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

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

Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung & Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Health
• Intervention / Treatment: Behavioral: Enriched home visiting; Behavioral: Routine home visiting

• Study Type: Interventional
• Enrollment (Estimated): 6400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori Burrell, MSW; Phone Number: 724-858-8201; Email: lburrel1@jh.edu

Study Locations

• United States
  • California
    • San Luis Obispo, California, United States, 93407
      • California Polytechnic Institute
      • Contact: Noemi Alarcon; Phone Number: 805-756-5694; Email: noalarco@calpoly.edu
      • Principal Investigator: Suzanne Phelan
  • Colorado
    • Aurora, Colorado, United States, 80045-7464
      • Colorado University
      • Contact: Katharine Gamalski; Phone Number: 720-499-4501; Email: katharine.gamalski@cuanschutz.edu
      • Principal Investigator: Mandy Allison
  • Illinois
    • Chicago, Illinois, United States, 60208
      • Northwestern University
      • Contact: Danielle Lorch; Phone Number: 630-222-2194; Email: dmlorch@northwestern.edu
      • Principal Investigator: Darius Tandon
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University
      • Contact: Cindy Schwartz; Phone Number: 314-346-7101; Email: cschwarz@wustl.edu
      • Principal Investigator: Debra Haire-Joshu
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27109
      • Wake Forest University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh
    • State College, Pennsylvania, United States, 16801
      • Pennsylvania State University
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Lifespan
      • Contact: Angelica McHugh; Phone Number: 401-793-8978; Email: amchugh1@lifespan.org
      • Principal Investigator: Rena Wing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Be currently enrolled in an evidence-based home visiting program participating in ENRICH
2. Be pregnant, with a single or multifetal gestation, at or less than 34 weeks 0 days gestation (per self-report at time of consent)
3. Be 18 years of age or older
4. Speak English or Spanish

Exclusion Criteria: There are no exclusion criteria being applied in assessing eligibility for participation in ENRICH.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enriched home visiting	Behavioral: Enriched home visiting; Enriched home visiting with cardiovascular health promotion content; Behavioral: Routine home visiting; Home visiting without cardiovascular health promotion content
Active Comparator: Routine home visiting	Behavioral: Enriched home visiting; Enriched home visiting with cardiovascular health promotion content; Behavioral: Routine home visiting; Home visiting without cardiovascular health promotion content

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent physical activity	Time spent in moderate and vigorous physical activity in parent participants	12 months after birth
Parent body mass index	Body mass index (BMI) of parent participants	12 months after birth
Parent blood pressure	blood pressure (BP) in parent participants	12 months after birth
Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale	Diet quality among parent participants as measured by Mediterranean Eating Pattern for Americans (MEPA) scale. The MEPA is a 16-item dietary screener designed to assess accordance with the Mediterranean-like diet patterns during the past 7 days among adults. A score of '0' will be given if the scoring condition is not met and a score of '1' will be given if the scoring condition is met. A score of '1' for any given item was indicative of Mediterranean-like diet accordance. If any condition was not met, a score of '0' was recorded for that item. The total MEPA score could range from 0 to 16. Scores will be converted to points on a 100-point scale based on quantiles of the 16-item measure. For example, scores from 0-3 (0 points), 4-7 (25 points), 8-11 (50 points), 12-14 (80 points), and 15-16 (100 points). Higher scores mean that the adult's diet is similar to a Mediterranean diet.	12 months after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child body mass index	body mass index in child	24 months old

Collaborators and Investigators

• Sponsor: JHSPH Center for Clinical Trials
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Home visiting
• Other Study ID Numbers: IRB00398712; 5U24HL163114-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No