UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

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

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

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

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)

Email

dialbetics-office@umin.ac.jp

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

Email

dialbetics-project@umin.ac.jp

Institute

Department of Healthcare Information Management, The University of Tokyo Hospital

Institute

Department

Personal name

Organization

Self-Managing Healthy Society, The University of Tokyo

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

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

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

Email

ethics@m.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東急百貨店健康保険組合（東京都）

Date of disclosure of the study information

2019

Year

09

Month

09

Day

URL releasing protocol

https://cardio.jmir.org/2023/1/e43940

Publication of results

Published

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

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 related 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