Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful attention
Exercise
Exercise with mindful attention
Sponsored by
About this trial
This is an interventional other trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- Metabolic syndrome, defined as meeting 3 or more of the following criteria in the last 6 months at the time of medical record review: (a) BMI > 30; (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)
Sites / Locations
- Beth Israel Deaconess Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Mindful attention
Exercise
Exercise with mindful attention
No intervention
Arm Description
16 sessions over 8 weeks (2x/week) of mindful attention audio recordings delivered via headphones
16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking
16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking utilizing mindful attention audio recordings delivered via headphones
No intervention sessions
Outcomes
Primary Outcome Measures
Feasibility of screening: screened to eligible ratio
percent of screened individuals that were determined eligible for the study
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
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
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
Feasibility of survey completion: survey completion rates at each assessment
percent of participants that complete surveys at post-intervention and 3-month follow-up
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
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
Perspectives on study interventions
Perspectives on study interventions will be assessed via exit interview
Secondary Outcome Measures
Ventilatory efficiency
Assessed via a maximal cardiopulmonary exercise test, using expired gas analysis under continuous electrocardiographic monitoring.
Heart rate dynamics
Assessed via 24-hour heart rate monitoring
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
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.
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
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
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
Objective physical activity
7 day activity monitoring (via ActiGraph monitor) to assess minutes per week in moderate-intensity exercise
In-session oxygen consumption
Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
In-session ventilatory efficiency
Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
In-session respiration rate
Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
In-session heart rate
Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
Full Information
NCT ID
NCT05242640
First Posted
January 27, 2022
Last Updated
August 14, 2023
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05242640
Brief Title
Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome
Official Title
Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindful attention
Arm Type
Experimental
Arm Description
16 sessions over 8 weeks (2x/week) of mindful attention audio recordings delivered via headphones
Arm Title
Exercise
Arm Type
Experimental
Arm Description
16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking
Arm Title
Exercise with mindful attention
Arm Type
Experimental
Arm Description
16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking utilizing mindful attention audio recordings delivered via headphones
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention sessions
Intervention Type
Other
Intervention Name(s)
Mindful attention
Intervention Description
Participants will listen to mindful attention audio recordings via headphones
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Participants will complete a moderate-intensity walking program
Intervention Type
Other
Intervention Name(s)
Exercise with mindful attention
Intervention Description
Participants will complete a moderate-intensity walking program while listening to mindful attention audio recordings via headphones
Primary Outcome Measure Information:
Title
Feasibility of screening: screened to eligible ratio
Description
percent of screened individuals that were determined eligible for the study
Time Frame
Through study completion, an average of 1 year
Title
Feasibility of enrollment: eligible to enrollment ratio
Description
percent of eligible individuals that enroll in the study; determined to be feasible if greater than or equal to 70% of eligible patients enroll
Time Frame
Through study completion, an average of 1 year
Title
Feasibility of retention: retention at each assessment
Description
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
Time Frame
6 months
Title
Feasibility of interventions: attendance rates for each session
Description
percent session attendance; determined to be feasible if participants attend greater than or equal to 75% of sessions
Time Frame
6 months
Title
Feasibility of survey completion: survey completion rates at each assessment
Description
percent of participants that complete surveys at post-intervention and 3-month follow-up
Time Frame
6 months
Title
Acceptability of interventions
Description
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
Time Frame
6 months
Title
Acceptability of study design
Description
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
Time Frame
6 months
Title
Perspectives on study interventions
Description
Perspectives on study interventions will be assessed via exit interview
Time Frame
Post-intervention (after 8 week intervention)
Secondary Outcome Measure Information:
Title
Ventilatory efficiency
Description
Assessed via a maximal cardiopulmonary exercise test, using expired gas analysis under continuous electrocardiographic monitoring.
Time Frame
Baseline (week 0), post-intervention (after 8 week intervention)
Title
Heart rate dynamics
Description
Assessed via 24-hour heart rate monitoring
Time Frame
Baseline (week 0), post-intervention (after 8 week intervention)
Title
Positive affect
Description
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
Time Frame
Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention
Title
Emotion regulation
Description
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.
Time Frame
Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention
Title
Interoceptive awareness
Description
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
Time Frame
Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention
Title
Self-efficacy
Description
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
Time Frame
Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention
Title
Self-reported physical activity
Description
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
Time Frame
Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention
Title
Objective physical activity
Description
7 day activity monitoring (via ActiGraph monitor) to assess minutes per week in moderate-intensity exercise
Time Frame
Baseline (week 0), post-intervention (after 8 week intervention)
Title
In-session oxygen consumption
Description
Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
Time Frame
Weeks 1 and 8
Title
In-session ventilatory efficiency
Description
Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
Time Frame
Weeks 1 and 8
Title
In-session respiration rate
Description
Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
Time Frame
Weeks 1 and 8
Title
In-session heart rate
Description
Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
Time Frame
Weeks 1 and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metabolic syndrome, defined as meeting 3 or more of the following criteria in the last 6 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen M Kraemer, PhD
Phone
617-754-1443
Email
kkraemer@bidmc.harvard.edu
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Kraemer, PhD
Phone
617-754-1443
Email
kkraemer@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Kristen M Kraemer, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome
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