臨床研究等提出・公開システム

Date of registration	April. 20, 2026
Last modified on	April. 20, 2026
Trial ID	jRCT1030260050

Scientific Title	Verification of the effects of lifestyle improvement using an application and hot spring health promotion facilities for patients with type 2 diabetes.
Public Title	Verification of the effects of lifestyle intervention on lifestyle improvement for patients with type 2 diabetes.

Contact for Scientific Queries	Name	Tanimoto Yukie
	Affiliation	University of Yamanashi Hospital
	Address	1110 Shimokato Chuo-shi Yamanashi-ken
	Telephone	+81-552733310
	E-mail	nyukie@yamanashi.ac.jp
Contact for Public Queries	Name	Tanimioto Yukie
	Affiliation	University of Yamanashi Hospital
	Address	1110 Shimokato Chuo-shi Yamanashi-ken
	Telephone	+81-552733310
	E-mail	de-yamanashi-as@yamanashi.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 01, 2026
Target sample size		80
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Type 2 diabetes patients: HbA1c 7.0% or higher but less than 9.0%. No complications that contraindicate exercise therapy and able to perform exercise therapy at a hot spring health promotion facility. Possess a smartphone capable of installing and operating the application. For the past six months, diabetes control has been good, and the doctor predicts that changes in diabetes medication will not be necessary during the intervention period.
	Exclusion Criteria	Individuals who are insulin-dependent and use insulin. Individuals who have difficulty communicating in Japanese. Individuals who have difficulty filling out questionnaires. Individuals who are unable to walk independently. Individuals for whom the physical or psychological burden of the intervention is significant, and the researchers deem them unsuitable for participation.
	Age Minimum	18age old over
	Age Maximum	74age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		TYpe 2 diabetes
Intervention(s)		Researchers will explain this study to patients with type 2 diabetes to improve their lifestyle habits. Consent from the research participants will be obtained, followed by a questionnaire administered at a medical institution. The participants will then visit a hot spring health promotion facility (Natural Hot Spring Healthy SPA Sun Road, 4144-4 Osato-cho, Kofu City, Yamanashi Prefecture) for the installation of an activity meter for monitoring, app installation, body composition analysis, and blood pressure measurement, and to receive guidance on how to use the facility. There will be a one-week observation period. After one week, the participants will use the hot spring health promotion facility for four months. Based on the bathing therapy prescription written by the doctor, the participants will undergo bathing therapy and exercise therapy at the hot spring health promotion facility once a week and receive guidance from a nutritionist every two weeks. The effects on HbA1c, lipid metabolism, blood pressure, weight, and body composition will be verified during regular medical examinations at 2 and 4 months.
Health Condition(s) Keyword		type 2 diabetes
Primary Outcome(s)		Reduction in HbA1c from baseline at the end of the study (at 4 months).

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor	Applicable

Name of Certified Review Board	University of Yamanashi, Certified Review Board
Address	1110 Shimokato Chuo-shi Yamanashi-ken, Yamanashi
Telephone	+81-55-273-1111
E-Mail	de-yamanashi-as@yamanashi.ac.jp
Approval Status	Not approval

Plan to share IPD	Yes

Countries of Recruitment（Except Japan）	none