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

Beth Israel Deaconess Medical Center34 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Metabolic Syndrome

Interventions

Mindful attention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Feasibility of screening: screened to eligible ratio

percent of screened individuals that were determined eligible for the study

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 6 months

Perspectives on study interventions

Perspectives on study interventions will be assessed via exit interview

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

Secondary Outcomes

Ventilatory efficiency

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)

Heart rate dynamics

Assessed via 24-hour heart rate monitoring

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

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

Time frame: 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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes