HypertensionNCT05220332
Church-based Intervention to Improve Blood Pressure in African Americans
A study testing Heart to Heart and Money Smart in people with Hypertension, run by Rush University Medical Center at 1 site in United States.
Trial summary
This is a 12-month behavioral cluster-randomized trial testing a church-based intervention to reduce blood pressure in African Americans with uncontrolled blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Heart to Heart and Money Smart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to Sep 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Churches:
- At least 75 members and ability to recruit 15 study participants
- Predominantly African American congregants
- Participants:
- Age 18 or older
- Has blood pressure readings with uncontrolled blood pressure, defined as exceeding the blood thresholds for initiation of antihypertensive medication according to the 2017 American College of Cardiology/ American Heart Association (ACC/AHA) guidelines.
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- The thresholds are 140/90 for the general population < 65 years old, and 130/80 for individuals ≥ 65 or with diabetes, chronic kidney disease, or high cardiovascular risk (self-report of prior diagnosis of myocardial infarction, coronary heart disease, stroke or heart failure)
- Attends church (virtually or in-person) at least once per month
- Able to attend weekly Zoom meetings
- Consents and completes all baseline assessments
Who cannot join
- Churches:
- Pastor unwilling to conduct Bible study
- Participants:
- Unable to make dietary changes due to lack of control over their food source (i.e., eat meals at shelter, nursing home)
- Has a medical condition that prohibits or severely restricts ability to eat vegetables (i.e., renal disease, Crohn's disease)
- Has a medical condition with an uncertain 6-month prognosis
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- Inability to give informed consent (i.e., cognitive impairment, does not speak Englis
- Plans to move within the 6 months following enrollment
- Participated in prior ALIVE intervention
- Member of household participating in another church
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60422
About this study
Official title: Abundant Living: A Church-based Intervention to Improve Blood Pressure in African Americans
This is a 12-month behavioral cluster-randomized trial testing a church-based intervention to reduce blood pressure in African Americans with uncontrolled blood pressure.
- Conditions
- Hypertension
- Being tested
- Heart to Heart, Money Smart
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart to HeartBehavioural
The Heart to Heart intervention will be delivered at the churches over 6 months. The intervention consists of 12 bible study sessions (45 minutes) led by the Senior Pastor and 24 behavior change small group sessions (90 minutes) led by a trained Rush staff interventionist. These sessions are open to the entire church membership and focus on improving diet and physical well being. A community health worker will provide individualized support to participants with uncontrolled blood pressure who do not reduce their blood pressure by participating in small groups.
Money SmartBehavioural
The Money Smart program for adults was developed by the Federal Deposit Insurance Corporation (FDIC). It consists of training modules that cover basic financial topics including deposit and credit services offered by financial institutions, how to obtain and use credit effectively, and the basics of building or repairing credit. This group-based program will be delivered in 14 sessions over 6 months and will be led by a trained instructor.
| Study group | Role | What they receive |
|---|---|---|
| Heart to Heart | Experimental | Not described Receives: Behavioral: Heart to Heart |
| Money Smart | Active comparator | Not described Receives: Behavioral: Money Smart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood pressure
The primary outcome is systolic blood pressure at 6 months post start of the intervention. The Omron digital blood pressure monitor will be utilized to measure blood pressure (Omron Healthcare, Inc., Lake Forest, IL). The participant will sit quietly for >5 minutes, 3 readings will be taken 1-2 minutes apart while seated, and an average of the last 2 readings will be taken to evaluate blood pressure.
Measured: Measured at baseline and 6 months and 12 months after start of the intervention
Secondary outcomes (8)
Change in Medication adherence
Medication adherence will be measured using the 15-item Adherence to Refills and Medications Scale (ARMS). The items are evaluated on a 4-point scale ranging from "none of the time" to "all of the time".
Measured: Measured at baseline and 6 months and 15 months after start of the intervention
Change in DASH diet adherence
Adherence to the Dietary Approaches to Stop Hypertension (DASH) diet will be measured using the food frequency questionnaire developed by Viocare (Princeton, NJ). This 156-item graphical, web-based FFQ queries respondents about usual intakes of 156 food and beverage items over the past three months. It also provides food and nutrient analyses to the research team based on the Nutrition Data System for Research 2018 (NDSR, University of Minnesota, Minneapolis, MN).
Measured: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Self efficacy
Self efficacy will be measured using the Hypertension Self-Care Profile Self-efficacy scale which evaluates self efficacy for 8 common self care recommendations for individuals with hypertension. The items are evaluated on a 4-point scale ranging from "not confident" to "very confident".
Measured: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Quality of life
Quality of life will be measured using the EuroQual (EQ-5D-5L) questionnaire. The measure evaluates the participant's perception of their "health today" with respect to mobility, self-care, usual activities, pain/discomfort, and anxiety depression. The items are evaluated on a 5-point scale ranging from "no problem" in the area to "extreme problem" in the area.
Measured: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Social support
Social support for eating a healthy diet will be measured using a 4-item questionnaire which will evaluate the participant's perception of social support received from family members, friends, church members, and their Pastor. The items are evaluated on a 5-point scale ranging from "never" to "always".
Measured: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Hypertension knowledge
Hypertension knowledge will be evaluated using a 10-item questionnaire adapted from the Hypertension Evaluation of Lifestyle and Management (HELM) Knowledge Scale. Systolic and diastolic blood pressure measurements will be evaluated using the following 4 categories: high, low, normal, and don't know. The frequency with which medication should be taken, lifestyle factors associated with hypertension, and health risks associated with hypertension will also be evaluated.
Measured: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Nutrition knowledge
Nutrition knowledge will be evaluated using an 18-item survey adapted from the International Food Policy Study 2020 - United States Survey. Common foods and food labels are evaluated on a 10-point scale ranging from "not healthy at all" to "extremely healthy".
Measured: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Barriers to medication use
Barriers to medication use will be measured using the 15-item BRIGHT study Barriers to Medication Scale. The scale evaluates different reasons why it is difficult for participants to take medications or to take the medications on time. The items are evaluated on a 5-point scale ranging from "never" to "all the time".
Measured: Measured at baseline and 6 months and 15 months after start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start15 Mar 2022
- Primary completion8 Mar 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Lynch, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220332
- Sponsor's protocol ID
- 18050306
- Status last verified
- Jun 2026
- First submitted
- 21 Jan 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abundant Living: A Church-based Intervention to Improve Blood Pressure in African Americans
- ClinicalTrials.gov ID
- NCT05220332
- Acronym / sponsor ID
- 18050306
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 8 Mar 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 2 Feb 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.
This is a 12-month behavioral cluster-randomized trial testing a church-based intervention to reduce blood pressure in African Americans with uncontrolled blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart to Heart | Experimental | Behavioral: Heart to Heart |
| Money Smart | Active comparator | Behavioral: Money Smart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 75 members and ability to recruit 15 study participants
- Predominantly African American congregants
- Age 18 or older
- Has blood pressure readings with uncontrolled blood pressure, defined as exceeding the blood thresholds for initiation of antihypertensive medication according to the 2017 American College of Cardiology/ American Heart Association (ACC/AHA) guidelines.
- Attends church (virtually or in-person) at least once per month
Key exclusion criteria (10 listed)
- Pastor unwilling to conduct Bible study
- Unable to make dietary changes due to lack of control over their food source (i.e., eat meals at shelter, nursing home)
- Has a medical condition that prohibits or severely restricts ability to eat vegetables (i.e., renal disease, Crohn's disease)
- Has a medical condition with an uncertain 6-month prognosis
- Inability to give informed consent (i.e., cognitive impairment, does not speak Englis
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 |
|---|---|---|
| Heart to HeartThe Heart to Heart intervention will be delivered at the churches over 6 months. The intervention consists of 12 bible study sessions (45 minutes) led by the Senior Pastor and 24 behavior change small group sessions (90 minutes) led by a trained Rush staff interventionist. These sessions are open to the entire church membership and focus on improving diet and physical well being. A community health worker will provide individualized support to participants with uncontrolled blood pressure who do not reduce their blood pressure by participating in small groups. | Behavioural | Heart to Heart |
| Money SmartThe Money Smart program for adults was developed by the Federal Deposit Insurance Corporation (FDIC). It consists of training modules that cover basic financial topics including deposit and credit services offered by financial institutions, how to obtain and use credit effectively, and the basics of building or repairing credit. This group-based program will be delivered in 14 sessions over 6 months and will be led by a trained instructor. | Behavioural | Money Smart |
Primary outcome
Change in Blood pressure
Time frame: Measured at baseline and 6 months and 12 months after start of the intervention
The primary outcome is systolic blood pressure at 6 months post start of the intervention. The Omron digital blood pressure monitor will be utilized to measure blood pressure (Omron Healthcare, Inc., Lake Forest, IL). The participant will sit quietly for >5 minutes, 3 readings will be taken 1-2 minutes apart while seated, and an average of the last 2 readings will be taken to evaluate blood pressure.
8 secondary outcomes
Change in Medication adherence
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in DASH diet adherence
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Self efficacy
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Quality of life
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Social support
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Hypertension knowledge
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Nutrition knowledge
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Barriers to medication use
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
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 15 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart to Heart and Money Smart in people with Hypertension, run by Rush University Medical Center 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 10 inclusion and 10 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 15 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. 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?
Change in Blood pressure (time frame: Measured at baseline and 6 months and 12 months after start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.