ENRICH Nurse-Family Partnership Study

NCT ID: NCT05798039

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-19

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

ENRICH

Intervention Type BEHAVIORAL

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NFP-Heart

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* \<18 years old
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Denver Health and Hospital Authority

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mandy Allison, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Study Coordinator

Role: CONTACT

720-957-5161

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Study Coordinator

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UG3HL162967

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-0021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nutrition Education
NCT00005728 COMPLETED
e-Care for Heart Wellness
NCT01077388 COMPLETED PHASE3