Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome

Study Overview
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Brief Summary
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The aim of this study is to assess the feasibility and acceptability (e.g., enrollment, adherence, retention, acceptability of procedures and interventions) of a pilot factorial study design that will help elucidate components of mind-body exercise interventions. The study involves completing a walking program, a mindful attention program, a walking program that includes mindful attention, or no program at all. A pilot study is a smaller study that helps researchers to understand whether the study design can be carried out and what participants think about the study.

Official Title
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Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: Mindful attention
* Other: Exercise
* Other: Exercise with mindful attention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metabolic syndrome, defined as meeting 3 or more of the following criteria in the last 12 months at the time of medical record review: (a) BMI ≥ 25; (b) fasting glucose ≥ 100 [5.6 mmol/L] or A1C ≥ 5.7 or medications; (c) blood pressure ≥ 130 systolic or ≥ 85 diastolic or medications; (d) triglycerides ≥ 150 or 1.7 mmol/L or medications; (e) or HDL < 40mg/ dL for men and 50mg/dL for women or medications; insufficiently active, defined as a score ≤ 23 (moderate-to-strenuous units) on Godin-Shepard Leisure-Time Physical Activity Questionnaire; age 18-70 years; given medical clearance for moderate-intensity exercise and exercise stress testing by their primary care physician (PCP); access to a device with internet and videoconferencing capabilities Exclusion Criteria: current diagnosis of any of the following: (a) coronary artery disease or other chronic heart diseases (e.g., heart failure); (b) any diabetes; (c) chronic obstructive pulmonary disease or other severe lung dysfunction (e.g., severe asthma); (d) severe cognitive impairment >2 self-reported classes or self-guided mindfulness or mindful movement sessions per week in past 3 months self-reported inability to speak and read in English current beta blocker or calcium channel blocker medication uncontrolled hypertension, defined as resting blood pressure ≥ 150 systolic or ≥ 90 diastolic in the last 6 months self- or physician-reported contraindications for exercise (e.g., severe balance impairment, musculoskeletal restrictions)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful attention<br>16 sessions over 8 weeks (2x/week) of mindful attention audio recordings delivered via headphones | Other: Mindful attention<br>* Participants will listen to mindful attention audio recordings via headphones<br>|
| Experimental: Exercise<br>16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking | Other: Exercise<br>* Participants will complete a moderate-intensity walking program<br>|
| Experimental: Exercise with mindful attention<br>16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking utilizing mindful attention audio recordings delivered via headphones | Other: Exercise with mindful attention<br>* Participants will complete a moderate-intensity walking program while listening to mindful attention audio recordings via headphones<br>|
| No Intervention: No intervention<br>No intervention sessions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of screening: screened to eligible ratio | percent of screened individuals that were determined eligible for the study | Through study completion, an average of 1 year | 
| Feasibility of enrollment: eligible to enrollment ratio | percent of eligible individuals that enroll in the study; determined to be feasible if greater than or equal to 70% of eligible patients enroll | Through study completion, an average of 1 year | 
| Feasibility of retention: retention at each assessment | percent of enrolled participants retained at post-intervention and 3-month follow-up; determined to be feasible if greater than or equal to 70% retention at each assessment | 6 months | 
| Feasibility of interventions: attendance rates for each session | percent session attendance; determined to be feasible if participants attend greater than or equal to 75% of sessions | 6 months | 
| Feasibility of survey completion: survey completion rates at each assessment | percent of participants that complete surveys at post-intervention and 3-month follow-up | 6 months | 
| Acceptability of interventions | Acceptability of the interventions will be assessed via overall satisfaction (1 = not at all to 10 = very much); determined to be acceptable if mean rating is greater than or equal to 7.5 across 80% of sessions | 6 months | 
| Acceptability of study design | Acceptability of the study design will be assessed via acceptability of study procedures (1= not at all to 10 = very much); determined to be acceptable if mean rating is greater than or equal to 7.5 across 80% of sessions | 6 months | 
| Perspectives on study interventions | Perspectives on study interventions will be assessed via exit interview | Post-intervention (after 8 week intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilatory efficiency | Assessed via a maximal cardiopulmonary exercise test, using expired gas analysis under continuous electrocardiographic monitoring. | Baseline (week 0), post-intervention (after 8 week intervention) | 
| Heart rate dynamics | Assessed via 24-hour heart rate monitoring | Baseline (week 0), post-intervention (after 8 week intervention) | 
| Positive affect | Positive and Negative Affect Schedule, a validated self-report measure, used to assess levels of positive affect. The positive affect subscale is made up of 10 items rated on a 5-point Likert scale. Scores range from 10 to 50 with higher scores indicating greater levels of positive affect | Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention | 
| Emotion regulation | Difficulties in Emotion Regulation Scale, a 36-item validated self-report measure, used to assess difficulties with emotion regulation; items are rated on a 5-point Likert scale, total scores range from 36 to 180, with higher scores reflecting greater emotion regulation difficulties. 6 subscale scores with higher scores reflecting greater emotion regulation difficulties. | Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention | 
| Interoceptive awareness | Multidimensional Assessment of Interoceptive Awareness Scale, a 32-item validated self-report measures, used to assess levels of interoceptive awareness; items are rated on a 6-point Likert scale, total scores range from 0 to 160, with higher scores reflecting greater interoceptive awareness. 8 subscales with higher scores reflecting greater interocpetive awareness | Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention | 
| Self-efficacy | Multidimensional Self-Efficacy Scale, a 9-item validated self-report measure, used to assess levels of self-efficacy; scores range from 0-90 with higher scores reflecting greater self-efficacy | Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention | 
| Self-reported physical activity | International Physical Activity Questionnaire, a validated self-report measure, used to assess levels of physical activity; walking MET mins/week, moderate MET mins/week and vigorous MET mins/week are calculated | Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention | 
| Objective physical activity | 7 day activity monitoring (via ActiGraph monitor) to assess minutes per week in moderate-intensity exercise | Baseline (week 0), post-intervention (after 8 week intervention) | 
| In-session oxygen consumption | Submaximal cardiopulmonary exercise testing (via standard metabolic cart) | Weeks 1 and 8 | 
| In-session ventilatory efficiency | Submaximal cardiopulmonary exercise testing (via standard metabolic cart) | Weeks 1 and 8 | 
| In-session respiration rate | Submaximal cardiopulmonary exercise testing (via standard metabolic cart) | Weeks 1 and 8 | 
| In-session heart rate | Submaximal cardiopulmonary exercise testing (via standard metabolic cart) | Weeks 1 and 8 |