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NCT Number: NCT06773299

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertension in Pregnancy Body Weight Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Maternal Morbidity and Mortality Maternal and Child Health Outcomes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy in Obesity Signs and Symptoms Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Abuja Teaching Hospital

Abuja, Nigeria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PAT+HEALTH curriculum - Nigeria

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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)

  12. 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)

  13. 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

  14. 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.

  15. Stillbirth or spontaneous abortion

    Time frame: Measured at Birth

    Between group difference in the composite rate of stillbirth or spontaneous abortion.

  16. 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.

  17. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • New York University
  • Parents as Teachers
  • University of Abuja Teaching Hospital

Registry information

Acronym: ENHANCE-CVH

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 14, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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