UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022680
Receipt number R000026139
Scientific Title Effects of nutritional education on physical activity in patients with type 2 diabetes
Date of disclosure of the study information 2016/06/09
Last modified on 2016/06/09 14:29:53

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Basic information

Public title

Effects of nutritional education on physical activity in patients with type 2 diabetes

Acronym

Effects of nutritional education on physical activity

Scientific Title

Effects of nutritional education on physical activity in patients with type 2 diabetes

Scientific Title:Acronym

Effects of nutritional education on physical activity

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of nutritional education on physical activity in Japanese patients with type 2 diabetes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in physical activity from 0 to 16 weeks

Key secondary outcomes

Changes or percent changes of following parameters from 0 to 16 weeks
1)height, body weight, BMI, waist circumference
2)General Self efficacy Score (GSES),nutritional intake and dietary behavior,QOL
3)Body composition
fat mass, muscle mass and total body water volume measured by bioelectrical impedance analysis
4)Blood test
HbA1c, fasting plasma glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, blood urea nitrogen, creatinine
5)Athletic ability
Grip power


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

1) using pedometers
2) nutritional education more than once every two month

Interventions/Control_2

using pedometers

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

1) Aged >= 20
2) Patients with Type 2 Diabetes
3) Outpatient
4) Has never received nutritional education nor receive nutritional education at least three years by a registered dietitian

Key exclusion criteria

1) New patient
2) Has severe complications (cancer, hemodialysis, or blindness, etc)
3) Has diseases that affects physical activity (dismemberment, or rheumatic arthritis, etc)
4) Has psychiatric disorder
5) Has dementia
6) Pregnant or lactating
7) Has condition to avoid exercise
8) Has condition to be in-patient (severe ketosis, or sick day etc)
9) Considered inadequate by the investigator

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoko Nakanishi

Organization

Shiga University of Medical Science

Division name

Clinical nutrition

Zip code


Address

Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192

TEL

077-548-2519

Email

nakanish@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ayaka Motoo

Organization

Shiga University of Medical Science

Division name

Clinical nutrition

Zip code


Address

Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192

TEL

077-548-2519

Homepage URL


Email

motoo@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Doshisha women's College

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 06 Month 09 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

No longer recruiting

Date of protocol fixation

2016 Year 03 Month 04 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 09 Day

Last modified on

2016 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026139


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name