Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)

December 11, 2024 updated by: Darius Tandon, Northwestern University

Early Intervention to Promote Cardiovascular Health of Mothers and Children at Northwestern University

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

Participants receiving the multi-component intervention will receive content on promoting cardiovascular health delivered by their home visitor and asynchronously. All participants will be asked to complete assessments at baseline, 2-month follow-up, and 4-month follow-up. The investigators will compare whether pregnant individuals and new mothers randomized to the intervention group, and their offspring, exhibit better cardiovascular health than pregnant individuals and new mothers randomized to the control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Poor cardiovascular health (CVH) is highly prevalent among pregnant individuals and is associated with adverse maternal and offspring outcomes. As CVH is already suboptimal by early adolescence, early-life interventions are needed. Interventions conducted in the community by trusted programs have the potential to improve CVH risk factors among perinatal individuals and their children. Home Visiting (HV) programs are trusted maternal and child health providers in diverse US communities, especially among low-income families.

This project is part of the National Heart Lung and Blood Institute (NHLBI) Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) consortium. Northwestern University is one seven clinical centers part of the ENRICH consortium. This project is funded via a UG3/UH3 mechanism in which during the UG3 period each clinical center is responsible for conducting a pilot study to inform the development of a common protocol that will be used across all seven clinical centers during the UH3 phase. This clinicaltrials.gov entry describes the pilot RCT protocol.

The pilot study will use a randomized controlled trial (RCT) longitudinal design. Forty individuals randomized to the intervention arm will receive usual home visiting services along with the ENRICH intervention. Ten individuals randomized to the control arm will receive usual home visiting without the ENRICH intervention. Among the individuals randomized to the intervention condition, 20 (50%) will receive the entire ENRICH intervention while the other 20 will receive only diet and physical activity content. The varying levels of intervention dosage is being delivered to assess acceptability and feasibility of a more- and less-intensive version of the intervention. Components of the intervention are described below. Assessments will be conducted at baseline, 2-month follow-up, and 4-month follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-39 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Full Intervention
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)
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.
Active Comparator: Diet/Physical Activity Intervention
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)
The partial ENRICH intervention will focus only on diet and physical activity.
No Intervention: Control
Participants randomized to this arm will receive no ENRICH intervention content. They will only receive usual home visiting services.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in diet assessed via the Mediterranean Eating Pattern for Americans Questionnaire
Time Frame: Change in eating patterns between baseline, 2 month follow-up, and 4 month follow-up
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)
Time Frame: Change in physical activity between baseline, 2 month follow-up, and 4 month follow-up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in maternal depression symptoms assessed via the Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Change in maternal depression between baseline, 2 month follow-up, and 4 month follow-up
Depressive symptoms. The EPDS is a 10-item scale with a range of 0-30. Higher scores reflect more depressive symptomatology
Change in maternal depression between baseline, 2 month follow-up, and 4 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00216961

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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