Mindful Walking Intervention for Physical Inactivity

Study Overview
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Brief Summary
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Mindful walking is a meditation practice that combines physical activity and mindfulness practice. The purpose of this study is to examine the effectiveness of mindfulness-based interventions provided for increasing physical activity among adults with low physical activity levels. A randomized controlled trial design will be utilized, with an intervention and waitlist control group (N = 160). Outcomes measured include physical activity, sleep quality, and functional fitness. Participants will receive a total of eight sessions of 60-minute mindful walking training within four weeks. The intervention group will receive the training in Weeks 1-4 and the control group will receive the training during Weeks 5-8. Each training group will consist of up to 20 individuals. Data will be collected at baseline, four weeks, and eight weeks to determine the efficacy of the intervention.

Official Title
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Mindfulness Training for Adults With Physical Inactivity

Conditions
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Physical Inactivity

Intervention / Treatment
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* Behavioral: Mindful Walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above English speaking Literacy 6th grade and above Willingness to share contact information (home address, phone number) No current mindfulness practice Greenville residents or persons who are patients of the partnering organizations in the investigator's study. Self-reported physical activity level below the CDC recommended guidelines (150 minutes (2 hours and 30 minutes) a week of moderate-intensity, or 75 minutes (1 hour and 15 minutes ) a week of vigorous-intensity aerobic activity, or an equivalence combination of moderate- and vigorous intensity aerobic activity Exclusion Criteria: <18 years old Non-English-speaking Literacy lower than 6th grade Inability to attend intervention sessions Already completed or attending a mindfulness-based intervention Current pregnancy Current/past psychosis Acute episode of a substance use disorder (past two weeks) Acute episode of depression in the past two weeks Moderate to severe traumatic brain injury or brain damage Persistent antisocial behavior Persistent self-injury requiring clinical management Unable to engage for physical or practical reasons (e.g., disabling physical problems, unable to comprehend material) Dementia Suicidality Inability to do light walking for 10 mins at a stretch Severely obese BMI (>50 kg/m2)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with a waitlist control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Walking<br>Eight weekly 60 minute mindful walking sessions involving observations of bodily sensations, experiences, and breath. Discussion of mindful walking experiences and encouragement to meet physical activity goals. The intervention will take place two times per week for four weeks (Weeks 1-4). During weeks 5-8 the experimental group will continue treatment as usual and will not be receiving the mindful walking intervention. | Behavioral: Mindful Walking<br>* Eight weekly 60 minute mindful walking sessions involving observations of bodily sensations, experiences, and breath. Discussion of mindful walking experiences and encouragement to meet physical activity goals.<br>|
| No Intervention: Control<br>Participants will engage in treatment as usual during the first four weeks and will not be receiving the experimental intervention (mindful walking) during weeks 1-4. After the experimental group completes the mindful walking intervention, the control group will complete the mindful walking intervention (weeks 5-8). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity | Rapid Assessment of Physical Activity Scale: self-report scale of physical activity, with total score ranging from 1-10; higher scores indicate increased activity | Scale administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) | 
| Change in muscle strength | Upper and lower muscle strength will be measured with the 30-second arm curl test (number of biceps curls completed while holding a hand weight of 2.27 kg for women and 3.63 kg for men) and the 30-second chair-stand test (Prakhinkit et al. 2014). | Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) | 
| Change in sleep quality | Pittsburgh Sleep Quality Index: 19 item self-report measure assessing sleep quality over the past month, total score ranging from 0 to 21, with higher scores indicating worse sleep quality | Assessment administered at pre-intervention/baseline, 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) | 
| Change in flexibility | The back scratch flexibility test (how close the hands can be brought together behind the back) and the chair sit-and-reach test will be used to measure upper and lower limb flexibility, respectively (Prakhinkit et al. 2014). | Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) | 
| Change in agility | The timed up-and-go test will be used as a measure of agility (Prakhinkit et al. 2014) | Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) | 
| Change in dynamic balance | The Star Excursion Balance Test will measure dynamic balance (Gribble, Hertel, and Plisky 2012) | Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) | 
| Change in cardiorespiratory endurance | 6 minute walk test, measure includes how many meters the individual walks in 6 minutes around a 50-yard course (Prakhinkit et al. 2014) | Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived stress | Perceived Stress Scale: 4 item self-report measure assessing perceived stress over the past month, total score ranges from 4 to 20, higher levels indicating higher levels of stress | Assessment administered at pre-intervention/baseline, 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) | 
| Change in adherence to medications | Adherence to Refills and Medications Scale: 12 item self-report scale assesses adherence to other medication treatments; scores range from 12-34, where lower scores indicate better adherence (adherence to medications not given as part of this study) (Kripalani et al. 2009) | Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) | 
| Change in mindfulness skills | The Five Facet Mindfulness Questionnaire: 39 self-report items assessing five dimensions of mindfulness. Items are rated on a 5 point scale ranging from 1 to 5, with total score ranging from 39 to 195. Higher scores indicate greater dispositional tendency to be mindful in daily life (e.g., observing, describing, acting with awareness, nonjudging of inner experience, nonreactivity to inner experiences). | Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) | 
| Change in executive functioning | Executive Function Index: A 27-item self-report inventory assessing five facets of executive functioning (Spinella, 2005); Items rated how well the following statement describes me 1 (not at all) to 5 (very much), range 27-135 with higher scores indicating higher levels of executive functioning. | Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) | 
| Mindfulness practice behavior | Additional mindfulness practices engaged in outside of the study sessions over the past month, assessed with four self-report items: 'Did you engage in mindfulness meditation in the past month?', 'How many days per week did you engage in mindfulness meditation?', 'How long in minutes did you meditate per session of mindfulness meditation?', 'Describe your practice of mindfulness meditation (what exercises/activities/techniques did you practice?) | Assessment administered at 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group) |