ENhancing Intergenerational HeAlth in Nigeria: Peripartum as Critical Life StagE for CardioVascular Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Change in maternal body weight from baseline
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control
Participants randomized to the control group will not receive the PAT+HEALTH intervention and will only receive standard ante- and postnatal care.
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.
Intervention: PAT+HEALTH curriculum - Nigeria (Behavioral)
Outcomes
Primary Outcomes
Change in maternal body weight from baseline
Time Frame: Baseline 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.
Secondary Outcomes
- Change in cardiovascular health score(Baseline to 18-month postnatal follow up)
- Change in cardiovascular health score - Tobacco Use/Exposure(Baseline to 18-month postnatal follow up)
- Change in cardiovascular health score - Diet(Baseline to 18-month postnatal follow up)
- Change in cardiovascular health score - Physical Activity(Baseline to 18-month postnatal follow up)
- Change in cardiovascular health score - BMI(Baseline to 18-month postnatal follow up)
- Change in cardiovascular health score - Blood Pressure(Baseline to 18-month postnatal follow up)
- Change in cardiovascular health score - Cholesterol(Baseline to 18-month postnatal follow up)
- Change in cardiovascular health score - Blood Sugar(Baseline to 18-month postnatal follow up)
- Change in cardiovascular health score - Sleep(Baseline to 18-month postnatal follow up)
- Change in Child CVH behaviors - Diet(Birth to 18 months)
- Change in Child CVH behaviors - Physical Activity(Birth to 18 months)
- Change in Child CVH behaviors - Sleep(Birth to 18 months)
- Maternal Mortality(Baseline to 18-month postnatal follow up)
- Maternal morbidity(Baseline to 18-month postnatal follow up)
- Stillbirth or spontaneous abortion(Measured at Birth)
- Neonatal, infant, and child mortality(Birth to 18 months)
- Neonatal, infant, and child morbidity(Birth to 18 months)
Investigators
Mark Huffman
Professor of Medicine
Washington University School of Medicine