N/A N=18 Other

The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men

Human Immunodeficiency Virus · Cardiometabolic Risk

Bottom Line

View on ClinicalTrials.gov: NCT03839212 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcome: Primary: Number of Eligible Participants Refusing to Participate. — 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: HOLA Component 1 (Behavioral); HOLA Component 2 (Behavioral); HOLA Component 3 (Behavioral); HOLA Component 4 (Behavioral)
Age: Adult, Older Adult · 50+ yrs
Sex: Male
Sponsor: University of Miami
Primary completion: Jul 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Eligible Participants Refusing to Participate.	—	—
PRIMARY Retention Rate	14	—
PRIMARY Acceptability of Intervention	111	—
SECONDARY Change in Cardiometabolic Risk as Measured by Waist Circumference	—	—
SECONDARY Change in Psychosocial Functioning as Measured by Depression Severity Scale	—	—
SECONDARY Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)	—	—
SECONDARY Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)	—	—
SECONDARY Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale	—	—
SECONDARY Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Perceived Stress Scale	—	—
SECONDARY Change in Psychosocial Functioning as Measured by the Social Support Received	—	—
SECONDARY Change in Lipid Profile as Measured by Total Cholesterol, HDL-C, LDL-C, Triglycerides	—	—
SECONDARY Change in Hypertension as Measured by Systolic and Diastolic Blood Pressure.	—	—
SECONDARY Change in Glucose as Measured by Glycated Hemoglobin (Hba1c)	—	—

Summary

The purpose of this study is to examine the feasibility of an intervention to prevent chronic diseases like diabetes, high blood pressure, and obesity in midlife and older Latino adults living with HIV. The investigators expect that the participant will be in this study for seven months. Participants will be interviewed and asked to take part in walking groups.

Eligibility Criteria

Inclusion Criteria

are Latino (self-identified);
are age 50+ years;
are male;
are HIV infected but are virologically suppressed (viral load <200 copies/mL);
volunteer informed consent;
have medical clearance by a physician;
expect to stay in Miami for the next 6 months; and
have documented risk of cardiometabolic disease.

Exclusion Criteria

diabetes diagnosis;
at baseline meet criteria for current major depressive disorder or generalized anxiety disorder;
meet criteria for current alcohol or other substance abuse disorders;
have a lifetime history of bipolar disorder or other psychotic disorder;
have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam score <24;
have contraindications to physical activity outlined in the American College of Sports Medicine standards;
have high suicide risk i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire);
are unable to complete 10 m walk test;
currently residing in a nursing or group home;
have a terminal physical illness expected to result in the death within one year;
have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03839212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.