UMIN-CTR Clinical Trial

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

Metabolic syndrome

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Nagoya university graduate school of medicine

Institute

Department

Personal name

Organization

JSPS KAKENHI

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Kasugai general health care center

Name of secondary funder(s)

Organization

Nagoya university hospital

Address

65 Tsurumai-cho,Showa-ku,Nagoya

Tel

052-744-2951

Email

ethics@med.nagoya-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2021

Year

03

Month

31

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048545

Publication of results

Published

URL related to results and publications

https://link.springer.com/article/10.1007/s12529-023-10173-2

Number of participants that the trial has enrolled

32

Results

Eight of the 40 participants declined to participate. The MMA was used average 4.4 days per week, but the rate of adherence declined over time. The follow-up rate was 100%, and there was no difference in participant satisfaction between the groups. There was no significant group-by-time interaction for weight loss (p = 0.924), but there was a significant interaction for the DEBQ restrained eating score (p = 0.033).

Results date posted

2023

Year

03

Month

30

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Eligibility criteria were used to select adults aged 20-75 years with MetS, as defined by the international diabetes federation (IDF) that had smartphones with mobile applications available. The exclusion criteria were a history of serious heart disease or other conditions that prohibited exercise therapy, severe depression, severe anxiety disorder, severe somatoform disorder, and psychotic symptoms. We recruited 1031 participants (663 females) by mail who met the eligibility criteria from among individuals who underwent physical examinations at a general healthcare center in Kasugai City, Japan. Participants were recruited from April 2020 to January 2021. Three evaluation sessions (baseline, week 13, and week 26) were conducted at the general healthcare center.

Participant flow

This open-label, parallel, pilot RCT included a 13week CLI, which comprised a supportive workshop after a physical examination at a city general health center plus telephone counseling every 4 weeks for the following 13 weeks with and without MMA use. The application was provided to all participants, but the provision period was divided into two phases: 1-26 weeks and 27-52 weeks. We compared data between the two groups over 26 weeks. Participants were stratified by sex and randomly assigned to the two groups using a 1:1 ratio. After allocation, participants underwent baseline assessment, and those who did not meet the eligibility criteria were excluded from the analyses. The intervention was provided free of charge. This pilot trial was not designed to have sufficient statistical power to assess the effectiveness of the MMA intervention on weight loss and eating behavior.

Adverse events

nothing

Outcome measures

Acceptability, adherence, and feasibility were measured by the number of people who refused to consent to the study after receiving orientation, the rate of adherence to the application (number of days application implementation was completed), follow up rate, participant satisfaction, and number of adverse events. The primary outcome of using the MMA was the rate of change in body weight. Body weight was measured in units of 0.1 kg, while wearing test clothes. Secondary outcome measures was eating behavior, the modified Japanese version of the Dutch Eating Behavior Questionnaire (DEBQ) was used to evaluate eating behavior.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

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 related information

Registered date

2020

Year

12

Month

02

Day

Last modified on

2023

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048545