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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042626
Receipt No. R000048545
Scientific Title An exploratory study of the Mindfulness App for Weight loss in metabolic syndrome
Date of disclosure of the study information 2021/03/31
Last modified on 2021/11/01

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Basic information
Public title An exploratory study of the Mindfulness App for Weight loss in metabolic syndrome
Acronym MATWLstudy
Scientific Title An exploratory study of the Mindfulness App for Weight loss in metabolic syndrome
Scientific Title:Acronym MATWLstudy
Region
Japan

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

Objectives
Narrative objectives1 To determine whether the use of a mindfulness app in conjunction with traditional diet and exercise-based health class, compared to traditional diet and exercise-based health class, has sustained long-term weight loss effect.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference in weight change at 3 and 6 months after the intervention.
The analysis includes ITT and Per protocol analysis, which specifies that the intervention group is defined as those who use the application more than 5 times per week on average, based on the application's log records.
Key secondary outcomes Changes in abdominal circumference, body composition (body mass index, body fat percentage, and muscle mass), systolic blood pressure change, diastolic blood pressure change, HDL change, LDL change, HbA1c change, and the results of the questionnaire survey (DEBQ, Motivation to Eat Healthy Scale, IPAQ Japanese version, Behavioral Change Stage Model) at 3 and 6 months.
The analysis includes ITT and Per protocol analysis, which specifies that the intervention group is defined as those who use the application more than 5 times per week on average, based on the application's log records.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Participation in a 3-month diet and exercise therapy health class.
In addition to the above, practice daily mobile app mindfulness for 3 months.
From month 4 to month 6 after the start of the study, check lifestyle by phone every 1 month.
Interventions/Control_2 Participation in a 3-month diet and exercise therapy health class.
From month 4 to month 6 after the start of the study, check lifestyle by phone every 1 month.
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients who underwent physical checkup at the Kasugai general health care center in 2020, and with one or more risk factors of the international diabetes federation (IDF) for metabolic syndrome.

Waist circumference: Male 90 cm or more, female 80 cm or more.
One or more of the following items (1) to (4).
(1)Fasting blood glucose 100 mg/dL or more or a history of type 2 diabetes.
(2) Blood pressure 130/85 mmHg or on treatment.
(3) Triglycerides 150 mg/dl or more.
(4) HDL cholesterol: less than 40 mg/dl in men, less than 50 mg/dl in women, or on treatment.

Key exclusion criteria Patients with a history of serious cardiac disease or other medical conditions, and who are prohibited by their physicians from exercising, etc.
Severe depression, severe anxiety disorder, severe somatoform disorder, psychotic symptoms, those with a history of these, or those who are currently in the hospital.
Those who do not have a cell phone that can use mobile applications.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takaharu
Middle name
Last name Matsuhisa
Organization Nagoya university hospital
Division name Department of general medicine
Zip code 466-8560
Address 65 Tsurumai-cho,Showa-ku,Nagoya
TEL 052-744-2951
Email matsukyuu413@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Takaharu
Middle name
Last name Matsuhisa
Organization Nagoya university hospital
Division name Department of general medicine
Zip code 466-8560
Address 65 Tsurumai-cho,Showa-ku,Nagoya
TEL 052-744-2951
Homepage URL
Email matsukyuu413@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya university graduate school of medicine
Institute
Department

Funding Source
Organization JSPS KAKENHI
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Kasugai general health care center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya university hospital
Address 65 Tsurumai-cho,Showa-ku,Nagoya
Tel 052-744-2951
Email ethics@med.nagoya-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 名古屋大学医学部附属病院(愛知県)、春日井市総合保健医療センター(愛知県)

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 31 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
2021 Year 02 Month 05 Day
Date of IRB
2021 Year 03 Month 22 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2021 Year 11 Month 01 Day
Date of closure to data entry
2021 Year 11 Month 01 Day
Date trial data considered complete
2021 Year 11 Month 01 Day
Date analysis concluded
2021 Year 11 Month 15 Day

Other
Other related information

Management information
Registered date
2020 Year 12 Month 02 Day
Last modified on
2021 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048545

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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