NCT03929393

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 collaboratively with the YMCA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

5 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

April 16, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 17, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 21, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2.7 years

First QC Date

April 16, 2019

Results QC Date

April 11, 2023

Last Update Submit

July 12, 2023

Conditions

Physical InactivtyWellbeingMindfulness

Keywords

Randomized controlled trialExercisePhysical ActivityBehavior ChangeMindfulnessAging

Outcome Measures

Primary Outcomes (2)

  • Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts

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

    Baseline

  • Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts

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

    Change score: 9 weeks - baseline

Secondary Outcomes (84)

  • Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts

    Change score: 26 weeks - baseline

  • Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts

    Change score: 52 weeks - baseline

  • Total Moderate-Vigorous Physical Activity (MVPA)

    Baseline

  • Total Moderate-Vigorous Physical Activity (MVPA)

    Change score: 9 weeks - baseline

  • Total Moderate-Vigorous Physical Activity (MVPA)

    Change score: 26 weeks - baseline

  • +79 more secondary outcomes

Study Arms (2)

Mindful Movement

EXPERIMENTAL

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

Behavioral: Mindful Movement

Keys to Health & Wellbeing

ACTIVE COMPARATOR

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

Other: Keys to Health & Wellbeing

Interventions

Mindful MovementBEHAVIORAL

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 suppo

Mindful Movement
Keys to Health & WellbeingOTHER

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.

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 if indicated
  • 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)
  • Terminal illness
  • Contraindications to mindfulness practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

YMCA Burnsville

Burnsville, Minnesota, 55337, United States

Location

YMCA Southdale

Edina, Minnesota, 55435, United States

Location

YMCA Cora McCorvey

Minneapolis, Minnesota, 55405, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

YMCA Midway

Saint Paul, Minnesota, 55104, United States

Location

Related Links

MeSH Terms

Conditions

Motor Activity

Interventions

Health

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Limitations and Caveats

The interventions were transitioned to remote delivery as the trial was ongoing due to the COVID-19 pandemic.

Results Point of Contact

Title
Brent Leininger
Organization
University of Minnesota
lein0122@umn.edu
(612) 626-6477

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

April 16, 2019

First Posted

April 26, 2019

Study Start

July 17, 2019

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

July 21, 2023

Results First Posted

July 21, 2023

Record last verified: 2023-07

Locations

US(5)