UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059549 |
|---|---|
| Receipt number | R000068101 |
| Scientific Title | Effects of a 12-week wearable accelerometer-based feedback and behavior change techniques (BCTs) intervention on physical activity and sedentary behavior patterns among community-dwelling older women. |
| Date of disclosure of the study information | 2025/10/27 |
| Last modified on | 2025/10/27 12:43:06 |
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Basic information
Public title
A 12-week study using wearable devices and behavior change coaching to increase physical activity and reduce sedentary time in older women
Acronym
Wearable Device and BCTs for Activity in Older Women
Scientific Title
Effects of a 12-week wearable accelerometer-based feedback and behavior change techniques (BCTs) intervention on physical activity and sedentary behavior patterns among community-dwelling older women.
Scientific Title:Acronym
Effects of a 12-week wearable accelerometer-based feedback and behavior
Region
| Asia(except Japan) |
Condition
Condition
Healthy, community-dwelling older women
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether a 12-week intervention combining wearable device (accelerometer) feedback with behavior change techniques (BCTs) can increase physical activity and modify sedentary behavior patterns among community-dwelling older women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Change from baseline (0-week) to post-intervention (12-weeks) in accelerometer-measured Total Physical Activity (LPA + MVPA), measured in minutes per day.
2. Change from baseline (0-week) to post-intervention (12-weeks) in accelerometer-measured frequency of 30-minute sedentary bouts.
Key secondary outcomes
1. Change from baseline (0-week) to post-intervention (12-weeks) in accelerometer-measured daily walking steps.
2. Change from baseline (0-week) to post-intervention (12-weeks) in accelerometer-measured Light Physical Activity (LPA), in minutes/day.
3. Change from baseline (0-week) to post-intervention (12-weeks) in accelerometer-measured Moderate-to-Vigorous Physical Activity (MVPA), in minutes/day.
4. Change from baseline (0-week) to post-intervention (12-weeks) in accelerometer-measured total Sedentary Time (ST), in minutes/day.
5. Change from baseline (0-week) to post-intervention (12-weeks) in accelerometer-measured total time (minutes) in 30-minute sedentary bouts.
6. Change from baseline (0-week) to post-intervention (12-weeks) in accelerometer-measured number of 1-minute sedentary breaks per day.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Arm 1: Intervention Group (IG)
Duration: 12 weeks Intervention: A multi-component intervention combining wearable accelerometer feedback (ActiGraph GT3X+) with behavior change techniques (BCTs). Details:
Wearable Device Monitoring: Participants used an ActiGraph GT3X+ to track physical activity (PA) and sedentary time (ST).
Step Count Goal: Encouraged to walk at least 7,000 steps per day.
Exercise Planning and Consultation: Received weekly guidance on exercise planning and personalized prescriptions from an expert coach.
Health Belief Model Education: Attended weekly sessions to identify and overcome barriers to a healthy lifestyle.
Sedentary Behavior Reduction: Introduced to strategies for replacing sedentary behavior (SB) with light physical activity (LPA), reinforced by weekly education on SB health risks and daily text messages from an expert via a social media group.
Interventions/Control_2
Arm 2: Control Group (CG) Duration: 12 weeks
Intervention: Active control receiving health-related information. Details: Participants attended courses on various healthy aging topics, including fall prevention, arthritis, bone health, cognitive function, social engagement, depression, stress management, sleep, and healthy eating. These courses were designed to maintain motivation but did not include cognitive education or behavioral strategies aimed at increasing PA or reducing SB.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Aged 65 or older
2. Residing in the community (excluding geriatric care institutions)
3. Self-identified as not engaging in strength training or meeting the recommended 150 minutes of moderate-intensity PA per week over the past three months
4. Willing to wear a wearable device on the waist
5. Able to walk independently without assistance
6. Possessing normal or corrected-to-normal vision
Key exclusion criteria
1. Having a fall-related fracture within the past year
2. Mini-Mental State Examination (MMSE) score of less than 24
3. Presence of diseases or physical frailty, such as cardiovascular, pulmonary, or neurological conditions
4. Functional and movement limitations that could interfere with participation in the study
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Ming-Chun |
| Middle name | |
| Last name | Hsueh |
Organization
University of Taipei
Division name
Institute of Sport Pedagogy
Zip code
11036
Address
No. 101, Sec. 2, Zhongcheng Rd., Shilin Dist., Taipei City 111036, Taiwan
TEL
8862287182885902
boxeo@utaipei.edu.tw
Public contact
Name of contact person
| 1st name | Ming-Chun |
| Middle name | |
| Last name | Hsueh |
Organization
University of Taipei
Division name
Institute of Sport Pedagogy
Zip code
11036
Address
No. 101, Sec. 2, Zhongcheng Rd., Shilin Dist., Taipei City 111036, Taiwan
TEL
8862287182885902
Homepage URL
boxeo@utaipei.edu.tw
Sponsor or person
Institute
University of Taipei
Institute
Department
Personal name
Funding Source
Organization
National Science and Technology Council and Technology of Taiwan
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Taiwan
Other related organizations
Co-sponsor
University of Taipei
Name of secondary funder(s)
Research and Development Office
IRB Contact (For public release)
Organization
University of Taipei Human Research Ethics Committee
Address
(Administration Building 2F), No. 101, Sec. 2, Zhongcheng Rd., Shilin Dist., Taipei City 111036, Taiwan
Tel
8862287182887812
irb-iacuc@go.utaipei.edu.tw
Secondary IDs
Secondary IDs
YES
Study ID_1
IRB-2021-090
Org. issuing International ID_1
University of Taipei review board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
Manuscript under review; URL will be provided upon publication
Publication of results
Unpublished
Result
URL related to results and publications
Manuscript under review; URL will be provided upon publication
Number of participants that the trial has enrolled
42
Results
After 12 weeks, the intervention group showed significant improvements compared to the control group in: total physical activity (F=30.31, p=.000), daily walking steps (F=7.10, p=.011), frequency of 30-min sedentary bouts (F=40.75, p=.000), and total time in 30-min sedentary bouts (F=39.00, p=.000). There were no significant group differences in LPA, MVPA, total sedentary time (ST), or the number of 1-min sedentary breaks.
Results date posted
| 2025 | Year | 10 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 10 | Month | 25 | Day |
Baseline Characteristics
A total of 42 older women completed the study (Intervention Group, IG, n=22; Control Group, CG, n=20). The mean age of all participants was 73.25 (SD 4.39) years and BMI was 22.82 (SD 2.48). There were no significant differences in baseline characteristics between the two groups (p > 0.05).
Participant flow
Initially, 74 individuals were recruited. 55 were assessed for eligibility, and 7 were excluded. 48 participants were randomized. Intervention Group (n=24): 2 participants dropped out (1 loss of interest, 1 incomplete information); 22 were analyzed. Control Group (n=24): 4 participants dropped out (1 loss of interest, 1 refused post-tests, 1 injured, 1 incomplete information); 20 were analyzed
Adverse events
There is no adverse event.
Outcome measures
Data reported as Intervention Group (IG) vs. Control Group (CG) adjusted 12-week means:
Total PA (min/day): Significant (p=.000). IG: 339.28; CG: 318.02.
Daily steps: Significant (p=.011). IG: 8198.12; CG: 6758.07.
ST 30-min frequency: Significant (p=.000). IG: 2.01; CG: 4.21.
ST 30-min total time (min): Significant (p=.000). IG: 80.95; CG: 183.95.
LPA (min/day): Not significant (p=.360).
MVPA (min/day): Not significant (p=.079).
ST (min/day): Not significant (p=.063).
1-min sedentary breaks: Not significant (p=.054).
Plan to share IPD
Yes
IPD sharing Plan description
The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 06 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068101
