MB-EAT rescue test for health education group

JRCT ID: jRCT1033210709

Registered date:30/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 30/03/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Mindfulness-Based Eating Awareness Training

Outcome(s)

• Primary Outcome: Mean Change from Baseline of Hunger Score in TFEQ subscale( Time Frame: Baseline, 7 weeks from baseline, 14visits and after 6 months (Self-Reported Questionnaire)

Secondary Outcome

Mean Change from baseline, 7 weeks from baseline, 14 visits, and after 6 months
(1)Body Mass Index
(2)Weight loss rate
(3)Three-Factor Eating Questionnaire(Total Score, Disinhibition subscale, Cognitive Restraint subscale)
(4)Beck Depression Inventory
(5)State-Trait Anxiety Inventory
(6)Rosenberg Self-Esteem Scale
(7)Barratt Impulsiveness Scale
(8)Positive and Negative Affect Schedule
(9)Binge Eating Scale
(10)Five Facet Mindfulness Quesionnaire
(11)Mindfulness Attention Awareness Scale
(12)Self-Cojmpassion Scale
(13)Exercise frequency(Meditation, Yoga, Number of steps)
(14)Drug name of concomitant drug and daily dose

Presence or absence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1)Primary diagnosis of Obesity with a BMI of 30 or higher .
2)The age between 18 to 65.
3)Patients with full consent of participation in the study.
4)Possible to communicate in Japanese.
5)Patients who have an internet environment at home and have a personal computer or tablet device.
6)No addition of weight loss drug or appetite suppressant during the study.
7)Possible to understand Mindfulness-Based Eating Awareness Training and have mental and physical.
8)If Ovesity is primary diagnosed, patients with Depressive Disorder and Anxiety Disorder will not be excluded from the study.
9)Patients who agree not to use weight loss drugs (Sanorex) or Diabetes drug (Ozempic) for about 6 months until the end of the study.
10)Patients who agree not to undergo Bariatric surgery for about 6 months until the end of the study.
11)Those who consent to contraception with their partner while undergoing mindfulness dietary meditation training for safety for approximately 6 months until the end of this study.

Exclude criteria

1)Pregnant,lactating or less than 6 months after giving birth.
2)Patients who taking weight loss drugs or Diabetes drug (Ozempic) .
3)Patinets who plan undergo Bariatric surgery.
4)Patients who have Organic brain disorder ( including Dementia), Psychosis, Substance abuse or dependence, other severemental disorders.
5)Active suicidality.
6)Repetitive anti-social behavior.
7)Severe physical condition.
8)Those who have mental retardation (refer to the evaluation scores such as JART-25: Japanese Adult Reading Test-25) and those who have autism spectrum disorder (AQ: refer to the autism spectrum index etc.).
9)Patients who cannot contact with the study organizer.
10)Other relevant reason decided by the investigator.

Related Information

• Primary Sponsor: Ono Hiraku
• Source(s) of Monetary Support: JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE,Reseach Center for Child Mental Development Chiba University