Postpartum Depression (PPD)LHMomsNCT06666400
Living Healthy for Moms RCT
A study testing LHMoms Intervention in people with Postpartum Depression (PPD) and Cardiac Event, run by Columbia University at 4 sites in United States.
Trial summary
LHMoms is a novel integrated care intervention that focuses intensively on care continuity and community-to-healthcare linkages for postpartum birthing individuals. The intervention starts prior to discharge in the delivery hospitalization and extends to six months post-partum, thus covering critical windows to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression (PPD), Cardiac Event
- What is being tested?
- LHMoms Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Jan 2025to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Birthing individuals aged 18 years or older
- Delivery of singleton live birth; and
- Minority race (self-identified Black), minority ethnicity (self-identified Latinx), and/or Medicaid beneficiary.
Who cannot join
- Individuals unable to conduct visits and complete surveys via computer or phone,
- Younger than 18 years
- Individuals unable to communicate (reading, writing, speaking) in English, Spanish or Haitian Creole
- multifetal pregnancy
- gestational age less than 24 weeks at delivery
- known major fetal anomaly in current pregnancy
Show all 12Show fewer
- known fetal demise
- on hemodialysis
- active user of IV drugs
- active suicidal ideation with intent and plan
- known primary psychotic disorder
- plans to move out of the area within 6 months
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
New York City Health + Hospitals/ Queens
Jamaica, New York, 11432
NewYork-Presbyterian Allen Hospital
New York, New York, 10034
Weill Cornell Medicine
New York, New York, 10065
About this study
Official title: Living Healthy for Moms (LHM) Randomized Type I Hybrid EffectivenessImplementation Trial: A Doula-Delivered Cognitive Behavioral Training (CBT) + Cardiovascular Health (CVH) Intervention for Birthing Individuals
LHMoms is a novel integrated care intervention that focuses intensively on care continuity and community-to-healthcare linkages for postpartum birthing individuals. The intervention starts prior to discharge in the delivery hospitalization and extends to six months post-partum, thus covering critical windows to prevent long-term physical and mental health sequelae.
Read the detailed description
Most preventable maternal deaths occur in the intrapartum and immediate postpartum (PP) periods, as do complications from undetected/undertreated mental health (MH) conditions (e.g., suicide, overdose) and cardiovascular (CV) events. In New York City (NYC), maternal deaths are 8-12 times higher for Black than for White birthing parents. However, most community-based programs addressing the health of birthing individuals in this population have been narrowly focused on basic services (e.g., breastfeeding, social support), with limited focus on evidence-based care. Holistic interventions addressing physical, mental, and social health needs in the critical PP transition and moving from trauma- and "risk"-based to a strength- and empowerment-based approach are urgently needed. Many hospital, community, and governmental barriers preclude broad adoption and scaling of doula-delivered care, and it is not known how facilitators, assets, and resources can improve care continuity and community-hospital linkages to support birthing individuals at diverse sites across NYC. The impact of doula-led interventions at patient- and health-system levels have yet to be rigorously evaluated. In collaboration with the Caribbean Women's Health Association and the Northern Manhattan Perinatal Partnership, this study will address these gaps by implementing and evaluating Living Healthy for Moms (LHMoms) in three complementary settings and populations (Brooklyn, Queens, and Northern Manhattan). LHMoms is a novel integrated care intervention that focuses intensively on care continuity and community-to-healthcare linkages that starts prior to discharge and during the first 7 days post-discharge (PD) and extends into six months post-partum, as critical windows to prevent long-term physical and mental health sequelae, while also addressing key determinants of lifelong health risk. The investigators have developed several innovative, evidence-based interventions, including an online education empowerment program (using a Patient Activated Learning System platform we developed) to build patient self-advocacy beginning in-hospital; a doula-led health emergency detection program during the critical first 7 days PD; and a trauma-informed doula-delivered cognitive behavioral training (CBT) intervention to address PP depression and cardiovascular risks for the critical six months following delivery. This study proposes a rigorous, mixed-methods study of LHMoms to address three specific aims. In Aim 1, the study will test the effectiveness of LHMoms vs. attention control in a Hybrid Type 1 Implementation Trial with 600 randomized birthing individuals at three hospital sites in Brooklyn, Queens, and Northern Manhattan. This will include refining and tailoring the intervention to each site to maximize care quality, building capacity for doulas to deliver LHMoms, and assessing effectiveness in lowering PP depression, improving CV health. In Aim 2, the study will analyze the effects of LHMoms on PP healthcare utilization and satisfaction. In Aim 3, the study will examine the implementation process and outcomes of the LHMoms intervention at the three sites. This project will advance the overall goals of NY-CHAMP to optimize PP outcomes for historically disadvantaged birthing individuals.
- Conditions
- Postpartum Depression (PPD), Cardiac Event
- Being tested
- LHMoms Intervention, No intervention
- Keywords
- severe maternal morbidity, maternal mortality, mental health, cardiovascular events, health disparity, maternal welfare, structural racism
- Medical subject headings
- Depression, Postpartum, Cardiovascular Diseases, Maternal Death, Psychological Well-Being, Systemic Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHMoms InterventionBehavioural
Also called LHM Arm
The LHM arm (N=300) will receive a CBT+ Cardiovascular Health (CVH) Intervention to reduce CV risk. LHM employs a (CBT) + cardiovascular health (CVH) intervention delivered by doulas and integrating a healthy lifestyle intervention to reduce CV risk. The LHM intervention integrates the following key elements: (1) doula-led emergency detection in the first 7 days post-discharge; (2) home BP monitoring (HBPM); and (3) 12-sessions of the doula-delivered intervention to prevent PPD and reduce CV risk from 1 week to 6 months post-discharge, supported by (4) education through the Patient-Activated Learning System (PALS), a novel education platform used to engage low-literacy, racially marginalized individuals. LHM is based on the Thinking Healthy Programme (THP), an intervention originally designed to treat PPD in low and middle-income countries using community health workers.
No interventionOther
Standard doula care and the same number of telephone or video-delivered sessions and will last the same amount of time on general postpartum health topics not related to CV health or depression. Attention control participants will not receive doula-initiated outreach during the first 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control | Active comparator | The attention control arm (N=300) will receive standard doula care and the same number of telephone or video-delivered sessions and will last the same amount of time on general postpartum health topics not related to CV health or depression. Attention control participants will not receive doula-initiated outreach during the first 7 days. Receives: Other: No intervention |
| LHMoms Intervention Arm | Experimental | The LHM arm (N=300) will receive a CBT+ Cardiovascular Health (CVH) Intervention to reduce CV risk. LHM employs a cognitive behavioral training (CBT) + cardiovascular health (CVH) intervention delivered by doulas and integrating a healthy lifestyle intervention to reduce CV risk. The LHM intervention integrates the following key elements: (1) doula-led emergency detection in the first 7 days post-discharge; (2) home BP monitoring (HBPM); and (3) 11-sessions of the doula-delivered intervention to prevent PPD and reduce CV risk from 1 week to 6 months post-discharge, supported by (4) education through the Patient-Activated Learning System (PALS), a novel education platform used to engage low-literacy, racially marginalized individuals. LHM is based on the Thinking Healthy Programme (THP), an intervention originally designed to treat PPD in low and middle-income countries using community health workers. Receives: Behavioral: LHMoms Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale (EPDS) score
The primary outcome of PPD, operationalized as the presence or absence of postpartum depressive symptoms, is defined by EPDS score (≥9). EPDS ≥9 was chosen specifically because that is the score used as the cut-off to refer for clinical evaluation, and the rate of EPDS ≥9 ranges from about 30-40% depending on other characteristics of the clinics. Assuming 1:1 randomization, a design effect of 1.5 to account for variance among sites and doulas, a power of 0.80, a two-sided significance level of 0.05, and 20-25% attrition, to detect a PPD symptom rate reduction from 33.5% in the control arm to 23% in the intervention, a sample size of approximately 450 individuals (225 in each study arm) is needed. The EPDS scale ranges from 0 to 30, and a higher score indicates more severe depression.
Measured: 6 months post hospital discharge
Heart Score
The "Heart Score" is a metric calculated through the American Heart Association's online calculator. It incorporates the behavioral and biological components Life's Essential 8 (LE8) (diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure). These components will be collected from participants during the study but are not being assessed as individual outcomes; instead, the Heart Score from 1-100 as calculated by the AHA online calculator will be used as the outcome of CV health.
Measured: 6 months post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start17 Jan 2025
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized type 1 Hybrid Effectiveness-Implementation Trial will enroll 600 birthing individuals post-delivery, while they are still in the hospital, pre-discharge. These individuals will be randomized to one of two groups: the LHM arm (N=300) will receive a CBT+ Cardiovascular Health (CVH) Intervention to reduce CV risk, and the attention control arm (N=300) will receive standard doula care and the same number of telephone or video call-delivered sessions on general health education topics not related to CV health or depression.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Weill Medical College of Cornell University, Northern Manhattan Perinatal Partnership, New York City Health and Hospitals Corporation, Caribbean Women's Health Association
- Responsible party
- Principal investigator, Mary E. D'Alton, Columbia University
- Investigators
- Mary E. D'Alton, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666400
- Sponsor's protocol ID
- AAAV1436
- Other IDs
- 5U54HD113172-02
- Acronym
- LHMoms
- Status last verified
- Jan 2026
- First submitted
- 17 Oct 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Faiz JM, Bylinsky I, Rincones Rojas L, Kopatsis K, St Clair V, Dorval-Moller M, Voegtline K, Lipkind H, Safford MM, Hall KS, Reddy U, Osborne LM. Doula-Delivered Cognitive Behavioral Training and Cardiovascular Health Intervention for Birthing Individuals in a Low-Income New York City Population: Protocol for a Living Healthy for Moms Randomized Type I Hybrid Effectiveness-Implementation Trial. JMIR Res Protoc. 2025 Dec 10;14:e76871. doi: 10.2196/76871.
PubMed 41370009
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Healthy for Moms (LHM) Randomized Type I Hybrid EffectivenessImplementation Trial: A Doula-Delivered Cognitive Behavioral Training (CBT) + Cardiovascular Health (CVH) Intervention for Birthing Individuals
- ClinicalTrials.gov ID
- NCT06666400
- Acronym / sponsor ID
- LHMoms / AAAV1436
- Conditions
- Postpartum Depression (PPD), Cardiac Event
- Keywords
- severe maternal morbidity, maternal mortality, mental health, cardiovascular events, health disparity, maternal welfare, structural racism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Weill Medical College of Cornell University, Northern Manhattan Perinatal Partnership, New York City Health and Hospitals Corporation, Caribbean Women's Health Association
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 30 Oct 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.
LHMoms is a novel integrated care intervention that focuses intensively on care continuity and community-to-healthcare linkages for postpartum birthing individuals. The intervention starts prior to discharge in the delivery hospitalization and extends to six months post-partum, thus covering critical windows to prevent long-term physical and mental health sequelae.
Detailed description
Most preventable maternal deaths occur in the intrapartum and immediate postpartum (PP) periods, as do complications from undetected/undertreated mental health (MH) conditions (e.g., suicide, overdose) and cardiovascular (CV) events. In New York City (NYC), maternal deaths are 8-12 times higher for Black than for White birthing parents. However, most community-based programs addressing the health of birthing individuals in this population have been narrowly focused on basic services (e.g., breastfeeding, social support), with limited focus on evidence-based care. Holistic interventions addressing physical, mental, and social health needs in the critical PP transition and moving from trauma- and "risk"-based to a strength- and empowerment-based approach are urgently needed. Many hospital, community, and governmental barriers preclude broad adoption and scaling of doula-delivered care, and it is not known how facilitators, assets, and resources can improve care continuity and community-hospital linkages to support birthing individuals at diverse sites across NYC. The impact of doula-led interventions at patient- and health-system levels have yet to be rigorously evaluated. In collaboration with the Caribbean Women's Health Association and the Northern Manhattan Perinatal Partnership, this study will address these gaps by implementing and evaluating Living Healthy for Moms (LHMoms) in three complementary settings and populations (Brooklyn, Queens, and Northern Manhattan). LHMoms is a novel integrated care intervention that focuses intensively on care continuity and community-to-healthcare linkages that starts prior to discharge and during the first 7 days post-discharge (PD) and extends into six months post-partum, as critical windows to prevent long-term physical and mental health sequelae, while also addressing key determinants of lifelong health risk. The investigators have developed several innovative, evidence-based interventions, including an online education empowerment program (using a Patient Activated Learning System platform we developed) to build patient self-advocacy beginning in-hospital; a doula-led health emergency detection program during the critical first 7 days PD; and a trauma-informed doula-delivered cognitive behavioral training (CBT) intervention to address PP depression and cardiovascular risks for the critical six months following delivery. This study proposes a rigorous, mixed-methods study of LHMoms to address three specific aims. In Aim 1, the study will test the effectiveness of LHMoms vs. attention control in a Hybrid Type 1 Implementation Trial with 600 randomized birthing individuals at three hospital sites in Brooklyn, Queens, and Northern Manhattan. This will include refining and tailoring the intervention to each site to maximize care quality, building capacity for doulas to deliver LHMoms, and assessing effectiveness in lowering PP depression, improving CV health. In Aim 2, the study will analyze the effects of LHMoms on PP healthcare utilization and satisfaction. In Aim 3, the study will examine the implementation process and outcomes of the LHMoms intervention at the three sites. This project will advance the overall goals of NY-CHAMP to optimize PP outcomes for historically disadvantaged birthing individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized type 1 Hybrid Effectiveness-Implementation Trial will enroll 600 birthing individuals post-delivery, while they are still in the hospital, pre-discharge. These individuals will be randomized to one of two groups: the LHM arm (N=300) will receive a CBT+ Cardiovascular Health (CVH) Intervention to reduce CV risk, and the attention control arm (N=300) will receive standard doula care and the same number of telephone or video call-delivered sessions on general health education topics not related to CV health or depression.
| Arm | Type | Receives |
|---|---|---|
| Attention Control | Active comparator | Other: No interventionThe attention control arm (N=300) will receive standard doula care and the same number of telephone or video-delivered sessions and will last the same amount of time on general postpartum health topics not related to CV health or depression. Attention control participants will not receive doula-initiated outreach during the first 7 days. |
| LHMoms Intervention Arm | Experimental | Behavioral: LHMoms InterventionThe LHM arm (N=300) will receive a CBT+ Cardiovascular Health (CVH) Intervention to reduce CV risk. LHM employs a cognitive behavioral training (CBT) + cardiovascular health (CVH) intervention delivered by doulas and integrating a healthy lifestyle intervention to reduce CV risk. The LHM intervention integrates the following key elements: (1) doula-led emergency detection in the first 7 days post-discharge; (2) home BP monitoring (HBPM); and (3) 11-sessions of the doula-delivered intervention to prevent PPD and reduce CV risk from 1 week to 6 months post-discharge, supported by (4) education through the Patient-Activated Learning System (PALS), a novel education platform used to engage low-literacy, racially marginalized individuals. LHM is based on the Thinking Healthy Programme (THP), an intervention originally designed to treat PPD in low and middle-income countries using community health workers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Birthing individuals aged 18 years or older
- Delivery of singleton live birth; and
- Minority race (self-identified Black), minority ethnicity (self-identified Latinx), and/or Medicaid beneficiary.
Key exclusion criteria (12 listed)
- Individuals unable to conduct visits and complete surveys via computer or phone,
- Younger than 18 years
- Individuals unable to communicate (reading, writing, speaking) in English, Spanish or Haitian Creole
- multifetal pregnancy
- gestational age less than 24 weeks at delivery
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 |
|---|---|---|
| LHMoms InterventionAlso: LHM ArmThe LHM arm (N=300) will receive a CBT+ Cardiovascular Health (CVH) Intervention to reduce CV risk. LHM employs a (CBT) + cardiovascular health (CVH) intervention delivered by doulas and integrating a healthy lifestyle intervention to reduce CV risk. The LHM intervention integrates the following key elements: (1) doula-led emergency detection in the first 7 days post-discharge; (2) home BP monitoring (HBPM); and (3) 12-sessions of the doula-delivered intervention to prevent PPD and reduce CV risk from 1 week to 6 months post-discharge, supported by (4) education through the Patient-Activated Learning System (PALS), a novel education platform used to engage low-literacy, racially marginalized individuals. LHM is based on the Thinking Healthy Programme (THP), an intervention originally designed to treat PPD in low and middle-income countries using community health workers. | Behavioural | LHMoms Intervention Arm |
| No interventionStandard doula care and the same number of telephone or video-delivered sessions and will last the same amount of time on general postpartum health topics not related to CV health or depression. Attention control participants will not receive doula-initiated outreach during the first 7 days. | Other | Attention Control |
Primary outcome
Edinburgh Postnatal Depression Scale (EPDS) score
Time frame: 6 months post hospital discharge
The primary outcome of PPD, operationalized as the presence or absence of postpartum depressive symptoms, is defined by EPDS score (≥9). EPDS ≥9 was chosen specifically because that is the score used as the cut-off to refer for clinical evaluation, and the rate of EPDS ≥9 ranges from about 30-40% depending on other characteristics of the clinics. Assuming 1:1 randomization, a design effect of 1.5 to account for variance among sites and doulas, a power of 0.80, a two-sided significance level of 0.05, and 20-25% attrition, to detect a PPD symptom rate reduction from 33.5% in the control arm to 23% in the intervention, a sample size of approximately 450 individuals (225 in each study arm) is needed. The EPDS scale ranges from 0 to 30, and a higher score indicates more severe depression.
Heart Score
Time frame: 6 months post hospital discharge
The "Heart Score" is a metric calculated through the American Heart Association's online calculator. It incorporates the behavioral and biological components Life's Essential 8 (LE8) (diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure). These components will be collected from participants during the study but are not being assessed as individual outcomes; instead, the Heart Score from 1-100 as calculated by the AHA online calculator will be used as the outcome of CV health.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 41370009Faiz JM, Bylinsky I, Rincones Rojas L, Kopatsis K, St Clair V, Dorval-Moller M, Voegtline K, Lipkind H, Safford MM, Hall KS, Reddy U, Osborne LM. Doula-Delivered Cognitive Behavioral Training and Cardiovascular Health Intervention for Birthing Individuals in a Low-Income New York City Population: Protocol for a Living Healthy for Moms Randomized Type I Hybrid Effectiveness-Implementation Trial. JMIR Res Protoc. 2025 Dec 10;14:e76871. doi: 10.2196/76871.
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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.
Mary E. D'Alton, MD principal investigator
Columbia University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LHMoms Intervention in people with Postpartum Depression (PPD) and Cardiac Event, run by Columbia University at 4 sites 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 3 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Edinburgh Postnatal Depression Scale (EPDS) score (time frame: 6 months post hospital discharge). 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?
On the ClinicalTrials.gov record for NCT06666400, which also lists 1 linked publication.
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 14 Jan 2026.