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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,000
This intervention is an adaption of the PAT Curriculum and the HEALTH intervention specifically tailored for the Nigerian context.
University of Abuja Teaching Hospital
Abuja, Nigeria
RECRUITINGChange 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.
Time frame: Baseline to 18-month postnatal follow up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 18-month postnatal follow up
Change in cardiovascular health score - BMI
Between group difference in change in BMI subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Time frame: Baseline to 18-month postnatal follow up
Change in cardiovascular health score - Blood Pressure
Between group difference in change in blood pressure subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Time frame: Baseline to 18-month postnatal follow up
Change in cardiovascular health score - Cholesterol
Between group difference in change in cholesterol subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Time frame: Baseline to 18-month postnatal follow up
Change in cardiovascular health score - Blood Sugar
Between group difference in change in Blood Sugar subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Time frame: Baseline to 18-month postnatal follow up
Change in cardiovascular health score - Sleep
Between group difference in change in Sleep subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.
Time frame: Baseline to 18-month postnatal follow up
Change in Child CVH behaviors - Diet
Between group difference in child cardiovascular health behaviors as measured through parent-reported diet from birth to 18 months.
Time frame: Birth to 18 months
Change in Child CVH behaviors - Physical Activity
Between group difference in child cardiovascular health behaviors as measured through parent-reported activity from birth to 18 months using the Movement Behavior Questionnaire - Child Open Version (MBQ-C)
Time frame: Birth to 18 months
Change in Child CVH behaviors - Sleep
Between group difference in child cardiovascular health behaviors as measured through parent-reported sleep from birth to 18 months using the Brief Infant Sleep Questionnaire - Revised version (BISQ-R)
Time frame: Birth to 18 months
Maternal Mortality
Between group difference in composite rate of maternal mortality from baseline to 18 months postnatal follow-up
Time frame: Baseline to 18-month postnatal follow up
Maternal morbidity
Between group difference in composite rate of maternal morbidity (defined as occurrence of any serious adverse event) from baseline to 18 month postnatal follow-up.
Time frame: Baseline to 18-month postnatal follow up
Stillbirth or spontaneous abortion
Between group difference in the composite rate of stillbirth or spontaneous abortion.
Time frame: Measured at Birth
Neonatal, infant, and child mortality
Between group difference in the composite rate of neonatal, infant, or childhood mortality from birth to 18 months.
Time frame: Birth to 18 months
Neonatal, infant, and child morbidity
Between group difference in the composite rate of neonatal, infant, or childhood morbidity as defined by occurrence of any serious adverse events from birth to 18 months.
Time frame: Birth to 18 months
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