UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006279
Receipt number R000007431
Scientific Title Self-weighing twice a day promote weight loss in overweight and obese people: A randomized controlled trial
Date of disclosure of the study information 2011/09/05
Last modified on 2011/09/02 22:16:46

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Basic information

Public title

Self-weighing twice a day promote weight loss in overweight and obese people: A randomized controlled trial

Acronym

Self-weighing twice a day promote weight loss

Scientific Title

Self-weighing twice a day promote weight loss in overweight and obese people: A randomized controlled trial

Scientific Title:Acronym

Self-weighing twice a day promote weight loss

Region

Japan


Condition

Condition

Obesity

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of frequent self-weighing in a day

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Body weight
Or Success in weight loss (>5% of initial weight)

Key secondary outcomes

Steps, Total energy expenditure, adherence


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

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

Self-weighing once a day

Interventions/Control_2

Self-weighing twice a day

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

40 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

A body mass index is 24 or more and either in the contemplation or preparation stage of starting a weight loss program

Key exclusion criteria

Participation in a weight-loss program during the previous 6 months.
Current or planned pregnancy

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitake Oshima

Organization

University of Marketing and Distribution Sciences

Division name

Faculty of Service Industries Sports and Health Management Course

Zip code


Address

3-1 Gakuen-Nishimachi, Nishi-ku, Kobe

TEL

078-796-5121

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshitake Oshima

Organization

University of Marketing and Distribution Sciences

Division name

Faculty of Service Industries Sports and Health Management Course

Zip code


Address

3-1 Gakuen-Nishimachi, Nishi-ku, Kobe

TEL

078-796-5121

Homepage URL


Email

Yoshitake_Oshima@red.umds.ac.jp


Sponsor or person

Institute

Omron Healthcare Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Omron Healthcare Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Hospital Organization Kyoto Medical Center

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

オムロンヘルスケア株式会社


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 05 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

A self-weighing twice a day is more effective in promoting weight loss than once-daily self-measurement.

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

2008 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2009 Year 03 Month 01 Day

Last follow-up date

2009 Year 06 Month 01 Day

Date of closure to data entry

2009 Year 09 Month 01 Day

Date trial data considered complete

2010 Year 02 Month 01 Day

Date analysis concluded

2011 Year 08 Month 01 Day


Other

Other related information

The 30th Annual Meeting of Japan Society for The Study of Obesity


Management information

Registered date

2011 Year 09 Month 02 Day

Last modified on

2011 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007431


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name