age 18+ v2.0
Time frame: Change in scores from baseline to post-intervention 6 months
Spectroscopy-Based Veggie Meter®
Time frame: Change in scores from baseline to post-intervention 6 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 19 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Susan Hughes, PhD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAILAMOS dance program plus MIND diet and BAILAMOS dance program plus Health Education in people with Cognitive Function 1, Social, run by University of Illinois at Urbana-Champaign 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 10 inclusion and 11 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 19 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?
Montreal Cognitive Assessment (MoCA) (time frame: Change in scores from baseline to post-intervention 6 months). The study lists 6 primary outcomes in all. 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 19 Aug 2025.