Metabolic SyndromePhase 2NCT02899910
Nutrition and Exercise Study to Understand Metabolic Syndrome
A Phase 2 study testing Health education and Yoga in people with Metabolic Syndrome and Obesity, run by Vanderbilt University Medical Center.
Trial summary
The purpose of this study is to measure the metabolic and behavioral effects of a 12-week yoga program coupled to health education (HED) compared to HED alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Obesity, Insulin Resistance
- What is being tested?
- Health education and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jan 2014
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated waist circumference (Men greater than 102cm; women greater than 88cm)
- Impaired fasting glucose (100-125 mg/dl)
- Elevated blood pressure (systolic ≥130 and/or diastolic ≥ 85)
- Dyslipidemia (triglycerides ≥150 and/or HDL≤ 40 for men; 50 for women)
- Age ≥ 18
- English speaking
Who cannot join
- Currently taking blood pressure medications, oral diabetic medication or insulin, or lipid medication
- Systolic blood pressure ≥160 and/or diastolic ≥100
- Unstable cardiac disease e.g. angina, life threatening arrhythmia
- Lung disease requiring oxygen supplementation at rest or with ambulation
- History of dementia or cognitive impairment
- Uncontrolled psychiatric disorders, such as major depression or psychosis
- Current participation in a mind-body practice/program
About this study
The purpose of this study is to measure the metabolic and behavioral effects of a 12-week yoga program coupled to health education (HED) compared to HED alone.
Read the detailed description
The purpose of this study is to measure the metabolic and behavioral effects of a 12-week yoga program coupled to health education (HED) compared to HED alone. In a randomized clinical trial of 90 patients (45 patients per arm), investigators will measure the effects of the two interventions on IR, HTN, dysplidemia, and body composition (See Figure 1. Study Diagram). Subjects will be scheduled for outcome assessment at baseline, 12 weeks, and 24 weeks. In addition, investigators will collect data at baseline and 12 weeks on self-efficacy, stress, mindfulness, and mood. As a sub-study to the randomized controlled trial, investigators will measure the aerobic intensity of the yoga to estimate the dose of physical exercise provided by the yoga (n=10).
Subjects willing and eligible to participate in the RCT will receive written consent. Consented subjects will be randomized to either 12 weeks of yoga with HED versus HED alone. Subjects randomized to yoga will receive 30 to 45 minutes of weekly yoga instruction, followed by 30 to 45 minutes of HED. Subjects will receive written instructions for home yoga practice and lifestyle changes based on HED. Subjects randomized to HED alone will receive a weekly standardized HED curriculum which will be attention and time matched to the yoga with HED arm.
- Conditions
- Metabolic Syndrome, Obesity, Insulin Resistance
- Being tested
- Health education, Yoga
- Medical subject headings
- Metabolic Syndrome, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationBehavioural
Education on lifestyle changes for treatment of metabolic syndrome
YogaBehavioural
Training in the practice of yoga for treatment of metabolic syndrome
| Study group | Role | What they receive |
|---|---|---|
| Yoga with health education | Experimental | 12 week yoga program coupled to standardized health education for weight loss Receives: Behavioral: Health education; Behavioral: Yoga |
| Health education | Active comparator | Standardized health education for weight loss Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin resistance
Measured: Baseline, 12 weeks, and 24 weeks
Secondary outcomes (10)
Change in hypertension
Blood pressure
Measured: Baseline, 12, and 24 weeks
Change in dyslipidemia
Fasting lipids
Measured: Baseline, 12, and 24 weeks
Change in body composition
Waist circumference and bioelectrical impedance
Measured: Baseline, 12, and 24 weeks
Change in diet
Dietary intake assessed with Block Brief 200 Food Frequency
Measured: Baseline, 12, and 24 weeks
Change in physical activity measured with accelerometers
Assessed with accelerometers
Measured: Baseline, 12, and 24 weeks
Change in self-efficacy
Perceived Health Competence Scale
Measured: Baseline and 12 weeks
Change in stress
Perceived Stress Scale-10
Measured: Baseline and 12 weeks
Change in quality of life
SF-36
Measured: Baseline and 12 weeks
Change in mindfulness
Mindful Attention and Awareness Scale
Measured: Baseline and 12 weeks
Change in affect measured through questionnaire Profile of Mood States
Profile of Mood States
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurjeet Birdee, Vanderbilt University Medical Center
- Investigators
- Gurjeet Birdee, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899910
- Sponsor's protocol ID
- Vanderbilt University
- Status last verified
- Dec 2016
- First submitted
- 6 Sep 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and Exercise Study to Understand Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02899910
- Acronym / sponsor ID
- Vanderbilt University
- Conditions
- Metabolic Syndrome, Obesity, Insulin Resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Sep 2016 (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 purpose of this study is to measure the metabolic and behavioral effects of a 12-week yoga program coupled to health education (HED) compared to HED alone.
Detailed description
The purpose of this study is to measure the metabolic and behavioral effects of a 12-week yoga program coupled to health education (HED) compared to HED alone. In a randomized clinical trial of 90 patients (45 patients per arm), investigators will measure the effects of the two interventions on IR, HTN, dysplidemia, and body composition (See Figure 1. Study Diagram). Subjects will be scheduled for outcome assessment at baseline, 12 weeks, and 24 weeks. In addition, investigators will collect data at baseline and 12 weeks on self-efficacy, stress, mindfulness, and mood. As a sub-study to the randomized controlled trial, investigators will measure the aerobic intensity of the yoga to estimate the dose of physical exercise provided by the yoga (n=10).
Subjects willing and eligible to participate in the RCT will receive written consent. Consented subjects will be randomized to either 12 weeks of yoga with HED versus HED alone. Subjects randomized to yoga will receive 30 to 45 minutes of weekly yoga instruction, followed by 30 to 45 minutes of HED. Subjects will receive written instructions for home yoga practice and lifestyle changes based on HED. Subjects randomized to HED alone will receive a weekly standardized HED curriculum which will be attention and time matched to the yoga with HED arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga with health education | Experimental | Behavioral: Health education, Behavioral: Yoga12 week yoga program coupled to standardized health education for weight loss |
| Health education | Active comparator | Behavioral: Health educationStandardized health education for weight loss |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Elevated waist circumference (Men greater than 102cm; women greater than 88cm)
- Impaired fasting glucose (100-125 mg/dl)
- Elevated blood pressure (systolic ≥130 and/or diastolic ≥ 85)
- Dyslipidemia (triglycerides ≥150 and/or HDL≤ 40 for men; 50 for women)
- Age ≥ 18
Key exclusion criteria (7 listed)
- Currently taking blood pressure medications, oral diabetic medication or insulin, or lipid medication
- Systolic blood pressure ≥160 and/or diastolic ≥100
- Unstable cardiac disease e.g. angina, life threatening arrhythmia
- Lung disease requiring oxygen supplementation at rest or with ambulation
- History of dementia or cognitive impairment
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 |
|---|---|---|
| Health educationEducation on lifestyle changes for treatment of metabolic syndrome | Behavioural | Health education, Yoga with health education |
| YogaTraining in the practice of yoga for treatment of metabolic syndrome | Behavioural | Yoga with health education |
Primary outcome
Change in insulin resistance
Time frame: Baseline, 12 weeks, and 24 weeks
10 secondary outcomes
Change in hypertension
Time frame: Baseline, 12, and 24 weeks
Change in dyslipidemia
Time frame: Baseline, 12, and 24 weeks
Change in body composition
Time frame: Baseline, 12, and 24 weeks
Change in diet
Time frame: Baseline, 12, and 24 weeks
Change in physical activity measured with accelerometers
Time frame: Baseline, 12, and 24 weeks
Change in self-efficacy
Time frame: Baseline and 12 weeks
Change in stress
Time frame: Baseline and 12 weeks
Change in quality of life
Time frame: Baseline and 12 weeks
Change in mindfulness
Time frame: Baseline and 12 weeks
Change in affect measured through questionnaire Profile of Mood States
Time frame: Baseline and 12 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 2 Jan 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.
Gurjeet Birdee, MD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Health education and Yoga in people with Metabolic Syndrome and Obesity, run by Vanderbilt University Medical Center.
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 6 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 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in insulin resistance (time frame: Baseline, 12 weeks, and 24 weeks). 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 2 Jan 2017.