StressNCT06707636
Using Life's Essential 8 in Midlife Black Women
A study testing Experimental: Black Women's Stress and Wellness (B-SWELL) arm and Active Comparator: Wellness (WE) arm in people with Stress and Self-Efficacy, run by Ohio State University at 1 site in United States.
Trial summary
This research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease risk in midlife Black women. The B-SWELL leverages stress reduction to facilitate the adoption and adherence to healthier lifestyle behaviors. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Self-Efficacy, Heart Disease Risk Factors
- What is being tested?
- Experimental: Black Women's Stress and Wellness (B-SWELL) arm and Active Comparator: Wellness (WE) arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Identifies as Black/ African American
- Age 45-64.
- Willing to adhere to the study requirements.
Who cannot join
- Incarcerated or on house arrest,
- Diagnosed with terminal illness, severe mental illness, or dementia.
- Unable or unwilling to participate in 8 weekly sessions and 4 phone interviews.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Life's Essential 8 to Lower Heart Disease Risk in Midlife Black Women
This research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease risk in midlife Black women. The B-SWELL leverages stress reduction to facilitate the adoption and adherence to healthier lifestyle behaviors. This research study will use choice to increase engagement and minimize the effect of social determinants of health on research participation among midlife Black women.
A comparative clinical trial will be conducted. Midlife Black women (ages 45-64) who reside in the Greater Cincinnati area will be recruited for participation. Women are eligible if they self-identify as Black/ African American, are between the ages of 45-64, and are willing to commit to the requirements of the study (e.g., attend 8 weekly sessions and 4 phone interviews). Participants will be randomly placed (like the flip of a coin) into either the B-SWELL or WE group. Both the B-SWELL and WE groups are 8-week programs that focus on healthy lifestyle behaviors and heart disease awareness. Women will have the choice to participate in person or virtually. Survey phone interviews will be conducted at baseline, 8-, 12-, and 16-weeks. Data collected will provide information about adherence, healthy lifestyle behaviors, and cardiovascular health. Heart health will be measured using the American Heart Association's Life's Essential 8 metric.
Outcome measures include heart disease awareness, Life's Essential 8 score, stress, self-efficacy, depressive symptoms, and symptoms.
Read the detailed description
Conduct a RCT pilot of the modified B-SWELL consisting of 64 women randomized to B-SWELL (n=32) or control (n=32). The RCT will take place in two phases. Each phase will consist of virtual and in-person groups (n=8 for groups) for the B-SWELL and attention control. Participants will receive the B-SWELL materials (binder, flash drive) prior to start. Each weekly 90-minute session is devoted to a specific LE8 behavior. Sessions will begin with meditative practice followed by interactive presentations, review of case studies, and discussion. Coaching will occur via phone during the first weeks of the intervention with booster sessions at weeks 10 and 14. The attention control (virtual or in person) will mirror the B-SWELL in format and duration however, participants will only receive publicly available AHA materials and information. The Attention control will not receive stress information, goal setting, or coaching. Facilitators and coaches will be purposefully recruited and representative of midlife Black women.
This study will take place in Cincinnati. Women will be eligible if they identify as Black/African American; are between the ages of 45 and 64 during the trial; have a reliable phone for messaging and data collection calls; and willing to commit to the study duration and data collection phone calls (at 8, 12 and 16 weeks). Women will be excluded if they have recently immigrated or resettled in the U.S. or have major health conditions prohibiting safe participation. Having CVD will not be an exclusion as those with CVD can still show improvement in LE8. Recruitment activities will include fliers, email, snowballing, and social media. Community in-person sites will be selected based upon safety, accessibility, and resources. The C-RAB members will inform recruitment through their knowledge of the communities. For example, they may recommend that fliers be placed in particular high-traffic areas or sent to specific community organizations. C-RAB members are not personnel and, thus, will be instructed to refer any questions regarding this research to the PI and/or research staff. All C-RAB activities will be monitored by the PI.
- Conditions
- Stress, Self-Efficacy, Heart Disease Risk Factors, Depression Symptoms, Awareness, Perceived Stress
- Being tested
- Experimental: Black Women's Stress and Wellness (B-SWELL) arm, Active Comparator: Wellness (WE) arm
- Keywords
- perceived stress, heart disease risk factors, lifestyle intervention, behavior change, strong woman syndrome, choice
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Black Women's Stress and Wellness (B-SWELL) armBehavioural
The B-SWELL arm consists of 8-weekly sessions. Sessions last 90 minutes and focus on stress reduction, heart disease, and healthy lifestyle changes. The American Heart Association's Life's Essential 8 metrics are leveraged and culturally tailored in the B-SWELL materials. Participants will also receive personalized health coaching.
Active Comparator: Wellness (WE) armBehavioural
This is an attention control group. Participants placed in his arm will receive 8-weekly sessions focused on the Life's Essential 8 metrics.
| Study group | Role | What they receive |
|---|---|---|
| Black Women's Stress and Wellness (B-SWELL) arm | Experimental | The B-SWELL arm consists of 8-weekly sessions. Sessions last 90 minutes and focus on stress reduction, heart disease, and healthy lifestyle changes. The American Heart Association's Life's Essential 8 metrics are leveraged and culturally tailored in the B-SWELL materials. Participants will also receive personalized health coaching. Receives: Behavioral: Experimental: Black Women's Stress and Wellness (B-SWELL) arm |
| Wellness (WE) arm | Active comparator | This is an attention control group. Participants placed in his arm will receive 8-weekly sessions focused on the Life's Essential 8 metrics. Sessions will last approximately 90 minutes. Receives: Behavioral: Active Comparator: Wellness (WE) arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life's Essential 8 (LE8) score
Life's Essential 8 (LE8) is a recognized metric for cardiovascular health as defined by the American Heart Association. The LE8 score consists of 8 sub-measures. There are 4 lifestyle behaviors (Diet, Physical Activity, Nicotine Exposure and Sleep Health) and 4 health factors (BMI, Blood Lipids, Blood Glucose, and Blood Pressure). The total LE8 score is calculated as the average of the 8 individual component scores. Total scores range from 0 to 100 points. Higher scores correspond to better cardiovascular health.
Measured: From baseline to 16 weeks
Secondary outcomes (3)
Patient Health Questionnaire (PHQ-9)
Diagnostic instrument for depression symptoms. The PHQ-9 scores each of the 9 DSM-IV criteria. Question 9 screens for the presence of suicide ideation. Total scores greater than 15 are associated with moderately severe and severe depression.
Measured: from baseline to 16 weeks.
Pittsburgh Sleep Quality Index (PSQI)
19-item self-report assessment of sleep quality for the previous 1-month period. Yields 7 sleep components. Each component score ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
Measured: From baseline to 16 weeks
researcher-developed symptoms check list
Participants self-report symptoms experienced over previous 2 weeks in the checklist. Responses are yes/no.
Measured: From baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start11 Oct 2024
- Primary completion28 Feb 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Jones, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707636
- Sponsor's protocol ID
- 2024B0010
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will provide prospective survey data from a randomized pilot trial at four timepoints over a period of 16 weeks. The sample (N=64) consists of Black women ages 45-64. The data collected will include survey responses designed to assess viability of the optimized Midlife Black Women's Stress and Wellness intervention (B-SWELL). Surveys will include researcher developed tools (i.e., demographics, satisfaction, feedback, and symptoms check list), and seven validated tools (Cohen's Perceived Stress Scale, General Self-Efficacy scale, American Heart Association's Life's Essential 8 score, Perceived General Health scale, Patient Health Questionnaire, and Pittsburgh Sleep Quality Index). Coding, recodes, and analyses related to each tool will be performed according to instruction as they have been validated to ensure production of accurate results.
Publications
Jones HJ, Helsabeck N, Bakas T, Kovacic MB, Christian L, White-Heisel R, Oglesby L, Williams KP. Community-engaged protocol for the modified B-SWELL program randomized control pilot trial. Contemp Clin Trials. 2026 Oct 28:108517. doi: 10.1016/j.cct.2026.108517. Online ahead of print.
PubMed 42951100
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Life's Essential 8 to Lower Heart Disease Risk in Midlife Black Women
- ClinicalTrials.gov ID
- NCT06707636
- Acronym / sponsor ID
- 2024B0010
- Conditions
- Stress, Self-Efficacy, Heart Disease Risk Factors, Depression Symptoms, Awareness, Perceived Stress
- Keywords
- perceived stress, heart disease risk factors, lifestyle intervention, behavior change, strong woman syndrome, choice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 27 Nov 2024 (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 research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease risk in midlife Black women. The B-SWELL leverages stress reduction to facilitate the adoption and adherence to healthier lifestyle behaviors. This research study will use choice to increase engagement and minimize the effect of social determinants of health on research participation among midlife Black women.
A comparative clinical trial will be conducted. Midlife Black women (ages 45-64) who reside in the Greater Cincinnati area will be recruited for participation. Women are eligible if they self-identify as Black/ African American, are between the ages of 45-64, and are willing to commit to the requirements of the study (e.g., attend 8 weekly sessions and 4 phone interviews). Participants will be randomly placed (like the flip of a coin) into either the B-SWELL or WE group. Both the B-SWELL and WE groups are 8-week programs that focus on healthy lifestyle behaviors and heart disease awareness. Women will have the choice to participate in person or virtually. Survey phone interviews will be conducted at baseline, 8-, 12-, and 16-weeks. Data collected will provide information about adherence, healthy lifestyle behaviors, and cardiovascular health. Heart health will be measured using the American Heart Association's Life's Essential 8 metric.
Outcome measures include heart disease awareness, Life's Essential 8 score, stress, self-efficacy, depressive symptoms, and symptoms.
Detailed description
Conduct a RCT pilot of the modified B-SWELL consisting of 64 women randomized to B-SWELL (n=32) or control (n=32). The RCT will take place in two phases. Each phase will consist of virtual and in-person groups (n=8 for groups) for the B-SWELL and attention control. Participants will receive the B-SWELL materials (binder, flash drive) prior to start. Each weekly 90-minute session is devoted to a specific LE8 behavior. Sessions will begin with meditative practice followed by interactive presentations, review of case studies, and discussion. Coaching will occur via phone during the first weeks of the intervention with booster sessions at weeks 10 and 14. The attention control (virtual or in person) will mirror the B-SWELL in format and duration however, participants will only receive publicly available AHA materials and information. The Attention control will not receive stress information, goal setting, or coaching. Facilitators and coaches will be purposefully recruited and representative of midlife Black women.
This study will take place in Cincinnati. Women will be eligible if they identify as Black/African American; are between the ages of 45 and 64 during the trial; have a reliable phone for messaging and data collection calls; and willing to commit to the study duration and data collection phone calls (at 8, 12 and 16 weeks). Women will be excluded if they have recently immigrated or resettled in the U.S. or have major health conditions prohibiting safe participation. Having CVD will not be an exclusion as those with CVD can still show improvement in LE8. Recruitment activities will include fliers, email, snowballing, and social media. Community in-person sites will be selected based upon safety, accessibility, and resources. The C-RAB members will inform recruitment through their knowledge of the communities. For example, they may recommend that fliers be placed in particular high-traffic areas or sent to specific community organizations. C-RAB members are not personnel and, thus, will be instructed to refer any questions regarding this research to the PI and/or research staff. All C-RAB activities will be monitored by the PI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black Women's Stress and Wellness (B-SWELL) arm | Experimental | Behavioral: Experimental: Black Women's Stress and Wellness (B-SWELL) armThe B-SWELL arm consists of 8-weekly sessions. Sessions last 90 minutes and focus on stress reduction, heart disease, and healthy lifestyle changes. The American Heart Association's Life's Essential 8 metrics are leveraged and culturally tailored in the B-SWELL materials. Participants will also receive personalized health coaching. |
| Wellness (WE) arm | Active comparator | Behavioral: Active Comparator: Wellness (WE) armThis is an attention control group. Participants placed in his arm will receive 8-weekly sessions focused on the Life's Essential 8 metrics. Sessions will last approximately 90 minutes. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Identifies as Black/ African American
- Age 45-64.
- Willing to adhere to the study requirements.
Key exclusion criteria (3 listed)
- Incarcerated or on house arrest,
- Diagnosed with terminal illness, severe mental illness, or dementia.
- Unable or unwilling to participate in 8 weekly sessions and 4 phone interviews.
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 |
|---|---|---|
| Experimental: Black Women's Stress and Wellness (B-SWELL) armThe B-SWELL arm consists of 8-weekly sessions. Sessions last 90 minutes and focus on stress reduction, heart disease, and healthy lifestyle changes. The American Heart Association's Life's Essential 8 metrics are leveraged and culturally tailored in the B-SWELL materials. Participants will also receive personalized health coaching. | Behavioural | Black Women's Stress and Wellness (B-SWELL) arm |
| Active Comparator: Wellness (WE) armThis is an attention control group. Participants placed in his arm will receive 8-weekly sessions focused on the Life's Essential 8 metrics. | Behavioural | Wellness (WE) arm |
Primary outcome
Life's Essential 8 (LE8) score
Time frame: From baseline to 16 weeks
Life's Essential 8 (LE8) is a recognized metric for cardiovascular health as defined by the American Heart Association. The LE8 score consists of 8 sub-measures. There are 4 lifestyle behaviors (Diet, Physical Activity, Nicotine Exposure and Sleep Health) and 4 health factors (BMI, Blood Lipids, Blood Glucose, and Blood Pressure). The total LE8 score is calculated as the average of the 8 individual component scores. Total scores range from 0 to 100 points. Higher scores correspond to better cardiovascular health.
3 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: from baseline to 16 weeks.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: From baseline to 16 weeks
researcher-developed symptoms check list
Time frame: From baseline to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Derived from this study: PubMed 42951100Jones HJ, Helsabeck N, Bakas T, Kovacic MB, Christian L, White-Heisel R, Oglesby L, Williams KP. Community-engaged protocol for the modified B-SWELL program randomized control pilot trial. Contemp Clin Trials. 2026 Oct 28:108517. doi: 10.1016/j.cct.2026.108517. Online ahead of print.
- Individual participant dataSharing planned: Yes. This study will provide prospective survey data from a randomized pilot trial at four timepoints over a period of 16 weeks. The sample (N=64) consists of Black women ages 45-64. The data collected will include survey responses designed to assess viability of the optimized Midlife Black Women's Stress and Wellness intervention (B-SWELL). Surveys will include researcher developed tools (i.e., demographics, satisfaction, feedback, and symptoms check list), and seven validated tools (Cohen's Perceived Stress Scale, General Self-Efficacy scale, American Heart Association's Life's Essential 8 score, Perceived General Health scale, Patient Health Questionnaire, and Pittsburgh Sleep Quality Index). Coding, recodes, and analyses related to each tool will be performed according to instruction as they have been validated to ensure production of accurate results.
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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 Experimental: Black Women's Stress and Wellness (B-SWELL) arm and Active Comparator: Wellness (WE) arm in people with Stress and Self-Efficacy, run by Ohio State University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 1 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (LE8) score (time frame: From baseline to 16 weeks). 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 NCT06707636, which also lists 1 linked publication.
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 1 Jul 2026.