Clinical trial NCT04277026: Mindful Walking Intervention for Physical Inactivity
Official title: Mindfulness Training for Adults With Physical Inactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Lead sponsor: Clemson University
Sponsor class: OTHER
Collaborators: name: YMCA
name: Prisma Health-Upstate
First posted: 2020-02-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with a waitlist control group
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in physical activity
timeFrame: 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)
measure: Change in muscle strength
timeFrame: 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)
measure: Change in sleep quality
timeFrame: 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)
measure: Change in flexibility
timeFrame: 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)
measure: Change in agility
timeFrame: 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)
measure: Change in dynamic balance
timeFrame: 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)
measure: Change in cardiorespiratory endurance
timeFrame: 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 outcomes:
measure: Change in perceived stress
timeFrame: 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)
measure: Change in adherence to medications
timeFrame: 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)
measure: Change in mindfulness skills
timeFrame: 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)
measure: Change in executive functioning
timeFrame: 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)
measure: Mindfulness practice behavior
timeFrame: Assessment administered at 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Other outcomes:
measure: Demographic Information
timeFrame: Assessed at pre-intervention/baseline
measure: Satisfaction with treatment
timeFrame: Administered at 4 weeks for experimental group and 8 weeks for control group.
measure: Adverse childhood experiences
timeFrame: First 18 years of life
measure: Traumatic event history
timeFrame: Assessed at pre-intervention/baseline
measure: Use of psychological services
timeFrame: Assessed at pre-intervention/baseline
Locations:
city: Clemson
country: United States
facility: Clemson University
state: South Carolina
city: Greenville
country: United States
facility: Caine Halter Family YMCA
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health-Upstate Internal Medicine Clinic
state: South Carolina
Study officials:
affiliation: Clemson University
name: Lu Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References: