Metabolic Syndrome
Conditions
Brief summary
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.
Interventions
OTHERMindful attention
Participants will listen to mindful attention audio recordings via headphones
OTHERExercise
Participants will complete a moderate-intensity walking program
OTHERExercise with mindful attention
Participants will complete a moderate-intensity walking program while listening to mindful attention audio recordings via headphones
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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) in which exercise would be contraindicated or that would preclude HRV analyses (e.g., some arrhythmias); (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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of screening: screened to eligible ratio | Through study completion, an average of 1 year | percent of screened individuals that were determined eligible for the study |
| Feasibility of enrollment: eligible to enrollment ratio | Through study completion, an average of 1 year | percent of eligible individuals that enroll in the study; determined to be feasible if greater than or equal to 70% of eligible patients enroll |
| Feasibility of retention: retention at each assessment | 6 months | 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 |
| Feasibility of interventions: attendance rates for each session | 6 months | percent session attendance; determined to be feasible if participants attend greater than or equal to 75% of sessions |
| Feasibility of survey completion: survey completion rates at each assessment | 6 months | percent of participants that complete surveys at post-intervention and 3-month follow-up |
| Acceptability of interventions | 6 months | 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 |
| Acceptability of study design | 6 months | 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 |
| Perspectives on study interventions | Post-intervention (after 8 week intervention) | Perspectives on study interventions will be assessed via exit interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilatory efficiency | Baseline (week 0), post-intervention (after 8 week intervention) | Assessed via a maximal cardiopulmonary exercise test, using expired gas analysis under continuous electrocardiographic monitoring. |
| Heart rate dynamics | Baseline (week 0), post-intervention (after 8 week intervention) | Assessed via 24-hour heart rate monitoring |
| Positive affect | Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention | 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 |
| Emotion regulation | Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention | 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. |
| Interoceptive awareness | Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention | 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 |
| Self-efficacy | Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention | 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 |
| Self-reported physical activity | Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention | 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 |
| Objective physical activity | Baseline (week 0), post-intervention (after 8 week intervention) | 7 day activity monitoring (via ActiGraph monitor) to assess minutes per week in moderate-intensity exercise |
| In-session oxygen consumption | Weeks 1 and 8 | Submaximal cardiopulmonary exercise testing (via standard metabolic cart) |
| In-session ventilatory efficiency | Weeks 1 and 8 | Submaximal cardiopulmonary exercise testing (via standard metabolic cart) |
| In-session respiration rate | Weeks 1 and 8 | Submaximal cardiopulmonary exercise testing (via standard metabolic cart) |
| In-session heart rate | Weeks 1 and 8 | Submaximal cardiopulmonary exercise testing (via standard metabolic cart) |
Countries
United States
Outcome results
None listed