HomelessnessHBNCT06743685
Pilot Feasibility Trial of HEALthy Beginnings for Middle-Aged, and Older Homeless Women
A study testing HEALthy Beginnings in people with Homelessness and Health Promotion, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Homelessness, Health Promotion, Chronic Disease Self-care
- What is being tested?
- HEALthy Beginnings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 6 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Downtown Women's Center
Los Angeles, California, 90013
About this study
Official title: 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.
Read the 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.
- Being tested
- HEALthy Beginnings
- Keywords
- Middle-aged and older, People experiencing homelessness, Women, Elderly, Trauma-informed care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEALthy BeginningsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| HEALthy Beginnings Intervention group | Experimental | Middle-aged, and older, homeless women (MAO-HW) participating in the HEALthy Beginnings Intervention Receives: Behavioral: HEALthy Beginnings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment as a measure of feasibility of the HEALthy Beginnings intervention
Number of eligible participants who enroll in the program after screening
Measured: Day 1
Completion as a measure of feasibility of the HEALthy Beginnings intervention
Number of enrolled participants who complete the intervention
Measured: Upon completion of all group and individual sessions, approximately 12 Weeks
Secondary outcomes (1)
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.
Measured: Upon completion of all group and individual sessions, approximately 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start3 Mar 2025
- Primary completion6 Dec 2025
- Study completion6 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HomelessnessStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Hillman Foundation
- Responsible party
- Principal investigator, Benissa E. Salem, University of California, Los Angeles
- Investigators
- Benissa E. Salem, PhD, MSN, RN, CNL, PHN, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743685
- Sponsor's protocol ID
- 24-001117
- Other IDs
- 85834
- Acronym
- HB
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No