UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022207 |
|---|---|
| Receipt number | R000025571 |
| Scientific Title | Examination of the efficacy of the healthy lifestyles improving based on chrononutrition in women's university students. |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2019/07/20 19:35:02 |
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Basic information
Public title
Examination of the efficacy of the healthy lifestyles improving based on chrononutrition in women's university students.
Acronym
Efficacy of the healthy lifestyles improving based on chrononutrition.
Scientific Title
Examination of the efficacy of the healthy lifestyles improving based on chrononutrition in women's university students.
Scientific Title:Acronym
Efficacy of the healthy lifestyles improving based on chrononutrition.
Region
| Japan |
Condition
Condition
Overweight and normal BMI with higher body fat percentage
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the efficacy of the healthy lifestyles improving (Behavioral approach) based on chrononutrition for prevention of overweight and normal BMI with higher body fat in women's university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight, BMI, fat weight, body fat percentage, body muscle mass
Overweight and normal BMI with higher body fat percentage
Primary and secondary outcomes will be measured at baseline, 4-weeks, 8-weeks, 12-weeks and 24-weeks follow-up.
Key secondary outcomes
Healthy-related QOL, depression, self-esteem, study motivation, sleep status, constipation
Primary and secondary outcomes will be measured at baseline, 4-weeks, 8-weeks, 12-weeks and 24-weeks follow-up.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Conduct Lifestyle intervention (Behavioral approach) based on chrononutrition for 12 weeks (active approach). The intervention contents are as the following:
(1)Teaching and provision of the healthy information of dietary habits and lifestyle.
(2)Appropriate physical activity
(3)Self-monitoring use of body composition (InBody)
(4)Physical activity mater and the smartphone application.
(5)Peer-support
After the active behavioral approach, the passive approach (observations) is conducted for 12weeks.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Eligible participants were women (over 18years of age) and at least two of the following factors : (1)BMI>=22, (2)body fat percentage>=28%, (3)chronic constipation or sleep disorders, (4)normal BMI with body fat percentage>=28%.
Key exclusion criteria
Exclusion criteria are pregnant woman and patients with chronic disease at enrollment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kanae |
| Middle name | |
| Last name | Konishi |
Organization
Showa Women's University
Division name
Department of Food Science and Nutrition
Zip code
154-8533
Address
1-7-57 Taishido, Setagaya-ku,
TEL
+81334115199
k-konishi@swu.ac.jp
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | |
| Last name | Konishi |
Organization
Showa Women's University
Division name
Department of Food Science and Nutrition
Zip code
154-8533
Address
1-7-57 Taishido, Setagaya-ku, Tokyo, Japan
TEL
+81334115199
Homepage URL
k-konishi@swu.ac.jp
Sponsor or person
Institute
Showa Women's University
Institute
Department
Personal name
Funding Source
Organization
Showa Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa Women's University Study and Research Support Section
Address
1-7-57 Taishido, Setagaya-ku, Tokyo, Japan
Tel
03-3411-7351
kenkyu@swu.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
| 2016 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 05 | Day |
Last modified on
| 2019 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025571
