UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009138
Receipt number R000010711
Scientific Title Randomized controlled trial of a dietary educational intervention for managing sleep quality and fatigue in healthy women
Date of disclosure of the study information 2012/10/18
Last modified on 2013/04/18 11:34:47

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Basic information

Public title

Randomized controlled trial of a dietary educational intervention for managing sleep quality and fatigue in healthy women

Acronym

A dietary educational intervention managing sleep quality and fatigue.

Scientific Title

Randomized controlled trial of a dietary educational intervention for managing sleep quality and fatigue in healthy women

Scientific Title:Acronym

A dietary educational intervention managing sleep quality and fatigue.

Region

Japan


Condition

Condition

Subjects with sleep problems

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of a dietary educational intervention in improving sleeping quality and fatigue

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in sleep quality

Key secondary outcomes

Changes in fatigue
Changes in autonomic function
Changes in salivary cortisol and melatonin
Changes in sleep-awaking cycle


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

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Dietary education

Interventions/Control_2

No ddietary education

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

30 years-old <=

Age-upper limit

69 years-old >=

Gender

Female

Key inclusion criteria

1) Subjects with sleep problems
2)At least one meet following requirements;
(1) having a hard time eating quietly because of housework or child rearing
(2) tend to be overweight by eating at night, or irregular eating schedule
(3) having irregular eating schedule for other reasons.

Key exclusion criteria

1) inpatients or outpatients
2) taking sleeping pills
3) shiftworker
4) BMI <16, or >=28
5) energy intake >= 3,000 kcal
6) with a medical history of mental diseases, liver dysfunction, renal dysfunction
7) requirement of a daily restricted diet
8) other requirements

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sanae Fukuda

Organization

Osaka City University, Graduate School of Medicine

Division name

Department of Medical Science on Fatigue

Zip code


Address

1-4-3 Asahi-machi, Abeno, Osaka, Japan

TEL

+81(0)6-6645-2637

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hisako Fujii

Organization

Osaka City University, Graduate School of Medicine

Division name

Department of Physiology

Zip code


Address

1-4-3 Asahi-machi, Abeno, Osaka, Japan

TEL

+81(0)6-6645-3443

Homepage URL


Email



Sponsor or person

Institute

Osaka City University, Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Women's Health Science Research Grant Roth and Grant - in - Aid for Scientific Research, Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

2012 Year 10 Month 18 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

2012 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 20 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

2012 Year 10 Month 18 Day

Last modified on

2013 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010711


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name