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Early Cardiovascular Health Intervention for Preventing Heart Disease (ENRICH Trial)

N/A

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in eating patterns between baseline, 2 month follow-up, and 4 month follow-up

Awards & highlights

ENRICH Trial Summary

This trial will examine if a multi-component intervention can improve cardiovascular health of pregnant individuals, new mothers, and their offspring. Participants will receive content from their home visitor and assessments will be done to compare any changes.

Who is the study for?

This trial is for pregnant individuals or new mothers with a child under 3 months, aged between 18-39, enrolled in specific home visiting programs in Illinois or Indiana. It's not for those expecting multiples or whose fetus has a known chromosomal abnormality.Check my eligibility

What is being tested?

The study tests if a multi-component intervention (covering diet, physical activity, and other health content) can improve cardiovascular health of the mother and child when delivered during pregnancy and after birth.See study design

What are the potential side effects?

Since this trial focuses on lifestyle interventions like diet and exercise rather than medication, typical drug side effects are not expected. However, any changes to routine may cause discomfort.

ENRICH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in eating patterns between baseline, 2 month follow-up, and 4 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in eating patterns between baseline, 2 month follow-up, and 4 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in eating patterns between baseline, 2 month follow-up, and 4 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

ENRICH Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Full InterventionExperimental Treatment1 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.

Group II: ControlActive Control1 Intervention

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

Group III: Diet/Physical Activity InterventionActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,076 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are minors allowed to take part in the trial?

"Patients aged between 18 and 39 years old are eligible to enrol in this clinical trial."

Answered by AI

Are there any opportunities for volunteers to participate in this clinical exploration?

"The current status of this clinical trial, according to the data hosted on clinicaltrials.gov, is actively recruiting patients. This medical study was first posted August 1st 2023 with its latest update occurring October 12th 2023."

Answered by AI

What is the upper limit on participants in this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this medical experiment is actively enrolling participants, having been first posted on August 1st 2023 and most recently updated on October 12th 2023. A total of 50 individuals need to be sourced from one trial location."

Answered by AI

What criteria must an individual satisfy in order to be eligible for this experiment?

"This medical study is seeking 50 participants aged between 18 to 39 who have cardiovascular disease. Criteria for acceptance include being pregnant or having a child younger than 3 months, and enrollment in either Healthy Families America or Parents as Teachers programs from Illinois and Indiana."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Early Intervention to Promote Cardiovascular Health of Mothers and Children

Darius Tandon 2023. "Early Intervention to Promote Cardiovascular Health of Mothers and Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05856162.