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

NCT05242640 | Completed

• 1 other identifier: 2022P000037
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (12)

• Ventilatory efficiency

  Baseline (week 0), post-intervention (after 8 week intervention)

• Heart rate dynamics

  Baseline (week 0), post-intervention (after 8 week intervention)

• Positive affect

  Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention

• Emotion regulation

  Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention

• Interoceptive awareness

  Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention

Study Arms (4)

Mindful attention

EXPERIMENTAL

16 sessions over 8 weeks (2x/week) of mindful attention audio recordings delivered via headphones

Other: Mindful attention

Exercise

EXPERIMENTAL

16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking

Other: Exercise

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

Other: Exercise with mindful attention

No intervention

NO INTERVENTION

No intervention sessions

Interventions

Exercise OTHER

Participants will complete a moderate-intensity walking program

Exercise

Mindful attention OTHER

Participants will listen to mindful attention audio recordings via headphones

Mindful attention

Exercise with mindful attention OTHER

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

Exercise with mindful attention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 16, 2022
• Study Start: January 31, 2023
• Primary Completion: March 9, 2026
• Study Completion: March 9, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)