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

October 20, 2022 updated by: Michael Laymon, Touro University Nevada

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change rom baseline in body Weight
Time Frame: Baseline, 10 days, 30 days, and 60 days.
Weight in kilograms
Baseline, 10 days, 30 days, and 60 days.
Change from baseline in Body Mass Index
Time Frame: Baseline, 10 days, 30 days, and 60 days.
DEXA Measurement of % total fat
Baseline, 10 days, 30 days, and 60 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Human Growth Hormone - Metabolic rate
Time Frame: baseline, 10 days, 30 days, 60 days
Measurement of Human Growth Hormone
baseline, 10 days, 30 days, 60 days
VO2 at rest, Oxygen consumption at rest-resting metabolic rate(RMR)
Time Frame: Baseline, 10 days, 30 days, and 60 days.
Oxygen consumption via oxygen plethysmograph
Baseline, 10 days, 30 days, and 60 days.
Respiratory quotient (RQ) - metabolic rate
Time Frame: Baseline, 10 days, 30 days, and 60 days.
CO2 eliminated/O2 consumed
Baseline, 10 days, 30 days, and 60 days.
lipid panel - metabolic rate
Time Frame: Baseline, 10 days, 30 days, and 60 days.
Total cholesterol, high density lipids, low density lipids, triglycerides
Baseline, 10 days, 30 days, and 60 days.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
stress level - autonomic function
Time Frame: Baseline, 10 days, 30 days, 60 days
Heart Rate Variability
Baseline, 10 days, 30 days, 60 days
Depression
Time Frame: 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.
Baseline, 10 days, 30 days, and 60 days.
Sleep
Time Frame: Baseline, 10 days, 30 days, and 60 days.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Touro University Nevada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael S Laymon, DSc, PT, Touro University Nevada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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