UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized Controlled Trial to Assess the Effectiveness of Peer-assisted Learning on Body Weight Reduction in Health Guidance
Title of the study (Brief title)	Effectiness of Peer-assisted Learning on Body Weight Reduction in Health Guidance
Region	Japan

Condition
Condition	Obesity
Classification by specialty	Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of "Peer-Assisted Learning" among the counselors in health guidance on the clients' weight reduction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	change in the clients' body weight
Key secondary outcomes	1.OSCE evaluation in the counselors 2.BMI change in the clients 3.change in the clients' abdominal circumference 4.change in the food habit of clients

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	"Peer-assisted Learning" among counselors in addition to training in advance by the counselor educator
Interventions/Control_2	training in advance by the counselor educator alone
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.abdominal circumference >= 85cm in men or >= 90cm in women, or BMI>= 25 in both sex 2.equal to or more than 18 years old, and equal to or less than 65 years old 3.availability of web services in home or the workplace 4.written informed consent
Key exclusion criteria	patients receiving prescribed medication for diabetes or kidney disease
Target sample size	180

Research contact person
Name of lead principal investigator	Takashi Kawamura
Organization	Kyoto university School of Public Health
Division name	Department of Preventive services
Address	Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL	075-753-2426
Email	kawax@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Mie Imanaka
Organization	Health Service
Division name	Department of Preventive services
Address	Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL	090-7485-7611
Homepage URL
Email	m-imanaka@mail.koka.ac.jp

Sponsor
Institute	Department of Preventive Services, Kyoto university School of Public health
Institute
Department

Funding Source
Organization	Department of Preventive Services, Kyoto university School of Public health
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2011 Year 07 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2011 Year 06 Month 20 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 09 Month 30 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 06 Month 28 Day
Last modified on	2018 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006936