Enhancing Intergenerational Health in Nigeria: Peripartum as Critical Life Stage for Cardiovascular Health (ENHANCE-CVH)

The Washington University

Status: Enrolling

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

Treatments: Behavioral: PAT+HEALTH curriculum - Nigeria

Study type: Interventional

Funder types: Other

Identifiers

NCT06773299

R01HL168771 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,000 participants in 2 patient groups

PAT+HEALTH Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: PAT+HEALTH curriculum - Nigeria

Control

No Intervention group

Description:

Participants randomized to the control group will not receive the PAT+HEALTH intervention and will only receive standard ante- and postnatal care.