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

April 2, 2024 updated by: Gareth R. Dutton PhD, University of Alabama at Birmingham
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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Camille Schneider-Worthington, PhD
  • Phone Number: 205-975-8873
  • Email: cschneid@uab.edu

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Gareth Dutton, PhD
        • Sub-Investigator:
          • Camille Schneider-Worthington, PhD
        • Sub-Investigator:
          • Amber Kinsey, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Mothers currently pregnant or within one year of giving birth currently enrolled in a partner home-visiting program and employees of partner home-visiting programs

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Mothers
Mothers enrolled in Home Visiting Programs that have or will be participating in past or future projects.
Home Visitors
Home Visitors/Educators employed by Home Visiting Programs that have or will be participating in past or future projects.
Supervisors
Supervising staff of Home Visiting Programs that have or will be participating in past or future projects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Home Visiting Caregivers who are pregnant or within one-year post delivery
Time Frame: At Enrollment
Percentage of survey respondents (out of total respondents) who self-report they are currently pregnant or gave birth within the last year. Participants will self-report by responding to a one-item, multiple choice survey question. In response, they can mark all that apply of the following: a) I am currently pregnant, b) I gave birth to a child who currently is less than 6 months old, c) I gave birth to a child who is currently between 6 months and less than 1 year old, d) I gave birth to a child who is currently between 1 year and 2 years old, e) None of these apply to me
At Enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort level of home visiting staff discussing eating healthy with home visiting clients.
Time Frame: At Enrollment
Proportion of respondents responding very uncomfortable vs uncomfortable vs neither comfortable nor uncomfortable vs comfortable vs very comfortable with "very comfortable" indicating the most comfort to the following question: how comfortable are you discussing eating healthy with your home visiting clients?
At Enrollment
Comfort level of home visiting staff discussing being more active with home visiting clients.
Time Frame: At Enrollment
Proportion of respondents responding very uncomfortable vs uncomfortable vs neither comfortable nor uncomfortable vs comfortable vs very comfortable with "very comfortable" indicating the most comfort with "very comfortable" indicating the most comfort to the following question: how comfortable are you discussing being more active with your home visiting clients?
At Enrollment
Comfort level of home visiting staff discussing getting healthy sleep with home visiting clients.
Time Frame: At Enrollment
Proportion of respondents responding very uncomfortable vs uncomfortable vs neither comfortable nor uncomfortable vs comfortable vs very comfortable with "very comfortable" indicating the most comfort to the following question: how comfortable are you discussing getting healthy sleep with your home visiting clients?
At Enrollment
Comfort level of home visiting staff discussing weight management with home visiting clients.
Time Frame: At Enrollment
Proportion of respondents responding very uncomfortable vs uncomfortable vs neither comfortable nor uncomfortable vs comfortable vs very comfortable with "very comfortable" indicating the most comfort to the following question: how comfortable are you discussing weight management with your home visiting clients?
At Enrollment
Comfort level of home visiting staff discussing stress management with home visiting clients.
Time Frame: At Enrollment
Proportion of respondents responding very uncomfortable vs uncomfortable vs neither comfortable nor uncomfortable vs comfortable vs very comfortable with "very comfortable" indicating the most comfort to the following question: how comfortable are you discussing stress management with your home visiting clients?
At Enrollment
Comfort level of home visiting staff discussing quitting tobacco with home visiting clients.
Time Frame: At Enrollment
Proportion of respondents responding very uncomfortable vs uncomfortable vs neither comfortable nor uncomfortable vs comfortable vs very comfortable with "very comfortable" indicating the most comfort to the following question: how comfortable are you discussing quitting tobacco with your home visiting clients?
At Enrollment
Comfort level of home visiting staff discussing controlling cholesterol with home visiting clients.
Time Frame: At Enrollment
Proportion of respondents responding very uncomfortable vs uncomfortable vs neither comfortable nor uncomfortable vs comfortable vs very comfortable with "very comfortable" indicating the most comfort to the following question: how comfortable are you discussing controlling cholesterol with your home visiting clients?
At Enrollment
Comfort level of home visiting staff discussing managing blood sugar with home visiting clients.
Time Frame: At Enrollment
Proportion of respondents responding very uncomfortable vs uncomfortable vs neither comfortable nor uncomfortable vs comfortable vs very comfortable with "very comfortable" indicating the most comfort to the following question: how comfortable are you discussing managing blood sugar with your home visiting clients?
At Enrollment
Comfort level of home visiting staff discussing managing blood pressure with home visiting clients.
Time Frame: At Enrollment
Proportion of respondents responding very uncomfortable vs uncomfortable vs neither comfortable nor uncomfortable vs comfortable vs very comfortable with "very comfortable" indicating the most comfort to the following question: how comfortable are you discussing managing blood pressure with your home visiting clients?
At Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Gareth Dutton, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-300008424

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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