UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Using a web-based intervention to promote weight loss maintenance: A randomized controlled trial
Title of the study (Brief title)	Web-based intervention for weight loss maintenance
Region	Japan

Condition
Condition	Obesity
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test the effects of web-based intervention in promoting weight loss maintenance
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 -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
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
Interventions/Control_1	No intervention
Interventions/Control_2	A web-based weight loss maintenance program
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 25 or more but less than 40, and the presence of at least one of the following components. 1. Abdominal obesity: waist circumference 85 cm or more in males and 90 cm or more in females 2. Hyperglycemia: fasting plasma glucose level 100 mg/dL or more; HbA1c 5.6% or more; medication for diabetes mellitus 3. Dyslipidemia: triglycerides level 150 mg/dL or more; high-density lipoprotein cholesterol level less than 40 mg/dL; medication for dyslipidemia 4. Hypertension: systolic blood pressure 130 mmHg or more; diastolic blood pressure 85 mmHg or more; medication for hypertension
Key exclusion criteria	Past hisory of coronary disease Past history of stroke Current or planned pregnancy Participation in a weight-loss program during the last 6 months Having cohabiting family member participated in this study
Target sample size	130

Research contact person
Name of lead principal investigator	Yoshio Nakata
Organization	University of Tsukuba
Division name	Faculty of Medicine
Address	1-1-1 Tennodai, Tsukuba
TEL	029-853-3076
Email	nakata@md.tsukuba.ac.jp

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

Sponsor
Institute	Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	2014 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 28 Day
Anticipated trial start date	2014 Year 08 Month 17 Day
Last follow-up date	2017 Year 02 Month 12 Day
Date of closure to data entry	2017 Year 05 Month 31 Day
Date trial data considered complete	2017 Year 08 Month 31 Day
Date analysis concluded	2018 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	2014 Year 06 Month 30 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=R000016793