ACTIVE_NOT_RECRUITING

Living Healthy for Moms RCT

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-01-17
Study Completion:2030-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06666400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Birthing individuals aged 18 years or older
  2. * Delivery of singleton live birth; and
  3. * Minority race (self-identified Black), minority ethnicity (self-identified Latinx), and/or Medicaid beneficiary.
  1. * Individuals unable to conduct visits and complete surveys via computer or phone,
  2. * Younger than 18 years
  3. * Individuals unable to communicate (reading, writing, speaking) in English, Spanish or Haitian Creole
  4. * multifetal pregnancy
  5. * gestational age less than 24 weeks at delivery
  6. * known major fetal anomaly in current pregnancy
  7. * known fetal demise
  8. * on hemodialysis
  9. * active user of IV drugs
  10. * active suicidal ideation with intent and plan
  11. * known primary psychotic disorder
  12. * plans to move out of the area within 6 months

Contacts and Locations

Principal Investigator

Uma Reddy, MD, MPH
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
United States
New York City Health + Hospitals/ Queens
Jamaica, New York, 11432
United States
NewYork-Presbyterian Allen Hospital
New York, New York, 10034
United States
Weill Cornell Medicine
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Uma Reddy, MD, MPH, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-17
Study Completion Date2030-06-01

Study Record Updates

Study Start Date2025-01-17
Study Completion Date2030-06-01

Terms related to this study

Keywords Provided by Researchers

  • severe maternal morbidity
  • maternal mortality
  • mental health
  • cardiovascular events
  • health disparity
  • maternal welfare
  • structural racism

Additional Relevant MeSH Terms

  • Postpartum Depression (PPD)
  • Cardiac Event