Online Mindfulness-Based Eating Awareness Training for obesity.

JRCT ID: jRCT1030200197

Registered date:12/11/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 29/09/2020
• Target sample size: 32
• 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, 14visits and after 6 months (Self-Reported Questionnaire)

Secondary Outcome

Mean Change from Baseline to 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 Questionnaire.
(11)Mindfulness Attention Awareness Scale.
(12)Self-Compassion Scale.
(13)Exercise frequency(Meditation,Yoga,Number of steps)
(14)Drug name of concomitant drug and daily dose.

Mean Change from Baseline to 14 visits.
(15)Serum protein(Leptin, Adiponectin, BDNF, Cortisol)

Mean Change from Baseline to 6 months later.
Changes in brain function and structure due to resting images, diffusion tensor images, and morphological brain images

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
condition that can be participate the session for at least 6 months.
8)If Obesity 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) 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

Exclude criteria

1)Pregnant, lactating or less than 6 months after giving birth.
2)Patients who taking weight loss drugs or appetite suppressants.
3)Patients who plan undergo Bariatric surgery.
4)Patients who have Org anic brain disorder (including Dementia), Psychosis, Substance abuse or dependence, other severe mental disorders.
5)Active suicidality
6)Repetitive anti-social behavior
7)Severe physical condition
8)IQ under 80 by evaluating the JART25 (Japanese Adult Reading Test25) or IQ under 70 by Wechsler Adult Intelligence Scale.
9)Patients with Autism Spectrum Disorder.
10)Patients who cannot contact with the study organizer.
11)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
• Secondary ID(s): R000048249