NCT05560893

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

September 15, 2022

Last Update Submit

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

EXPERIMENTAL

In 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.

Behavioral: Relational Savoring Intervention

Waitlist Control Group

OTHER

In 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.

Behavioral: Relational Savoring 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.

Intervention GroupWaitlist Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Publications (33)

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Study Officials

  • Jessica L Borelli, PhD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: In this randomized controlled waitlist design, following a baseline assessment, the investigators 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.
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.

Locations