HEALthy Beginnings for Homelessness

(HB Trial)

Overseen By Benissa E. Salem, PhD, MSN, RN, CNL, PHN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Hallucinations, Intoxication, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

23 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a program called HEALthy Beginnings, designed to help middle-aged and older homeless women improve their health. Nurses lead the program, focusing on women with multiple physical and mental health issues. Participants will share their experiences in group discussions to help refine the program. Suitable candidates for this trial are women aged 40 or older who are homeless or living in transitional housing, have at least two health conditions, and can communicate in English. As an unphased trial, this study offers participants the opportunity to contribute to developing a program that could significantly enhance their health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the HEALthy Beginnings intervention is safe for middle-aged and older homeless women?

Research has shown that similar housing programs, such as Healthy Beginnings at Home, have successfully improved health for people experiencing homelessness. For example, a study on Healthy Beginnings at Home found that housing support improved health for mothers and their babies. This suggests that the HEALthy Beginnings program, which uses a similar approach, is likely safe and beneficial. Reports of negative effects from these types of programs have not emerged. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HEALthy Beginnings program because it offers a fresh approach to supporting middle-aged and older homeless women, a group often underserved by traditional methods. Unlike existing treatments that might focus on immediate shelter or short-term relief, this program emphasizes a comprehensive intervention tailored specifically to the unique challenges faced by this demographic. By addressing not only the physical but also the emotional and social needs of these women, HEALthy Beginnings aims to provide a more holistic solution that could lead to sustainable improvements in their well-being.

What evidence suggests that the HEALthy Beginnings intervention is effective for middle-aged and older homeless women?

Research has shown that programs like HEALthy Beginnings can greatly improve the health of homeless women and their children. In a similar program, Healthy Beginnings at Home, 78% of babies born to mothers who received support were full-term and healthy, compared to only 55% in the group without support. This suggests that comprehensive assistance can lead to better pregnancy and birth outcomes. The focus on stable housing and regular healthcare access is key. Overall, these findings support the idea that programs like HEALthy Beginnings can enhance health outcomes for homeless women and their babies. ^{1 2 3 6 7}

Who Is on the Research Team?

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

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for middle-aged and older women who are homeless. It aims to help them manage chronic diseases and promote overall health. Participants should be interested in joining a nurse-led program that includes group activities.

Inclusion Criteria

Self-reported multimorbidity (at least 2 physical/mental health conditions)

I was assigned female at birth.

I am 40 years old or older.

Exclusion Criteria

Exhibiting signs of acute intoxication (e.g., slurred speech, pin-point pupils, difficulty walking)

Non-English speaking

I experience hallucinations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Participants engage in the HEALthy Beginnings intervention, including nine group sessions and six private sessions

12 weeks

9 group sessions, 6 private sessions

Post-intervention Evaluation

Participants complete a follow-up questionnaire and participate in a qualitative focus group to evaluate the intervention

1 week

1 focus group session

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HEALthy Beginnings

Trial Overview

The HEALthy Beginnings intervention is being tested, which is designed to support the health of homeless women with chronic illnesses through nursing care. The study will also gather feedback from participants after the intervention.

How Is the Trial Designed?

Group I: HEALthy Beginnings Intervention group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Hillman Foundation

Collaborator

Trials

2

Recruited

130+

Published Research Related to This Trial

Participants in a case management program for chronically ill, homeless individuals reported significant improvements in their health and well-being, largely due to the social support provided by case managers.

Key themes from interviews highlighted the importance of personal relationships with case managers, assistance in navigating healthcare systems, and the reduction of social isolation, suggesting that comprehensive social support is crucial for effective case management interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Because somebody cared about me. That's how it changed things": homeless, chronically ill patients' perspectives on case management. Davis, E., Tamayo, A., Fernandez, A.[2022]

Citations

1.

healthpolicyohio.org

healthpolicyohio.org/files/publications/hbahfinalreportesy06.25.2021.pdf

Healthy Beginnings at Home

Forty of the 51 live births in the intervention group (78%) were infants born full-term at a healthy weight, compared to. 24 of 44 in the control group (55%) ( ...

2.

huduser.gov

huduser.gov/portal/casestudies/study-101322.html

Healthy Beginnings at Home Explores a Novel Approach to ...

HBAH was designed to test whether providing housing interventions to homeless pregnant women could improve their health outcomes and those of their babies.

3.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2825817

Homelessness and Maternal and Infant Health

In a weighted sample of 146 943 postpartum people representing a population of 8 249 272, 2.4% (95% CI 2.3%-2.5%) reported homelessness in the ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12592753/

Maternal and Infant Outcomes for Women Experiencing ...

To explore whether women experiencing homelessness during pregnancy have higher risks of adverse pregnancy outcomes compared to housed women ...

5.

endhomelessness.org

endhomelessness.org/wp-content/uploads/2023/08/Healthy-Parents-Healthy-Babies-Final-Report-7.15.23.pdf

Healthy Parents Healthy Babies

Healthy Parents Healthy Babies (HPHB) was established to document and disseminate strategies to reduce racial disparities, increase housing.

6.

amchp.org

amchp.org/wp-content/uploads/2025/01/Promising-Handout-Healthy-Beginnings-at-Home.pdf

MCH Innovations Database

The original HBAH intervention began in 2018 and demonstrated success in reducing adverse birth outcomes in a randomized control trial in Columbus, Ohio. The ...

7.

columbus.gov

columbus.gov/files/sharedassets/city/v/1/celebrateone/hbah-policy-brief-v8-71420.pdf

Healthy Moms and Babies: Housing and Health Integration

The preliminary HBAH research findings, aligned with other research that has documented the negative health consequences of homelessness and housing instability ...