Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06773299

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersNot accepted

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

Full registry 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.

Treatments and study arms

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

Change in maternal body weight from baselineBaseline 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Abuja Teaching Hospital🌐 Abuja, Nigeria

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