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Completed

NCT Number: NCT06743685

Pilot Feasibility Trial of HEALthy Beginnings 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.

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Key information

Conditions

Homelessness Chronic Disease Self-care Health Promotion Multimorbidity Unhoused

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Downtown Women's Center

Los Angeles, California, 90013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Primary outcomes

  1. Recruitment as a measure of feasibility of the HEALthy Beginnings intervention

    Time frame: Day 1

    Number of eligible participants who enroll in the program after screening

  2. Completion as a measure of feasibility of the HEALthy Beginnings intervention

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

    Number of enrolled participants who complete the intervention

Secondary outcomes

  1. Participant evaluation of HEALthy beginnings intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Hillman Foundation

Registry information

Official study title

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

Acronym: HB

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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