UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051904 |
|---|---|
| Receipt number | R000058951 |
| Scientific Title | Mobile app-based peer support to increase walking steps for older people: a cluster-randomized controlled trial |
| Date of disclosure of the study information | 2023/08/14 |
| Last modified on | 2026/08/16 09:51:41 |
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Basic information
Public title
Mobile app-based peer support to increase walking steps for older people
Acronym
Mobile app-based peer support to increase walking steps for older people
Scientific Title
Mobile app-based peer support to increase walking steps for older people: a cluster-randomized controlled trial
Scientific Title:Acronym
Mobile app-based peer support to increase walking steps for older people: a cluster-randomized controlled trial
Region
| Japan |
Condition
Condition
ADL and IADL disabilities
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether mobile app-based peer support increases walking steps among older people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Changes in walking steps per a week from baseline to three months after installation of the peer support app
Key secondary outcomes
Changes in walking steps per a week from baseline to one month after installation of the peer support app
Changes in subjective health, well-being, loneliness, social isolation, blood pressure, and etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Two lectures of a peer support app; installing a health care app (Google Fit (Android) or The Apple Health (iPhone) and a peer support app (Minchale)
Interventions/Control_2
Two lectures of smartphone; installing a health care app (Google Fit (Android) or The Apple Health (iPhone))
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who are using a smartphone when consent is obtained
(2) Those who can communicate in Japanese
(3) Those who are 60 years or older
(4) Those who have obtained consent for participation in the research from the research subjects themselves
Key exclusion criteria
(1) Those who do not have a smartphone by which the peer support app can be installed.
(2) Those who do not consent to participate in this study
(3) Those who cannot walk with their smartphone
(4) Those who have a walking restriction by a doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakagomi |
Organization
Center for Preventive Medical Sciences, Chiba University, Chiba, Japan
Division name
Department of Social Preventive Medical Sciences
Zip code
263-8522
Address
1-33 Yayoicho, Inage Ward, Chiba
TEL
043-251-1111
anakagomi0211@chiba-u.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakagomi |
Organization
Center for Preventive Medical Sciences, Chiba University, Chiba, Japan
Division name
Department of Social Preventive Medical Sciences
Zip code
263-8522
Address
1-33 Yayoicho, Inage Ward, Chiba
TEL
043-251-1111
Homepage URL
anakagomi0211@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Atsushi Nakagomi
Funding Source
Organization
Japan Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
A10 Lab Inc.
IRB Contact (For public release)
Organization
Research ethics committee of Chiba University
Address
1-8-1Inohaba, Chuo-ku, Chiba, Chiba
Tel
043-251-1111
inohana-rinri@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.jmir.org/2026/1/e75708/
Publication of results
Published
Result
URL related to results and publications
https://www.jmir.org/2026/1/e75708/
Number of participants that the trial has enrolled
156
Results
For the primary outcome, change in weekly average daily steps from baseline to Week 12, the unadjusted MMRM showed a significantly greater increase in the intervention arm (difference=579 steps, 95% CI 36-1123, P=.04); sensitivity analyses were consistent. No significant difference was found for total MET-minutes/week (P=.054) or walking 30 min/day or more (P=.33), whereas daily smartphone use (OR 4.10, P=.03) and number of use purposes (P=.01) were higher.
Results date posted
| 2026 | Year | 08 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The analytic sample was 117 participants (control n=53, intervention n=64). Mean age was 81.2 (SD 4.7) vs 79.0 (SD 4.5) years (P=.009). Men 32.1% vs 28.1%, iOS 17.0% vs 28.1%, almost-daily smartphone use 77.4% vs 85.9%, college or above 47.2% vs 31.7%, married 49.1% vs 48.4%, self-rated health 6.8 in both, total MET 3274 vs 3372, walking 30 min/day or more 69.8% vs 67.2%, baseline daily steps 3951 vs 4583. Apart from age, arms were well balanced.
Participant flow
From September 2023 to June 2024, 177 were assessed for eligibility and 21 excluded (declined 12, app already installed 8, did not attend information session 1). The 156 remaining formed 40 clusters of 3-5 and were randomized by cluster (intervention 20 clusters, n=80; control 20 clusters, n=76). Sixteen per arm were lost to follow-up; 124 (79.5%) completed the 3-month follow-up (n=64 and n=60). A linkage error lost step data for 7 controls, leaving 117 analyzed.
Adverse events
No intervention-related adverse events were reported during the trial.
Outcome measures
Primary outcome: change in weekly average daily step count from baseline to Week 12, measured by smartphone, with days under 1000 steps treated as missing. Secondary outcomes: weekly steps at Weeks 1-11 and monthly averages (Months 1-3), total physical activity (MET-minutes/week, IPAQ short form), self-reported walking 30 min/day or more, almost-daily smartphone use, and number of smartphone use purposes (12-item checklist), assessed by questionnaire at Week 12.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 14 | Day |
Last modified on
| 2026 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058951
