Clinical trial NCT05839691: Improving the Cardiovascular Health of High-Risk Families Through an Innovative Home Visitation Intervention
Official title: Improving the Cardiovascular Health of High-Risk Families Through an Innovative Home Visitation Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition, Healthy
Maternal Behavior
Health Behavior
Keywords: Home Visiting Program
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-05-03
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Home Visiting Caregivers who are pregnant or within one-year post delivery
timeFrame: At Enrollment
Secondary outcomes:
measure: Comfort level of home visiting staff discussing eating healthy with home visiting clients.
timeFrame: At Enrollment
measure: Comfort level of home visiting staff discussing being more active with home visiting clients.
timeFrame: At Enrollment
measure: Comfort level of home visiting staff discussing getting healthy sleep with home visiting clients.
timeFrame: At Enrollment
measure: Comfort level of home visiting staff discussing weight management with home visiting clients.
timeFrame: At Enrollment
measure: Comfort level of home visiting staff discussing stress management with home visiting clients.
timeFrame: At Enrollment
measure: Comfort level of home visiting staff discussing quitting tobacco with home visiting clients.
timeFrame: At Enrollment
measure: Comfort level of home visiting staff discussing controlling cholesterol with home visiting clients.
timeFrame: At Enrollment
measure: Comfort level of home visiting staff discussing managing blood sugar with home visiting clients.
timeFrame: At Enrollment
measure: Comfort level of home visiting staff discussing managing blood pressure with home visiting clients.
timeFrame: At Enrollment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Gareth Dutton, PhD
role: PRINCIPAL_INVESTIGATOR
References: