UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033152
Receipt number R000036739
Scientific Title Effects of agricultural and horticultural activity
Date of disclosure of the study information 2018/07/01
Last modified on 2020/08/06 10:30:27

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Basic information

Public title

Effects of agricultural and horticultural activity

Acronym

Effects of agricultural and horticultural activity

Scientific Title

Effects of agricultural and horticultural activity

Scientific Title:Acronym

Effects of agricultural and horticultural activity

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify whether agricultural and horticultural activity improves eating behavior in patients with diabetes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Eating behavior

Key secondary outcomes

HbA1c, body composition, physical activity, psychological condition


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Agricultural and horticultural activity for 4 months

Interventions/Control_2

Conventional diet therapy and exercise

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

Patients with diabetes attending Kyoto University Hospital who can engage in agricultural and horticultural activity

Key exclusion criteria

Those who cannot responce self-administered questionnaires
Those who cannot express their intention during the process of informed consent

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kaori
Middle name
Last name Ikeda

Organization

Kyoto University

Division name

Department of Diabetes, Endocrinology and Nutrition

Zip code

6068507

Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto

TEL

075-751-3560

Email

krikeda@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Kaori
Middle name
Last name Ikeda

Organization

Kyoto University

Division name

Department of Diabetes, Endocrinology and Nutrition

Zip code

6068507

Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto

TEL

075-751-3560

Homepage URL


Email

krikeda@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

JSPS

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Konoecho, Yoshida, Sakyo-ku Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.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



Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 06 Month 25 Day

Date of IRB

2018 Year 06 Month 25 Day

Anticipated trial start date

2018 Year 06 Month 26 Day

Last follow-up date

2020 Year 02 Month 01 Day

Date of closure to data entry

2020 Year 06 Month 15 Day

Date trial data considered complete

2020 Year 06 Month 15 Day

Date analysis concluded

2020 Year 06 Month 15 Day


Other

Other related information



Management information

Registered date

2018 Year 06 Month 26 Day

Last modified on

2020 Year 08 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036739


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name