- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05233813
Active Body and Mind Intervention for Older Adults
February 9, 2022 updated by: Weiyun Chen, University of Michigan
A Pilot Study of Testing the Multilevel Active Body and Mind (ABM) Intervention for Older Adults
This study aimed to examine the effectiveness and acceptability of wearable activity trackers with self-regulatory techniques for promoting physical activity (PA) in older adults.
In addition, this study aimed to investigate the impact of a multicomponent PA intervention on life satisfaction, happiness, eudaimonic well-being, and depressive symptoms, reflecting different dimensions of psychological well-being, in older adults.
Study Overview
Detailed Description
Fifty-nine participants living in retirement communities were voluntarily assigned to a 12-week multi-component PA intervention program or an attention control group.
Participants in the intervention group were asked to take three 45-min supervised group exercise lessons per week and wear wearable activity trackers during the weekdays for 12 weeks.
Four components of psychological well-being were assessed at baseline and the end of the intervention including life satisfaction, happiness, eudaimonic well-being, and depressive symptoms.
The intervention effect on each component of psychological well-being was analyzed using linear mixed models after controlling for potential confounders.
Participants' experiences of using the wearable activity tracker were assessed after the 12-week intervention through an 8-item questionnaire and individual interviews
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 65 or older,
- able to speak and read English fluently
- able to walk for 10 feet without human assistance
Exclusion Criteria:
- conditions preventing them from doing exercises
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ABM intervention group
The intervention group received three, 45-min group exercise lessons for 12 weeks.
The group exercise lessons were taught by two experienced instructors..
Each participant in the intervention group received a Fitbit (Model InspireHR) activity tracker to self-monitor their daily PA, 5 days per week for 12 weeks.
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The intervention group attended three 45-min group exercise lessons per week and wore a Fitbit activity tracker during the weekdays for 12 weeks combined with weekly feedback and personalized activity goals.
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No Intervention: Comparison group
The comparison group continued their usual activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Depression
Time Frame: Baseline (the week before the intervention)
|
Depression was measured using the 10-item Centre for Epidemiological Studies Depression Inventory on a 4-point Likert scale.
The level of depressive symptoms was reflected by summing the responses of the ten items, with higher scores indicating greater levels of depressive symptoms.
|
Baseline (the week before the intervention)
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Baseline Happiness
Time Frame: Baseline (the week before the intervention)
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Happiness was measured using the 4-item Subjective Happiness Scale on a 7-point Likert scale.
The mean score of all items was calculated to indicate the level of happiness with higher scores indicating greater happiness.
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Baseline (the week before the intervention)
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Baseline Life Satisfaction
Time Frame: Baseline (the week before the intervention)
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Life satisfaction was measured using the 5-item Satisfaction With Life Scale on a 7-point Likert scale.
The sum of all items provides a composite score, with higher scores representing higher levels of life satisfaction.
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Baseline (the week before the intervention)
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Baseline Eudaimonic Well-Being
Time Frame: Baseline (the week before the intervention)
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Eudaimonic well-being was assessed using the 18-item Psychological Well-Being Scale on a 7-point Likert scale.
An overall score was computed by averaging the scores of all items.
Higher scores indicate higher levels of eudaimonic well-being.
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Baseline (the week before the intervention)
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Posttest Depression
Time Frame: Post-intervention test (the week after the intervention)
|
Depression was measured using the 10-item Centre for Epidemiological Studies Depression Inventory on a 4-point Likert scale.
The level of depressive symptoms was reflected by summing the responses of the ten items, with higher scores indicating greater levels of depressive symptoms.
|
Post-intervention test (the week after the intervention)
|
Posttest Happiness
Time Frame: Post-intervention test (the week after the intervention)
|
Happiness was measured using the 4-item Subjective Happiness Scale on a 7-point Likert scale.
The mean score of all items was calculated to indicate the level of happiness with higher scores indicating greater happiness.
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Post-intervention test (the week after the intervention)
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Posttest Life Satisfaction
Time Frame: Post-intervention test (the week after the intervention)
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Life satisfaction was measured using the 5-item Satisfaction With Life Scale on a 7-point Likert scale.
The sum of all items provides a composite score, with higher scores representing higher levels of life satisfaction.
|
Post-intervention test (the week after the intervention)
|
Posttest Eudaimonic Well-Being
Time Frame: Post-intervention test (the week after the intervention)
|
Eudaimonic well-being was assessed using the 18-item Psychological Well-Being Scale on a 7-point Likert scale.
An overall score was computed by averaging the scores of all items.
Higher scores indicate higher levels of eudaimonic well-being.
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Post-intervention test (the week after the intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Weiyun Chen, Ph.D., University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 13, 2019
Primary Completion (Actual)
December 6, 2019
Study Completion (Actual)
December 6, 2019
Study Registration Dates
First Submitted
January 13, 2022
First Submitted That Met QC Criteria
February 9, 2022
First Posted (Actual)
February 10, 2022
Study Record Updates
Last Update Posted (Actual)
February 10, 2022
Last Update Submitted That Met QC Criteria
February 9, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- HUM00158279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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