臨床研究等提出・公開システム

Date of registration	Oct. 04, 2024
Last modified on	Oct. 04, 2024
Trial ID	jRCT1030240374

Scientific Title	Effectiveness of pre-conception care programmes in diabetes.
Public Title	Effectiveness of pre-conception care programmes.

Contact for Scientific Queries	Name	Yamada Mihoko
	Affiliation	National Center for Child Health and Development
	Address	2-10-1, Okura, Setagaya-ku, Tokyo
	Telephone	+81-3-3416-0181
	E-mail	kanba-m@ncchd.go.jp
Contact for Public Queries	Name	Yamada Mihoko
	Affiliation	National Center for Child Health and Development
	Address	2-10-1, Okura, Setagaya-ku, Tokyo
	Telephone	+81-3-3416-0181
	E-mail	kanba-m@ncchd.go.jp

Recruitment status	Pending

Anticipated date of first enrollment		Sept. 13, 2024
Actual date of first enrollment		Sept. 27, 2024
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	single blind
	control	uncontrolled control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(i) Patients have attended a study session on pre-conception care at a summer camp organised by the Ayumi no Kai, our patient association (ii) Patients have a diagnosis of type 1 diabetes (iii) Patients aged 9 years or older who are preadolescents at the time consent is obtained are eligible (iv) Patients have written research subject consent and consent from a legal guardian, a substitute consentor.
	Exclusion Criteria	Patients who cannot understand and speak Japanese or have intellectual and developmental disabilities.
	Age Minimum	9age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Type 1 diabetes
Intervention(s)		The PCC programme and materials and the programme were reviewed with collaborators with skilled diabetes care and diabetes care support skills, referring to materials on preconception care (hereafter PCC) prepared based on the revised International Guidelines for Sexuality Education and other guidelines and the Diabetes Care Guidelines. The contents of the programme are related to diabetes in relation to preconception care, including the role of the family in diabetes, the private zone, the mechanism of pregnancy, pregnancy and blood glucose levels, familiarity and menstruation, menstruation and blood glucose levels, the need for planned pregnancy and basal body temperature. The programme is explained verbally during outpatient visits, individually and directly to the patient, with the patient being shown the material. Verbal explanations are conducted by the principal investigator and co-investigator nurses. Three interventions will be carried out.
Primary Outcome(s)		The primary endpoint will be the difference between pre- and post-intervention questionnaires administered before and after the three interventions, and the secondary endpoints will be changes in PCC-related behaviour, changes in glycaemic control, changes in lifestyle (diet, exercise, sleep) and patients' speech and behaviour before and after the intervention. Evaluation will be carried out before the supportive intervention and one month after the third implementation of the supportive intervention.

Primary Sponsor	National Center for Child Health and Development

Secondary Sponsor

Source of Monetary Support	2021 Medical Staff Development Research Grant from the Japan Diabetes Association.
Secondary Sponsor	Not applicable

Name of Certified Review Board	National Centre for Child Health and Development Clinical Research Ethics Review Committee
Address	2-10-1, Okura, Setagaya-ku, Tokyo, Tokyo
Telephone	+81-3-3416-0181
E-Mail	rinken@ncchd.go.jp
Approval Status	Approval
Date of approval	Sept. 13, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none