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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
PAT+HEALTH curriculum - Nigeria
BehavioralThis intervention is an adaption of the PAT Curriculum and the HEALTH intervention specifically tailored for the Nigerian context.
Treatment groups
Trial outcomes
Primary outcomes
Change in maternal body weight from baseline
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
Between group difference in change in maternal cardiovascular health score (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Change in cardiovascular health score - Tobacco Use/Exposure
Between group difference in change in Tobacco Use/exposure subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Change in cardiovascular health score - Diet
Between group difference in change in Diet subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Change in cardiovascular health score - Physical Activity
Between group difference in change in Physical Activity subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Other outcomes
Child Weight for length
Between group difference in child weight-for-length z-score at 6 and 18 months, adjusted for weight-for-length z-score at birth.
Child BMI
Between group difference in child BMI z-score at 6 and 18 months, adjusted for weight-for-length z-score at birth.
Parental feeding behaviors
Parental feeding behaviors measured by the Feeding to Manage Child Behavior Questionnaire (FMCBQ)
Sponsors and contacts
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Washington University School of Medicine
Lead sponsor
University of Abuja Teaching Hospital
Collaborator
New York University
Collaborator
Parents as Teachers
Collaborator