Enhancing Intergenerational Health in Nigeria: Peripartum as Critical Life Stage for Cardiovascular Health

NCT06773299 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-06-27

No results posted yet for this study

Summary

The purpose of the ENHANCE-CVH study is to promote intergenerational cardiovascular health (CVH) of women and children in Abuja and the surrounding Federal Capital Territory of Nigeria. The study team plans to achieve this through an adaptation of an existing evidence based intervention - Parents as Teachers (PAT) curriculum + Healthy Eating Active Living Taught at Home (HEALTH) - among pregnant women with obesity and their children in Nigeria. The aim of the study is to evaluate the effectiveness and implementation of community health educator-led delivery of the PAT+HEALTH intervention via home visits to answer the following main questions:

* Will the women participating in the intervention have a greater change in weight from baseline to 18-month follow up compared to the women who do not?
* Will the women and children in the intervention group display better CVH promoting lifestyle behaviors compared to those in the control group?

Participants in the study will complete baseline surveys and have clinical data, lab data, and body measurements captured. Participants will also have these procedures repeated at birth and every 6 months up to 24 months post-delivery. Once randomized to the intervention group, participants will complete 40 biweekly PAT+HEALTH curriculum delivery sessions, each lasting approximately 60-90 minutes.

Conditions

  • Hypertension in Pregnancy
  • Hypertension
  • Obesity and Overweight
  • Maternal Morbidity and Mortality
  • Maternal and Child Health Outcomes

Interventions

BEHAVIORAL

PAT+HEALTH curriculum - Nigeria

This intervention is an adaption of the PAT Curriculum and the HEALTH intervention specifically tailored for the Nigerian context.

Sponsors & Collaborators

  • University of Abuja Teaching Hospital

    collaborator OTHER
  • New York University

    collaborator OTHER
  • Parents as Teachers

    collaborator UNKNOWN
  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Dike B Ojji, MD · University of Abuja Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-23
Primary Completion
2027-10-31
Completion
2028-08-31

Countries

  • Nigeria

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06773299 on ClinicalTrials.gov