- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04630561
Great Posture, Great Health (GPGH)
April 9, 2024 updated by: Benjamin (Ben) D. Holmes, Mayo Clinic
Great Posture, Great Health - A Community-Based Postural Intervention for Improving Holistic Health
The purpose of this study is to examine the effect of a posture intervention on specific areas of daily function and health: physical, psychological, cognitive, social, and environmental characteristics.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This project promotes community health through postural movement to demonstrate strong physical and mental health benefits.
Specifically, Great Posture, Great Health will address two of the top five priorities of general health concerns: 1) obesity and 2) mental health.
First, obesity is on the rise although more individuals are meeting or exceeding the current federal physical activity guidelines based on the data provided by the US Department of Health and Human Services (2020).
Obesity is a common problem in adults with all socioeconomic status and all races, except Asians.
In fact, Asians have low rates of heart disease, asthma, cancer, and a longer life expectancy than other races, potentially due to health behaviors, environment, and stress coping strategies (Acciai et al., 2015).
Therefore, we should not overlook the importance of stress coping strategies practiced in Asian countries on obesity.
It is becoming more evident that chronic stress (such as elevated cortisol levels) and steroid-based medications are strongly associated with obesity and chronic diseases.
It is critical to develop and validate community health strategies to address both priorities.
Great Posture, Great Health will introduce one of the most common mind-body postural exercises practiced in Asian countries to a large and diverse population.
Study Type
Interventional
Enrollment (Actual)
114
Phase
- 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
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
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
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants must be physically capable (defined as easy to moderate physical activities daily at least 60 minutes).
- Participants also must have a normal (18.5-24.9kg/m2) or overweight BMI (25-29.9kg/m2).
- Participants must be able to speak, listen, read, and understand sentences written in English.
Exclusion Criteria:
- More than two risk factors for coronary artery disease (high blood pressure, high blood cholesterol level (LDL), family history (a close relative with heart disease), diabetes mellitus, chronic kidney disease
- History of falls, osteoporosis, osteoarthritis, or orthopedic or neurological conditions (i.e., stroke)
- Medications that cause dizziness or slow movement
- Smoke
- Body mass to height squared ratio greater than 30kg/m2 or less than 18.4kg/m2, blood pressure greater than 140/90 mmHg, or a history of heart conditions.
- Individuals with progressive cognitive, neurologic disorders, cancer treatment, chronic heart failure, or unstable medical conditions
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Subjects will participate in a 15 minute postural intervention program 2-3 times per week
|
Dynamic warmup program designed to target several areas of physical and mental wellbeing.
|
|
No Intervention: Control Group
Subjects will NOT participate in any postural intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thigh Strength
Time Frame: 12-week differences (Pre- and Post-intervention measures)
|
Isometric measurement (Newtons) of quadriceps and hamstrings musculature
|
12-week differences (Pre- and Post-intervention measures)
|
|
Posture
Time Frame: 12-week differences (Pre- and Post-intervention measures)
|
Posture will be measured via the Posture Screen Mobile app.
Displacement (mm)
|
12-week differences (Pre- and Post-intervention measures)
|
|
Bone density
Time Frame: 12-week differences (Pre- and Post-intervention measures)
|
Bone densiometry will be measured via quantitative ultrasound (Achilles EXPII, GE).
T-score.
|
12-week differences (Pre- and Post-intervention measures)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PROMIS - Physical Activity
Time Frame: 12-week differences (Pre- and Post-intervention measures)
|
Patient Reported Outcomes from a computerized adaptive test (T-score; normative score is 1.0; higher score equates to a better outcome)
|
12-week differences (Pre- and Post-intervention measures)
|
|
PROMIS - Physical Function
Time Frame: 12-week differences (Pre- and Post-intervention measures)
|
Patient Reported Outcomes from a computerized adaptive test (T-score; normative score is 1.0; higher score equates to a better outcome)
|
12-week differences (Pre- and Post-intervention measures)
|
|
PROMIS - Pain Interference
Time Frame: 12-week differences (Pre- and Post-intervention measures)
|
Patient Reported Outcomes from a computerized adaptive test (T-score; normative score is 1.0; higher score equates to a better outcome)
|
12-week differences (Pre- and Post-intervention measures)
|
|
Mindful Attention Awareness Scale (MAAS)
Time Frame: 12-week differences (Pre- and Post-intervention measures)
|
Patient Reported Outcomes (Mean score range: 1-6; higher score equates to increased mindfulness)
|
12-week differences (Pre- and Post-intervention measures)
|
|
Perceived Stress Scale (PSS-10)
Time Frame: 12-week differences (Pre- and Post-intervention measures)
|
Patient Reported Outcomes (Score range: 0-40; higher score equates to increased stress)
|
12-week differences (Pre- and Post-intervention measures)
|
|
Generalized Anxiety Disorder (GAD7)
Time Frame: 12-week differences (Pre- and Post-intervention measures)
|
Patient Reported Outcomes (Score range: 0-21; higher score equates to increased anxiety)
|
12-week differences (Pre- and Post-intervention measures)
|
|
Patient Health Questionnaire Depression Scale (PHQ)
Time Frame: 12-week differences (Pre- and Post-intervention measures)
|
Patient Reported Outcomes (Score range: 0-27; score of 10 or greater is considered major depression, 20 or more is severe major depression.)
|
12-week differences (Pre- and Post-intervention measures)
|
|
Sex
Time Frame: Through study completion, an average of 1 year
|
Demographic co-variate. (M/F)
|
Through study completion, an average of 1 year
|
|
Age
Time Frame: Through study completion, an average of 1 year
|
Demographic co-variate (years)
|
Through study completion, an average of 1 year
|
|
BMI
Time Frame: 12-week differences (Pre- and Post-intervention measures)
|
Demographic co-variate (BMI index; kg/m^2)
|
12-week differences (Pre- and Post-intervention measures)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin Holmes, DC, PhD, Mayo Clinic
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.
Helpful Links
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)
November 19, 2020
Primary Completion (Actual)
March 19, 2024
Study Completion (Actual)
March 19, 2024
Study Registration Dates
First Submitted
October 28, 2020
First Submitted That Met QC Criteria
November 13, 2020
First Posted (Actual)
November 16, 2020
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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