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

Sponsor

Touro University Nevada (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05488574

Collaborator

(none)

Enrollment

Arms

2.3

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss Metabolism	Other: Deep breathing with Yoga positioning	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized control group, investigator blinded, repeated measure interventional program.A randomized control group, investigator blinded, repeated measure interventional program.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Investigators doing data collection will not know which subjects are interventional and which are controls. Outcomes assessor will not be aware of which group of subjects were interventional and which did not participate in intervention.

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Sep 7, 2022

Anticipated Primary Completion Date :

Nov 15, 2022

Anticipated Study Completion Date :

Nov 15, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change rom baseline in body Weight [Baseline, 10 days, 30 days, and 60 days.]
Weight in kilograms
Change from baseline in Body Mass Index [Baseline, 10 days, 30 days, and 60 days.]
DEXA Measurement of % total fat

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Touro University Nevada

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Laymon, Professor, Director Human Performance Laboratory, Touro University Nevada

ClinicalTrials.gov Identifier:

NCT05488574

Other Study ID Numbers:

ML-CHHS-22-338

First Posted:

Aug 4, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michael Laymon, Professor, Director Human Performance Laboratory, Touro University Nevada

metabolism

obesity

mentation

Additional relevant MeSH terms:

Body Weight

Weight Loss

Study Results

No Results Posted as of Aug 4, 2022