HypertensionSERVEOCNCT05641519
Skills-Based Educational Strategies for Reduction of Vascular Events in Orange County
A study testing SERVE OC Intervention and Enhanced Standard Intervention in people with Hypertension, run by University of California, Irvine at 1 site in United States.
Trial summary
The Skills-Based Educational strategies for Reduction of Vascular Events in Orange County, CA (SERVE OC) study aims to evaluate the efficacy of a culturally tailored, skills-based, cardiovascular health (CVH) intervention amongst a cohort of Latinx and Vietnamese families in Santa Ana, CA. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- SERVE OC Intervention and Enhanced Standard Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 483 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Living in Santa Ana, Anaheim, Westminster or Garden Grove
- Speaks one of the languages in which the survey is administered in (English, Spanish, and Vietnamese)
- Aged >=18 years old at time of enrollment
- Has at least one friend/family/household member participating in the study with them, (if they are a minor they must have at least one adult participant participating with them)
- If child turns 5 during the 3 years of the study they will be eligible to participate and we will enroll them with parent permission
Who cannot join
- Dementia history, cognitive impairment, or any condition impairing his/her ability to participate in education
- Life expectancy less than 1 year
- Unable to give informed consent or unable to obtain parent/guardian permission (minors)
- Lives in a nursing home or requires 24-hour care
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
The Skills-Based Educational strategies for Reduction of Vascular Events in Orange County, CA (SERVE OC) study aims to evaluate the efficacy of a culturally tailored, skills-based, cardiovascular health (CVH) intervention amongst a cohort of Latinx and Vietnamese families in Santa Ana, CA. The SERVE OC intervention was adapted from our previous work, the Discharge Educational Strategies for Reduction of Vascular Events (DESERVE) intervention, for the primordial prevention of hypertension (HTN) and other risk factors for cardiovascular disease (CVD). (The DESERVE study was conducted at New York University under their IRB). The intervention will be delivered by community health workers (CHWs) and will focus on: 1) optimizing risk perception, 2) enhancing provider-family communication, and 3) identifying challenges to CVH. Participants will receive multi-lingual materials and access to an app/web portal to identify healthy goals and strategies around modifiable risk factors for CVH, Life's Essential 8. SERVE OC will follow participants for 36-months to examine changes in CVH using Life's Simple 7 (LS7): smoking status, physical activity, weight, diet, blood glucose, cholesterol, and blood pressure (BP) scores and changes in systolic blood pressure (SBP) among adult participants versus enhanced standard intervention (ESI). Remote blood pressure (BP) monitoring will also be used to assess BP over time. CHWs will engage families in identifying barriers to CVH and solutions to share with community stakeholders. Using this community-based research (CBPR) approach the investigators hope to improve health equity within the community through enhanced social capital, empowerment, and advocacy capacity. This study is part of a multi-center projected coordinated by the UCLA-UCI Center for Eliminating Cardio-Metabolic Disparities in Multi-Ethnic Populations (UC END-DISPARITIES), aimed at improving CVH among underserved populations in Los Angeles and Orange County.
Read the detailed description
- Participants from the Santa Ana Cares (SAC) cohort will be invited to participate in SERVE OC until projected sample size is reached. Vietnamese households will be over sampled to enhance recruitment of this population.
- Informed consent/parent permission/assent will be collected from eligible participants who agree to participate in the study. The study team and trained CHWs, will collect informed consent.
- Families will then be randomized into SERVE OC or to Enhanced Standard Intervention (ESI)
- The study team, will conduct baseline assessments for each family. Baseline assessments includes a bio-measure assessment which includes measuring blood pressure, height, weight, waist circumference, HbA1c, and cholesterol. During baseline, participants will also answer questions about diet, physical activity, sleep, their vascular health, socio-demographics, and behavioral, social network, and health equity measures. The CHWs will be trained and will help the study team with administering the participant surveys. CHWs will be UCI affiliated and all CHWs will be added to the research personnel tracking log. All study team members will also be added to the research personnel tracking log.
- Families randomized to ESI will be given informational materials from the American Heart Association on cardiovascular health. ESI includes self-management which is standard care. At 12, 24, and 36 months they will be asked to return for in person follow-up to collect bio measures again and complete follow up surveys during scheduled community data collection events.
- Families randomized to SERVE OC will receive AHA informational materials, access to the app/web portal, and will be assigned a CHW to work with over the 3 years of the study. The CHW will facilitate the SERVE OC intervention for the family which includes 1) Conducting a family "intake" of risk factors through the LE8 assessment and discussing prevention/risk reduction 2) Facilitate the creation of a family network-tailored action plan 3) Provide guidance to activate/reinforce action plans using the interactive part of the app/web portal. They will meet with their CHW monthly to learn about CVH, work on their goals, and action plans. Meetings with CHWs will take place in their homes, the UCI FQHC in Santa Ana, over zoom, or other locations such as local churches, parks, community centers, or grocery stores (for field trips) They will also receive messages from them throughout the duration of the study using their preferred method of contact (text, email, web portal/app, phone call) for reinforcement and scheduling meetings. Families will be asked to return for follow-up at 12, 24, and 36 months to collect bio measures and complete follow up surveys/interviews.
- CHWs: CHWs will be UCI affiliated. All CHWs will be added to the research personnel tracking log. Over the 3 years of the study, the CHWs will interact with families in their home, or at community sites depending on the family's preference. They will encourage family level activities to improve CVH using interactive curriculums, narrative videos, informational workbooks (available in Spanish, Vietnamese, or English), the web portal/app, and reinforcement. They will ask families to identify barriers to improving CVH and possible solutions to utilize later for SERVE OC community activities. CHWs will also respond to other issues families may have including poverty, food insecurity, domestic abuse, and substance misuse. After 1 year, the team will incorporate relevant educational materials and protocols into the intervention to help CHWs respond to these issues and to provide families with resources. App/Web portal: For SERVE OC, the existing FURRThERhealth.com interactive web portal/app which was used in previous studies will be updated for the needs of the SERVE OC intervention. The web portal will facilitate the creation of tailored action plans, including setting goals and planning activities; allow groups to track activities and earn stars and trophies for their accomplishments; facilitate online communication in preferred languages; and provides curated AHA and other resources to support primary and secondary prevention. During the initial meeting, the CHW will introduce the portal to families. Each individual will be assigned a unique profile with corresponding avatar handle that is linked to their identifying information. With the CHW, the login process and site functionality will be demonstrated to all members of the group. Tech support information will be made available. There are 2 sections of the web portal: 1) the resource section and 2) the facilitated network engagement (goal creation, activity tracking, chat and photo sharing, push notifications and e-messages). The CHW will work with the families to enter chosen goals and activities into the portal and demonstrate the process of tracking activity completion. After goal setting, families will start to receive push messages about working together on healthy lifestyle and risk reduction. The initial messages focus on support for the transition to engaging in healthy lifestyles as a family. The investigators anticipate that there will be changes to goals and times when networks go into holding patterns (no activity or motivation). Messages from SERVE OC will change to address new barriers and challenges.
- All participants will also be invited to attend community events, which will occur a few time a year. At these events the study team will facilitate discussions between community members, community health organizations, local government, and subject matter experts to identify issues and possible solutions to improve health the community of Santa Ana. Food, childcare, and fun, healthy, educational activities will be provided for all.
- All families/household will receive a Withings BPM Connect, which is a remote blood pressure measuring monitor, that allows their blood pressure readings to be sent directly to our research team through an online cloud to allow us to examine BP trends over time. All participating adult family members, 18 years of age and older, will be asked to take their blood pressure readings once a week. The study team will teach them how to use the blood pressure monitor and provide them with instructions to take home. If they are in the SERVE OC intervention the CHWs will ask them how they are doing with the weekly BP readings or remind them to take their measurements using the app/web portal.
- The investigators will also conduct focus groups throughout the 3 years of the study as the SERVE OC intervention is iterative and will be informed by community stakeholders as it goes on. This is a CBPR practice.
- At baseline and 3 years, COVID-19 antibody testing will be conducted.
- Conditions
- Hypertension
- Being tested
- SERVE OC Intervention, Enhanced Standard Intervention
- Keywords
- Hypertension, Life's Essential 8, Social Networks, Community Health Workers, Hispanic/Latinx, Vietnamese
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SERVE OC InterventionBehavioural
Also called Community Health Worker Intervention, Family Based Intervention
SERVE OC intervention for the family which includes 1) Conducting a family "intake" of risk factors through the LE8 assessment and discussing prevention/risk reduction 2) Facilitate the creation of a family network-tailored action plan 3) Provide guidance to activate/reinforce action plans using the interactive part of the app/web portal. They will meet with their CHW monthly to learn about CVH, work on their goals, and action plans. Meetings with CHWs will take place in their homes, the UCI FQHC in Santa Ana, over zoom, or other locations such as local churches, parks, community centers, or grocery stores (for field trips) They will also receive messages from them throughout the duration of the study using their preferred method of contact (text, email, webportal/app, phone call) for reinforcement and scheduling meetings
Enhanced Standard InterventionBehavioural
Also called Usual Care, Standard of Care
Enhanced Standard Intervention will be given informational materials from the American Heart Association on cardiovascular health. ESI includes self-management which is standard care
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Standard Intervention | Placebo comparator | Families randomized to enhanced standard intervention (ESI) will be given informational materials from the American Heart Association on cardiovascular health. ESI includes self-management which is standard care. At 12, 24, and 36 months they will be asked to return for in person follow-up to collect bio measures again and complete follow up surveys at the UCI FQHC in Santa Ana or during scheduled community data collection events. All adults will be asked to take their blood pressure with the device once a week. Receives: Behavioral: Enhanced Standard Intervention |
| SERVE OC Intervention | Experimental | In the SERVE OC intervention, participants will receive AHA informational materials, access to the app/web portal, and will be assigned a CHW to work with over the 3 years of the study. The CHW will facilitate the intervention for the family which includes 1) Conducting a family "intake" of risk factors through the LE8 assessment 2) Facilitate the creation of a family network-tailored action plan 3) Provide guidance to activate/reinforce action plans using the interactive part of the app/web portal. They will meet with their CHW monthly to learn about CVH, work on their goals, and action plans. Meetings with CHWs will take place in their homes, the UCI FQHC in Santa Ana, over zoom, or other locations. All adults will be asked to take their blood pressure with the device once a week. Receives: Behavioral: SERVE OC Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life's Essential 8
To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.
Measured: Baseline
Life's Essential 8
To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.
Measured: 1 year
Life's Essential 8
To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.
Measured: 2 year
Life's Essential 8
To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.
Measured: 3 year
Secondary outcomes (4)
Systolic Blood Pressure
To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.
Measured: Baseline
Systolic Blood Pressure
To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.
Measured: Year 1
Systolic Blood Pressure
To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.
Measured: Year 2
Systolic Blood Pressure
To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start18 Nov 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SERVE OC is a randomized controlled trial that utilizes block randomization, and the family/household will be the unit of randomization (participants in the same household will be randomized to the same intervention arm). We will prospectively enroll 150-200 households with school-age children from the SAC cohort and randomize the Hispanic/Latinx, Vietnamese, and non-Hispanic/ Vietnamese households to the SERVE OC intervention or enhanced standard intervention (ESI) to ensure balance between intervention arms within each race and ethnic group. Participant follow-up will occur at 12, 24, and 36 months.
- Masking
- None (open label)
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Ohio State University, Latino Health Access, Vietnamese American Cancer Foundation, Radiate Consulting, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Bernadette Boden-Albala, University of California, Irvine
- Investigators
- Bernadette Boden-Albala, DrPH, MPH, Principal investigator, UCI Program in Pubic Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641519
- Sponsor's protocol ID
- 283
- Other IDs
- 5P50MD017366-04
- Acronym
- SERVEOC
- Status last verified
- Jun 2026
- First submitted
- 16 Sep 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boden-Albala B, Wing JJ, Landry MJ, Castro M, Gutierrez D, Cardenas C, Rousseau J, Rahmani A, Chavez A, Ding X, Kurzman A, Albala B. A Randomized Controlled Trial Evaluating a Community-Based, Family Network Heart Health Intervention - the SERVE OC Trial: Design, Rationale and Baseline Findings. medRxiv [Preprint]. 2026 Sep 2:2026.08.31.26361871. doi: 10.64898/2026.08.31.26361871.
PubMed 42922824Boden-Albala B, Draughter-Espinoza D, Castro M, Gutierrez D, Cardenas C, Landry MJ, Wing J, Albala B. Knowledge, barriers, and facilitators for promoting cardiovascular health in a Latino community: a qualitative sub-study of the Skills-based Educational Strategies for Reduction of Vascular Events in Orange County. Front Public Health. 2025 Jun 18;13:1531775. doi: 10.3389/fpubh.2025.1531775. eCollection 2025.
PubMed 40606080
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skills-Based Educational Strategies for Reduction of Vascular Events in Orange County
- ClinicalTrials.gov ID
- NCT05641519
- Acronym / sponsor ID
- SERVEOC / 283
- Conditions
- Hypertension
- Keywords
- Hypertension, Life's Essential 8, Social Networks, Community Health Workers, Hispanic/Latinx, Vietnamese
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 483 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Ohio State University, Latino Health Access, Vietnamese American Cancer Foundation, Radiate Consulting, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Dec 2022 (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 Skills-Based Educational strategies for Reduction of Vascular Events in Orange County, CA (SERVE OC) study aims to evaluate the efficacy of a culturally tailored, skills-based, cardiovascular health (CVH) intervention amongst a cohort of Latinx and Vietnamese families in Santa Ana, CA. The SERVE OC intervention was adapted from our previous work, the Discharge Educational Strategies for Reduction of Vascular Events (DESERVE) intervention, for the primordial prevention of hypertension (HTN) and other risk factors for cardiovascular disease (CVD). (The DESERVE study was conducted at New York University under their IRB). The intervention will be delivered by community health workers (CHWs) and will focus on: 1) optimizing risk perception, 2) enhancing provider-family communication, and 3) identifying challenges to CVH. Participants will receive multi-lingual materials and access to an app/web portal to identify healthy goals and strategies around modifiable risk factors for CVH, Life's Essential 8. SERVE OC will follow participants for 36-months to examine changes in CVH using Life's Simple 7 (LS7): smoking status, physical activity, weight, diet, blood glucose, cholesterol, and blood pressure (BP) scores and changes in systolic blood pressure (SBP) among adult participants versus enhanced standard intervention (ESI). Remote blood pressure (BP) monitoring will also be used to assess BP over time. CHWs will engage families in identifying barriers to CVH and solutions to share with community stakeholders. Using this community-based research (CBPR) approach the investigators hope to improve health equity within the community through enhanced social capital, empowerment, and advocacy capacity. This study is part of a multi-center projected coordinated by the UCLA-UCI Center for Eliminating Cardio-Metabolic Disparities in Multi-Ethnic Populations (UC END-DISPARITIES), aimed at improving CVH among underserved populations in Los Angeles and Orange County.
Detailed description
- Participants from the Santa Ana Cares (SAC) cohort will be invited to participate in SERVE OC until projected sample size is reached. Vietnamese households will be over sampled to enhance recruitment of this population.
- Informed consent/parent permission/assent will be collected from eligible participants who agree to participate in the study. The study team and trained CHWs, will collect informed consent.
- Families will then be randomized into SERVE OC or to Enhanced Standard Intervention (ESI)
- The study team, will conduct baseline assessments for each family. Baseline assessments includes a bio-measure assessment which includes measuring blood pressure, height, weight, waist circumference, HbA1c, and cholesterol. During baseline, participants will also answer questions about diet, physical activity, sleep, their vascular health, socio-demographics, and behavioral, social network, and health equity measures. The CHWs will be trained and will help the study team with administering the participant surveys. CHWs will be UCI affiliated and all CHWs will be added to the research personnel tracking log. All study team members will also be added to the research personnel tracking log.
- Families randomized to ESI will be given informational materials from the American Heart Association on cardiovascular health. ESI includes self-management which is standard care. At 12, 24, and 36 months they will be asked to return for in person follow-up to collect bio measures again and complete follow up surveys during scheduled community data collection events.
- Families randomized to SERVE OC will receive AHA informational materials, access to the app/web portal, and will be assigned a CHW to work with over the 3 years of the study. The CHW will facilitate the SERVE OC intervention for the family which includes 1) Conducting a family "intake" of risk factors through the LE8 assessment and discussing prevention/risk reduction 2) Facilitate the creation of a family network-tailored action plan 3) Provide guidance to activate/reinforce action plans using the interactive part of the app/web portal. They will meet with their CHW monthly to learn about CVH, work on their goals, and action plans. Meetings with CHWs will take place in their homes, the UCI FQHC in Santa Ana, over zoom, or other locations such as local churches, parks, community centers, or grocery stores (for field trips) They will also receive messages from them throughout the duration of the study using their preferred method of contact (text, email, web portal/app, phone call) for reinforcement and scheduling meetings. Families will be asked to return for follow-up at 12, 24, and 36 months to collect bio measures and complete follow up surveys/interviews.
- CHWs: CHWs will be UCI affiliated. All CHWs will be added to the research personnel tracking log. Over the 3 years of the study, the CHWs will interact with families in their home, or at community sites depending on the family's preference. They will encourage family level activities to improve CVH using interactive curriculums, narrative videos, informational workbooks (available in Spanish, Vietnamese, or English), the web portal/app, and reinforcement. They will ask families to identify barriers to improving CVH and possible solutions to utilize later for SERVE OC community activities. CHWs will also respond to other issues families may have including poverty, food insecurity, domestic abuse, and substance misuse. After 1 year, the team will incorporate relevant educational materials and protocols into the intervention to help CHWs respond to these issues and to provide families with resources. App/Web portal: For SERVE OC, the existing FURRThERhealth.com interactive web portal/app which was used in previous studies will be updated for the needs of the SERVE OC intervention. The web portal will facilitate the creation of tailored action plans, including setting goals and planning activities; allow groups to track activities and earn stars and trophies for their accomplishments; facilitate online communication in preferred languages; and provides curated AHA and other resources to support primary and secondary prevention. During the initial meeting, the CHW will introduce the portal to families. Each individual will be assigned a unique profile with corresponding avatar handle that is linked to their identifying information. With the CHW, the login process and site functionality will be demonstrated to all members of the group. Tech support information will be made available. There are 2 sections of the web portal: 1) the resource section and 2) the facilitated network engagement (goal creation, activity tracking, chat and photo sharing, push notifications and e-messages). The CHW will work with the families to enter chosen goals and activities into the portal and demonstrate the process of tracking activity completion. After goal setting, families will start to receive push messages about working together on healthy lifestyle and risk reduction. The initial messages focus on support for the transition to engaging in healthy lifestyles as a family. The investigators anticipate that there will be changes to goals and times when networks go into holding patterns (no activity or motivation). Messages from SERVE OC will change to address new barriers and challenges.
- All participants will also be invited to attend community events, which will occur a few time a year. At these events the study team will facilitate discussions between community members, community health organizations, local government, and subject matter experts to identify issues and possible solutions to improve health the community of Santa Ana. Food, childcare, and fun, healthy, educational activities will be provided for all.
- All families/household will receive a Withings BPM Connect, which is a remote blood pressure measuring monitor, that allows their blood pressure readings to be sent directly to our research team through an online cloud to allow us to examine BP trends over time. All participating adult family members, 18 years of age and older, will be asked to take their blood pressure readings once a week. The study team will teach them how to use the blood pressure monitor and provide them with instructions to take home. If they are in the SERVE OC intervention the CHWs will ask them how they are doing with the weekly BP readings or remind them to take their measurements using the app/web portal.
- The investigators will also conduct focus groups throughout the 3 years of the study as the SERVE OC intervention is iterative and will be informed by community stakeholders as it goes on. This is a CBPR practice.
- At baseline and 3 years, COVID-19 antibody testing will be conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SERVE OC is a randomized controlled trial that utilizes block randomization, and the family/household will be the unit of randomization (participants in the same household will be randomized to the same intervention arm). We will prospectively enroll 150-200 households with school-age children from the SAC cohort and randomize the Hispanic/Latinx, Vietnamese, and non-Hispanic/ Vietnamese households to the SERVE OC intervention or enhanced standard intervention (ESI) to ensure balance between intervention arms within each race and ethnic group. Participant follow-up will occur at 12, 24, and 36 months.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Standard Intervention | Placebo comparator | Behavioral: Enhanced Standard InterventionFamilies randomized to enhanced standard intervention (ESI) will be given informational materials from the American Heart Association on cardiovascular health. ESI includes self-management which is standard care. At 12, 24, and 36 months they will be asked to return for in person follow-up to collect bio measures again and complete follow up surveys at the UCI FQHC in Santa Ana or during scheduled community data collection events. All adults will be asked to take their blood pressure with the device once a week. |
| SERVE OC Intervention | Experimental | Behavioral: SERVE OC InterventionIn the SERVE OC intervention, participants will receive AHA informational materials, access to the app/web portal, and will be assigned a CHW to work with over the 3 years of the study. The CHW will facilitate the intervention for the family which includes 1) Conducting a family "intake" of risk factors through the LE8 assessment 2) Facilitate the creation of a family network-tailored action plan 3) Provide guidance to activate/reinforce action plans using the interactive part of the app/web portal. They will meet with their CHW monthly to learn about CVH, work on their goals, and action plans. Meetings with CHWs will take place in their homes, the UCI FQHC in Santa Ana, over zoom, or other locations. All adults will be asked to take their blood pressure with the device once a week. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Living in Santa Ana, Anaheim, Westminster or Garden Grove
- Speaks one of the languages in which the survey is administered in (English, Spanish, and Vietnamese)
- Aged >=18 years old at time of enrollment
- Has at least one friend/family/household member participating in the study with them, (if they are a minor they must have at least one adult participant participating with them)
- If child turns 5 during the 3 years of the study they will be eligible to participate and we will enroll them with parent permission
Key exclusion criteria (4 listed)
- Dementia history, cognitive impairment, or any condition impairing his/her ability to participate in education
- Life expectancy less than 1 year
- Unable to give informed consent or unable to obtain parent/guardian permission (minors)
- Lives in a nursing home or requires 24-hour care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SERVE OC InterventionAlso: Community Health Worker Intervention, Family Based InterventionSERVE OC intervention for the family which includes 1) Conducting a family "intake" of risk factors through the LE8 assessment and discussing prevention/risk reduction 2) Facilitate the creation of a family network-tailored action plan 3) Provide guidance to activate/reinforce action plans using the interactive part of the app/web portal. They will meet with their CHW monthly to learn about CVH, work on their goals, and action plans. Meetings with CHWs will take place in their homes, the UCI FQHC in Santa Ana, over zoom, or other locations such as local churches, parks, community centers, or grocery stores (for field trips) They will also receive messages from them throughout the duration of the study using their preferred method of contact (text, email, webportal/app, phone call) for reinforcement and scheduling meetings | Behavioural | SERVE OC Intervention |
| Enhanced Standard InterventionAlso: Usual Care, Standard of CareEnhanced Standard Intervention will be given informational materials from the American Heart Association on cardiovascular health. ESI includes self-management which is standard care | Behavioural | Enhanced Standard Intervention |
Primary outcome
Life's Essential 8
Time frame: Baseline
To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.
Life's Essential 8
Time frame: 1 year
To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.
Life's Essential 8
Time frame: 2 year
To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.
Life's Essential 8
Time frame: 3 year
To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.
4 secondary outcomes
Systolic Blood Pressure
Time frame: Baseline
Systolic Blood Pressure
Time frame: Year 1
Systolic Blood Pressure
Time frame: Year 2
Systolic Blood Pressure
Time frame: Year 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Derived from this study: PubMed 42922824Boden-Albala B, Wing JJ, Landry MJ, Castro M, Gutierrez D, Cardenas C, Rousseau J, Rahmani A, Chavez A, Ding X, Kurzman A, Albala B. A Randomized Controlled Trial Evaluating a Community-Based, Family Network Heart Health Intervention - the SERVE OC Trial: Design, Rationale and Baseline Findings. medRxiv [Preprint]. 2026 Sep 2:2026.08.31.26361871. doi: 10.64898/2026.08.31.26361871.
- Derived from this study: PubMed 40606080Boden-Albala B, Draughter-Espinoza D, Castro M, Gutierrez D, Cardenas C, Landry MJ, Wing J, Albala B. Knowledge, barriers, and facilitators for promoting cardiovascular health in a Latino community: a qualitative sub-study of the Skills-based Educational Strategies for Reduction of Vascular Events in Orange County. Front Public Health. 2025 Jun 18;13:1531775. doi: 10.3389/fpubh.2025.1531775. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Bernadette Boden-Albala, DrPH, MPH principal investigator
UCI Program in Pubic Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SERVE OC Intervention and Enhanced Standard Intervention in people with Hypertension, run by University of California, Irvine 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 5 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Life's Essential 8 (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05641519, which also lists 2 linked publications.
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 22 Jun 2026.