Pilot Feasibility Trial of HEALthy Beginnings for Middle-Aged, and Older Homeless Women (HB)

A Pilot Feasibility Trial of HEALthy Beginnings: A Trauma-Informed, Chronic Disease Self-Care Intervention for Middle-Aged, and Older Homeless Women

This is a mixed methods pilot feasibility trial of HEALthy Beginnings, an innovative, nurse-driven intervention. Middle-aged and older, homeless women (MAO-HW) will participate in the HEALthy Beginnings intervention and select MAO-HW will be invited to participate in post-intervention qualitative focus groups to evaluate the program.

Study Overview

• Status: Completed
• Conditions: Health Promotion; Multimorbidity; Homelessness; Chronic Disease Self-care; Unhoused
• Intervention / Treatment: Behavioral: HEALthy Beginnings

Detailed Description

This pilot feasibility trial will enroll middle-aged and older, homeless women (MAO-HW) in the HEALthy Beginnings intervention. Participants will be asked to complete a baseline questionnaire and locator guide. Participants will then engage over a period of approximately three months in nine 60-90 minute group sessions focused on health topics, and to meet with a research team member for six private sessions which will last up to 45 minutes each to assess the program and discuss content.

Fifteen participants will be asked to return at completion of the group/individual sessions to participate in a post-intervention qualitative focus group and follow-up questionnaire to evaluate the HEALthy Beginnings intervention.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90013
      • Downtown Women's Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Self-reported age 40 years or older
• Sex assigned Female at birth
• Homeless, or living in a shelter designed to provide transitional housing
• Self-reported multimorbidity (at least 2 physical/mental health conditions)
• Able to communicate in English

Exclusion Criteria:

• Experiencing hallucinations
• Exhibiting signs of acute intoxication (e.g., slurred speech, pin-point pupils, difficulty walking)
• Non-English speaking
• Unable to understand study procedures (e.g., screening questions)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEALthy Beginnings Intervention group; Middle-aged, and older, homeless women (MAO-HW) participating in the HEALthy Beginnings Intervention	Behavioral: HEALthy Beginnings; HEALthy Beginnings, an innovative, enhanced, trauma-informed, chronic disease self-care program and nurse-driven intervention, developed and tailored for middle-aged, and older, homeless women (MAO-HW).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment as a measure of feasibility of the HEALthy Beginnings intervention	Number of eligible participants who enroll in the program after screening	Day 1
Completion as a measure of feasibility of the HEALthy Beginnings intervention	Number of enrolled participants who complete the intervention	Upon completion of all group and individual sessions, approximately 12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant evaluation of HEALthy beginnings intervention	HEALthy Beginnings will be evaluated by post-intervention focus group participants via a questionnaire consisting of 12 questions in 3 subscales. Response to each question is a 5-point Likert scale, with a score range of 12-60 points for an overall representation of acceptability, appropriateness & feasibility. Higher scores indicate more favorable evaluation.	Upon completion of all group and individual sessions, approximately 12 Weeks

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Hillman Foundation
• Investigators: Principal Investigator: Benissa E. Salem, PhD, MSN, RN, CNL, PHN, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Actual): December 6, 2025
• Study Completion (Actual): December 6, 2025

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Elderly; Women; Trauma-informed care; People experiencing homelessness; Middle-aged and older
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 24-001117; 85834 (Other Grant/Funding Number: Hillman)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No