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ENRICH Nurse-Family Partnership Study

Sponsor
University of Colorado, Denver (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05798039
Collaborator
Denver Health and Hospital Authority (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
40
Enrollment
7.5
Anticipated Duration (Months)

Study Details

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, we will develop new NFP materials promoting healthy diet, activity, sleep, and smoking behaviors, along with optimal weight, glycemia, lipid, and blood pressure profiles. We 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ENRICH

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Colorado Nurse Family Heart Trial for the ENRICH Program
Anticipated Study Start Date :
Apr 17, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Denver Health Nurse-Family Partnership clients

Women who are either pregnant or less than 24 months postpartum, and actively participating in Denver Health's Nurse-Family Partnership home visiting program.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maternal BMI [Enrollment]

      Height and weight will be measured and combined to report BMI

    Secondary Outcome Measures

    1. A1C [Enrollment]

      Blood draw

    2. Blood pressure [Enrollment]

      automatic blood pressure monitor

    3. Diet Quality [Enrollment]

      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)

    4. Physical Activity [Enrollment]

      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.

    5. Smoking frequency [Enrollment]

      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).

    6. Maternal adiposity [Enrollment]

      Percent of total mass that is fat mass, as measured by air displacement plethysmography using the BOD POD device

    7. Sleep Quality [Enrollment]

      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.).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Katherine Sauder, PhD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT05798039
    Other Study ID Numbers:
    • 22-0021
    • 1UG3HL162967-01
    First Posted:
    Apr 4, 2023
    Last Update Posted:
    Apr 4, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Body Weight

    Study Results

    No Results Posted as of Apr 4, 2023