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ENRICH Nurse-Family Partnership Study

Primary Purpose

Blood Pressure, Body Composition, Blood Sugar

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ENRICH
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Pregnant or <24 months postpartum Nulliparous (if pregnant) or primiparous (if post-partum) Aged 18 years or older English- or Spanish-speaking Currently enrolled in NFP through Denver Health Exclusion Criteria: Non-gestational diabetes (type 1, type 2) Bachelor's degree or higher level of education Diagnosed with substance use disorder Currently homeless Significant intellectual disability

Sites / Locations

  • University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ENRICH

Control

Arm Description

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.

Participants will receive standard NFP services

Outcomes

Primary Outcome Measures

Maternal BMI
Height and weight will be measured and combined to report BMI

Secondary Outcome Measures

A1C
Blood draw
Blood pressure
automatic blood pressure monitor will be used to measure both systolic and diastolic blood pressure
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)
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.
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).
Maternal adiposity
Percent of total mass that is fat mass, as measured by air displacement plethysmography using the BOD POD device
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.).

Full Information

First Posted
March 22, 2023
Last Updated
June 28, 2023
Sponsor
University of Colorado, Denver
Collaborators
Denver Health and Hospital Authority, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05798039
Brief Title
ENRICH Nurse-Family Partnership Study
Official Title
Colorado Nurse Family Heart Trial for the ENRICH Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Denver Health and Hospital Authority, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 40 prenatal or postpartum NFP clients and their nurses to determine feasibility and acceptability of the materials and study protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Body Composition, Blood Sugar, Body Weight, Diet Habit, Physical Inactivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ENRICH
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive standard NFP services
Intervention Type
Behavioral
Intervention Name(s)
ENRICH
Other Intervention Name(s)
NFP-Heart
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal BMI
Description
Height and weight will be measured and combined to report BMI
Time Frame
Enrollment
Secondary Outcome Measure Information:
Title
A1C
Description
Blood draw
Time Frame
Enrollment
Title
Blood pressure
Description
automatic blood pressure monitor will be used to measure both systolic and diastolic blood pressure
Time Frame
Enrollment
Title
Diet Quality
Description
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)
Time Frame
Enrollment
Title
Physical Activity
Description
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.
Time Frame
Enrollment
Title
Smoking frequency
Description
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).
Time Frame
Enrollment
Title
Maternal adiposity
Description
Percent of total mass that is fat mass, as measured by air displacement plethysmography using the BOD POD device
Time Frame
Enrollment
Title
Sleep Quality
Description
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.).
Time Frame
Enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant or <24 months postpartum Nulliparous (if pregnant) or primiparous (if post-partum) Aged 18 years or older English- or Spanish-speaking Currently enrolled in NFP through Denver Health Exclusion Criteria: Non-gestational diabetes (type 1, type 2) Bachelor's degree or higher level of education Diagnosed with substance use disorder Currently homeless Significant intellectual disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
720-957-5161
Email
enrich@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Sauder, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Email
enrich@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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ENRICH Nurse-Family Partnership Study

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