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

Not Applicable

Recruiting

• Conditions: Homelessness; Health Promotion; Chronic Disease Self-care; Multimorbidity; Unhoused

• Registration Number: NCT06743685
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Status Verified: 2025-03
• Study Start: 2025-03-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Participant evaluation of HEALthy beginnings intervention	Upon completion of all group and individual sessions, approximately 12 Weeks	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.

Trial Locations

Locations (1)

Downtown Women's Center; 🇺🇸 Los Angeles, California, United States