Well AgingNCT05233813
Active Body and Mind Intervention for Older Adults
A study testing Active Body and Mind in people with Well Aging, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well Aging
- What is being tested?
- Active Body and Mind
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2019to 6 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged 65 or older,
- able to speak and read English fluently
- able to walk for 10 feet without human assistance
Who cannot join
- conditions preventing them from doing exercises
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Conditions
- Well Aging
- Being tested
- Active Body and Mind
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Body and MindBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ABM intervention group | Experimental | 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. Receives: Behavioral: Active Body and Mind |
| Comparison group | No intervention | The comparison group continued their usual activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (the week before the intervention)
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.
Measured: Baseline (the week before the intervention)
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.
Measured: Baseline (the week before the intervention)
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.
Measured: Baseline (the week before the intervention)
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.
Measured: Post-intervention test (the week after the intervention)
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.
Measured: Post-intervention test (the week after the intervention)
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.
Measured: Post-intervention test (the week after the intervention)
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.
Measured: Post-intervention test (the week after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start13 Sep 2019
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Well AgingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiyun Chen, University of Michigan
- Investigators
- Weiyun Chen, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233813
- Sponsor's protocol ID
- HUM00158279
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Testing the Multilevel Active Body and Mind (ABM) Intervention for Older Adults
- ClinicalTrials.gov ID
- NCT05233813
- Acronym / sponsor ID
- HUM00158279
- Conditions
- Well Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABM intervention group | Experimental | Behavioral: Active Body and MindThe 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. |
| Comparison group | No intervention | –The comparison group continued their usual activities. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- aged 65 or older,
- able to speak and read English fluently
- able to walk for 10 feet without human assistance
Key exclusion criteria (1 listed)
- conditions preventing them from doing exercises
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Body and MindThe 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. | Behavioural | ABM intervention group |
Primary outcome
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 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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Derived from this study: PubMed 35313819Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiyun Chen, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Body and Mind in people with Well Aging, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Depression (time frame: Baseline (the week before the intervention)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05233813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.