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

NCT03839212 | Completed Results

• 2 other identifiers: 20181032U54MD002266
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus; Cardiometabolic Risk

Outcome Measures

Primary Outcomes (3)

• Number of Eligible Participants Refusing to Participate.

  Number of eligible participants refusing to participate.

  Baseline

• Retention Rate

  Retention rate will be reported as the number of participants completing the post-intervention assessment.

  Up to 3 months post intervention

• Acceptability of Intervention

  As measured by the total number of sessions attended by the participants as a whole.

  Up to week 16

Secondary Outcomes (10)

• Change in Cardiometabolic Risk as Measured by Waist Circumference

  Baseline, 7 months post intervention

• Change in Psychosocial Functioning as Measured by Depression Severity Scale

  Baseline, Month 4, Month 7

• Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)

  Baseline, Month 4, Month 7

• Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)

  Baseline, Month 4, Month 7

• Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale

  Baseline, Month 4, Month 7

Study Arms (1)

Happy Older Latinos are Active (HOLA)

EXPERIMENTAL

A 16-week multi-component, health promotion intervention

Behavioral: HOLA Component 1; Behavioral: HOLA Component 2; Behavioral: HOLA Component 3; Behavioral: HOLA Component 4

Interventions

HOLA Component 1 BEHAVIORAL

At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.

Happy Older Latinos are Active (HOLA)

HOLA Component 2 BEHAVIORAL

A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.

Happy Older Latinos are Active (HOLA)

HOLA Component 3 BEHAVIORAL

A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.

Happy Older Latinos are Active (HOLA)

HOLA Component 4 BEHAVIORAL

One booster walking session twice a month for three months post intervention for reinforcement.

Happy Older Latinos are Active (HOLA)

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Jackson Memorial Mental Health Hospital

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Jimenez DE, Weinstein ER, Batsis J. You gotta walk the walk to talk the talk: protocol for a feasibility study of the Happy Older Latino Adults (HOLA) health promotion intervention for older HIV-positive Latino men. Pilot Feasibility Stud. 2023 Feb 28;9(1):32. doi: 10.1186/s40814-023-01262-w.

  PMID: 36855194 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

All clinical research activities at the University of Miami were suspended due to the Coronavirus Disease of 2019 (COVID-19) pandemic. As a result, data collection and participant retention were impacted.

Results Point of Contact

• Title: Daniel E. Jimenez, Ph.D., Associate Professor
• Organization: University of Miami

dej18@miami.edu

3052432776

Study Officials

• Daniel Jimenez, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 15, 2019
• Study Start: October 1, 2019
• Primary Completion: July 27, 2020
• Study Completion: October 27, 2020
• Last Updated: August 16, 2021
• Results First Posted: August 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)