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Cardiovascular Health Promotion for Prevention of Heart Disease and Childhood Obesity (ENRICH Trial)

N/A

Recruiting

Led By Ian M Paul, MD, MSc

Research Sponsored by Penn State University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

ENRICH Trial Summary

This trial tests adding a heart health module to a nurse home visit program to help people in Pennsylvania stay healthy.

Who is the study for?

This trial is for mothers over 18 with newborns under one month old, enrolled in the Nurse Family Partnership program in Central Pennsylvania. They must speak English and have reliable internet access. The baby should be born at or after 35 weeks' gestation.Check my eligibility

What is being tested?

The study tests adding a cardiovascular health module to an existing home visitation program by nurses. It focuses on early intervention to improve heart health for both mothers and their children in the Northern Appalachian region.See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medications, traditional side effects are not expected. However, there may be indirect impacts on lifestyle choices that could affect mother and child.

ENRICH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Feasibility of integration of a cardiovascular health module into the existing Nurse-Family Partnership (NFP) home visiting program.

Secondary outcome measures

Number of participants completing maternal feeding data collection

Number of participants consenting to participate in the pilot study.

Participant intervention acceptability.

+1 more

ENRICH Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

All participants will be enrolled into the intervention arm of this pilot study.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Penn State UniversityLead Sponsor

355 Previous Clinical Trials

125,717 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,084 Total Patients Enrolled

Ian M Paul, MD, MScPrincipal InvestigatorPenn State University

9 Previous Clinical Trials

2,364 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals are enrolled in this research program?

"Affirmative. According to clinicaltrials.gov, this experimental trial is presently seeking participants. It was initially posted on August 1st 2023 and was most recently updated on November 14th 2023. The study requires 40 volunteers from 2 research sites."

Answered by AI

Are there any vacancies for this trial open to applicants?

"According to information published on clinicaltrials.gov, this clinical trial is actively seeking eligible participants. The study was launched on August 1st 2023 and its details were amended as recently as November 14th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ian M. Paul, M.D., M.Sc. 2023. "Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05824741.