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Trial record 1 of 1 for:    05233813
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Active Body and Mind Intervention for Older Adults

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ClinicalTrials.gov Identifier: NCT05233813
Recruitment Status : Completed
First Posted : February 10, 2022
Last Update Posted : February 10, 2022
Sponsor:
Information provided by (Responsible Party):
Weiyun Chen, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Well Aging Behavioral: Active Body and Mind Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Testing the Multilevel Active Body and Mind (ABM) Intervention for Older Adults
Actual Study Start Date : September 13, 2019
Actual Primary Completion Date : December 6, 2019
Actual Study Completion Date : December 6, 2019

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.
Behavioral: Active Body and Mind
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.

No Intervention: Comparison group
The comparison group continued their usual activities.



Primary Outcome Measures :
  1. 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.

  2. Baseline Happiness [ Time Frame: Baseline (the week before 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.

  3. Baseline Life Satisfaction [ Time Frame: Baseline (the week before the intervention) ]
    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.

  4. Baseline Eudaimonic Well-Being [ Time Frame: Baseline (the week before 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.

  5. 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.

  6. 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.

  7. Posttest Life Satisfaction [ Time Frame: Post-intervention test (the week after the intervention) ]
    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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05233813


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Weiyun Chen, Ph.D. University of Michigan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weiyun Chen, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT05233813    
Other Study ID Numbers: HUM00158279
First Posted: February 10, 2022    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No