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

NCT ID: NCT03839212

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-10-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Happy Older Latinos are Active (HOLA)

A 16-week multi-component, health promotion intervention

Group Type: EXPERIMENTAL

HOLA Component 1

Intervention Type: 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.

HOLA Component 2

Intervention Type: 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.

HOLA Component 3

Intervention Type: 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.

HOLA Component 4

Intervention Type: BEHAVIORAL

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

Interventions

HOLA Component 1

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.

Intervention Type: BEHAVIORAL

HOLA Component 2

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.

Intervention Type: BEHAVIORAL

HOLA Component 3

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.

Intervention Type: BEHAVIORAL

HOLA Component 4

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Daniel Enrique Jimenez

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Jimenez, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Jackson Memorial Mental Health Hospital

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36855194 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U54MD002266

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20181032

Identifier Type: -

Identifier Source: org_study_id