HealthyGPGHNCT04630561
Great Posture, Great Health
A study testing Postural Intervention Program in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Postural Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to 19 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Postural Intervention Program
- Keywords
- posture, exercise, community
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural Intervention ProgramBehavioural
Dynamic warmup program designed to target several areas of physical and mental wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Subjects will participate in a 15 minute postural intervention program 2-3 times per week Receives: Behavioral: Postural Intervention Program |
| Control Group | No intervention | Subjects will NOT participate in any postural intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh Strength
Isometric measurement (Newtons) of quadriceps and hamstrings musculature
Measured: 12-week differences (Pre- and Post-intervention measures)
Posture
Posture will be measured via the Posture Screen Mobile app. Displacement (mm)
Measured: 12-week differences (Pre- and Post-intervention measures)
Bone density
Bone densiometry will be measured via quantitative ultrasound (Achilles EXPII, GE). T-score.
Measured: 12-week differences (Pre- and Post-intervention measures)
Secondary outcomes (10)
PROMIS - Physical Activity
Patient Reported Outcomes from a computerized adaptive test (T-score; normative score is 1.0; higher score equates to a better outcome)
Measured: 12-week differences (Pre- and Post-intervention measures)
PROMIS - Physical Function
Patient Reported Outcomes from a computerized adaptive test (T-score; normative score is 1.0; higher score equates to a better outcome)
Measured: 12-week differences (Pre- and Post-intervention measures)
PROMIS - Pain Interference
Patient Reported Outcomes from a computerized adaptive test (T-score; normative score is 1.0; higher score equates to a better outcome)
Measured: 12-week differences (Pre- and Post-intervention measures)
Mindful Attention Awareness Scale (MAAS)
Patient Reported Outcomes (Mean score range: 1-6; higher score equates to increased mindfulness)
Measured: 12-week differences (Pre- and Post-intervention measures)
Perceived Stress Scale (PSS-10)
Patient Reported Outcomes (Score range: 0-40; higher score equates to increased stress)
Measured: 12-week differences (Pre- and Post-intervention measures)
Generalized Anxiety Disorder (GAD7)
Patient Reported Outcomes (Score range: 0-21; higher score equates to increased anxiety)
Measured: 12-week differences (Pre- and Post-intervention measures)
Patient Health Questionnaire Depression Scale (PHQ)
Patient Reported Outcomes (Score range: 0-27; score of 10 or greater is considered major depression, 20 or more is severe major depression.)
Measured: 12-week differences (Pre- and Post-intervention measures)
Sex
Demographic co-variate. (M/F)
Measured: Through study completion, an average of 1 year
Age
Demographic co-variate (years)
Measured: Through study completion, an average of 1 year
BMI
Demographic co-variate (BMI index; kg/m^2)
Measured: 12-week differences (Pre- and Post-intervention measures)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start19 Nov 2020
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin (Ben) D. Holmes, Mayo Clinic
- Investigators
- Benjamin Holmes, DC, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630561
- Sponsor's protocol ID
- 20-004586
- Acronym
- GPGH
- Status last verified
- Apr 2024
- First submitted
- 28 Oct 2020
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Great Posture, Great Health - A Community-Based Postural Intervention for Improving Holistic Health
- ClinicalTrials.gov ID
- NCT04630561
- Acronym / sponsor ID
- GPGH / 20-004586
- Conditions
- Healthy
- Keywords
- posture, exercise, community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Postural Intervention ProgramSubjects will participate in a 15 minute postural intervention program 2-3 times per week |
| Control Group | No intervention | –Subjects will NOT participate in any postural intervention. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postural Intervention ProgramDynamic warmup program designed to target several areas of physical and mental wellbeing. | Behavioural | Intervention Group |
Primary outcome
Thigh Strength
Time frame: 12-week differences (Pre- and Post-intervention measures)
Isometric measurement (Newtons) of quadriceps and hamstrings musculature
Posture
Time frame: 12-week differences (Pre- and Post-intervention measures)
Posture will be measured via the Posture Screen Mobile app. Displacement (mm)
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.
10 secondary outcomes
PROMIS - Physical Activity
Time frame: 12-week differences (Pre- and Post-intervention measures)
PROMIS - Physical Function
Time frame: 12-week differences (Pre- and Post-intervention measures)
PROMIS - Pain Interference
Time frame: 12-week differences (Pre- and Post-intervention measures)
Mindful Attention Awareness Scale (MAAS)
Time frame: 12-week differences (Pre- and Post-intervention measures)
Perceived Stress Scale (PSS-10)
Time frame: 12-week differences (Pre- and Post-intervention measures)
Generalized Anxiety Disorder (GAD7)
Time frame: 12-week differences (Pre- and Post-intervention measures)
Patient Health Questionnaire Depression Scale (PHQ)
Time frame: 12-week differences (Pre- and Post-intervention measures)
Sex
Time frame: Through study completion, an average of 1 year
Age
Time frame: Through study completion, an average of 1 year
BMI
Time frame: 12-week differences (Pre- and Post-intervention measures)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Holmes, DC, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postural Intervention Program in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thigh Strength (time frame: 12-week differences (Pre- and Post-intervention measures)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.