Nutrition, HealthyNCT05839691
Improving the Cardiovascular Health of High-Risk Families Through an Innovative Home Visitation Intervention
An observational study of Nutrition, Healthy and Maternal Behavior, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Nutrition, Healthy, Maternal Behavior, Health Behavior
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
Read the 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.
- Conditions
- Nutrition, Healthy, Maternal Behavior, Health Behavior
- Keywords
- Home Visiting Program
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Enrollment
Secondary outcomes (9)
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?
Measured: At Enrollment
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?
Measured: At Enrollment
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?
Measured: At Enrollment
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?
Measured: At Enrollment
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?
Measured: At Enrollment
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?
Measured: At Enrollment
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?
Measured: At Enrollment
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?
Measured: At Enrollment
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?
Measured: At Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start5 Oct 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Gareth R. Dutton PhD, University of Alabama at Birmingham
- Investigators
- Gareth Dutton, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839691
- Sponsor's protocol ID
- IRB-300008424
- Other IDs
- UG3HL162973
- Status last verified
- Dec 2024
- First submitted
- 20 Apr 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Cardiovascular Health of High-Risk Families Through an Innovative Home Visitation Intervention
- ClinicalTrials.gov ID
- NCT05839691
- Acronym / sponsor ID
- IRB-300008424
- Conditions
- Nutrition, Healthy, Maternal Behavior, Health Behavior
- Keywords
- Home Visiting Program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
Comfort level of home visiting staff discussing eating healthy with home visiting clients.
Time frame: At Enrollment
Comfort level of home visiting staff discussing being more active with home visiting clients.
Time frame: At Enrollment
Comfort level of home visiting staff discussing getting healthy sleep with home visiting clients.
Time frame: At Enrollment
Comfort level of home visiting staff discussing weight management with home visiting clients.
Time frame: At Enrollment
Comfort level of home visiting staff discussing stress management with home visiting clients.
Time frame: At Enrollment
Comfort level of home visiting staff discussing quitting tobacco with home visiting clients.
Time frame: At Enrollment
Comfort level of home visiting staff discussing controlling cholesterol with home visiting clients.
Time frame: At Enrollment
Comfort level of home visiting staff discussing managing blood sugar with home visiting clients.
Time frame: At Enrollment
Comfort level of home visiting staff discussing managing blood pressure with home visiting clients.
Time frame: At Enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gareth Dutton, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition, Healthy and Maternal Behavior, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Home Visiting Caregivers who are pregnant or within one-year post delivery (time frame: At Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.