About this trial
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
Qualifiers
Pregnant women under 14 weeks gestation,
Singleton gestation,
Body mass index > 30 kg/m2
Willing to participate in ENHANCE CVH for 2 years,
Disqualifiers
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),
Trial design
Treatments tested in this trial
- PAT+HEALTH curriculum - Nigeria
Treatment groups
Sponsors and collaborators
Washington University School of Medicine
Lead sponsor
University of Abuja Teaching Hospital
Collaborator
New York University
Collaborator
Parents as Teachers
Collaborator