Integration of Yoga and Mindfulness for the Treatment of Obesity in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Fidelity to the yoga interventions
研究概览
简要总结
The focus of this study is to examine the feasibility of integrating Vinyasa yoga into a Standard Behavioral Weight Loss Intervention, to examine whether engagement differs between Vinyasa yoga and a restorative form of Hatha yoga within a Standard Behavioral Weight Loss Intervention, and to use this information to inform an expanded study to directly test the effectiveness of these interventions on weight loss in adults.
详细描述
The focus of this study is to examine the feasibility of integrating Vinyasa yoga into a Standard Behavioral Weight Loss Intervention, to examine whether engagement differs between Vinyasa yoga and a restorative form of Hatha yoga within a Standard Behavioral Weight Loss Intervention, and to use this information to inform an expanded study to directly test the effectiveness of these interventions on weight loss in adults. Thus, study will pursing the following aims:
- Vinyasa yoga will be integrated into the Standard Behavioral Weight Loss Intervention. This will require refinement of the Vinyasa yoga intervention to assure that this is appropriate for adults with obesity and to develop the necessary Vinyasa yoga intervention materials.
- The feasibility of randomizing and retaining participants within the context of a Standard Behavioral Weight Loss Intervention that also includes either a restorative Hatha style of yoga or Vinyasa style of yoga will be examined.
- The fidelity and compliance to the yoga components of the intervention will be examined.
To examine the aims listed above potential participants will be recruited through a variety of advertisement methods. Those individuals responding to these advertisements will have the study explained to them and informed consent will be obtained. These participants will complete a series of screening assessments that will be used to determine eligibility (height and weight to determine body mass index, resting blood pressure, heart rate, cardiorespiratory fitness). For participants deemed to be eligible and randomized to participate in this study, these measures will also be used as their baseline data from analysis. Additional data collection will be collected at the baseline assessment visit, with assessments repeated following the 6 month intervention. Assessments will include the following:
- Height and Weight
- Resting Blood Pressure and Heart Rate
- Cardiorespiratory Fitness
- Anthropometric Measures (girth of waist and hips)
- Physical Activity
- Dietary Intake
- Additional Questionnaires to assess demographics, physical activity barriers, eating behaviors, sedentary behavior, physical activity self-efficacy, mindfulness, psychological flexibility and self-regulation, affect, perceived stress, anxiety, sleep, depressive symptoms, and treatment satisfaction.
Assessments will be completed at both baseline and following the 6-month intervention. Moreover, following the intervention, participants will engage in group-based qualitative interviews. These qualitative interviews will focus on better understanding strengths, weaknesses, and barriers to engagement in the intervention that was used in this study. This information will be used to refine our approach prior to pursuing additional studies in this areas of research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcomes assessors will be masked to intervention condition. Selected investigators who are overseeing the intervention will also be masked to study outcomes.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both males and females of all race/ethnic groups are eligible for participation in this study.
- •18-60 years of age.
- •Body mass index (BMI) between 25.0 to <40.0 kg/m
- •Ability to provide informed consent prior to participation in this study.
- •Ability to provide clearance from their primary care physician to engage in the diet and physical activity components of the weight loss intervention.
排除标准
- •Report moderate-to-vigorous exercise on >3 days per week or a total of >60 minutes per week over the past 3 months.
- •Engaging in any style of yoga on an average of at least 1 day per week over the past 3 months.
- •Report weight loss of >3% or participating in a weight reduction diet in the past 3 months.
- •Females who are pregnant or breastfeeding, or reporting a planned pregnancy during the study period.
- •History of bariatric surgery.
- •Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver disease; cancer; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.
- •Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e. recent or recurrent DVT).
- •Resting systolic blood pressure of >160 mmHg or resting diastolic blood pressure of >100 mmHg.
- •Eating disorders that would contraindicate weight loss or physical activity.
- •Alcohol or substance abuse.
- •Currently treated for psychological issues (i.e., depression, bipolar disorder, etc.), taking psychotropic medications within the previous 12 months, or hospitalized for depression within the previous 5 years.
- •Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments.
- •Physical activity or weight loss deemed to be contraindicated based on response to the cardiorespiratory fitness test that will be conducted as part of the screening procedures.
结局指标
主要结局
Fidelity to the yoga interventions
时间窗: Across the 6 month intervention period
Fidelity will be based on the number of days that yoga was performed during the intervention compared to the prescribed number of days that yoga was to be completed in both the Hatha Yoga Group and the Vinyasa Yoga Group
Compliance to the yoga interventions
时间窗: Across the 6 month intervention period
Compliance will be based on the number of days that the yoga was completed at the prescribed duration compared to the prescribed number of days that yoga was to be completed in both the Hatha Yoga Group and the Vinyasa Yoga Group
次要结局
未报告次要终点
研究者
John M. Jakicic, PhD
Professor
University of Pittsburgh