NCT03114709

Brief Summary

Physical inactivity has reached pandemic proportions and is associated with increased morbidity, mortality, and healthcare costs. Of particular concern is that most middle to older age adults fall far short of recommendations for health enhancing physical activities. This research takes a novel approach to tackling this problem by combining mindfulness with behavioral strategies in a unique 'Mindful Movement' program offered through YMCA community facilities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

March 7, 2017

Last Update Submit

October 30, 2019

Conditions

Keywords

MindfulnessExercisePhysical activityBehavior changeAgingRandomized controlled trialPilot

Outcome Measures

Primary Outcomes (1)

  • Moderate-Vigorous Physical Activity (MVPA)

    Minutes/week spent in ≥10-min bouts of MVPA

    Change score: 9 weeks score - baseline score

Secondary Outcomes (11)

  • Quality of Life-Euroqol 5D (EQ5D)

    0, 9 weeks

  • Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) scale

    0, 9 weeks

  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) scale

    0, 9 weeks

  • Mindfulness- Mindful Attention Awareness Scale (MAAS), Frieberg Mindfulness Inventory (FMI)

    0, 9 weeks

  • Wellbeing-8-item Flourishing Scale

    0, 9 weeks

  • +6 more secondary outcomes

Study Arms (2)

Mindful Movement

EXPERIMENTAL

8, 90-minute, in-person, group sessions over 8 weeks

Other: Mindful Movement

10 Keys to Health & Wellbeing

ACTIVE COMPARATOR

8, 90-minute, in-person, group sessions over 8 weeks

Other: 10 Keys to Health & Wellbeing

Interventions

The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception, by providing opportunities for education, practice, and social support in mindfulness practices and physical activity.

Mindful Movement

This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.

10 Keys to Health & Wellbeing

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 50 years of age
  • Accelerometer wear time ≥10 hours on at least 4 days in a 7 consecutive day period between baselines
  • Self-report of \<140 minutes of MVPA per week in 3 months prior to baseline AND accelerometer recorded \<100 minutes of MVPA between baselines
  • Mini-Mental State score ≥ 24
  • Independent self-ambulation
  • Provides consent and is willing to participate in data collection activities

You may not qualify if:

  • Pregnancy
  • Unwilling or unable to participate in study activities
  • Current or upcoming participation in educational programs similar to those under study
  • Medical restrictions to increasing Moderate Vigorous Physical Activity (MVPA) AND health care provider does not provide clearance
  • Terminal illness
  • Contraindications to mindfulness practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

YMCA Southdale

Edina, Minnesota, 55435, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

YMCA Midway

Saint Paul, Minnesota, 55104, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Health

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Roni Evans, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2017

First Posted

April 14, 2017

Study Start

March 27, 2018

Primary Completion

August 31, 2018

Study Completion

February 28, 2019

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Data will be provided in aggregate.

Locations