ENRICH Nurse-Family Partnership Study

Colorado Nurse Family Heart Trial for the ENRICH Program

The overarching goal of the proposed study is to develop and test an enrichment to Nurse-Family Partnership (NFP) using an existing, evidence-based program to improve clients' and their children's cardiovascular health from early pregnancy to 24 months postpartum. With support from NFP supervisors and nurses, the investigators will develop new NFP materials promoting healthy diet, activity, sleep, and smoking behaviors, along with optimal weight, glycemia, lipid, and blood pressure profiles. The investigators will conduct a pilot study with up to 40 NFP clients (or women similar to NFP client population) and their nurses to determine feasibility and acceptability of the materials and study protocol.

Study Overview

• Status: Recruiting
• Conditions: Body Weight; Body Composition; Blood Pressure; Diet Habit; Physical Inactivity; Blood Sugar
• Intervention / Treatment: Behavioral: ENRICH

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 720-957-5161; Email: enrich@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Study Coordinator; Email: enrich@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

Current clients of Denver Health's Nurse-Family Partnership program

Description

Inclusion Criteria:

• Pregnant or <24 months postpartum
• Aged 18 years or older
• English- or Spanish-speaking

Exclusion Criteria:

• <18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ENRICHed NFP; Participants will receive additional heart health-focused materials and guidance in sessions with their nurse home visitor. The nurse will help them choose and work towards behavior goals to support their health. This will include goals for activity, diet, weight, blood pressure, diabetes, smoking, social relationships, sleep, parenting, and getting health care.

Behavioral: ENRICH; Participants will receive additional heart health-focused materials and guidance in sessions with their nurse home visitor. The nurse will help them choose and work towards behavior goals to support their health. This will include goals for activity, diet, weight, blood pressure, diabetes, smoking, social relationships, sleep, parenting, and getting health care.; Other Names: NFP-Heart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal BMI	Height and weight will be measured and combined to report BMI	Enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1C	Blood draw	Enrollment
Diet Quality	Diet will be assessed with 24-hour dietary recalls using the Automated Self-Administered system (ASA24). This system uses the USDA multiple-pass method to query all foods and supplements consumed in the prior 24 hours and produces daily and individual food estimates for macronutrients, micronutrients, and MyPyramid Equivalents (such as servings of vegetables, fruits, whole grains, solid fats, and added sugars)	Enrollment
Physical Activity	Assessed using the Pregnancy Physical Activity Questionnaire (PPAQ), while adjusting metabolic task equivalents for pregnancy. Investigators will calculate average activity intensity (sedentary to vigorous) and type (household, occupational, exercise, transportation) over the past 3 months at collection point. Physical activity outcomes include daily minutes of sedentary, light, moderate, vigorous, household, occupational, exercise, transportation activity.	Enrollment
Smoking frequency	Participants will be asked about lifetime and recent (past 6 months) usage of cigarette and marijuana. Smoking outcomes include any smoking in pregnancy (binary) and number of cigarettes (total, trimester-specific).	Enrollment
Maternal adiposity	Percent of total mass that is fat mass, as measured by air displacement plethysmography using the BOD POD device	Enrollment
Sleep Quality	Assessed using a sleep questionnaire developed and validated by the NIH Patient Report Outcome Information System (PROMIS), adapted for this study. This form queries daytime and nighttime sleep start times, stop times, and duration, and also collect data on sleep disturbances and sleep-related impairments (trouble falling asleep, staying asleep, number of nighttime awakenings, feeling refreshed upon waking, etc.).	Enrollment
Blood pressure	automatic blood pressure monitor will be used to measure both systolic and diastolic blood pressure	Enrollment

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Denver Health and Hospital Authority
• Investigators: Principal Investigator: Mandy Allison, MD, MSPH, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: 22-0021; UG3HL162967 (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