Recruiting

Nurse-Family Partnership

Sponsor:

University of Colorado, Denver

Code:

NCT05798039

Conditions

Blood Pressure

Body Composition

Blood Sugar

Body Weight

Diet Habit

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

ENRICH

Study Details

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 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.

Conditions

Blood Pressure

Body Composition

Blood Sugar

Body Weight

Diet Habit

Study ID

NCT05798039

Start date

Jun 19, 2023

Status verified date

Mar, 2024

Completion date

Apr 30, 2024

Anticipated

Primary completion date

Apr 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • <18 years old

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Maternal BMI [ Time Frame: Enrollment ]

Central Contacts and Locations

Central contacts

Study Coordinator

720-957-5161enrich@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

enrich@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Mar 18, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-03-18.