Enhancing Intergenerational Health in Nigeria: Peripartum as Critical Life Stage for Cardiovascular Health

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWashington University School of Medicine

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 volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PAT+HEALTH curriculum - Nigeria

    Behavioral

    This intervention is an adaption of the PAT Curriculum and the HEALTH intervention specifically tailored for the Nigerian context.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: PAT+HEALTH InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 18-month postnatal follow up

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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.

Time frame
Birth, 6 months, 18 months
2

Child BMI

Between group difference in child BMI z-score at 6 and 18 months, adjusted for weight-for-length z-score at birth.

Time frame
Birth, 6 months, 18 months
3

Parental feeding behaviors

Parental feeding behaviors measured by the Feeding to Manage Child Behavior Questionnaire (FMCBQ)

Time frame
6 months, 12 months, 18 months, 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

University of Abuja Teaching Hospital

Collaborator

New York University

Collaborator

Parents as Teachers

Collaborator