UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of weight-loss tools and a group-based weight-loss support program: A randomized controlled trial
Title of the study (Brief title)	Effects of weight-loss tools and a group-based weight-loss support program
Region	Japan

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

Objectives
Narrative objectives1	To examine the effects of weight-loss tools and a group-based weight-loss support program
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Body weight
Key secondary outcomes	Waist circumference Systolic blood pressure Diastolic blood pressure Triglycerides High-density lipoprotein cholesterol Fasting plasma glucose

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but 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	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	A single motivational lecture on weight loss
Interventions/Control_2	A single motivational lecture on weight loss and provision of weight-loss tools
Interventions/Control_3	A single motivational lecture on weight loss, provision of weight-loss tools, and a 6-month group-based weight-loss support program (8 times in a 6-month period)
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 25 or more but less than 40, and the presence of at least one of the following conditions. 1. Waist circumference 85cm or more in males and 90cm or more in females 2. Systolic blood pressure 130mmHg or more 3. Diastolic blood pressure 85mmHg or more 4. Triglycerides level 150mg/dL or more 5. High-density lipoprotein cholesterol level less than 40mg/dL 6. Fasting plasma glucose level 110mg/dL or more
Key exclusion criteria	Drug treatment for diabetes Past history of coronary disease Past history of stroke Current or planned pregnancy Participation in a weight-loss program during the previous 6 months Having participated of one's family living together in this study
Target sample size	180

Research contact person
Name of lead principal investigator	Yoshio Nakata
Organization	University of Tsukuba
Division name	Graduate School of Comprehensive Human Sciences
Address	1-1-1 Tennodai, Tsukuba
TEL	029-853-3076
Email

Public contact
Name of contact person	Yoshio Nakata
Organization	University of Tsukuba
Division name	Graduate School of Comprehensive Human Sciences
Address	1-1-1 Tennodai, Tsukuba
TEL	029-853-3076
Homepage URL
Email	nakata@md.tsukuba.ac.jp

Sponsor
Institute	Course of life-style related disorders donated by JA Ibaraki Public Welfare Federation
Institute
Department

Funding Source
Organization	JA Ibaraki Public Welfare Federation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Mito Kyodo General Hospital
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	水戸協同病院（茨城県）

Other administrative information
Date of disclosure of the study information	2008 Year 07 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 07 Month 04 Day
Anticipated trial start date	2008 Year 11 Month 01 Day
Last follow-up date	2011 Year 10 Month 01 Day
Date of closure to data entry	2012 Year 03 Month 01 Day
Date trial data considered complete	2012 Year 09 Month 01 Day
Date analysis concluded	2013 Year 03 Month 01 Day

Related information
URL releasing protocol	http://www.ncbi.nlm.nih.gov/pubmed/21061562
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/25428509
Results	The 6-month randomised controlled trial provides evidence that using educational materials and group-based support is effective components of weight-loss program. The effects of group-based support disappear within 2 years. Increasing physical activity may be crucial factor for successful maintenance of weight loss.
Other related information	Nippon Koshu Eisei Zasshi 57(9): 835-842, 2010. Obesity Facts 4(3): 222-228, 2011. Obesity Facts 7(6): 376-387, 2014.

Management information
Registered date	2008 Year 07 Month 22 Day
Last modified on	2018 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001520