NCT06884501

Brief Summary

The purpose of the study is to conduct a 6-month randomized controlled trial among Latinos ages 50+ at risk for cognitive decline and compare the efficacy of a remote-delivered, culturally tailored Latin dance program and strength training coupled with a Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet (IG) compared to a Latin dance and MIND diet program (CG) on cognitive performance, CVD risk factors, MIND diet adherence, physical activity, biomarkers, and psychosocial outcomes. Participants will:

  • Randomly be placed in the intervention (IG) or control group (CG)
  • Have 2 pre and post intervention testing visits
  • Have weekly sessions during the 6-month trial

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

November 19, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

November 19, 2024

Last Update Submit

July 1, 2025

Conditions

Keywords

strength trainingLatinosLatin dancephysical activitycognitionbrain healthdietary pattern

Outcome Measures

Primary Outcomes (4)

  • 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 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.

    Change in score from baseline to 6 months

  • Digit Span Test (Wechsler, 1987)

    Digit Span Test will be used to measure executive function. 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 6 months

  • Trail Making Test (A&B)

    Trail Making Test (A\&B) will be used to measure executive function. Part A consists of numbers spread out in a grid with a dedicated start and end point. Participants must trace in sequential order. Part B will consist of numbers and letters in sequential order spread across a grid with a start and end point as well. Participants much trace the starting number to letter. Scoring will be based on seconds needed to complete each test with Part A having a max of 100 seconds and Part B with a max of 300 seconds. Test will discontinue when the time limit has been reached.

    Change in scores from baseline to post-intervention 6 months

Secondary Outcomes (15)

  • Minutes per day of light and moderate-to-vigorous physical activity via GT3x Actigraph Accelerometer

    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

    Change in score from baseline to 6 months

  • Non-exercise Cardiorespiratory Fitness Questionnare

    Change in score from baseline to 6 months

  • Spectroscopy-Based Veggie Meter®

    Change in scores from baseline to post-intervention 6 months

  • Plasma Structural Lipidomics

    Change in scores from baseline to post-intervention 6 months

  • +10 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Remote-delivered BAILAMOS™ dance program, MIND diet \& strength training

Behavioral: Latin dance, MIND diet, and Strength training

Control Group

ACTIVE COMPARATOR

Remote-delivered BAILAMOS™ dance program and MIND diet

Behavioral: Latin dance and MIND Diet

Interventions

This will be a 6 month remote-delivered BAILAMOS™ dance program, MIND diet and strength training intervention.

Intervention Group

This will be a 6 month remote-delivered BAILAMOS™ dance and MIND diet program.

Control Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) self-identify as a Latino/Hispanic, 2) age 50+, 3) documented cardiovascular disease (CVD) or at least one CVD risk factor (i.e., hypertension, hyperlipidemia, diabetes, obesity, current smoker, or family history of CVD), 3) participate in \<3 days or \<90 minutes of moderate-to-vigorous PA per week, 4) able to understand Spanish, 5) Wi-Fi Access, 6) score of greater than 21 on the TICS-M

You may not qualify if:

  • uncontrolled illness including diabetes (e.g., participant reports high glucose levels despite treatment efforts), hypertension (e.g., participant is hypertensive while on medication or not adhering to medication), or thyroid disease (e.g., patient reports experiencing hyperthyroidism).
  • history of musculoskeletal, cardiorespiratory, or neurological diseases that preclude the participation in moderate intensity exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Susan Aguinaga, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 19, 2024

First Posted

March 19, 2025

Study Start

September 1, 2025

Primary Completion

November 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

July 4, 2025

Record last verified: 2025-07