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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06773299
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23
• Study Start: 2025-06-01
• Primary Completion: 2027-10
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in maternal body weight from baseline	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.

Secondary Outcome Measures

Name	Time	Method
Change in cardiovascular health score	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.
Change in cardiovascular health score - Tobacco Use/Exposure	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.
Change in cardiovascular health score - Diet	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.
Change in cardiovascular health score - Physical Activity	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.
Change in cardiovascular health score - BMI	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.
Change in cardiovascular health score - Blood Pressure	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.
Change in cardiovascular health score - Cholesterol	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.
Change in cardiovascular health score - Blood Sugar	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.
Change in cardiovascular health score - Sleep	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.
Change in Child CVH behaviors - Diet	Birth to 18 months	Between group difference in child cardiovascular health behaviors as measured through parent-reported diet from birth to 18 months.
Change in Child CVH behaviors - Physical Activity	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)
Change in Child CVH behaviors - Sleep	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)
Maternal Mortality	Baseline to 18-month postnatal follow up	Between group difference in composite rate of maternal mortality from baseline to 18 months postnatal follow-up
Maternal morbidity	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.
Stillbirth or spontaneous abortion	Measured at Birth	Between group difference in the composite rate of stillbirth or spontaneous abortion.
Neonatal, infant, and child mortality	Birth to 18 months	Between group difference in the composite rate of neonatal, infant, or childhood mortality from birth to 18 months.
Neonatal, infant, and child morbidity	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.