Trial Outcomes & Findings for Happy Older Latinos Are Active - Cognitive Decline (NCT NCT04791709)

NCT ID: NCT04791709

Last Updated: 2025-10-20

Results Overview

Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2025-10-20

Participant Flow

Participant milestones

Measure	HOLA Group Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

HOLA Group Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.

Overall Study Withdrawal by Subject

3

Baseline Characteristics

Happy Older Latinos Are Active - Cognitive Decline

Baseline characteristics by cohort

Measure	HOLA Group n=30 Participants Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
Age, Continuous	61.7 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment.

Outcome measures

Measure

HOLA Group n=30 Participants Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.

Percentage of Participants Completing the Study

90 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Trail Making Test (TMT). Time to accurately complete Part A and Part B. The TMT measures neurocognitive functioning and consists of two parts; the first part requires participants to connect numbers in ascending order, while the second part requires individuals to connect numbers and letters in sequence. The test is scored by the time it takes to accurately complete each test. Increases in time correlate with greater impairment measured in seconds.

Outcome measures

Measure	HOLA Group n=27 Participants Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
Changes in Neurocognitive Impairment as Measured by the Trails Making Test Trail Making Test (TMT) A-Baseline	48.7 seconds Standard Deviation 24.0
Changes in Neurocognitive Impairment as Measured by the Trails Making Test Trail Making Test (TMT) B-Baseline	172.0 seconds Standard Deviation 79.0
Changes in Neurocognitive Impairment as Measured by the Trails Making Test Trail Making Test (TMT) A-16 weeks	44.3 seconds Standard Deviation 19.0
Changes in Neurocognitive Impairment as Measured by the Trails Making Test Trail Making Test (TMT) B-16 weeks	137.0 seconds Standard Deviation 70.6

SECONDARY outcome

Timeframe: Baseline, 16 weeks

The Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) asks participants to repeat 2-9 numbers forward, backward and in ascending order to assess attention, processing speed, and working memory. Each correct response earns 1 point, and the total raw score is converted to a scaled score ranging from 1 to 19. Higher scores indicate better cognitive performance; lower scores reflect increased neurocognitive impairment.

Outcome measures

Measure	HOLA Group n=27 Participants Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
Changes in Neurocognitive Impairment as Measured by the WAIS-IV Digit Span Baseline	6.5 score on a scale Standard Deviation 1.93
Changes in Neurocognitive Impairment as Measured by the WAIS-IV Digit Span 16 weeks	6.81 score on a scale Standard Deviation 2.34

SECONDARY outcome

Timeframe: Baseline, 16 weeks

The Global Physical Activity Questionnaire (GPAQ) scoring is based on the amount of time a person spends being physically active in a typical week. It looks at three areas: activity at work or during daily tasks (including heavy lifting, digging, carrying loads, or light activities like cleaning); traveling from place to place (like walking or cycling); and recreational activities (such as exercise, sports, or active hobbies). Each activity is converted into a standard unit called MET-minutes (Metabolic Equivalent of Task). This allows different types of activity to be compared on the same scale. The total MET-minutes per week are calculated by multiplying: Minutes per day × Days per week × MET value with higher scores indicating greater levels of activity.

Outcome measures

Measure	HOLA Group n=27 Participants Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
Changes in Physical Activity as Measured by the Global Physical Activity Questionnaire (GPAQ) Baseline	1,743 MET-minutes per week Standard Deviation 2,842
Changes in Physical Activity as Measured by the Global Physical Activity Questionnaire (GPAQ) 16 weeks	4,533 MET-minutes per week Standard Deviation 5,008

SECONDARY outcome

Timeframe: Baseline, 16 weeks

The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire that measures depression severity. The total score ranges from 0-27 with higher scores indicating more severe depression.

Outcome measures

Measure	HOLA Group n=27 Participants Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
Changes in Depression as Measured by the PHQ-9 Baseline	6.67 score on a scale Standard Deviation 4.84
Changes in Depression as Measured by the PHQ-9 16 weeks	4.26 score on a scale Standard Deviation 3.35

SECONDARY outcome

Timeframe: Baseline, 16 weeks

The Generalized Anxiety Disorder (GAD-7) is a 7 item questionnaire that measures anxiety severity. The total score ranges from 0-21 with higher scores indicating more severe anxiety.

Outcome measures

Measure	HOLA Group n=27 Participants Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
Changes in Anxiety as Measured by the GAD-7 Baseline	4.83 score on a scale Standard Deviation 3.97
Changes in Anxiety as Measured by the GAD-7 16 weeks	3.56 score on a scale Standard Deviation 2.81

SECONDARY outcome

Timeframe: Baseline, 16 weeks

The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12 item questionnaire that measures perceived social support. The total score ranges from 1-84 with higher scores indicating more perceived social support.

Outcome measures

Measure	HOLA Group n=27 Participants Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
Changes in Psychosocial Functioning as Measured by the MSPSS Multidimensional Scale of Perceived Social Support (MSPSS) baseline	5 score on a scale Standard Deviation 1.2
Changes in Psychosocial Functioning as Measured by the MSPSS Multidimensional Scale of Perceived Social Support (MSPSS) 16 weeks	5 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Biomarkers of cognition including interleukin-15, brain derived neurotrophic factor (BDNF), and vascular endothelial growth factor (VEG-F) reported in pg/ml will be assessed from blood samples.

Outcome measures

Measure	HOLA Group n=27 Participants Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
Changes in Biomarkers of Cognition interleukin-15 Baseline	6.6 pg/ml Standard Deviation 1.26
Changes in Biomarkers of Cognition interleukin-15 16 weeks	6.6 pg/ml Standard Deviation 1.5
Changes in Biomarkers of Cognition brain derived neurotrophic factor (BDNF) baseline	3117.1 pg/ml Standard Deviation 1853.5
Changes in Biomarkers of Cognition brain derived neurotrophic factor (BDNF) 16 weeks	3411.3 pg/ml Standard Deviation 2336.5
Changes in Biomarkers of Cognition vascular endothelial growth factor (VEG-F) baseline	34.1 pg/ml Standard Deviation 22.1
Changes in Biomarkers of Cognition vascular endothelial growth factor (VEG-F) 16 weeks	32.3 pg/ml Standard Deviation 18.1

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Biomarkers of cognition levels including irisin and insulin like growth factor (IGF-1) reported in ng/ml will be assessed from blood samples.

Outcome measures

Measure	HOLA Group n=27 Participants Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
Changes in Biomarkers of Cognition Levels irisin Baseline	39.9 ng/ml Standard Deviation 36.1
Changes in Biomarkers of Cognition Levels irisin 16 weeks	36.6 ng/ml Standard Deviation 30.8
Changes in Biomarkers of Cognition Levels insulin like growth factor (IGF-1) baseline	79.4 ng/ml Standard Deviation 51.1
Changes in Biomarkers of Cognition Levels insulin like growth factor (IGF-1) 16 weeks	65.8 ng/ml Standard Deviation 34.3

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Adiponectin will be assessed from blood samples measured by ng/ml

Outcome measures

Measure	HOLA Group n=27 Participants Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
Changes in Adiponectin Baseline	13999.1 ng/ml Standard Deviation 3571.6
Changes in Adiponectin 16 weeks	14289.6 ng/ml Standard Deviation 3946.8

Adverse Events

HOLA Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Jimenez

University of Miami

Phone: 305-243-2776

Email: dej18@miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place