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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindful attention | Experimental | 16 sessions over 8 weeks (2x/week) of mindful attention audio recordings delivered via headphones |
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| Exercise | Experimental | 16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking |
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| Exercise with mindful attention | Experimental | 16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking utilizing mindful attention audio recordings delivered via headphones |
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| No intervention | No Intervention | No intervention sessions |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful attention | Other | Participants will listen to mindful attention audio recordings via headphones |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise | Other | Participants will complete a moderate-intensity walking program |
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| Exercise with mindful attention | Other | Participants will complete a moderate-intensity walking program while listening to mindful attention audio recordings via headphones |
|
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) |
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 |
| D009750 |
| Nutritional and Metabolic Diseases |