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

NCT ID: NCT05242640

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mindful attention

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

Group Type: EXPERIMENTAL

Mindful attention

Intervention Type: OTHER

Participants will listen to mindful attention audio recordings via headphones

Exercise

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Participants will complete a moderate-intensity walking program

Exercise with mindful attention

16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking utilizing mindful attention audio recordings delivered via headphones

Group Type: EXPERIMENTAL

Exercise with mindful attention

Intervention Type: OTHER

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

No intervention

No intervention sessions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindful attention

Participants will listen to mindful attention audio recordings via headphones

Intervention Type: OTHER

Exercise

Participants will complete a moderate-intensity walking program

Intervention Type: OTHER

Exercise with mindful attention

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kristen Kraemer

Instructor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristen M Kraemer, PhD

Role: CONTACT

kkraemer@bidmc.harvard.edu

617-754-1443

Facility Contacts

Kristen Kraemer, PhD

Role: primary

kkraemer@bidmc.harvard.edu

617-754-1443

Other Identifiers

2022P000037

Identifier Type: -

Identifier Source: org_study_id