Health Education
BehavioralEducation on lifestyle changes for treatment of metabolic syndrome
NCT Number: NCT02899910
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Education on lifestyle changes for treatment of metabolic syndrome
Training in the practice of yoga for treatment of metabolic syndrome
Time frame: Baseline, 12 weeks, and 24 weeks
Time frame: Baseline, 12, and 24 weeks
Blood pressure
Time frame: Baseline, 12, and 24 weeks
Fasting lipids
Time frame: Baseline, 12, and 24 weeks
Waist circumference and bioelectrical impedance
Time frame: Baseline, 12, and 24 weeks
Dietary intake assessed with Block Brief 200 Food Frequency
Time frame: Baseline, 12, and 24 weeks
Assessed with accelerometers
Time frame: Baseline and 12 weeks
Perceived Health Competence Scale
Time frame: Baseline and 12 weeks
Perceived Stress Scale-10
Time frame: Baseline and 12 weeks
SF-36
Time frame: Baseline and 12 weeks
Mindful Attention and Awareness Scale
Time frame: Baseline and 12 weeks
Profile of Mood States
Vanderbilt University Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06697977
Body Weight, Diabetes
Amman, Jordan
View Trial DetailsNCT03344718
Atrophy, Avitaminosis
Tainan, Taiwan
View Trial DetailsNCT07241741
Body Weight, C-reactive Protein
View Trial DetailsNCT04392284
Body Weight, Cardiovascular Diseases
Birmingham, Alabama, United States
View Trial Details