The Heart of the Community Study

NCT05560893 | Completed Results

• 2 other identifiers: 1596P50MD017366
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 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).

Conditions

Heart Rate Variability

Outcome Measures

Primary Outcomes (11)

• Impact of Intervention on Heart Rate Variability

  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 (per minute) indicating greater autonomic regulation and improved cardiovascular health. Due to feasibility and data quality issues with the wearable ECG device, HRV data collection was discontinued after the first two assessment periods (Baseline 1 and the 4-week assessment \[post-intervention for the intervention group/Baseline 2 for the waitlist control group\]); therefore, post-intervention HRV data were not collected for the waitlist control group.

  Assessed at Baseline 1 for both groups and 4 weeks later (post-intervention for intervention participants and Baseline 2 for waitlist control participants). Post-intervention data were not collected for the waitlist control group.

• Acceptability of the Relational Savoring Intervention

  Intervention acceptability was assessed using participant self-report items evaluating frequency of use of the intervention skills, perceived value of the intervention, willingness to recommend the intervention to others, and intention to continue engaging in the intervention skills. Acceptability was assessed only after completion of the intervention and at the 3-month follow-up. Acceptability scores were summarized using mean scores reported separately at post-intervention and at the 3-month follow-up across the sample. Possible scores ranged from 0 to 30, with higher scores indicating greater acceptability.

  Immediately following completion of the 4-week intervention and at 3 months post-intervention.

• Impact of Intervention on Perceived Closeness to the Community

  Perceived closeness to community was assessed using the Inclusion of Other in the Self-Community Version (IOS-C), a single-item visual self-report measure. Participants selected one of seven images depicting increasing overlap between two circles representing the self and the community. Greater overlap indicates greater perceived closeness to the community, whereas less overlap indicates lower perceived closeness. The measure was administered immediately before and after each intervention session (four sessions total). Scores ranged from 1 (not close at all) to 7 (very close), with higher scores indicating greater perceived closeness to the community.

  Immediately before and after each weekly intervention session (Sessions 1-4, approximately 1 hour apart per session), during the 4-week intervention period.

• Impact of Intervention on Negative Emotional Valence

  Emotional valence was assessed using the valence subscale of the Self-Assessment Manikin (SAM), a nonverbal pictorial self-report measure. Participants selected one of five pictograms ranging from smiling to frowning to indicate their current emotional state. Scores ranged from 1 to 5, with lower scores indicating more positive emotional valence and higher scores indicating more negative emotional valence. The measure was administered immediately before and after each intervention session.

  Immediately before and after each weekly intervention session (Sessions 1-4, approximately 1 hour apart per session), during the 4-week intervention period.

• Impact of Intervention on Sleep Quality

  Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire that assesses subjective sleep quality over the past month. The PSQI yields a global sleep quality score derived from seven component scores, with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.

  Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.

• Impact of Intervention on Diet

  can you revise to make it clear that scoring was dichotomized as ither true or false and thus scores ranged from: Changes in diet-related behavior were assessed using the Emotional Eating subscale of the Three-Factor Eating Questionnaire (TFEQ). The subscale consists of 3 items assessing the extent to which individuals eat in response to emotional states. Items are rated on a 4-point scale ranging from 0 (definitely true) to 3 (definitely false). Item responses were summed to create a total emotional eating score ranging from 0 to 9, with lower scores indicating greater emotional eating and higher scores indicating less emotional eating.

  Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.

• Impact of Intervention on Burnout

  Burnout related to the COVID-19 pandemic was assessed using the COVID-19 Burnout Scale, a 10-item self-report measure. Items assess feelings of emotional exhaustion and hopelessness related to the pandemic and are rated on a 7-point scale ranging from 0 (never) to 6 (all the time). Item responses are summed to create a total burnout score ranging from 0 to 60, with higher scores indicating greater burnout. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.

  From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.

• Impact of Intervention on Job Satisfaction

  Job satisfaction was assessed using the Job Satisfaction Scale, a 36-item self-report questionnaire measuring participants' overall attitudes toward their job. Items were rated on a 6-point Likert-type scale ranging from 1 (disagree very much) to 6 (agree very much). Item responses were summed to create a total job satisfaction score ranging from 36 to 216, with higher scores indicating greater job satisfaction. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.

  From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.

• Impact of Intervention on Psychological Distress

  Psychological distress was assessed using the Brief Symptom Inventory (BSI), a 19-item self-report measure assessing symptoms of depression, anxiety, and somatic distress. Items were rated on a 6-point scale ranging from 0 (not at all) to 5 (extremely). Item responses were summed to create a global psychological distress score ranging from 0 to 95, with higher scores indicating greater overall distress. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.

  From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.

• Impact of Intervention on General Health

  General health was assessed using the General Health subscale of the Short Form Health Survey (SF-36). Participants completed the full SF-36 questionnaire, and the 5 items comprising the General Health subscale were scored according to standard SF-36 procedures. Item responses were recoded and summed, and the raw subscale score was transformed to a 0-100 scale, with higher scores indicating better perceived physical health. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.

  From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.

• Impact of Intervention on Community Outreach

  Community outreach was assessed using a composite measure of community engagement and reach in community health programming. The composite index captured the extent to which community members were reached by community health programming and was calculated using four indicators: (1) number of days community service providers (CSPs) worked, (2) number of health-related events offered by CSPs, (3) community attendance at CSP-led events, and (4) retention of community members across multi-day programs. Indicators were combined to create a total community outreach score, with higher scores reflecting greater outreach and a higher number of community members reached through community health programming.

  Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.

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 Intervention BEHAVIORAL

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 Group; Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Emory University: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Latino Health Access

Santa Ana, California, 92701, United States

Location

Related Publications (34)

• Borelli JL, Kerr ML, Smiley PA, Rasmussen HF, Hecht HK, Campos B. Relational savoring intervention: Positive impacts for mothers and evidence of cultural compatibility for Latinas. Emotion. 2023 Mar;23(2):303-320. doi: 10.1037/emo0001102. Epub 2022 May 12.

  PMID: 35549365 BACKGROUND

• Borelli JL, Smiley PA, Kerr ML, Hong K, Hecht HK, Blackard MB, Falasiri E, Cervantes BR, Bond DK. Relational savoring: An attachment-based approach to promoting interpersonal flourishing. Psychotherapy (Chic). 2020 Sep;57(3):340-351. doi: 10.1037/pst0000284. Epub 2020 Jan 30.

  PMID: 31999188 BACKGROUND

• Borelli JL, Bond DK, Fox S, Horn-Mallers M. Relational Savoring Reduces Physiological Reactivity and Enhances Psychological Agency in Older Adults. J Appl Gerontol. 2020 Mar;39(3):332-342. doi: 10.1177/0733464819866972. Epub 2019 Aug 11.

  PMID: 31402745 BACKGROUND

• Lagomasino IT, Dwight-Johnson M, Miranda J, Zhang L, Liao D, Duan N, Wells KB. Disparities in depression treatment for Latinos and site of care. Psychiatr Serv. 2005 Dec;56(12):1517-23. doi: 10.1176/appi.ps.56.12.1517.

  PMID: 16339612 BACKGROUND

• Paz K, Massey KP. Health Disparity among Latina Women: Comparison with Non-Latina Women. Clin Med Insights Womens Health. 2016 Jul 20;9(Suppl 1):71-4. doi: 10.4137/CMWH.S38488. eCollection 2016.

  PMID: 27478393 BACKGROUND

• Velasco-Mondragon E, Jimenez A, Palladino-Davis AG, Davis D, Escamilla-Cejudo JA. Hispanic health in the USA: a scoping review of the literature. Public Health Rev. 2016 Dec 7;37:31. doi: 10.1186/s40985-016-0043-2. eCollection 2016.

  PMID: 29450072 BACKGROUND

• Cabarkapa S, Nadjidai SE, Murgier J, Ng CH. The psychological impact of COVID-19 and other viral epidemics on frontline healthcare workers and ways to address it: A rapid systematic review. Brain Behav Immun Health. 2020 Oct;8:100144. doi: 10.1016/j.bbih.2020.100144. Epub 2020 Sep 17.

  PMID: 32959031 BACKGROUND

• Danet Danet A. Psychological impact of COVID-19 pandemic in Western frontline healthcare professionals. A systematic review. Med Clin (Engl Ed). 2021 May 7;156(9):449-458. doi: 10.1016/j.medcle.2020.11.003. Epub 2021 Mar 19.

  PMID: 33758782 BACKGROUND

• Steptoe A, Kivimaki M. Stress and cardiovascular disease. Nat Rev Cardiol. 2012 Apr 3;9(6):360-70. doi: 10.1038/nrcardio.2012.45.

  PMID: 22473079 BACKGROUND

• Kivimaki M, Virtanen M, Elovainio M, Kouvonen A, Vaananen A, Vahtera J. Work stress in the etiology of coronary heart disease--a meta-analysis. Scand J Work Environ Health. 2006 Dec;32(6):431-42. doi: 10.5271/sjweh.1049.

  PMID: 17173200 BACKGROUND

• Kloner RA. Lessons learned about stress and the heart after major earthquakes. Am Heart J. 2019 Sep;215:20-26. doi: 10.1016/j.ahj.2019.05.017. Epub 2019 Jun 6.

  PMID: 31260902 BACKGROUND

• Balcazar H, Alvarado M, Cantu F, Pedregon V, Fulwood R. A promotora de salud model for addressing cardiovascular disease risk factors in the US-Mexico border region. Prev Chronic Dis. 2009 Jan;6(1):A02. Epub 2008 Dec 15.

  PMID: 19080008 BACKGROUND

• Lujan J, Ostwald SK, Ortiz M. Promotora diabetes intervention for Mexican Americans. Diabetes Educ. 2007 Jul-Aug;33(4):660-70. doi: 10.1177/0145721707304080.

  PMID: 17684167 BACKGROUND

• O'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.

  PMID: 26023095 BACKGROUND

• Philis-Tsimikas A, Fortmann A, Lleva-Ocana L, Walker C, Gallo LC. Peer-led diabetes education programs in high-risk Mexican Americans improve glycemic control compared with standard approaches: a Project Dulce promotora randomized trial. Diabetes Care. 2011 Sep;34(9):1926-31. doi: 10.2337/dc10-2081. Epub 2011 Jul 20.

  PMID: 21775748 BACKGROUND

• Shepherd-Banigan M, Hohl SD, Vaughan C, Ibarra G, Carosso E, Thompson B. "The Promotora Explained Everything": Participant Experiences During a Household-Level Diabetes Education Program. Diabetes Educ. 2014 Jul;40(4):507-515. doi: 10.1177/0145721714531338. Epub 2014 May 2.

  PMID: 24793637 BACKGROUND

• Spinner JR, Alvarado M. Salud Para Su Carozon--a Latino promotora-led cardiovascular health education program. Fam Community Health. 2012 Apr-Jun;35(2):111-9. doi: 10.1097/FCH.0b013e3182465058.

  PMID: 22367258 BACKGROUND

• Borelli JL, Yates TM, Hecht HK, Cervantes BR, Russo LN, Arreola J, Leal F, Torres G, Guerra N. Confia en mi, Confio en ti: Applying developmental theory to mitigate sociocultural risk in Latinx families. Dev Psychopathol. 2021 May;33(2):581-597. doi: 10.1017/S0954579420001364.

  PMID: 33269671 BACKGROUND

• Thayer JF, Ahs F, Fredrikson M, Sollers JJ 3rd, Wager TD. A meta-analysis of heart rate variability and neuroimaging studies: implications for heart rate variability as a marker of stress and health. Neurosci Biobehav Rev. 2012 Feb;36(2):747-56. doi: 10.1016/j.neubiorev.2011.11.009. Epub 2011 Dec 8.

  PMID: 22178086 BACKGROUND

• Thayer JF, Yamamoto SS, Brosschot JF. The relationship of autonomic imbalance, heart rate variability and cardiovascular disease risk factors. Int J Cardiol. 2010 May 28;141(2):122-31. doi: 10.1016/j.ijcard.2009.09.543. Epub 2009 Nov 11.

  PMID: 19910061 BACKGROUND

• Hillebrand S, Gast KB, de Mutsert R, Swenne CA, Jukema JW, Middeldorp S, Rosendaal FR, Dekkers OM. Heart rate variability and first cardiovascular event in populations without known cardiovascular disease: meta-analysis and dose-response meta-regression. Europace. 2013 May;15(5):742-9. doi: 10.1093/europace/eus341. Epub 2013 Jan 30.

  PMID: 23370966 BACKGROUND

• Benichou T, Pereira B, Mermillod M, Tauveron I, Pfabigan D, Maqdasy S, Dutheil F. Heart rate variability in type 2 diabetes mellitus: A systematic review and meta-analysis. PLoS One. 2018 Apr 2;13(4):e0195166. doi: 10.1371/journal.pone.0195166. eCollection 2018.

  PMID: 29608603 BACKGROUND

• Thayer JF, Sternberg E. Beyond heart rate variability: vagal regulation of allostatic systems. Ann N Y Acad Sci. 2006 Nov;1088:361-72. doi: 10.1196/annals.1366.014.

  PMID: 17192580 BACKGROUND

• Williams DP, Koenig J, Carnevali L, Sgoifo A, Jarczok MN, Sternberg EM, Thayer JF. Heart rate variability and inflammation: A meta-analysis of human studies. Brain Behav Immun. 2019 Aug;80:219-226. doi: 10.1016/j.bbi.2019.03.009. Epub 2019 Mar 11.

  PMID: 30872091 BACKGROUND

• Williams DP, Cash C, Rankin C, Bernardi A, Koenig J, Thayer JF. Resting heart rate variability predicts self-reported difficulties in emotion regulation: a focus on different facets of emotion regulation. Front Psychol. 2015 Mar 10;6:261. doi: 10.3389/fpsyg.2015.00261. eCollection 2015.

  PMID: 25806017 BACKGROUND

• Berlin JA, Colditz GA. A meta-analysis of physical activity in the prevention of coronary heart disease. Am J Epidemiol. 1990 Oct;132(4):612-28. doi: 10.1093/oxfordjournals.aje.a115704.

  PMID: 2144946 BACKGROUND

• Walker KZ, O'Dea K, Gomez M, Girgis S, Colagiuri R. Diet and exercise in the prevention of diabetes. J Hum Nutr Diet. 2010 Aug;23(4):344-52. doi: 10.1111/j.1365-277X.2010.01061.x. Epub 2010 Mar 23.

  PMID: 20337844 BACKGROUND

• Wang D, Li W, Cui X, Meng Y, Zhou M, Xiao L, Ma J, Yi G, Chen W. Sleep duration and risk of coronary heart disease: A systematic review and meta-analysis of prospective cohort studies. Int J Cardiol. 2016 Sep 15;219:231-9. doi: 10.1016/j.ijcard.2016.06.027. Epub 2016 Jun 16.

  PMID: 27336192 BACKGROUND

• Ntoumanis N, Ng JYY, Prestwich A, Quested E, Hancox JE, Thogersen-Ntoumani C, Deci EL, Ryan RM, Lonsdale C, Williams GC. A meta-analysis of self-determination theory-informed intervention studies in the health domain: effects on motivation, health behavior, physical, and psychological health. Health Psychol Rev. 2021 Jun;15(2):214-244. doi: 10.1080/17437199.2020.1718529. Epub 2020 Feb 3.

  PMID: 31983293 BACKGROUND

• Ehrlich H, McKenney M, Elkbuli A. Protecting our healthcare workers during the COVID-19 pandemic. Am J Emerg Med. 2020 Jul;38(7):1527-1528. doi: 10.1016/j.ajem.2020.04.024. Epub 2020 Apr 17. No abstract available.

  PMID: 32336585 BACKGROUND

• Conroy D, Hagger MS. Imagery interventions in health behavior: A meta-analysis. Health Psychol. 2018 Jul;37(7):668-679. doi: 10.1037/hea0000625. Epub 2018 May 28.

  PMID: 29809020 BACKGROUND

• Borelli JL, Russo LN, Arreola J, Cervantes BR, Marquez CM, Montiel G, Avalos V, Carballo J, Garcia J, Bhatt I, Torres G, Leal F, Guerra N. Saving a seat at the table for community members: co-creating an attachment-based intervention for low-income Latinx parent-youth dyads using a promotor/a model. Res Psychother. 2022 Feb 4;25(1):598. doi: 10.4081/ripppo.2022.598.

  PMID: 35373959 BACKGROUND

• Rowley CA, Arcos D, Jensen O, Russo LN, Zhou E, Kazmierski K, Naranjo V, Borelli JL. Pilot test of an adapted relational savoring intervention for Latine-serving community health workers. J Couns Psychol. 2026 Jul;73(4):460-472. doi: 10.1037/cou0000875. Epub 2026 May 4.

  PMID: 42080865 DERIVED

• Arcos D, Russo LN, Kazmierski KFM, Zhou E, Montiel GI, Bracho A, Mejia N, Borelli JL. A Relationship-Based Resilience Program for Promotores: Protocol for a Randomized Controlled Waitlist Trial. JMIR Res Protoc. 2023 Dec 19;12:e51427. doi: 10.2196/51427.

  PMID: 38113093 DERIVED

Limitations and Caveats

Due to unforeseen technology issues, physiological outcomes originally specified in the protocol, including heart rate variability (HRV), could not be assessed. As a result, the study was unable to evaluate intervention effects on HRV. Additionally, analyses shifted from the originally planned cardiometabolic and community programming outcomes to intervention acceptability and psychosocial outcomes among participants (e.g., physical and mental health, emotional valence, burnout, etc.).

Results Point of Contact

• Title: Jessica Borelli
• Organization: University of California, Irvine

jessica.borelli@uci.edu

1 (203) 887-8857‬

Study Officials

• Jessica L Borelli, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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

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.

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: August 10, 2026
• Results First Posted: August 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)