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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05839691
• Other study ID #: IRB-300008424
• Status: Active, not recruiting
• Start date: October 5, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior
• Maternal Behavior

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Home Visiting Caregivers who are pregnant or within one-year post delivery	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	Comfort level of home visiting staff discussing eating healthy with home visiting clients.	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
Secondary	Comfort level of home visiting staff discussing being more active with home visiting clients.	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
Secondary	Comfort level of home visiting staff discussing getting healthy sleep with home visiting clients.	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
Secondary	Comfort level of home visiting staff discussing weight management with home visiting clients.	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
Secondary	Comfort level of home visiting staff discussing stress management with home visiting clients.	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
Secondary	Comfort level of home visiting staff discussing quitting tobacco with home visiting clients.	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
Secondary	Comfort level of home visiting staff discussing controlling cholesterol with home visiting clients.	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
Secondary	Comfort level of home visiting staff discussing managing blood sugar with home visiting clients.	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
Secondary	Comfort level of home visiting staff discussing managing blood pressure with home visiting clients.	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