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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: Mindful attention; Other: Exercise; Other: Exercise with mindful attention

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen M Kraemer, PhD; Phone Number: 617-754-1443; Email: kkraemer@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Kristen Kraemer, PhD; Phone Number: 617-754-1443; Email: kkraemer@bidmc.harvard.edu
      • Principal Investigator: Kristen M Kraemer, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 2022P000037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No