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Improving the Cardiovascular Health of High-Risk Families Through an Innovative Home Visitation Intervention

NCT ID: NCT05839691

Last Updated: 2024-12-09

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

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-05

Study Completion Date

2023-11-30

Brief Summary

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The purpose of this study is to conduct formative work with relevant stakeholders, including families and home visitation program staff involved in previous studies and/or future projects, to understand facilitators, barriers, and other attitudes related to incorporating cardiovascular health topics into existing curricula and to obtain input on treatment modifications for future programs.

Detailed Description

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Alabama Department of Early Childhood Education administers an annual electronic survey to all home-visiting program staff and enrolled families. The survey queries these individuals about demographics, program satisfaction, and interest in new programming. We will request deidentified survey data to understand what proportion of families currently being served are currently expecting (pregnant) or are within one year post-partum. Those that fall in that category will be asked survey questions gauging their interest in cardiovascular health topics. Additionally, home-visiting staff will be asked about their comfort-level discussing the cardiovascular health topics with their clients. Home-visiting program staff will also be invited to participate in group-setting qualitative interviews focused on facilitators, barriers, and other attitudes related to any new programming or material related to cardiovascular health topics in the future. Interviews will be audio-recorded, transcribed verbatim, and the file will be erased after the transcripts have been verified for completeness. The transcription will not have any identifiable data included as participants will use anonymous names or nicknames and/or their study identification number during the interview sessions.

Conditions

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Nutrition, Healthy Maternal Behavior Health Behavior

Keywords

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Home Visiting Program

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Mothers

Mothers enrolled in Home Visiting Programs that have or will be participating in past or future projects.

No interventions assigned to this group

Home Visitors

Home Visitors/Educators employed by Home Visiting Programs that have or will be participating in past or future projects.

No interventions assigned to this group

Supervisors

Supervising staff of Home Visiting Programs that have or will be participating in past or future projects.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- capable and willing to complete an electronic survey and/or an online group interview via Zoom

AND

* participants must be an expectant mother (currently pregnant) OR
* a mother within one year of giving birth AND
* currently enrolled in a partner home-visiting program

OR

\- participants are an employee of a partner home-visiting program

Exclusion Criteria

\- individuals are not an employee of a partner home-visiting program

Nor

* an expectant mother (currently pregnant) or within one year of giving birth AND
* not currently enrolled in a partner home-visiting program
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Gareth R. Dutton PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gareth Dutton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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UG3HL162973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300008424

Identifier Type: -

Identifier Source: org_study_id