Clinical trial NCT06884501: Latinos Increasing Fuerza (Strength) Through Exercise and Diet
Official title: Latinos Increasing Fuerza (Strength) Through Exercise and Diet
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Older Adults (50-90 Years)
Cognition
Physical Activity
Keywords: strength training
Latinos
Latin dance
physical activity
cognition
brain health
dietary pattern
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2025-03-19
Enrollment: 90
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: 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

Detailed description: Screening and Consent: Potential participants can consent to be screened via email or by calling our office to be screened. Bilingual study staff will screen all interested individuals for eligibility based on inclusion/exclusion criteria. Participants will be administered the Exercise and Screening for You (EASY) tool. The EASY tool consists of 6 questions to assess one's risk factors associated with exercise. Depending on how participants respond to the 6 questions, they may need to obtain medical clearance to participate in the study.

To obtain medical clearance, we will ask interested participants for the name and contact information of physician. We will send a letter via email or fax to the physician requesting medical clearance. Once we receive medical clearance vi email or fax, we will then begin the Informed Consent process. Once determined eligible, study staff will email Qualtrics link to Informed Consent and will go over the consent form. Participants will be instructed to save/print a copy of the document for their records. After participants have signed the Informed Consent, they will be invited to the first testing session at Freer Hall at the University of Illinois at Urbana-Champaign.

Baseline first testing session (\~2 hours): At the first testing session, research personnel will collect demographics, health history, self-reported physical activity (Godin \& non-exercise measure of cardiorespiratory fitness), and the Food Frequency Questionnaire will be administered. Anthropometrics such as height, weight, blood pressure, waist circumference, and DEXA scan will also be conducted.

Trained research staff will guide the participant through drop sets (increasing weight with decreasing repetitions) with 10 reps (2lbs), 8 reps (3lbs), 6 reps (5lbs), and 4 reps (8lbs) for the following exercises: Dumbbell overhead press, dumbbell squat, dumbbell single arm row, dumbbell deadlift, seated dumbbell chest fly, and dumbell side lunges. We will have participants begin with light weights and slowly progress with heavier weights (if possible, otherwise participants will stick to lighter weights). These exercise have been chosen for the baseline and posttesting because they are reflective of the exercise that they wil do at home.

Participants will be provided with an accelerometer and the accelerometer log. Participants will be asked to wear the accelerometer for 7 consecutive days. Participants will be asked to wear the monitor on a belt or attached to a clip placed on their non-dominant hip during wake times only. They will be asked to remove the monitor during any water-related activities and sleep. Accelerometer-wearing instructions and logs will be provided to participants. After the 7 days, participants will be scheduled for their second visit.

Randomization: Participants will be randomly assigned to one of two groups after participants complete the first baseline visit: 1) intervention group (IG) remote-delivered BAILAMOS™ dance program, MIND diet \& strength training; or 2) control group (CG) remote-delivered BAILAMOS™ dance program and MIND diet. Participants in the IG group will meet 3 times a week for a total of 4 hrs per week and the CG will meet twice week for 3 hrs per week.

Baseline second testing session (\~2 hours): At the second testing session, vegetable consumption will be assessed through the Veggie Meter. In brief, the Veggie Meter is a non-invasive device that measures vegetable consumption through LED lighting. Participants are asked to insert their non-dominant ring finger into the scanner and a caotenoid score between 0-800 is provided to participant. A cognitive battery will also be administered. A set of psychosocial questionnaires (NIH Toolbox Perceived Stress, General Life Satisfaction, Sadness, and Loneliness) will also be administered. Given that this is a remote-delivered intervention, participants will then be instructed to download Zoom to their computer or iPad device (they will be asked to bring these devices). Research staff will provide participants with an e-mail with a LIFTED study ID. Additionally, research staff will help participants troubleshoot through Zoom, if needed. Participants in the IG will be provided with resistance bands and two sets of weights (5lb and 10lb weights) for the strength training program.

Interventions:

Remote-delivered BAILAMOS™ dance program: BAILAMOS™ is a Latin dance, Spanish-language intervention that encompasses six dance styles. The program meets twice weekly for 60 minutes per session during 6-months. It encompasses six dance styles: Merengue, Cha Cha Cha, Bachata, Salsa, Cumbia and Flamenco. The instructor will follow a specific protocol containing a step-by-step guide of each dance class. It will be delivered via Zoom. A trained dance instructor (with 5+ years of dance instruction experience) who is bilingual and bicultural with experience in leading dance classes for older adults will deliver the dance sessions. Each session will begin with reviewing safety procedures, stepping in place as a warm-up, followed by stretching. Instruction begins with the basics of the respective styles of dance, followed by advanced steps for singles. Over each month, activity increases and progresses in terms of movement, specificity of dance moves, and complexity. Basic principles are targeted, such as partnership, timing, footwork, and movement quality. Each session ends with a 5-minute cool-down. Logs will assess the rate of perceived exertion and heart rate. Participants will completes these via paper logs. They will receive 6-months worth of log sheets during baseline testing visit 2. Participants will be reminded to increase their lifestyle PA.

Remote-delivered MIND Diet program: The Mediterranean-DASH diet intervention for neurodegenerative delay (MIND) is a diet that is tailored for the protection of the brain and contains the most compelling evidence of reduction of dementia. The MIND diet consists of 10 brain-healthy food groups (green leafy vegetables, other vegetables, nuts, berries, beans, whole grains, seafood, poultry, olive oil, and wine). The MIND diet also recommends a limited intake of foods that are unhealthy for the brain (high saturated fat or sugar intakes, such as red meat and meat products, butter, whole-fat cheese, pastries and sweets, and fried/fast foods). The intervention group will receive one MIND diet session per week. The MIND Diet program will be delivered via Zoom in a group discussion setting by a trained bilingual and bicultural graduate student with a background in nutrition (Bachelor's degree in nutrition or current training in nutrition). The instructor will follow a specific study protocol that contains information on all sessions. The first 30 minutes of the session will introduce the food item, describe its benefits, and describe ways to incorporate these food items into their diet. During this portion, the instructor will make participants aware of any allergy concerns related to the food items that are introduced. The second half of the session (30 minutes) will consist of culturally appropriate recipes, food demonstrations, and recipe sharing by both instructors and participants.

Remote delivered strength training program: The IG will receive a two 30 minute strength group training sessions led by an ACSM certified personal trainer. The program includes a twice a week session of 30-minutes, delivered over 6-months and is group-based. The study-specific strength training protocol consists of three sets of 8-12 repetitions of six different resistance exercises targeting all major muscle groups. Participants will begin with bodyweight and progress to use 5lbs, and if possible, 10lbs weights. Instructions will be provided on proper form. Exercises include Dumbbell overhead press, dumbbell squat, dumbbell single arm row, dumbbell deadlift, seated dumbbell chest fly, and dumbell side lunges however, exercises may be modified to accommodate participant's physical abilities. Each session will end with a 5-minute cool-down.

All sessions will be recorded, and stored in a secure server. Participants will be invited to make-up missed sessions using the recorded videos. These will be completed on a one-on-one basis with a trained researcher.

Post-testing: All participants will then be asked to participate in the 6-month post-intervention testing sessions (2 testing sessions). All tests will be administered in the same order at baseline and month 6 testing. Each participant will have three weeks to complete testing, thus we may test participants at month 6+3 weeks. After that, participants will not be allowed to be tested for the 6-month testing.

Post-testing first testing session (\~2 hours): The pre and post surveys will be linked via participant ID numbers. At the first testing session, research personnel will collect anthropometrics such as height, weight, blood pressure, waist circumference, and DEXA scan. Self-reported physical activity questionnaires will be administered (Godin \& non-exercise measure of cardiorespiratory fitness). Trained research staff will guide the participant through drop sets (increasing weight with decreasing repetitions) with 10 reps (2lbs), 8 reps (3lbs), 6 reps (5lbs), and 4 reps (8lbs) for the following exercises: Dumbbell overhead press, dumbbell squat, dumbbell single arm row, dumbbell deadlift, seated dumbbell chest fly, and dumbell side lunges.

Participants will be provided with an accelerometer and the accelerometer log. Participants will be asked to wear the accelerometer for 7 consecutive days. Participants will be asked to wear the monitor on a belt or attached to a clip placed on their non-dominant hip during wake times only. They will be asked to remove the monitor during any water-related activities and sleep. Accelerometer-wearing instructions and logs will be provided to participants. After the 7 days, participants will be scheduled for their second visit.

Post-testing second testing session (\~2 hours): At second testing session, the Food Frequency Questionnaire will be administered. A set of psychosocial questionnaires (NIH Toolbox Perceived Stress, General Life Satisfaction, Sadness, and Loneliness) will also be administered. Vegetable consumption will be assessed through the Veggie Meter. The Veggie Meter measures vegetable and fruit consumption using light spectroscopy. Participants are asked to insert their non-dominant ring finger into the scanner and a carotenoid score between 0-800 is provided to participants. A cognitive battery will also be administered.

All measures will be available in Spanish or English. A description of all measures and questionnaires is provided in the appendix.

Eligibility criteria: Inclusion Criteria:

1) 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 \&lt;3 days or \&lt;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

Exclusion Criteria:

1. 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).
2. history of musculoskeletal, cardiorespiratory, or neurological diseases that preclude the participation in moderate intensity exercise

Primary outcomes:
measure: Stroop Neuropsychological Screening Test (Trennerry et al., 1989)
timeFrame: Change in score from baseline to 6 months
measure: Word fluency Test (Welsh et al., 1994)
timeFrame: Change in score from baseline to 6 months
measure: Digit Span Test (Wechsler, 1987)
timeFrame: Change in score from baseline to 6 months
measure: Trail Making Test (A&amp;B)
timeFrame: Change in scores 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
timeFrame: Change in score from baseline to 6 months
measure: Non-exercise Cardiorespiratory Fitness Questionnare
timeFrame: Change in score from baseline to 6 months
measure: Spectroscopy-Based Veggie Meter®
timeFrame: Change in scores from baseline to post-intervention 6 months
measure: Plasma Structural Lipidomics
timeFrame: Change in scores 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: MIND Diet Adherence
timeFrame: Change in scores from baseline to post-intervention 6 months
measure: Blood pressure
timeFrame: Change from baseline to post-intervention 6 months
measure: Fasting Blood glucose
timeFrame: Change from baseline to post-intervention 6 months
measure: Waist Circumference
timeFrame: Change from baseline to post-intervention 6 months
measure: DEXA
timeFrame: Change from baseline to post-intervention 6 months
measure: MOCA-Blind Version 8.1
timeFrame: Change in score from baseline to 6 months
Other outcomes:
Locations:
Study officials:
References: