ENRICH Nurse-Family Partnership Study

Blood Pressure Clinical Trial

Official title:

Colorado Nurse Family Heart Trial for the ENRICH Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05798039
• Other study ID #: 22-0021
• Secondary ID: UG3HL162967
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Study Coordinator
• Phone: 720-957-5161
• Email: enrich[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• <18 years old

Related Conditions & MeSH terms

• Blood Pressure
• Blood Sugar
• Body Composition
• Body Weight
• Diet Habit
• Physical Inactivity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Denver Health and Hospital Authority, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal BMI	Height and weight will be measured and combined to report BMI	Enrollment
Secondary	A1C	Blood draw	Enrollment
Secondary	Blood pressure	automatic blood pressure monitor will be used to measure both systolic and diastolic blood pressure	Enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal adiposity	Percent of total mass that is fat mass, as measured by air displacement plethysmography using the BOD POD device	Enrollment
Secondary	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