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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Weight Loss; Metabolism
• Intervention / Treatment: Other: Deep breathing with Yoga positioning

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Michael Laymon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep breathing with Yoga positioning; 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; Deep breathing with yoga positioning 10min in morning, 1 minute noon, and 1 minute evening (diner); Other Names: Novel breathing and mindfulness moving-meditation.
No Intervention: Control; No changes in lifestyle or activities over the 60 day period.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
stress level - autonomic function	Heart Rate Variability	Baseline, 10 days, 30 days, 60 days
Depression	Hamilton Depression Rating Scale (HAM-D) depression index self reported survey scored 0-62 with higher score indicating a worse outcome.	Baseline, 10 days, 30 days, and 60 days.
Sleep	Insomnia Severity Index (ISI) self reported survey scored 0-28 with higher score indicating worse outcome.	Baseline, 10 days, 30 days, and 60 days.

Collaborators and Investigators

• Sponsor: Touro University Nevada
• Investigators: Principal Investigator: Michael S Laymon, DSc, PT, Touro University Nevada

Publications and helpful links

General Publications

• Sato K, Kawamura T, Yamagiwa S. The "Senobi" breathing exercise ameliorates depression in obese women through up-regulation of sympathetic nerve activity and hormone secretion. Biomed Res. 2011 Apr;32(2):175-80. doi: 10.2220/biomedres.32.175.
• Sato K, Kawamura T, Yamagiwa S. The "Senobi" breathing exercise is recommended as first line treatment for obesity. Biomed Res. 2010 Aug;31(4):259-62. doi: 10.2220/biomedres.31.259.
• Sato K, Kawamura T, Abo T. "Senobi" stretch ameliorates asthma symptoms by restoring autonomic nervous system balance. J Investig Med. 2010 Dec;58(8):968-70. doi: 10.231/JIM.0b013e3181f9167b.
• Nivethitha L, Mooventhan A, Manjunath NK. Evaluation of Cardiovascular Functions during the Practice of Different Types of Yogic Breathing Techniques. Int J Yoga. 2021 May-Aug;14(2):158-162. doi: 10.4103/ijoy.IJOY_61_20. Epub 2021 May 10.
• Nivethitha L, Mooventhan A, Manjunath NK, Bathala L, Sharma VK. Cerebrovascular Hemodynamics During the Practice of Bhramari Pranayama, Kapalbhati and Bahir-Kumbhaka: An Exploratory Study. Appl Psychophysiol Biofeedback. 2018 Mar;43(1):87-92. doi: 10.1007/s10484-017-9387-8.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Anticipated): November 23, 2022
• Study Completion (Anticipated): November 23, 2022

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: obesity; metabolism; mentation
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: ML-CHHS-22-338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect privacy of subjects, Data will be reported as cumulative without individual participant data. In the event of potential health adverse disease process IPD may be shared with individuals' consent to their designated, licensed, healthcare provider.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No