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Completed

NCT Number: NCT05242640

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindful attention

Other

Participants will listen to mindful attention audio recordings via headphones

Exercise

Other

Participants will complete a moderate-intensity walking program

Exercise with mindful attention

Other

Participants will complete a moderate-intensity walking program while listening to mindful attention audio recordings via headphones

Primary outcomes

  1. Feasibility of screening: screened to eligible ratio

    Time frame: Through study completion, an average of 1 year

    percent of screened individuals that were determined eligible for the study

  2. Feasibility of enrollment: eligible to enrollment ratio

    Time frame: 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

  3. Feasibility of retention: retention at each assessment

    Time frame: 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

  4. Feasibility of interventions: attendance rates for each session

    Time frame: 6 months

    percent session attendance; determined to be feasible if participants attend greater than or equal to 75% of sessions

  5. Feasibility of survey completion: survey completion rates at each assessment

    Time frame: 6 months

    percent of participants that complete surveys at post-intervention and 3-month follow-up

  6. Acceptability of interventions

    Time frame: 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

  7. Acceptability of study design

    Time frame: 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

  8. Perspectives on study interventions

    Time frame: Post-intervention (after 8 week intervention)

    Perspectives on study interventions will be assessed via exit interview

Secondary outcomes

  1. Ventilatory efficiency

    Time frame: Baseline (week 0), post-intervention (after 8 week intervention)

    Assessed via a maximal cardiopulmonary exercise test, using expired gas analysis under continuous electrocardiographic monitoring.

  2. Heart rate dynamics

    Time frame: Baseline (week 0), post-intervention (after 8 week intervention)

    Assessed via 24-hour heart rate monitoring

  3. Positive affect

    Time frame: 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

  4. Emotion regulation

    Time frame: 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.

  5. Interoceptive awareness

    Time frame: 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

  6. Self-efficacy

    Time frame: 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

  7. Self-reported physical activity

    Time frame: 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

  8. Objective physical activity

    Time frame: 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

  9. In-session oxygen consumption

    Time frame: Weeks 1 and 8

    Submaximal cardiopulmonary exercise testing (via standard metabolic cart)

  10. In-session ventilatory efficiency

    Time frame: Weeks 1 and 8

    Submaximal cardiopulmonary exercise testing (via standard metabolic cart)

  11. In-session respiration rate

    Time frame: Weeks 1 and 8

    Submaximal cardiopulmonary exercise testing (via standard metabolic cart)

  12. In-session heart rate

    Time frame: Weeks 1 and 8

    Submaximal cardiopulmonary exercise testing (via standard metabolic cart)

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 16, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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