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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ •≥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.

Locations
Other Locations
Nigeria
University of Abuja Teaching Hospital
RECRUITING
Abuja
Contact Information
Primary
Mark D Huffman, MD, MPH
m.huffman@wustl.edu
314-362-1291
Backup
Guhan R Iyer, MPH
guhaniyer@wustl.edu
314-362-1291
Time Frame
Start Date: 2025-06-23
Estimated Completion Date: 2028-08
Participants
Target number of participants: 1000
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: University of Abuja Teaching Hospital, New York University, Parents as Teachers

This content was sourced from clinicaltrials.gov

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