Cardiovascular Risk FactorB-SWELLNCT04404478
Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)
A study testing B-SWELL: Midlife Black Women's Stress Reduction Wellness Program and WE: Wellness program for Midlife Black Women in people with Cardiovascular Risk Factor and Stress, run by University of Cincinnati at 1 site in United States.
Trial summary
This research study examines the unique cultural and gender-based factors that influence how midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily life. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Stress, Self Efficacy
- What is being tested?
- B-SWELL: Midlife Black Women's Stress Reduction Wellness Program and WE: Wellness program for Midlife Black Women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2021to 12 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- fluent in the English language,
- ability to hear and talk well enough to engage in everyday conversation,
- access to a telephone with messaging,
- access to WIFI,
- willingness to participate for duration of the study.
Who cannot join
- recent immigration to the U.S.,
- prisoner or on house arrest,
- pregnant,
- terminal illness (i.e., late stage cancer, end-of-life condition, renal failure requiring dialysis),
- history of Alzheimer's, dementia, or severe mental illness (i.e., suicidal tendencies, schizophrenia, or severe untreated depression),
- any other major health conditions or disabilities prohibiting safe participation in the program.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati, College of Nursing
Cincinnati, Ohio, 45219
About this study
This research study examines the unique cultural and gender-based factors that influence how midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily life. The B-SWELL intervention uses stress reduction and goal setting to increase self efficacy in adopting healthy lifestyle behaviors. The B-SWELL intervention will be compared to an inattention control wellness group in a randomized control trial. The long-term outcome is to decrease cardiovascular disease risk in this high-risk population, midlife Black women.
Read the detailed description
Cardiovascular disease (CVD) is the primary cause of death in all women, and as women transition through midlife, the prevalence of CVD exceeds that of men.1 Midlife Black women, defined as ages 40-64,unduly shoulder the burden of CVD (49%), hypertension (40%), and heart failure (50% greater risk). Midlife Black women also report higher levels of chronic stress and greater numbers of stressful life events in comparison to midlife White women, putting them at greater risk for CVD. In addition to the physical impact, coping with chronic stress takes time and energy away from self-care, functioning as a barrier to the adoption of healthy lifestyle behaviors. Existent interventions do not fully address the unique factors contributing to the experience of stress, lifestyle behaviors, and CVD risk in midlife Black women.
The purpose of this research proposal is to develop a midlife Black women's Stress-reduction WELLness intervention, B-SWELL, to promote healthy lifestyle behaviors based on the stressors and themes identified in preliminary research. Community-based participatory research (CBPR) methods will be used to engage the community and include midlife Black women in the development of the B-SWELL. We propose that the skills and knowledge gained through participation in the B-SWELL program will increase receptivity to the healthy lifestyle behaviors outlined in the American Heart Association's Life Simple 7 Success Plan (LS7). The LS7 targets seven risk factors known to increase cardiovascular related health risk: cholesterol, fasting glucose, blood pressure, body mass index, physical activity, diet, and smoking.
Our hypothesis proposes that low stress scores and greater self efficacy will be associated with the adoption of AHA's healthy lifestyle behaviors. Low stress and self efficacy will be facilitated through peer support and culturally relevant content, materials, and themes. B-SWELL participants will show improved self-efficacy in managing life stress and adopting the LS7 behaviors, compared to a control group receiving traditional wellness education (WE group).
Aim 1: Develop the B-SWELL intervention for midlife Black women through the innovative leveraging of CBPR methodology and LS7 modifiable healthy lifestyle behaviors.
- To develop components of the B-SWELL intervention prototype for midlife Black women.
- Obtain ratings of the new components of the B-SWELL from our community advisory board for degree of accuracy, relevance, and feasibility to inform further refinements.
Aim 2: Determine the feasibility of the B-SWELL intervention with a trial of 50 midlife Black women randomized to the B-SWELL intervention (25) or to a wellness education (WE) control group (25):
- Obtain recruitment, retention, treatment fidelity ratings, and satisfaction ratings for the intervention procedures for both groups;
- Compare mediator measures (stress, self-efficacy) for participants in the B-SWELL intervention group with those in the WE group at 8 and 12 weeks.
- Compare outcome measures (LS7 summary scores, unhealthy days, general health, depressive symptoms) for participants in the B-SWELL intervention group with those in the WE attention control group at 8 and 12 weeks.
- Being tested
- B-SWELL: Midlife Black Women's Stress Reduction Wellness Program, WE: Wellness program for Midlife Black Women
- Keywords
- Black women, Stress, Heart disease, Health behaviors, Midlife, Community-based research
- Medical subject headings
- Depression, Health Behavior, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-SWELL: Midlife Black Women's Stress Reduction Wellness ProgramBehavioural
Stress reduction and culturally tailored information on healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on per support, goal setting, stress reduction, and culturally relevant information.
WE: Wellness program for Midlife Black WomenBehavioural
Culturally tailored information will be provided about healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on peer support and culturally relevant content.
| Study group | Role | What they receive |
|---|---|---|
| B-SWELL | Experimental | Participants in the B-SWELL intervention will receive information about stress and goal setting in addition to healthy lifestyle behaviors. The intervention will take place weekly for eight weeks in groups of 11 to 13 midlife Black women for peer support. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks. Receives: Behavioral: B-SWELL: Midlife Black Women's Stress Reduction Wellness Program |
| WE | Active comparator | The attention control group (WE), will include education about healthy lifestyle behaviors and peer support. The attention control groups will also have weekly sessions for eight weeks in groups of 11 to 13 midlife Black women. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks. Receives: Behavioral: WE: Wellness program for Midlife Black Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Heart Association's Life's Simple Seven (LS7) Score
Life's Simple 7 score measures cardiovascular health. Minimum score is 0. Maximum score is 14. Each of the 7 metrics (weight loss, diet, exercise, cholesterol management, glucose management, smoking, and blood pressure management) is rated 0 (poor), 1 (average), or 2 (best). Higher scores indicate greater cardiovascular health. Lower scores indicate greater risk for heart disease.
Measured: Baseline to 12 weeks
Secondary outcomes (3)
Unhealthy Days
'Unhealthy Days' is measures by the number of unhealthy days reported by the participant. This question asks the participant how many days in past month that their physical/mental health was not good. This is a continuous numeric response. Higher numbers indicate poorer health during the reported timeframe.
Measured: baseline to 12 weeks
Perceived General Health
The Perceived General Health question is one item from the Short Form Health Survey. The participants will rate their health as 'excellent', 'very good', 'good', 'fair' and 'poor'. Responses are categorical. The reported outcome reflects the number of participants who rate their health as 'good'.
Measured: Baseline to 12 weeks
Patient Health Questionnaire (PHQ9)
The PHQ9 measures depressive symptoms. Participants rate their depressive symptoms from '0' (not at all) to '3' (every day). Scores range from 0 to 27. Higher scores indicate greater risk of clinical depression. Lower scores indicate less risk for depression.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start13 Feb 2021
- Primary completion12 Jun 2021
- Study completion12 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Randomized control trial comparing intervention group (B-SWELL) with an attention control group (WE) to assess the following outcomes: healthy lifestyle scores, perceived stress scores, self efficacy, unhealthy days, and depressive symptoms.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Holly Jones, University of Cincinnati
- Investigators
- Holly J Jones, PhD,RN,NP, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404478
- Sponsor's protocol ID
- B-SWELL2019
- Other IDs
- K01HL141676
- Acronym
- B-SWELL
- Status last verified
- Jan 2023
- First submitted
- 18 May 2020
- Last updated
- 3 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We anticipate that there will be manuscripts, not only from the findings addressing Specific Aims 1 and 2, but also from secondary analyses from data generated from this study. We will disseminate results from Specific Aims 1 and 2, as well as results from secondary analyses, in peer-reviewed journals. We will also make the data available to others. Data will be shared with undergraduate honors students, MSN students, DNP students, PhD students, post-doctoral students, and interested faculty members at the University of Cincinnati, College of Nursing, and other institutions.
Publications
Jones HJ, Norwood CR, Bankston K. Leveraging Community Engagement to Develop Culturally Tailored Stress Management Interventions in Midlife Black Women. J Psychosoc Nurs Ment Health Serv. 2019 Mar 1;57(3):32-38. doi: 10.3928/02793695-20180925-01. Epub 2018 Oct 1.
PubMed 30272812Jones HJ, Norwood CR, Bankston K, Bakas T. Stress Reduction Strategies Used by Midlife Black Women to Target Cardiovascular Risk. J Cardiovasc Nurs. 2019 Nov/Dec;34(6):483-490. doi: 10.1097/JCN.0000000000000615.
PubMed 31609281Jones HJ, Sternberg RM, Janson SL, Lee KA. A Qualitative Understanding of Midlife Sources of Stress and Support in African-American Women. J Natl Black Nurses Assoc. 2016 Jul;27(1):24-30.
PubMed 29932540Jones HJ, Bakas T, Nared S, Humphries J, Wijesooriya J, Butsch Kovacic M. Co-Designing a Program to Lower Cardiovascular Disease Risk in Midlife Black Women. Int J Environ Res Public Health. 2022 Jan 26;19(3):1356. doi: 10.3390/ijerph19031356.
PubMed 35162379Jones HJ, Kovacic MB, Bakas T. Establishing Validity of the Midlife Black Women's Stress-Reduction Wellness Program Materials Using a Mixed Methods Approach. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):446-455. doi: 10.1097/JCN.0000000000000876. Epub 2021 Dec 22.
PubMed 34935740Jones HJ, Kovacic MB, Bacchus P, Almallah W, Bakas T. Participant Satisfaction in a Cardiovascular Disease Prevention Intervention for Midlife Black Women. West J Nurs Res. 2024 Jan;46(1):3-9. doi: 10.1177/01939459231208420. Epub 2023 Oct 31.
PubMed 37905540Jones HJ, Butsch Kovacic M, Lambert J, Almallah WR, Becker R, de las Fuentes L, Bakas T. A randomized feasibility trial of the Midlife Black Women's Stress and Wellness intervention (B-SWELL); a community participatory intervention to increase adoption of Life's Simple 7 healthy lifestyle behaviors. Transl Behav Med. 2022 Nov 21;12(11):1084-1095. doi: 10.1093/tbm/ibac075.
PubMed 36208220
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)
- ClinicalTrials.gov ID
- NCT04404478
- Acronym / sponsor ID
- B-SWELL / B-SWELL2019
- Keywords
- Black women, Stress, Heart disease, Health behaviors, Midlife, Community-based research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 Feb 2021 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 12 Jun 2021 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Posted 3 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study examines the unique cultural and gender-based factors that influence how midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily life. The B-SWELL intervention uses stress reduction and goal setting to increase self efficacy in adopting healthy lifestyle behaviors. The B-SWELL intervention will be compared to an inattention control wellness group in a randomized control trial. The long-term outcome is to decrease cardiovascular disease risk in this high-risk population, midlife Black women.
Detailed description
Cardiovascular disease (CVD) is the primary cause of death in all women, and as women transition through midlife, the prevalence of CVD exceeds that of men.1 Midlife Black women, defined as ages 40-64,unduly shoulder the burden of CVD (49%), hypertension (40%), and heart failure (50% greater risk). Midlife Black women also report higher levels of chronic stress and greater numbers of stressful life events in comparison to midlife White women, putting them at greater risk for CVD. In addition to the physical impact, coping with chronic stress takes time and energy away from self-care, functioning as a barrier to the adoption of healthy lifestyle behaviors. Existent interventions do not fully address the unique factors contributing to the experience of stress, lifestyle behaviors, and CVD risk in midlife Black women.
The purpose of this research proposal is to develop a midlife Black women's Stress-reduction WELLness intervention, B-SWELL, to promote healthy lifestyle behaviors based on the stressors and themes identified in preliminary research. Community-based participatory research (CBPR) methods will be used to engage the community and include midlife Black women in the development of the B-SWELL. We propose that the skills and knowledge gained through participation in the B-SWELL program will increase receptivity to the healthy lifestyle behaviors outlined in the American Heart Association's Life Simple 7 Success Plan (LS7). The LS7 targets seven risk factors known to increase cardiovascular related health risk: cholesterol, fasting glucose, blood pressure, body mass index, physical activity, diet, and smoking.
Our hypothesis proposes that low stress scores and greater self efficacy will be associated with the adoption of AHA's healthy lifestyle behaviors. Low stress and self efficacy will be facilitated through peer support and culturally relevant content, materials, and themes. B-SWELL participants will show improved self-efficacy in managing life stress and adopting the LS7 behaviors, compared to a control group receiving traditional wellness education (WE group).
Aim 1: Develop the B-SWELL intervention for midlife Black women through the innovative leveraging of CBPR methodology and LS7 modifiable healthy lifestyle behaviors.
- To develop components of the B-SWELL intervention prototype for midlife Black women.
- Obtain ratings of the new components of the B-SWELL from our community advisory board for degree of accuracy, relevance, and feasibility to inform further refinements.
Aim 2: Determine the feasibility of the B-SWELL intervention with a trial of 50 midlife Black women randomized to the B-SWELL intervention (25) or to a wellness education (WE) control group (25):
- Obtain recruitment, retention, treatment fidelity ratings, and satisfaction ratings for the intervention procedures for both groups;
- Compare mediator measures (stress, self-efficacy) for participants in the B-SWELL intervention group with those in the WE group at 8 and 12 weeks.
- Compare outcome measures (LS7 summary scores, unhealthy days, general health, depressive symptoms) for participants in the B-SWELL intervention group with those in the WE attention control group at 8 and 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial comparing intervention group (B-SWELL) with an attention control group (WE) to assess the following outcomes: healthy lifestyle scores, perceived stress scores, self efficacy, unhealthy days, and depressive symptoms.
| Arm | Type | Receives |
|---|---|---|
| B-SWELL | Experimental | Behavioral: B-SWELL: Midlife Black Women's Stress Reduction Wellness ProgramParticipants in the B-SWELL intervention will receive information about stress and goal setting in addition to healthy lifestyle behaviors. The intervention will take place weekly for eight weeks in groups of 11 to 13 midlife Black women for peer support. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks. |
| WE | Active comparator | Behavioral: WE: Wellness program for Midlife Black WomenThe attention control group (WE), will include education about healthy lifestyle behaviors and peer support. The attention control groups will also have weekly sessions for eight weeks in groups of 11 to 13 midlife Black women. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- fluent in the English language,
- ability to hear and talk well enough to engage in everyday conversation,
- access to a telephone with messaging,
- access to WIFI,
- willingness to participate for duration of the study.
Key exclusion criteria (6 listed)
- recent immigration to the U.S.,
- prisoner or on house arrest,
- pregnant,
- terminal illness (i.e., late stage cancer, end-of-life condition, renal failure requiring dialysis),
- history of Alzheimer's, dementia, or severe mental illness (i.e., suicidal tendencies, schizophrenia, or severe untreated depression),
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 |
|---|---|---|
| B-SWELL: Midlife Black Women's Stress Reduction Wellness ProgramStress reduction and culturally tailored information on healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on per support, goal setting, stress reduction, and culturally relevant information. | Behavioural | B-SWELL |
| WE: Wellness program for Midlife Black WomenCulturally tailored information will be provided about healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on peer support and culturally relevant content. | Behavioural | WE |
Primary outcome
American Heart Association's Life's Simple Seven (LS7) Score
Time frame: Baseline to 12 weeks
Life's Simple 7 score measures cardiovascular health. Minimum score is 0. Maximum score is 14. Each of the 7 metrics (weight loss, diet, exercise, cholesterol management, glucose management, smoking, and blood pressure management) is rated 0 (poor), 1 (average), or 2 (best). Higher scores indicate greater cardiovascular health. Lower scores indicate greater risk for heart disease.
3 secondary outcomes
Unhealthy Days
Time frame: baseline to 12 weeks
Perceived General Health
Time frame: Baseline to 12 weeks
Patient Health Questionnaire (PHQ9)
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30272812Jones HJ, Norwood CR, Bankston K. Leveraging Community Engagement to Develop Culturally Tailored Stress Management Interventions in Midlife Black Women. J Psychosoc Nurs Ment Health Serv. 2019 Mar 1;57(3):32-38. doi: 10.3928/02793695-20180925-01. Epub 2018 Oct 1.
- Background: PubMed 31609281Jones HJ, Norwood CR, Bankston K, Bakas T. Stress Reduction Strategies Used by Midlife Black Women to Target Cardiovascular Risk. J Cardiovasc Nurs. 2019 Nov/Dec;34(6):483-490. doi: 10.1097/JCN.0000000000000615.
- Background: PubMed 29932540Jones HJ, Sternberg RM, Janson SL, Lee KA. A Qualitative Understanding of Midlife Sources of Stress and Support in African-American Women. J Natl Black Nurses Assoc. 2016 Jul;27(1):24-30.
- Background: PubMed 35162379Jones HJ, Bakas T, Nared S, Humphries J, Wijesooriya J, Butsch Kovacic M. Co-Designing a Program to Lower Cardiovascular Disease Risk in Midlife Black Women. Int J Environ Res Public Health. 2022 Jan 26;19(3):1356. doi: 10.3390/ijerph19031356.
- Background: PubMed 34935740Jones HJ, Kovacic MB, Bakas T. Establishing Validity of the Midlife Black Women's Stress-Reduction Wellness Program Materials Using a Mixed Methods Approach. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):446-455. doi: 10.1097/JCN.0000000000000876. Epub 2021 Dec 22.
- Derived from this study: PubMed 37905540Jones HJ, Kovacic MB, Bacchus P, Almallah W, Bakas T. Participant Satisfaction in a Cardiovascular Disease Prevention Intervention for Midlife Black Women. West J Nurs Res. 2024 Jan;46(1):3-9. doi: 10.1177/01939459231208420. Epub 2023 Oct 31.
- Derived from this study: PubMed 36208220Jones HJ, Butsch Kovacic M, Lambert J, Almallah WR, Becker R, de las Fuentes L, Bakas T. A randomized feasibility trial of the Midlife Black Women's Stress and Wellness intervention (B-SWELL); a community participatory intervention to increase adoption of Life's Simple 7 healthy lifestyle behaviors. Transl Behav Med. 2022 Nov 21;12(11):1084-1095. doi: 10.1093/tbm/ibac075.
- Individual participant dataSharing planned: Yes. We anticipate that there will be manuscripts, not only from the findings addressing Specific Aims 1 and 2, but also from secondary analyses from data generated from this study. We will disseminate results from Specific Aims 1 and 2, as well as results from secondary analyses, in peer-reviewed journals. We will also make the data available to others. Data will be shared with undergraduate honors students, MSN students, DNP students, PhD students, post-doctoral students, and interested faculty members at the University of Cincinnati, College of Nursing, and other institutions.
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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.
Holly J Jones, PhD,RN,NP principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-SWELL: Midlife Black Women's Stress Reduction Wellness Program and WE: Wellness program for Midlife Black Women in people with Cardiovascular Risk Factor and Stress, run by University of Cincinnati 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 6 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 3 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 3 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
American Heart Association's Life's Simple Seven (LS7) Score (time frame: Baseline to 12 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 NCT04404478, which also lists 7 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 3 Feb 2023.