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Active Not Recruiting NCT06773299

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

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

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1000
Sponsor: Washington University School of Medicine

Location: University of Abuja Teaching Hospital Abuja

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06773299). StuddyBuddy aggregates publicly available trial information.