Active Body and Mind Intervention for Older Adults

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

• Principal Investigator: Weiyun Chen, Ph.D.; University of Michigan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Weiyun Chen, Associate Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT05233813
• Other Study ID Numbers: HUM00158279
• First Posted: February 10, 2022
• Last Update Posted: February 10, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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