UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019415
Receipt number R000022456
Scientific Title Effect of breakfast skipping on eating behavior and physical activity
Date of disclosure of the study information 2015/11/02
Last modified on 2016/11/22 08:20:34

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Basic information

Public title

Effect of breakfast skipping on eating behavior and physical activity

Acronym

Effect of breakfast skipping on eating behavior and physical activity

Scientific Title

Effect of breakfast skipping on eating behavior and physical activity

Scientific Title:Acronym

Effect of breakfast skipping on eating behavior and physical activity

Region

Japan


Condition

Condition

Healthy Adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of physical activity and eating behavior in breakfast skipping

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Physical activity and energy intake (morning , afternoon, and a day)

Key secondary outcomes

Subjective hunger
Body temperature
Heart rate


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Breakfast consumption (1 day), washout period (at least 2 days), Breakfast skipping (1 day)
Breakfasts provide at 8:00 a.m. (542 kcal). The meals and physical activity after breakfast are under free-living conditions.

Interventions/Control_2

Breakfast skipping (1 day), washout period (at least 2 days), Breakfast consumption (1 day)
Breakfasts provide at 8:00 a.m. (542 kcal). The meals and physical activity after breakfast are under free-living conditions.

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

25 years-old >=

Gender

Male and Female

Key inclusion criteria

They were recruited a person who has regular breakfast (five days or more than)

Key exclusion criteria

1. The person under medication and medical treatment
2. Smoker

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiichi Yoshimura

Organization

Prefectural University of Kumamoto

Division name

Department of Food and Health Science

Zip code


Address

Tsukide 3-1-100, Higashi-ku, Kumamoto

TEL

096-383-2929

Email

publichealth-kku@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiichi Yoshimura

Organization

Prefectural University of Kumamoto

Division name

Department of Food and Health Science

Zip code


Address

Tsukide 3-1-100, Higashi-ku, Kumamoto

TEL

096-383-2929

Homepage URL


Email

publichealth-kku@umin.ac.jp


Sponsor or person

Institute

Prefectural University of Kumamoto

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


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

2015 Year 11 Month 02 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

2015 Year 05 Month 22 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 21 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 10 Month 20 Day

Last modified on

2016 Year 11 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022456


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name