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NCT05560893 · ClinicalTrials.gov registry record · NA
The Heart of the Community Study
A NA study of Heart Rate Variability, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT05560893: Completed NA study of Heart Rate Variability, sponsored by University of California, Irvine.
NCT05560893 is a NA study of Heart Rate Variability that has completed, run by University of California, Irvine. The registered enrollment target is 84 participants, below the 139-participant average among 5 other Heart Rate Variability trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05560893, a NA study of Heart Rate Variability, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
Community service providers (CSPs), such as promotores and other community health staff, play an essential role in preserving health and treating disease in underserved Hispanic/Latinx (HL) communities with disproportionately high rates of cardiometabolic (CM) disease. Although effective programs have been developed that deploy CSPs to reduce CM disease risk in the community, to our knowledge no interventions have sought to reduce CM risk among CSPs themselves. However, CSPs are also at high risk for adverse CM outcomes, as they have the same high-risk demographics as the communities they serve and they work in high-stress, frontline jobs. Reducing CM risk among HL CSPs is crucial to promote health at both the individual and community levels; that is, preventive interventions delivered to CSPs may not only promote the health of the individual CSPs who receive the intervention but also may bolster CSPs to more effectively deliver programming that protects CM health community-wide. The proposed study employs relational savoring (RS), a brief intervention rooted in positive psychology and attachment, which has previously been shown to promote psychosocial well-being and which is particularly efficacious in HL populations. Emerging research supports that RS may also promote more optimal cardiovascular regulation and health behavior. Therefore, the investigators deliver RS to CSPs in order to identify CM health protective effects for both CSPs and the high-risk communities they serve. Aims and Hypotheses: Aim 1: Examine effects of RS on CSPs' CM risk factors and outcomes. Hypotheses: RS (compared to wait-list control) will be associated with lower CM risk, as indexed by higher mean HRV, both during a stressor and at rest (H1A). RS will also be associated with a more favorable CM health behavior profile, indexed by higher quality sleep, more exercise, and healthier diet (H1B). Aim 2: Examine effects of RS on CSPs' delivery of CM health programming to the community. Hypo
Primary Outcome
Cardiovascular health was assessed using heart rate variability (HRV) measured during a socially relevant stressor task administered in each intervention session. HRV data were collected using the movisens device, a wearable chest-mounted sensor that records electrocardiogram (ECG) data. Vagally mediated HRV was calculated from the variability of inter-beat (R-R) intervals derived from these ECG recordings. Mean HRV values were calculated for each assessment period, with higher mean HRV values (
Conditions Studied
Interventions
- BEHAVIORAL Relational Savoring Intervention
Study Locations (1)
California
- Latino Health Access - Santa Ana
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2022-11-02 |
| Est. Completion | 2024-09-30 |
| Phase | NA |
What the finished NCT05560893 record still lists
NCT05560893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 139-participant average among 5 other Heart Rate Variability trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Heart Rate Variability appearing as the primary indexed condition, and to 1 intervention - of which Relational Savoring Intervention is the first listed.
NCT05560893 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05560893 about?
NCT05560893 is a clinical study titled "The Heart of the Community Study". Community service providers (CSPs), such as promotores and other community health staff, play an essential role in preserving health and treating disease in underserved Hispanic/Latinx (HL) communities with disproportionately high rates of cardiometabolic (CM) disease. Although effective programs ha...
What is the current status of trial NCT05560893?
This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2022-11-02. Estimated completion is 2024-09-30.
What conditions does trial NCT05560893 study?
This clinical trial studies the following conditions: Heart Rate Variability.
What interventions are being tested in trial NCT05560893?
The interventions under investigation include: Relational Savoring Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05560893?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05560893 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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