Early Intervention to Promote Cardiovascular Health of Mothers and Children

NCT05856162 | Completed

• 1 other identifier: STU00216961
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to examine whether a multi-component intervention delivered during pregnancy and after delivery can improve the cardiovascular health of pregnant individuals enrolled in home visiting programs, as well as their offspring's cardiovascular health. The main questions it aims to answer are:

1. 1.Does a multi-component intervention improve cardiovascular health of pregnant individuals and new mothers enrolled in home visiting programs?
2. 2.Does a multi-component intervention improve cardiovascular health of the offspring of pregnant individuals/new mothers enrolled in home visiting programs?

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Change in diet assessed via the Mediterranean Eating Pattern for Americans Questionnaire

  Use of Mediterranean/DASH diet. The MEPA range is from 0-16 with higher scores indicating greater use of a Mediterranean diet

  Change in eating patterns between baseline, 2 month follow-up, and 4 month follow-up

• Change in maternal physical activity assessed via the International Physical Activity Questionnaire (IPAQ)

  Engagement in physical activity. The IPAQ contains 12 questions with responses scored to create low, moderate, and high physical activity categories

  Change in physical activity between baseline, 2 month follow-up, and 4 month follow-up

Secondary Outcomes (1)

• Change in maternal depression symptoms assessed via the Edinburgh Postnatal Depression Scale (EPDS)

  Change in maternal depression between baseline, 2 month follow-up, and 4 month follow-up

Study Arms (3)

Full Intervention

EXPERIMENTAL

Participants randomized to this arm will receive the full ENRICH pilot which will consist of content on diet, physical activity, sleep, stress/mental health, and tobacco cessation. They will also receive usual home visiting services.

Behavioral: ENRICH pilot intervention (full intervention)

Diet/Physical Activity Intervention

ACTIVE COMPARATOR

Participants randomized to this arm will receive the partial ENRICH pilot which will consist of content on diet and physical activity. They will also receive usual home visiting services.

Behavioral: ENRICH pilot intervention (partial intervention: only diet and physical activity)

Control

NO INTERVENTION

Participants randomized to this arm will receive no ENRICH intervention content. They will only receive usual home visiting services.

Interventions

ENRICH pilot intervention (full intervention) BEHAVIORAL

The full ENRICH pilot intervention will consist of content related to diet, physical activity, stress/mental health, sleep, tobacco cessation, and child health. The investigators will use an adapted version of the Mothers and Babies stress management intervention to address mental health, an adapted version of the HEALTH curriculum to address diet/physical activity, and an adapted version of the INSIGHT curriculum to address child health.

Full Intervention

ENRICH pilot intervention (partial intervention: only diet and physical activity) BEHAVIORAL

The partial ENRICH intervention will focus only on diet and physical activity.

Diet/Physical Activity Intervention

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Pregnant or with child \< 3 months of age
• Enrolled in a Healthy Families America or Parents as Teachers home visiting program in Illinois or or Indiana

You may not qualify if:

• Individuals pregnant with twins (or higher order gestation)
• Individuals who have a fetus with a known chromosomal abnormality

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 12, 2023
• Study Start: August 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: October 31, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

US (1)