Improving intergenerational heart health for pregnant women and their children in Abuja
ENhancing Intergenerational HeAlth in Nigeria: Peripartum as Critical Life StagE for CardioVascular Health
This program will try a home-visit parenting and healthy-living curriculum for pregnant women with obesity in Abuja to see if it helps mothers lose weight and improves heart-healthy habits for them and their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (Abuja) |
| Trial ID | NCT06773299 on ClinicalTrials.gov |
What this trial studies
The trial adapts an evidence-based Parents as Teachers (PAT) plus Healthy Eating Active Living Taught at Home (HEALTH) curriculum for use with pregnant women with obesity in Abuja and the surrounding Federal Capital Territory. Community health educators will deliver the adapted PAT+HEALTH program via home visits and participants will be assigned to either the intervention or usual-care group. Primary outcomes include change in maternal weight from baseline to 18 months and measures of heart-healthy lifestyle behaviors in mothers and children. The design is a hybrid Type 2 effectiveness-implementation approach to test both health effects and how well the program can be delivered in this setting.
Who should consider this trial
Good fit: Ideal candidates are pregnant women age 18 or older, under 14 weeks gestation with a singleton pregnancy and BMI over 30 who plan to receive care and deliver at participating clinics and can commit to two years of follow-up.
Not a fit: Women already enrolled in a weight-loss program, taking medications that affect weight, unable to engage in a walking program, with active substance abuse, planning to relocate within two years, or unable/unwilling to provide informed consent are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could help pregnant women with obesity lose weight, adopt healthier behaviors, and reduce cardiovascular risk for themselves and their children.
How similar studies have performed: Elements of PAT and the HEALTH curriculum have shown benefits for parenting and weight-related behaviors in other settings, but combining and adapting them for peripartum cardiovascular health in Nigeria is a novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Abuja
- University of Abuja Teaching Hospital — Abuja, Nigeria (Recruiting)
Study contacts
- Principal investigator: Dike B Ojji, MD — University of Abuja Teaching Hospital
- Study coordinator: Mark D Huffman, MD, MPH
- Email: m.huffman@wustl.edu
- Phone: 314-362-1291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.