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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Trial of HEALthy Beginnings: A Trauma-Informed, Chronic Disease Self-Care Intervention for Middle-Aged, and Older Homeless Women
- ClinicalTrials.gov ID
- NCT06743685
- Acronym / sponsor ID
- HB / 24-001117
- Keywords
- Middle-aged and older, People experiencing homelessness, Women, Elderly, Trauma-informed care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Hillman Foundation
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 6 Dec 2025 (actual)
- Study completion
- 6 Dec 2025 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| HEALthy Beginnings Intervention group | Experimental | Behavioral: HEALthy BeginningsMiddle-aged, and older, homeless women (MAO-HW) participating in the HEALthy Beginnings Intervention |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEALthy BeginningsHEALthy 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). | Behavioural | HEALthy Beginnings Intervention group |
Primary outcome
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
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
1 secondary outcome
Participant evaluation of HEALthy beginnings intervention
Time frame: Upon completion of all group and individual sessions, approximately 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Homelessness
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Colorectal Cancer Screening in the Homeless
Colorectal Cancer
Not yet recruiting
Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment
HIV Infections, HIV Prevention
Not yet recruiting
Homeless Overdose Prevention- Expansion
Homelessness, Opioid Education and Naloxone Distribution (OEND)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benissa E. Salem, PhD, MSN, RN, CNL, PHN principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment as a measure of feasibility of the HEALthy Beginnings intervention (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.