UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037970 |
|---|---|
| Receipt number | R000042845 |
| Scientific Title | Effects of a smartphone-based self-management support system with enhanced goal setting and automated feedback to increase physical activity in people at high risk for lifestyle-related diseases (before-after study) |
| Date of disclosure of the study information | 2019/09/09 |
| Last modified on | 2023/09/14 11:50:07 |
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Basic information
Public title
Effects of a smartphone-based self-management support system to increase physical activity in people at high risk for lifestyle-related diseases (before-after study)
Acronym
Effects of a smartphone-based self-management support system to increase physical activity in people at high risk for lifestyle-related diseases (before-after study)
Scientific Title
Effects of a smartphone-based self-management support system with enhanced goal setting and automated feedback to increase physical activity in people at high risk for lifestyle-related diseases (before-after study)
Scientific Title:Acronym
Effects of a smartphone-based self-management support system with enhanced goal setting and automated feedback to increase physical activity in people at high risk for lifestyle-related diseases (before-after study)
Region
| Japan |
Condition
Condition
Hypertension, type 2 diabetes, and metabolic syndrome (including pre-disease states)
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of smartphone-based self-management support system DialBetes Step on the number of daily steps logged by people with hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Change in the mean number of steps/day recorded in the system between the baseline period and Week 5~6 of the intervention period
Key secondary outcomes
-Changes in other physical activity parameters (energy consumption by activity and self-reported walking time), self-efficacy, self-regulation for physical activity, self-management behaviors, intake of nutrients, biomedical characteristics (blood pressure at home and at hospital, BMI, visceral fat area, HbA1c, fasting/postprandial blood glucose, triglyceride, HDL cholesterol, calculated LDL cholesterol, and medications), and locomotive functions
-Primary assessment: during/after Week 5~6 of intervention, secondary assessment: during/after Week 23~24 of intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
1. Group session (for 110~125 minutes)
-Lecture on lifestyle-related diseases and general recommendations for diet and exercise
-Lecture, with practice using the system
2. Baseline period (2 weeks)
Participants use only recording function of DialBetics. They measure blood pressure twice a day, body weight once a day. Some participants also measure blood glucose levels once or twice a day. They record those measured data into the system right after measurement. Participants wear an accelerometer and record data into the system every night. They also input their diet and exercise into the system.
3. Intervention period (24 weeks)
Participants use all functions of DialBetes Step, which includes the functions in the original DialBetics application, such as sending evaluation messages and diet advice after participants record data. They (re)set their step goal and make/review their action plan on the system once a week. They are given automated daily feedback on their step goal achievement and individualized advice to promote physical activity after recording their accelerometer data. They are also given automated weekly feedback from the system.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Employees of private enterprises who are covered under the Tokyu Department Store Health Insurance Society
-Working in the Tokyo metropolitan area
-Systolic blood pressure 140 mmHg or higher at workplace health checkup in fiscal 2017
-Willing to increase physical activity through walking
-Able to engage in moderate physical activity
Key exclusion criteria
-Those who had been (would be) given specific health guidance in fiscal 2018
-Most recent systolic blood pressure being 180 mmHg or higher
-Most recent hemoglobin level lower than 10 g/dl
-Those who have diabetes, excepting type 2
-Those who were judged to be ineligible by occupational physicians
-Those who had experienced any hypoglycemic events within three months
-Those who are pregnant, lactating, or considering pregnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kayo |
| Middle name | |
| Last name | Waki |
Organization
The University of Tokyo
Division name
Department of Healthcare Information Management, The University of Tokyo Hospital
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411(ext.34462)
dialbetics-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Shibuta |
Organization
The University of Tokyo
Division name
Department of Healthcare Information Management, The University of Tokyo Hospital
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411(ext.34462)
Homepage URL
dialbetics-project@umin.ac.jp
Sponsor or person
Institute
Department of Healthcare Information Management, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-Managing Healthy Society, The University of Tokyo
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyu Department Store Health Insurance Society
Name of secondary funder(s)
-NTT DOCOMO, INC.
-Graduate Program for Social ICT Global Creative Leaders, The University of Tokyo
IRB Contact (For public release)
Organization
Office for Human Research Studies (OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.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
東急百貨店健康保険組合（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
https://cardio.jmir.org/2023/1/e43940
Publication of results
Published
Result
URL related to results and publications
https://cardio.jmir.org/2023/1/e43940
Number of participants that the trial has enrolled
34
Results
We included 30 participants in the main population for analyses. Steps per day significantly increased at Week 5~6 of the intervention period compared to the baseline period (median: +1493 steps per day, P < .001). However, the increases attenuated and did not remain significant at Week 23~24 of the intervention period (median: +1056 steps per day, P = .04).
Results date posted
| 2021 | Year | 03 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 21 | Day |
Baseline Characteristics
The mean age of the participants in the main population for analyses was 52.9 years (SD=5.3) and 19 (63%) were male. The mean blood pressure and BMI at hospital were 148.3 (SD=17.0)/97.8 (SD=9.1) mmHg, 23.5 (SD=3.3) kg/m2, respectively.
Participant flow
Of 34 participants who provided the informed consent and received intervention, 30 participants who met the qualifications for our theoretical target population were included in the main population for analyses. We could not follow-up one participant in the main population for analyses after primary assessment; 29 were included in secondary assessment.
Adverse events
We included all (34) participants in the assessment of adverse events. The score of the body pain did not change over time. Of participants whose item score of lower limbs pain increased by at least 1 point (primary assessment: 7 participants, secondary assessment: 6 participants), one participant's item score became 3 ("considerable pain").
Outcome measures
Steps per day significantly increased at Week 5~6 of the intervention period compared to the baseline period (median: +1493 steps per day, P < .001). However, the increases attenuated and did not remain significant at Week 23~24 of the intervention period (median: +1056 steps per day, P = .04).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042845
