Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06743685
Acronym
HB
Enrollment
23
Registered
2024-12-20
Start date
2025-03-03
Completion date
2025-12-06
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

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).

Sponsors

University of California, Los Angeles
Lead SponsorOTHER
Hillman Foundation
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Recruitment as a measure of feasibility of the HEALthy Beginnings interventionDay 1Number of eligible participants who enroll in the program after screening
Completion as a measure of feasibility of the HEALthy Beginnings interventionUpon completion of all group and individual sessions, approximately 12 WeeksNumber of enrolled participants who complete the intervention

Secondary

MeasureTime frameDescription
Participant evaluation of HEALthy beginnings interventionUpon completion of all group and individual sessions, approximately 12 WeeksHEALthy 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBenissa E. Salem, PhD, MSN, RN, CNL, PHN

University of California, Los Angeles

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026