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

NCT06743685 | Completed

• 2 other identifiers: 24-00111785834
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Homelessness; Health Promotion; Chronic Disease Self-care; Multimorbidity; Unhoused

Keywords

Middle-aged and older; People experiencing homelessness; Women; Elderly; Trauma-informed care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Participant evaluation of HEALthy beginnings intervention

  Upon completion of all group and individual sessions, approximately 12 Weeks

Study Arms (1)

HEALthy Beginnings Intervention group

EXPERIMENTAL

Middle-aged, and older, homeless women (MAO-HW) participating in the HEALthy Beginnings Intervention

Behavioral: HEALthy Beginnings

Interventions

HEALthy Beginnings BEHAVIORAL

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).

HEALthy Beginnings Intervention group

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Hillman Foundation: collaborator

Study Sites (1)

Downtown Women's Center

Los Angeles, California, 90013, United States

Location

Study Officials

• Benissa E. Salem, PhD, MSN, RN, CNL, PHN

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Model Details: All eligible participants will be invited to enroll in the HEALthy Beginnings intervention, a trauma-informed, chronic disease self-care intervention for middle-aged, and older homeless women. Participants will attend nine group sessions and six individual sessions over approximately 12 weeks. A subset of participants will be invited to participate in post-intervention focus groups as well as to complete a questionnaire evaluating the HEALthy Beginnings intervention.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: March 3, 2025
• Primary Completion: December 6, 2025
• Study Completion: December 6, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)