Cardiometabolic risk factors, including hypertension, dysglycaemia, hypercholesterolaemia, overweight and obesity, tobacco consumption, sedentary lifestyle, poor sleep, poor diet in women who experience an adverse pregnancy outcome (hypertensive disorder of pregnancy, gestational diabetes, preterm birth, fetal growth restriction, and obesity) and an adult household member. Pregnancy and Childbirth
Conditions
Interventions
This is a cluster randomised trial to evaluate a complex intervention delivered through the routine health services in each of the four countries. Clustering will be at the level of the Primary Health
Sponsors
University of the West Indies
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Eligible women will be those with one or more high-risk features in their pregnancy, including: 1. Any diagnosis of a hypertensive disorder of pregnancy (gestational hypertension, preeclampsia, eclampsia) or chronic hypertension diagnosed before pregnancy 2. Diagnosis of Gestational Diabetes Mellitus (GDM) during pregnancy as per local criteria, or prediabetes 3. Preterm delivery <37 weeks 4. Fetal growth restriction, defined as evidence of growth faltering or abnormal umbilical artery Dopplers on ultrasound, or size at birth of the baby < 10th percentile for gestational age and sex using the locally applied size at birth chart (or INTERGROWTH-21st chart if none is available) 5. Obesity as captured by the Body Mass Index (BMI) =30 kg/m2 or =25 kg/m2 in people of Caribbean-Indian or Asian ancestry. 6. Age over 18 years 7. Able to comprehend English Inclusion Criteria for adult household members: 1. Any adult resident in the same dwelling, or with whom regular meals are shared 2. Aged over 18 years 3. Able to comprehend English
Exclusion criteria
Exclusion criteria: Exclusion Criteria for postpartum women: 1. Frequent regular travel outside of the country 2. Plan to move to another region of the country in the next 6 months 3. Inability or unwillingness to provide informed consent 4. No intention to receive care at a primary health centre 5. Type 1 diabetes (pre-pregnancy) on insulin. Exclusion Criteria for adult household members: 1. Frequent regular travel outside of the country 2. Plan to move to another region of the country in the next 6 months 3. Inability or unwillingness to provide informed consent 4. No intention to receive care at a primary health centre 5. Existing cardiovascular disease or diabetes under the care of a specialist 6. Existing severe illness (e.g. cancer, major mental disorder) that would affect the ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Life's Essential 8 cardiovascular risk score in women following an adverse pregnancy outcome measured using American Heart Association Life's Essential 8 Score at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Life's Essential 8 cardiovascular risk score in household member of the postpartum woman measured using American Heart Association Life's Essential 8 Score at 12 months;Change in Life's Essential 8 cardiovascular risk score in women following an adverse pregnancy outcome measured using American Heart Association Life's Essential 8 Score at 6 months;Implementation measures of the trial measured using the RE-AIM framework at 6 and 12 months;Economic evaluation of the intervention compared to usual care measured using direct and indirect costs to the participants and health system at 6 and 12 months | — |
Countries
Dominica, Guyana, Jamaica, Saint Vincent and the Grenadines
Contacts
Public ContactJacki Wynter
Outcome results
None listed