Enhancing Intergenerational Health in Nigeria: Peripartum as Critical Life Stage for Cardiovascular Health (ENHANCE-CVH)

June 24, 2025 updated by: Mark Huffman, Washington University School of Medicine

ENhancing Intergenerational HeAlth in Nigeria: Peripartum as Critical Life StagE for CardioVascular Health

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Nigeria
      • Abuja, Nigeria
        • Recruiting
        • University of Abuja Teaching Hospital
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

•≥18 years of age,

  • Pregnant women under 14 weeks gestation,
  • Singleton gestation,
  • Body mass index > 30 kg/m2
  • Willing to participate in ENHANCE CVH for 2 years,
  • Planning to receive prenatal care and deliver at either one of the participating primary healthcare, centers or University of Abuja Teaching Hospital, and
  • Able to give informed consent for study participation, understanding she and her child will both be involved.

Exclusion Criteria:

  • Current enrollment in a weight loss program,
  • Inability to engage in a walking program,
  • Active substance abuse
  • Treatment with medications known to impact weight (e.g., corticosteroids, antipsychotics),
  • Plan to relocate within the next 2 years, or
  • Unwilling to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAT+HEALTH Intervention
Participants randomized to this arm will receive 40 biweekly PAT+HEALTH intervention delivery ante- and postnatally. These will primarily focus on promoting cardiovascular health for mother and child through lifestyle and behavioral modifications along with additional support and education for pregnancy and cardiovascular health.
Behavioral: PAT+HEALTH curriculum - Nigeria
This intervention is an adaption of the PAT Curriculum and the HEALTH intervention specifically tailored for the Nigerian context.
No Intervention: Control
Participants randomized to the control group will not receive the PAT+HEALTH intervention and will only receive standard ante- and postnatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maternal body weight from baseline
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in change in maternal body weight f rom baseline to 18-month follow-up measured in kilograms.
Baseline to 18-month postnatal follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiovascular health score
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in change in maternal cardiovascular health score (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Baseline to 18-month postnatal follow up
Change in cardiovascular health score - Tobacco Use/Exposure
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in change in Tobacco Use/exposure subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Baseline to 18-month postnatal follow up
Change in cardiovascular health score - Diet
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in change in Diet subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Baseline to 18-month postnatal follow up
Change in cardiovascular health score - Physical Activity
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in change in Physical Activity subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Baseline to 18-month postnatal follow up
Change in cardiovascular health score - BMI
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in change in BMI subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Baseline to 18-month postnatal follow up
Change in cardiovascular health score - Blood Pressure
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in change in blood pressure subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Baseline to 18-month postnatal follow up
Change in cardiovascular health score - Cholesterol
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in change in cholesterol subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Baseline to 18-month postnatal follow up
Change in cardiovascular health score - Blood Sugar
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in change in Blood Sugar subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Baseline to 18-month postnatal follow up
Change in cardiovascular health score - Sleep
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in change in Sleep subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Baseline to 18-month postnatal follow up
Change in Child CVH behaviors - Diet
Time Frame: Birth to 18 months
Between group difference in child cardiovascular health behaviors as measured through parent-reported diet from birth to 18 months.
Birth to 18 months
Change in Child CVH behaviors - Physical Activity
Time Frame: Birth to 18 months
Between group difference in child cardiovascular health behaviors as measured through parent-reported activity from birth to 18 months using the Movement Behavior Questionnaire - Child Open Version (MBQ-C)
Birth to 18 months
Change in Child CVH behaviors - Sleep
Time Frame: Birth to 18 months
Between group difference in child cardiovascular health behaviors as measured through parent-reported sleep from birth to 18 months using the Brief Infant Sleep Questionnaire - Revised version (BISQ-R)
Birth to 18 months
Maternal Mortality
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in composite rate of maternal mortality from baseline to 18 months postnatal follow-up
Baseline to 18-month postnatal follow up
Maternal morbidity
Time Frame: Baseline to 18-month postnatal follow up
Between group difference in composite rate of maternal morbidity (defined as occurrence of any serious adverse event) from baseline to 18 month postnatal follow-up.
Baseline to 18-month postnatal follow up
Stillbirth or spontaneous abortion
Time Frame: Measured at Birth
Between group difference in the composite rate of stillbirth or spontaneous abortion.
Measured at Birth
Neonatal, infant, and child mortality
Time Frame: Birth to 18 months
Between group difference in the composite rate of neonatal, infant, or childhood mortality from birth to 18 months.
Birth to 18 months
Neonatal, infant, and child morbidity
Time Frame: Birth to 18 months
Between group difference in the composite rate of neonatal, infant, or childhood morbidity as defined by occurrence of any serious adverse events from birth to 18 months.
Birth to 18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Weight for length
Time Frame: Birth, 6 months, 18 months
Between group difference in child weight-for-length z-score at 6 and 18 months, adjusted for weight-for-length z-score at birth.
Birth, 6 months, 18 months
Child BMI
Time Frame: Birth, 6 months, 18 months
Between group difference in child BMI z-score at 6 and 18 months, adjusted for weight-for-length z-score at birth.
Birth, 6 months, 18 months
Parental feeding behaviors
Time Frame: 6 months, 12 months, 18 months, 24 months
Parental feeding behaviors measured by the Feeding to Manage Child Behavior Questionnaire (FMCBQ)
6 months, 12 months, 18 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

New York University
University of Abuja Teaching Hospital
Parents as Teachers

Investigators

  • Principal Investigator: Dike B Ojji, MD, University of Abuja Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

June 23, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 14, 2025

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HL168771 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available after the conclusion of the study following the guidelines of BioData Catalyst. A codebook will be provided.

IPD Sharing Time Frame

Beginning not later than 6 months after publication of results with no end date.

IPD Sharing Access Criteria

Those who have privileges to access data stored within the BioData Catalyst repository may access the data as per the rules and regulations of that system. Data provided to BioData Catalyst will be completely de-identified following their criteria.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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