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
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
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
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
