Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06773299

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

Led by Washington University School of Medicine · Updated on 2025-06-27

1000

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

U

University of Abuja Teaching Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a program aimed at improving heart health for pregnant women with obesity and their children in Abuja, Nigeria. This study focuses on how a home-visit intervention based on the Parents as Teachers curriculum combined with a Healthy Eating Active Living program may help women and their children adopt healthier lifestyles to promote cardiovascular health. The study aims to compare weight changes and lifestyle behaviors between women who receive the intervention and those who do not. Participants will be randomly assigned to one of two groups. One group will receive 40 biweekly home visits that deliver the PAT+HEALTH curriculum, focusing on lifestyle and behavioral changes to support heart health during pregnancy and after childbirth. The control group will receive standard prenatal and postnatal care without the additional intervention. The program is led by community health educators and covers both prenatal and postnatal periods. Participants will complete surveys and have clinical, laboratory, and body measurements taken at the start of the study, at birth, and every six months for two years after delivery. Researchers will monitor changes in maternal weight, cardiovascular health scores, lifestyle behaviors such as diet and physical activity, and child health outcomes. The study includes safety tracking for maternal and child health events throughout the follow-up period, which lasts up to 24 months post-delivery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Pregnant women under 14 weeks gestation
  • Singleton pregnancy
  • Body mass index greater than 30 kg/m2
  • Willing to participate in the study for 2 years
  • Planning to receive prenatal care and deliver at participating healthcare centers
  • Able to give informed consent for participation including child involvement
Not Eligible

You will not qualify if you...

  • Currently enrolled in a weight loss program
  • Unable to engage in a walking program
  • Active substance abuse
  • Treatment with medications known to affect weight (e.g., corticosteroids, antipsychotics)
  • Planning to relocate within the next 2 years
  • Unwilling to provide informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 18 months from early pregnancy through postnatal period

Participants randomized to the intervention arm will receive 40 biweekly sessions of the PAT+HEALTH behavioral intervention focusing on cardiovascular health during pregnancy and after birth. Those in the control group will receive standard ante- and postnatal care.

Biweekly visits for up to 18 months

Trial Site Locations

Total: 1 location

1

University of Abuja Teaching Hospital

Abuja, Nigeria

Actively Recruiting

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Research Team

M

Mark D Huffman, MD, MPH

G

Guhan R Iyer, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Global age-sex-specific fertility, mortality, healthy life expectancy (HALE), and population estimates in 204 countries and territories, 1950-2019: a comprehensive demographic analysis for the Global Burden of Disease Study 2019.

GBD 2019 Demographics Collaborators

https://pubmed.ncbi.nlm.nih.gov/33069325

Quality and outcomes of maternal and perinatal care for 76,563 pregnancies reported in a nationwide network of Nigerian referral-level hospitals.

Jamilu Tukur, Tina Lavin, Abiodun Adanikin...

https://pubmed.ncbi.nlm.nih.gov/35518118

Adverse Pregnancy Outcomes and Cardiovascular Disease Risk: Unique Opportunities for Cardiovascular Disease Prevention in Women: A Scientific Statement From the American Heart Association.

Nisha I Parikh, Juan M Gonzalez, Cheryl A M Anderson...

https://pubmed.ncbi.nlm.nih.gov/33779213

Nurses' perceptions on implementing a task-shifting/sharing strategy for hypertension management in patients with HIV in Nigeria: a group concept mapping study.

Angela Aifah, Deborah Onakomaiya, Juliet Iwelunmor...

https://pubmed.ncbi.nlm.nih.gov/32885213

The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions.

Shannon Wiltsey Stirman, Ana A Baumann, Christopher J Miller

https://pubmed.ncbi.nlm.nih.gov/31171014

Randomized Controlled Trial of Home-Based Lifestyle Therapy on Postpartum Weight in Underserved Women with Overweight or Obesity.

Debra Haire-Joshu, Alison G Cahill, Richard I Stein...

https://pubmed.ncbi.nlm.nih.gov/30900408

Weight Control Program and Gestational Weight Gain in Disadvantaged Women with Overweight or Obesity: A Randomized Clinical Trial.

Alison G Cahill, Debra Haire-Joshu, W Todd Cade...

https://pubmed.ncbi.nlm.nih.gov/29464907

Characteristics, treatment, and control of hypertension in public primary healthcare centers in Nigeria: baseline results from the Hypertension Treatment in Nigeria Program.

Dike B Ojji, Abigail S Baldridge, Ikechukwu A Orji...

https://pubmed.ncbi.nlm.nih.gov/35034080