The Heart of the Community Study
El Corazon De La Comunidad Study - the Purpose of This Research Study is to Develop, Implement, and Evaluate a Community-based Approach to Bolstering the Health and Efficacy of Community Service Providers
2 other identifiers
interventional
84
1 country
1
Brief 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. Hypotheses: RS will be associated both with reduced threats to CSPs leaving the workforce, including higher satisfaction with work, greater agency, and lower burnout (H2A), and with a higher number of community members reached for CM health programming, as indexed by number of days CSP worked, number of health-related events offered by CSPs, community attendance at events, and retention of community members across multi-day programs (H2B).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 30, 2022
CompletedStudy Start
First participant enrolled
November 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedJanuary 15, 2025
January 1, 2025
1.9 years
September 15, 2022
January 13, 2025
Conditions
Outcome Measures
Primary Outcomes (16)
Higher mean heart rate variability (HRV) during a discrimination stressor task for CSPs in the RS intervention (compared to waitlist-control), measured via Photoplethysmography (PPG) using a Polar Verity sense device.
Higher mean HRV, measured via Photoplethysmography (PPG) using a polar verity sense device, will be detected during a discrimination stressor task (stream of consciousness task that includes having the participant discuss a discrimination experience for 4-minutes) that will be administered at baseline and again 4-weeks later following the completion of the intervention.
Change from Baseline HRV at 4 weeks.
Higher mean heart rate variability (HRV) during a discrimination stressor task at the 3-months follow-up measured via Photoplethysmography (PPG) using a Polar Verity sense device.
Higher mean HRV, measured via Photoplethysmography (PPG) using a polar verity sense device, will be detected during a discrimination stressor task (stream of consciousness task that includes having the participant discuss a discrimination experience for 4-minutes) that will be administered at baseline and again 3-months later following the completion of the intervention.
Change from Baseline HRV at 3 months.
Higher mean heart rate variability (HRV) during a resting task for CSPs in the RS intervention (compared to waitlist-control), measured via Photoplethysmography (PPG) using a Polar Verity sense device.
Higher mean HRV, measured via Photoplethysmography (PPG) using a polar verity sense device, will be detected during a resting task that will be administered at baseline and again 4-weeks later following the completion of the intervention.
Change from Baseline HRV at 4 weeks.
Higher mean heart rate variability (HRV) among CSPs during a resting task at the 3-month follow-up, measured via Photoplethysmography (PPG) using a Polar Verity sense device.
Higher mean HRV, measured via Photoplethysmography (PPG) using a polar verity sense device, will be detected during a resting task that will be administered at baseline and again 3-months later following the completion of the intervention.
Change from Baseline HRV at 3 months.
Relational savoring will be associated with higher quality sleep for CSPs as measured via the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)
Sleep quality, measured via the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989), will be reported at baseline and again 4-weeks later following the completion of the intervention. Scores on the PSQI range from 0 to 15, with higher scores indicating less quality and more disrupted sleep.
Change from Baseline Sleep Quality at 4 weeks.
Relational savoring will be associated with higher sleep quality for CSPs as measured via the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) at the 3-month follow-up.
Sleep quality, measured via the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989), will be reported at baseline and again 3-months later following the completion of the intervention. Scores on the PSQI range from 0 to 15, with higher scores indicating less quality and more disrupted sleep.
Change from Baseline Sleep Quality at 3 months.
Relational savoring will be associated with more physical activity for CSPs as measured via the International Physical Activity Questionnaire (IPAQ; Craig et al., 2017).
Physical activity, measured via the International Physical Activity Questionnaire (IPAQ; Craig et al., 2017), will be administered at baseline and again 4-weeks later following the completion of the intervention. The IPAQ is a self-report measure where respondents report the amount of physical activity they participate in within the last 7 days. Higher scores on the physical activity items, and lower scores on the rest items, are associated with more positive outcomes.
Change from Baseline Physical Activity at 4 weeks.
Relational savoring will be associated with more physical activity for CSPs as measured via the International Physical Activity Questionnaire (IPAQ; Craig et al., 2017) at the 3-month follow-up.
Physical activity, measured via the International Physical Activity Questionnaire (IPAQ; Craig et al., 2017), will be administered at baseline and again 3-months following the completion of the intervention. The IPAQ is a self-report measure where respondents report the amount of physical activity they participate in within the last 7 days. Higher scores on the physical activity items, and lower scores on the rest items, are associated with more positive outcomes.
Change from Baseline Physical Activity at 3 months.
Relational savoring will be associated with healthier eating habits for CSPs as measured via the Food Behavior Checklist (Banna et al., 2010).
Eating habits, measured via the International Food Behavior Checklist (FBC; Banna et al., 2010), will be administered at baseline and again 4-weeks later following the intervention. The FBC is a self-report measure where respondents report on their eating habits and the food they regularly eat. Higher scores on the less healthy food items, and lower scores on the healthier food items, are associated with less optimal outcomes.
Change from Baseline Eating Habits at 4 weeks.
Relational savoring will be associated with healthier eating habits for CSPs as measured via the Food Behavior Checklist (Banna et al., 2010) at the 3-month follow-up.
Eating habits, measured via the International Food Behavior Checklist (Banna et al., 2010), will be administered again 3-months following the completion of the intervention. The FBC is a self-report measure where respondents report on their eating habits and the food they regularly eat. Higher scores on the less healthy food items, and lower scores on the healthier food items, are associated with less optimal outcomes.
Change from Baseline Eating Habits at 3 months.
Relational Savoring will be associated with increased job satisfaction for CSPs, assessed via the Job Satisfaction Survey (Spector, 1994).
Job satisfaction, assessed via the Job Satisfaction Survey (JSS; Spector, 1994), will be administered at baseline and again 4-weeks later following the completion of the intervention. The JSS is a 36-item measure with scores ranging from 36 to 216, with higher scores indicating more satisfaction with one's job.
Change from Baseline Job Satisfaction at 4 weeks.
Relational Savoring will be associated with increased job satisfaction for CSPs, assessed via the Job Satisfaction Survey (Spector, 1994) at the 3-month follow-up.
Job satisfaction, assessed via the Job Satisfaction Survey (JSS; Spector, 1994), will be administered again 3-months following the completion of the intervention. The JSS is a 36-item measure with scores ranging from 36 to 216, with higher scores indicating more satisfaction with one's job.
Change from Baseline Job Satisfaction at 3 months.
Relational Savoring will be associated with reduced work-related burnout for CSPs, assessed via the Maslach Burnout Inventory (Maslach et al., 1997).
Work-related burnout, assessed via the Maslach Burnout Inventory (MBI; Maslach et al., 1997), will be administered at baseline and 4-weeks later following the completion of the intervention. The MBI is a 22-item scale with scores ranging from 0 to 132, with higher scores indicting more burnout.
Change from Baseline Work-Related Burnout at 4 weeks.
Relational Savoring will be associated with reduced work-related burnout for CSPs, assessed via the Maslach Burnout Inventory (Maslach et al., 1997) at the 3-month follow-up.
Work-related burnout, assessed via the Maslach Burnout Inventory (MBI; Maslach et al., 1997), will be administered again 3-months following the completion of the intervention. The MBI is a 22-item scale with scores ranging from 0 to 132, with higher scores indicting more burnout.
Change from Baseline Work-Related Burnout at 3 months.
Relational Savoring will be associated with more days worked by CSPs, assessed via self-reported number of days missed at work at the 3 month follow-up.
Number of community members reached for CM health programming is operationalized as the number of days CSPs worked and is measured via self-report of days missed at work by participants in the past 3 months (baseline) and 3 months later following the completion of the intervention.
Change from Baseline Days Worked at 3 months.
Relational Savoring will be associated with increased health-related events offered by CSPs at their workplace, assessed via self-reported number of health-related events held at their community agency.
Health-related events offered by CSPs at their workplace is measured via self-reported number of health-related events held at their community agency in the past 3-months (baseline) and 3 months later following the completion of the intervention.
Change from Baseline Health-Related Events at 3 months.
Study Arms (2)
Intervention Group
EXPERIMENTALIn this randomized controlled waitlist design, following a baseline assessment, we will randomly assign CSPs into the experimental group (n = 40) or a waitlist group (n = 40). The experimental group will receive the intervention immediately, whereas the waitlist control will wait 4 weeks and have a second baseline assessment before receiving the intervention. All participants will complete an identical assessment battery at pre-intervention baseline, immediately post-intervention, and 3-months following the intervention.
Waitlist Control Group
OTHERIn this randomized controlled waitlist design, following a baseline assessment, we will randomly assign CSPs into the experimental group (n = 40) or a waitlist group (n = 40). The experimental group will receive the intervention immediately, whereas the waitlist control will wait 4 weeks and have a second baseline assessment before receiving the intervention. All participants will complete an identical assessment battery at pre-intervention baseline, immediately post-intervention, and 3-months following the intervention.
Interventions
Relational savoring (RS) involves recalling a time when one supported or comforted another person and doing so brought deep positive emotion (joy, satisfaction, love, or peace); these moments of connection in service of another are common among the CSPs who work for our community agency, but may go unnoticed in the face of the urgent stressors the COVID-19 pandemic has brought about. Prolonging and enhancing attention to these moments has the potential to both help CSPs restore regulation in the face of stress and to motivate CSPs to continue engaging in meaningful work that serves their communities.
Eligibility Criteria
You may not qualify if:
- Not being an employee at one of the community health agencies involved in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Latino Health Access
Santa Ana, California, 92701, United States
Related Publications (33)
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PMID: 17684167BACKGROUNDO'Brien MJ, Perez A, Alos VA, Whitaker RC, Ciolino JD, Mohr DC, Ackermann RT. The feasibility, acceptability, and preliminary effectiveness of a Promotora-Led Diabetes Prevention Program (PL-DPP) in Latinas: a pilot study. Diabetes Educ. 2015 Aug;41(4):485-94. doi: 10.1177/0145721715586576. Epub 2015 May 28.
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PMID: 38113093DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica L Borelli, PhD
University of California, Irvine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 15, 2022
First Posted
September 30, 2022
Study Start
November 2, 2022
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
January 15, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share
Researchers will use participant information to conduct this study. Once the study is completed, we may share some data with other researchers so they can use it for other studies in the future. IDP sharing plan will be updated.