Effects of Novel Breathing Behavior Modification Yoga Positioning Integrated Program on Weight Loss

Study Overview
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Brief Summary
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This study is to evaluate the physical and cognitive effects of a 15 min per day novel breathing and mindfulness moving-meditation program on metabolism, cognition, and emotion health. It is thought that the breathing and movement program will increase basal metabolism, facilitate fat loss, and decrease depressive behaviors. Anthropometric, blood chemistries, and cognitive measures of depression, sleep, and hunger will be measured over a two-month interventional program.

Detailed Description
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Subjects will be randomized into two groups, an active group and control group. For the first 30 days, the active group will follow the movement/breath program and the controls will be instructed not to change their lifestyle (no change in diet, and no change in exercise / physical activities). The technicians taking measurements will be blinded as to which participants are actives vs controls. The following 30 days' intervention will consist of continuing the Phase I interventions combined with implementing the behavior change strategies on 2 to 3 habit changes self-selected from a list of 30 top bad habits that contribute to weight gain and undermine one's ability to lose weight with the control group again not changing any lifestyle activities. Measurements: Measurements will be taken at the start (baseline), 10 days, 30 days, and 60 days of intervention with the measurement days scheduled to evaluate people completing 10 full days of the program, 30 full days, and 60 full days respectively. Measurements taken at each interval to include weight, body composition (lean mass & fat percentages), anthropometric measurements (umbilicus, hips, right thigh, right upper arm), pO2, resting heart rate, HRV, blood pressure, pulmonary health (i.e., O2 max, spirometry), hunger, sleep, and depression rating (by self-assessment survey scale). Serum chemistry for basic metabolic panel, inflammatory markers, and lipids, hematology for oxygen carrying capacity and gross immune response, Human Growth Factor production via ELISA quantification, imaging ultrasound to measure subcutaneous fat thickness at the areas of girth measurements, DEXA for overall and targeted areas body composition, and resting metabolic rate via oxygen plethysmograph.

Official Title
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Effects of Novel Breathing, Behavior Modification, Yoga Positioning Integrated Program on Weight Loss.

Conditions
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Weight Loss, Metabolism

Intervention / Treatment
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* Other: Deep breathing with Yoga positioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age 18-70 years Body Mass Index at or above 27 Stable weight past 3 months able to stand for 10 minutes Able to lift arms overhead Exclusion Criteria: Chronic Obstructive Pulmonary Disease acute respiratory distress supplemental oxygen use inability to stand, flex trunk, or move arms overhead Pacemaker implant Taking beta blocking medications.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized control group, investigator blinded, repeated measure interventional program.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep breathing with Yoga positioning<br>subjects participating in breathing and moving meditation program. 12 minutes daily of deep breathing and yoga positioning first 30 days, then continuation of breathing and positioning and self-directed, mentored, behavior modification activities the second 30 days. | Other: Deep breathing with Yoga positioning<br>* Deep breathing with yoga positioning 10min in morning, 1 minute noon, and 1 minute evening (diner)<br>* Other names: Novel breathing and mindfulness moving-meditation.;|
| No Intervention: Control<br>No changes in lifestyle or activities over the 60 day period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change rom baseline in body Weight | Weight in kilograms | Baseline, 10 days, 30 days, and 60 days. | 
| Change from baseline in Body Mass Index | DEXA Measurement of % total fat | Baseline, 10 days, 30 days, and 60 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human Growth Hormone - Metabolic rate | Measurement of Human Growth Hormone | baseline, 10 days, 30 days, 60 days | 
| VO2 at rest, Oxygen consumption at rest-resting metabolic rate(RMR) | Oxygen consumption via oxygen plethysmograph | Baseline, 10 days, 30 days, and 60 days. | 
| Respiratory quotient (RQ) - metabolic rate | CO2 eliminated/O2 consumed | Baseline, 10 days, 30 days, and 60 days. | 
| lipid panel - metabolic rate | Total cholesterol, high density lipids, low density lipids, triglycerides | Baseline, 10 days, 30 days, and 60 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolism, obesity, mentation