NCT05233813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
Last Updated

February 10, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

January 13, 2022

Last Update Submit

February 9, 2022

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (2)

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.

Behavioral: Active Body and Mind

Comparison group

NO INTERVENTION

The comparison group continued their usual activities.

Interventions

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.

ABM intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • conditions preventing them from doing exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Weiyun Chen, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 10, 2022

Study Start

September 13, 2019

Primary Completion

December 6, 2019

Study Completion

December 6, 2019

Last Updated

February 10, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations