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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05233813
Other study ID # HUM00158279
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 13, 2019
Est. completion date December 6, 2019

Study information

Verified date February 2022
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date December 6, 2019
Est. primary completion date December 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (the week before the intervention)
Primary 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. Baseline (the week before the intervention)
Primary 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. Baseline (the week before the intervention)
Primary 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. Baseline (the week before the intervention)
Primary 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. Post-intervention test (the week after the intervention)
Primary 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. Post-intervention test (the week after the intervention)
Primary 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. Post-intervention test (the week after the intervention)
Primary 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. Post-intervention test (the week after the intervention)
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