Cardiovascular DiseaseNCT02019953
Effects of Health Promoting Programs on Cardiovascular Disease Risk
A study testing Yoga, Walking and Healthy Lifestyles Education in people with Cardiovascular Disease, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The overall approach to the study is to assess the feasibility of recruiting African Americans to participate in several health-promoting programs and to compare health outcomes among the three interventions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Yoga, Walking and Healthy Lifestyles Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- This study includes only one inclusion criterion: to participate in this study, one needs to be a member of the Jackson Heart Study cohort.
Who cannot join
- 1. Newly diagnosed (within the last six weeks) with a myocardial infarction, cerebrovascular disease, atrial fibrillation, cardiomyopathy, valvular heart disease, fatal cardiac arrhythmia, severe systolic and diastolic heart failure, uncontrolled COPD, uncontrolled moderate to severe hypertension, or a recent recipient of a pacemaker, and/or
- 2. Change in blood pressure medicine or lipid-lowering medication up to 30 days prior to or plans for a change in the 30 days after enrollment in the study, and/or
- 3. Already practicing yoga at least once per week or walking briskly for one hour at least three times per week, and/or
- 4. Inability to attend protocol sessions, and/or
- 5. Diagnosis of an underlying medical illness that might be considered by the principal investigator to potentially impair one's safety or ability to complete the study protocol (example could possibly include uncontrolled asthma), and/or
- 6. Current use of a prescription regimen that might be considered by the principal investigator to potentially impair one's safety or ability to complete the study protocol (examples could possibly include use of sedatives or other drugs that could affect a participant's ability to participate in any of the study arms).
- 7. Pregnant or planning to become pregnant in the next six (6) months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Effects of Health-Promoting Programs on Cardiovascular Disease Risk: JHS
The overall approach to the study is to assess the feasibility of recruiting African Americans to participate in several health-promoting programs and to compare health outcomes among the three interventions.
Read the detailed description
The project is designed to achieve five specific aims: (1) To determine the feasibility of attracting African Americans into Health Promotion Research studies;(2) To determine whether clinically recorded information can be used as a guide for recruitment inclusion in Health Promotion Studies from an active epidemiological research cohort;(3) To measure the ability to retain African Americans recruited into Health Promotion Studies from an active research cohort;(4) To measure the adherence to various protocols within a Health promotion Study; and(5) To provide informed estimates of effect sizes for designing future Health Promotion Research.
A total of 375 study participants from the Jackson Heart Study (JHS) cohort, all of whom are African American, will be randomly assigned to one of five, equally-sized study arms: (1) practicing yoga three times per week; (2) practicing yoga two times per week; (3) practicing yoga one time per week; (4) walking briskly three times per week; and (5) attending a weekly healthy lifestyles class.
All study arms will include a 24-week intervention. In addition, participants will have a total of four clinical visits with members of the study team baseline, 12 weeks, 24 weeks, and 48 weeks) in which the following measures will be recorded:
- Systolic and diastolic blood pressure and heart rates
- Highly sensitive C-reactive protein (hsCRP) - serum, fibrinogen - plasma (sodium citrate), homocysteine (plasma), and interleukin-6 levels (IL-6) (serum).
- Fasting total cholesterol, low density (LDL), direct high density lipoprotein (HDL), and triglyceride levels - all serum
- HbA1c level
- BMI, waist circumference
- Medication and supplement use and dosages
- Results of a study survey designed to measure participants' changes in their reported health-related quality of life, perceived stress, health behaviors, sleep patterns, and impact of pain on everyday life
In addition, we will also record systolic and diastolic blood pressure and heart rates before and after each intervention session for all five study arms.
- Conditions
- Cardiovascular Disease
- Being tested
- Yoga, Walking, Healthy Lifestyles Education
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
The yoga intervention, which is taught based on Hatha yoga, will be offered to study participants in Study Arms 1, 2, and 3, is a combination of asanas (poses), pranayams (breathing exercises), and meditation. Blood pressure and heart rate measurements are taken before and after each session.
WalkingOther
The walking intervention, which is Study Arm 4 includes, three guided walking sessions per week for 24 weeks. Each class is an hour in length and will include a minimum of 30 minutes of walking at the equivalent of a minimum of three miles per hour. Each session includes a ten-minute warm-up and ten-minute cool-down period of some stretches and walking at a leisurely pace. Blood pressure and heart rate measurements are taken before and after each session.
Healthy Lifestyles EducationOther
Also called Health Education
Participants randomly assigned to the fifth study arm attend one 60-minute healthy lifestyles class per week for 24 weeks. The Healthy Lifestyles curriculum includes 24 independent lesson modules, which allows participants to begin their intervention at any time during the course schedule. Blood pressure and heart rate measurements are taken before and after each session.
| Study group | Role | What they receive |
|---|---|---|
| Yoga 3 times per week | Other | Yoga participation 3 x per week for 24 weeks; 48 week follow-up. Receives: Other: Yoga |
| Yoga 2 times per week | Other | Yoga participation 2 x per week for 24 weeks; 48 week follow-up Receives: Other: Yoga |
| Yoga 1 time per week | Other | Yoga participation 1 x per week for 24 weeks; 48 week follow-up Receives: Other: Yoga |
| Walking 3 times per week | Other | Walking 3x per week for 24 weeks; 48 week follow-up Receives: Other: Walking |
| Healthy Lifestyles Education | Other | Healthy Lifestyles Education Participation 1 x per week for 24 weeks; 48 week follow-up Receives: Other: Healthy Lifestyles Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes for this feasibility study will focus on composite measures for recruitment, retention, and the reasons for refusal or dropout.
Primary outcomes for this feasibility study will focus on measures for recruitment, retention, and the reasons for refusal or dropout, and consist of (1) agreement to participate in the study (recruitment); (2) reasons for participating/not-participating; (3) dropout, defined as a monotone missingness pattern of stopping participation before completion of the study; (4) reasons for discontinuation/dropout; (5) attendance, defined as the potentially non-monotone pattern of coming to the scheduled study session; and (6) adherence, defined as attending and completing the scheduled sessions and clinical visits.
Measured: Bi-annual for up to 52 weeks after enrollment
Secondary outcomes (5)
Changes in participants' hypertension profiles.
Defined using measures of their systolic and diastolic blood pressure
Measured: 48 weeks
Changes in participants' inflammation markers
Defined using measures of participants' hsCRP, fibrinogen, homocysteine, and interleukin-6 levels.
Measured: 48 weeks
Changes in participants' lipids profiles.
Defined as using measures of participants' fasting total cholesterol, LDL, HDL, and triglycerides.
Measured: 48 weeks
Changes in participants' HbA1c levels.
Changes in participants' HbA1c levels.
Measured: 48 weeks
Changes in participants' reported health-related quality of life.
Quality of life measured as measured by perceived stress, health behaviors, sleep patterns, and impact of pain on everyday life.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJul 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gailen D. Marshall Jr., MD PhD, University of Mississippi Medical Center
- Investigators
- Gailen D Marshall, MD, PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019953
- Sponsor's protocol ID
- 2010-0057
- Status last verified
- Mar 2017
- First submitted
- 30 Apr 2013
- Last updated
- 8 Mar 2017
- 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 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Health-Promoting Programs on Cardiovascular Disease Risk: JHS
- ClinicalTrials.gov ID
- NCT02019953
- Acronym / sponsor ID
- 2010-0057
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Dec 2013 (estimated)
- 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 overall approach to the study is to assess the feasibility of recruiting African Americans to participate in several health-promoting programs and to compare health outcomes among the three interventions.
Detailed description
The project is designed to achieve five specific aims: (1) To determine the feasibility of attracting African Americans into Health Promotion Research studies;(2) To determine whether clinically recorded information can be used as a guide for recruitment inclusion in Health Promotion Studies from an active epidemiological research cohort;(3) To measure the ability to retain African Americans recruited into Health Promotion Studies from an active research cohort;(4) To measure the adherence to various protocols within a Health promotion Study; and(5) To provide informed estimates of effect sizes for designing future Health Promotion Research.
A total of 375 study participants from the Jackson Heart Study (JHS) cohort, all of whom are African American, will be randomly assigned to one of five, equally-sized study arms: (1) practicing yoga three times per week; (2) practicing yoga two times per week; (3) practicing yoga one time per week; (4) walking briskly three times per week; and (5) attending a weekly healthy lifestyles class.
All study arms will include a 24-week intervention. In addition, participants will have a total of four clinical visits with members of the study team baseline, 12 weeks, 24 weeks, and 48 weeks) in which the following measures will be recorded:
- Systolic and diastolic blood pressure and heart rates
- Highly sensitive C-reactive protein (hsCRP) - serum, fibrinogen - plasma (sodium citrate), homocysteine (plasma), and interleukin-6 levels (IL-6) (serum).
- Fasting total cholesterol, low density (LDL), direct high density lipoprotein (HDL), and triglyceride levels - all serum
- HbA1c level
- BMI, waist circumference
- Medication and supplement use and dosages
- Results of a study survey designed to measure participants' changes in their reported health-related quality of life, perceived stress, health behaviors, sleep patterns, and impact of pain on everyday life
In addition, we will also record systolic and diastolic blood pressure and heart rates before and after each intervention session for all five study arms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Yoga 3 times per week | Other | Other: YogaYoga participation 3 x per week for 24 weeks; 48 week follow-up. |
| Yoga 2 times per week | Other | Other: YogaYoga participation 2 x per week for 24 weeks; 48 week follow-up |
| Yoga 1 time per week | Other | Other: YogaYoga participation 1 x per week for 24 weeks; 48 week follow-up |
| Walking 3 times per week | Other | Other: WalkingWalking 3x per week for 24 weeks; 48 week follow-up |
| Healthy Lifestyles Education | Other | Other: Healthy Lifestyles EducationHealthy Lifestyles Education Participation 1 x per week for 24 weeks; 48 week follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- This study includes only one inclusion criterion: to participate in this study, one needs to be a member of the Jackson Heart Study cohort.
Key exclusion criteria (7 listed)
- 1. Newly diagnosed (within the last six weeks) with a myocardial infarction, cerebrovascular disease, atrial fibrillation, cardiomyopathy, valvular heart disease, fatal cardiac arrhythmia, severe systolic and diastolic heart failure, uncontrolled COPD, uncontrolled moderate to severe hypertension, or a recent recipient of a pacemaker, and/or
- 2. Change in blood pressure medicine or lipid-lowering medication up to 30 days prior to or plans for a change in the 30 days after enrollment in the study, and/or
- 3. Already practicing yoga at least once per week or walking briskly for one hour at least three times per week, and/or
- 4. Inability to attend protocol sessions, and/or
- 5. Diagnosis of an underlying medical illness that might be considered by the principal investigator to potentially impair one's safety or ability to complete the study protocol (example could possibly include uncontrolled asthma), and/or
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 |
|---|---|---|
| YogaThe yoga intervention, which is taught based on Hatha yoga, will be offered to study participants in Study Arms 1, 2, and 3, is a combination of asanas (poses), pranayams (breathing exercises), and meditation. Blood pressure and heart rate measurements are taken before and after each session. | Other | Yoga 1 time per week, Yoga 2 times per week, Yoga 3 times per week |
| WalkingThe walking intervention, which is Study Arm 4 includes, three guided walking sessions per week for 24 weeks. Each class is an hour in length and will include a minimum of 30 minutes of walking at the equivalent of a minimum of three miles per hour. Each session includes a ten-minute warm-up and ten-minute cool-down period of some stretches and walking at a leisurely pace. Blood pressure and heart rate measurements are taken before and after each session. | Other | Walking 3 times per week |
| Healthy Lifestyles EducationAlso: Health EducationParticipants randomly assigned to the fifth study arm attend one 60-minute healthy lifestyles class per week for 24 weeks. The Healthy Lifestyles curriculum includes 24 independent lesson modules, which allows participants to begin their intervention at any time during the course schedule. Blood pressure and heart rate measurements are taken before and after each session. | Other | Healthy Lifestyles Education |
Primary outcome
Primary outcomes for this feasibility study will focus on composite measures for recruitment, retention, and the reasons for refusal or dropout.
Time frame: Bi-annual for up to 52 weeks after enrollment
Primary outcomes for this feasibility study will focus on measures for recruitment, retention, and the reasons for refusal or dropout, and consist of (1) agreement to participate in the study (recruitment); (2) reasons for participating/not-participating; (3) dropout, defined as a monotone missingness pattern of stopping participation before completion of the study; (4) reasons for discontinuation/dropout; (5) attendance, defined as the potentially non-monotone pattern of coming to the scheduled study session; and (6) adherence, defined as attending and completing the scheduled sessions and clinical visits.
5 secondary outcomes
Changes in participants' hypertension profiles.
Time frame: 48 weeks
Changes in participants' inflammation markers
Time frame: 48 weeks
Changes in participants' lipids profiles.
Time frame: 48 weeks
Changes in participants' HbA1c levels.
Time frame: 48 weeks
Changes in participants' reported health-related quality of life.
Time frame: 48 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 8 Mar 2017.
- 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.
Gailen D Marshall, MD, PhD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga, Walking and Healthy Lifestyles Education in people with Cardiovascular Disease, run by University of Mississippi 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 1 inclusion and 7 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 8 Mar 2017. 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?
Primary outcomes for this feasibility study will focus on composite measures for recruitment, retention, and the reasons for refusal or dropout. (time frame: Bi-annual for up to 52 weeks after enrollment). 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 8 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.