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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031862
Receipt No. R000036374
Scientific Title Study of weight Loss Intervention to find effective strategy for obesity Management and the TARGET of weight loss amount for reducing health disorders
Date of disclosure of the study information 2018/03/23
Last modified on 2020/03/26

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Basic information
Public title Study of weight Loss Intervention to find effective strategy for obesity Management and the TARGET of weight loss amount for reducing health disorders
Acronym Study of weight Loss Intervention to find effective strategy for obesity Management and the TARGET of weight loss amount for reducing health disorders (SLIM-TARGET)
Scientific Title Study of weight Loss Intervention to find effective strategy for obesity Management and the TARGET of weight loss amount for reducing health disorders
Scientific Title:Acronym Study of weight Loss Intervention to find effective strategy for obesity Management and the TARGET of weight loss amount for reducing health disorders (SLIM-TARGET)
Region
Japan

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

Objectives
Narrative objectives1 This study aims to assess the efficacy and safety of intervention treatment for obesity patients to reduce body weight for reducing health disorder and to reveal the target of weight reduction for effective improvement of the health disorder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ratio of patients in whom body weight decreases and two or more health disorders are improved among which the patients had had at the enrollment at 12 months of treatment intervention to reduce body weight
Key secondary outcomes [Efficacy endpoints]
1. Ratio of patients in whom two or more health disorders are improved among six health disorders described in the primary outcome above at 24 months of treatment intervention to reduce body weight
2. Ratio of patients in whom dose of therapeutic agents for the health disorders described above are reduced at 12 months of treatment intervention
3. Ratio of patients in whom dose of therapeutic agents for the health disorders described above are reduced at 24 months of treatment intervention
4. Ratio of patients in whom one health disorders are improved among six health disorders described in the primary outcome above at 12 months of treatment intervention
5. Ratio of patients in whom one health disorders are improved among six health disorders described in the primary outcome above at 24 months of treatment intervention
6. Ratio of patients in whom the number of the health disorder becomes zero
7. Percent change of body weight
8. Percent change of visceral fat mass
9. Percent change of HbA1c
10. Percent change of serum lipids
11. Percent change of AST
12. Percent change of ALT
13. Percent change of gamma-GTP
14. Percent change of systolic and diastolic blood pressure
15. Percent change of Epworth Sleepiness Scale score
16. Percent change of questionnaire scores about patients' motivation for obesity management, joint pain, and menstrual abnormality
17. Dropout ratio of participating patients

[Safety endpoints]
1. Frequency of adverse events
2. Frequency of sudden death, onset of cardiovascular events, onset of stroke, onset of malignant tumor, onset or aggravation of psychiatric disorder, and onset or aggravation of musculoskeletal impairment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 [Standard treatment group without IoT]
The target of body weight reduction is 3% (5% in case of morbid obesity (BMI is 35 kg/m2 or higher)) compared with the body weight at baseline. Patients record their meal contents and body weight and conduct diet and exercise therapy as follows according to the obesity treatment guideline 2016
Diet therapy: caloric restriction up to 25 kcal/kg * ideal body weight / day (20-25 kcal/kg * ideal body weight / day in case of morbid obesity) and nutrition education at baseline and every 6-12 months
(Patients who had already had regular nutrition education at baseline can continue it without reducing the frequency.)
Exercise therapy: moderate-intensity 150 min exercise per week (corresponding to fast walking 15000 steps/week) under the instruction by medical staff (less frequency, intensity and time in case of morbid obesity)
Hospitalization for obesity treatment is allowed.
Interventions/Control_2 [Standard treatment group with IoT]
In addition to the standard treatment above, patients install health-management application software to their own smartphones and connect it with IoT (Internet-of-Things) devices (hemopiezometer, body composition meter, and physical activity meter). Their attending physicians and medical staff team check their health status and progress of body weight reduction to achieve the target in real-time manner, and utilize the information to their treatment.
Interventions/Control_3 [Intensive treatment group without IoT]
The target of body weight reduction is 7% (10% in case of morbid obesity (BMI is 35 kg/m2 or higher)) compared with the body weight at baseline. Patients record their meal contents and body weight and conduct diet and exercise therapy as same as the standard treatment described above, except the nutrition education is conducted at baseline and every 1-2 months
Consider formula food once/day for caloric restriction, high-intensity exercise therapy, or 225 min exercise per week.
Hospitalization for obesity treatment is allowed.
If patients cannot achieve the 3% body weight reduction (5% in case of morbid obesity) at 6 months of treatment intervention, consider additional treatments according to the obesity treatment guideline 2016.
Interventions/Control_4 [Intensive treatment group with IoT]
In addition to the intensive treatment above, IoT application software is used as same as the standard treatment group with IoT.
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
75 years-old >
Gender Male and Female
Key inclusion criteria The inclusion criteria are as follows:
1) Patients with BMI of 25 kg/m2 or higher, and those who have two or more complications among six health disorders (diabetes mellitus or abnormal glucose tolerance, dyslipidemia, hypertension, hyperuricemia, liver steatosis, and obesity-related renal disease), which are some of the diagnostic criteria on obesity according to the Japan Society for the Study of Obesity
2) Male and female patients aged 18 years or older and younger than 75 years at obtaining consent
3) Written consent form to participate in the study signed by patients themselves after full explanation of this study and its ethical considerations
4) Patients who have smartphone compatible to application software used in this study (OMRON connect, Asken and Asfit) and who can manipulate and browse it by themselves
Key exclusion criteria The exclusion criteria are as follows:
1) Secondary obesity (symptomatic obesity)
2) Patients who had a history of wasting disease or pathology with drastic weight loss within six months before the consent acquisition (such as severe infection disease, highly invasive surgery, malignant tumor, severe trauma, hyperthyroidism)
3) Patients with severe diabetic mellitus (HbA1c is 10% or higher)
4) Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher)
5) Patients with severe impairment in cardiorespiratory, renal or liver function to whom exercise therapy is not applicable
6) Patients with severe musculoskeletal impairment to whom exercise therapy is not applicable
7) Patients with unmanageable psychiatric disorder
8) Patients who are breastfeeding, pregnant, suspected of being pregnant or within 28 days of parturition
9) Patients who cannot provide written consent form or those who cannot understand study summary and obejective
10) patients who are considered unsuitable subjects by the attending physician
Target sample size 360

Research contact person
Name of lead principal investigator
1st name Koutaro
Middle name
Last name Yokote
Organization Chiba University
Division name Graduate School of Medicine
Zip code 260-8677
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN
TEL 043-222-7171
Email kyokote@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code 260-8677
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 03-3295-1350
Homepage URL https://himaniot.org/
Email takayama@soiken.com

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Chiba University Hospital Ethics Review Board
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba , JAPAN
Tel 043-222-7171
Email chibacrc@mac.com

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
2018 Year 03 Month 23 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 21 Day
Date of IRB
2018 Year 02 Month 19 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 23 Day
Last modified on
2020 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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