ENRICH Nurse-Family Partnership Study

Study Overview
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Brief Summary
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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.

Official Title
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Colorado Nurse Family Heart Trial for the ENRICH Program

Conditions
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Blood Pressure, Body Composition, Blood Sugar, Body Weight, Diet Habit, Physical Inactivity

Intervention / Treatment
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* Behavioral: ENRICH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENRICH<br>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<br>* 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.<br>* Other names: NFP-Heart;|
| No Intervention: Control<br>Participants will receive standard NFP services | |

What is the study measuring?
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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 | 
| Blood pressure | automatic blood pressure monitor will be used to measure both systolic and diastolic blood pressure | 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 |