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CompletedNCT05233813Updated Feb 10, 2022

Active Body and Mind Intervention for Older Adults

An interventional study of Active Body and Mind in Well Aging, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-10.

Sponsored by University of Michigan · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Sep 2019, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Well Aging
03

In context

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • aged 65 or older,
  • able to speak and read English fluently
  • able to walk for 10 feet without human assistance

Exclusion criteria

Exclusion Criteria:

  • conditions preventing them from doing exercises
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • 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

  • No intervention
    Comparison group

    The comparison group continued their usual activities.

Interventions

  • BehavioralActive 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.

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What researchers measure

Primary outcomes

  1. Baseline Depression

    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.

    Time frame: Baseline (the week before the intervention)

  2. Baseline Happiness

    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.

    Time frame: Baseline (the week before the intervention)

  3. Baseline Life Satisfaction

    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.

    Time frame: Baseline (the week before the intervention)

  4. Baseline Eudaimonic Well-Being

    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.

    Time frame: Baseline (the week before the intervention)

  5. Posttest Depression

    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.

    Time frame: Post-intervention test (the week after the intervention)

  6. Posttest Happiness

    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.

    Time frame: Post-intervention test (the week after the intervention)

  7. Posttest Life Satisfaction

    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.

    Time frame: Post-intervention test (the week after the intervention)

  8. Posttest Eudaimonic Well-Being

    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.

    Time frame: Post-intervention test (the week after the intervention)

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Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
08

References and documents

Publications

  • Zhang Z, Giordani B, Margulis A, Chen W. Efficacy and acceptability of using wearable activity trackers in older adults living in retirement communities: a mixed method study. BMC Geriatr. 2022 Mar 21;22(1):231. doi: 10.1186/s12877-022-02931-w. PubMed 35313819 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05233813
Lead sponsor
University of Michigan
Responsible party
Weiyun Chen (Associate Professor, University of Michigan) — Principal investigator
First posted
Feb 10, 2022
Start date
Sep 13, 2019
Primary completion
Dec 6, 2019
Completion
Dec 6, 2019
Last update
Feb 10, 2022

Study contacts

Weiyun Chen, Ph.D.
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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