UMIN-CTR Clinical Trial

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

obesity

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan Agency for Medical Research and Development

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

03

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

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 related information

Registered date

2018

Year

03

Month

23

Day

Last modified on

2024

Year

03

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036374