UMIN-CTR Clinical Trial

Basic information
Public title	Effect of behavior change program for improvement of lifestyle habit on health and beauty images
Acronym	Effect of behavior change program on health and beauty images
Scientific Title	Effect of behavior change program for improvement of lifestyle habit on health and beauty images
Scientific Title:Acronym	Effect of behavior change program on health and beauty images
Region	Japan

Condition
Condition	Overweight, obesity
Classification by specialty	Medicine in general Endocrinology and Metabolism Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of behavior change program for improvement of lifestyle habits on health and beauty images
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Risk factor related to metabolic syndrome 2. Beauty images
Key secondary outcomes	1. Health Literacy 2. Health Competence 3. Sleep Quality 4. Physical Activity 5. Eating Behavior 6. Stress 7. Depression 8. Low Back Pain

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group: 3-month of behavior change program and health education in 1 time per month (total 3 times).
Interventions/Control_2	Control group: health education in 1 time per month (total 3 times).
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. City hall officials 2. Without regular exercise habits (Moderate-intensity exercise >= 2 day/week, or >= 150 min/week) 3. Without weight loss of diet and disease within the past 6 months 4. Did not intake supplements within 1 month 5. Without a patient receiving therapeutic agents for diabetes. 6. Did not participate in other clinical trials within 1 year 7. Agree with informed consent
Key exclusion criteria	1. Waist circumference was < 85 cm in men, < 90 cm in female, or < 25 kg/m2 of BMI 2. Pregnant or is planning to become pregnant 3. Medical history of neurological disorder of abdomen 4. Medical history of cerebrovascular disease and heart disease 5. Medication for fat metabolism and weight control 6. Medical history of orthopedic disease or operation within 1 year 7. Artificial joints or other type of metal objects in body 8. The sense of pressure of the abdomen 9. Chemical fiber allergy
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kazushige Middle name Last name Ihara
Organization	Hirosaki University
Division name	Graduate School of Medicine
Zip code	036-8562
Address	5 Zaihu, Hirosaki, Aomori 036-8562 Japane
TEL	0172-39-5041
Email	ihara@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Hiroko Middle name Last name Matsubara
Organization	Hirosaki University
Division name	Graduate School of Medicine
Zip code	036-8562
Address	5 Zaihu, Hirosaki, Aomori 036-8562 Japane
TEL	0172-39-5041
Homepage URL
Email	matsubara@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University
Institute
Department

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Hirosaki University
Address	5 Zaihu, Hirosaki, Aomori 036-8562 Japane
Tel	0172-39-5041
Email	hara@hirosaki-u.ac.jp

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	弘前大学（青森県)/Hirosaki University(Aomori)

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 06 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	No longer recruiting
Date of protocol fixation	2019 Year 02 Month 27 Day
Date of IRB	2019 Year 02 Month 22 Day
Anticipated trial start date	2020 Year 06 Month 22 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 06 Day
Last modified on	2020 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041132