Comparison of effectiveness of mindfulness- based eating awareness training (MB-EAT) and its integration with the implementation intentions on weight loss and biological, psychological and behavioral indices in women with obesity
Comparison of effectiveness of mindfulness- based eating awareness training (MB-EAT) and its integration with the implementation intentions on weight loss and biological, psychological and behavioral indices in women with obesity
Design
A clinical trial with two intervention groups and a control group with factorial groups and purposive sampling with random replacement will be performed on at least 45 patients.
Settings and conduct
Participants who meet the inclusion criteria are invited to attend a research at the Bahonar Hospital Clinic in Karaj. Participants are then given the opportunity to register for the study if they wish.Group training in Alborz School of Medical Sciences will be performed for experimental and control groups.In pandemic conditions, education will be online. The selection of subjects will be purposeful and will be done in the clinic of Bahonar Hospital in Karaj
Participants/Inclusion and exclusion criteria
Inclusion criteria
BMI ≥ 25
Gender: Female
Age : 20 years and older
Education: Diploma and higher
Exclusion criteria
Receive psychotherapy; other regular weight loss; exercise programs at the same time.
Use of psychotropic or weight-affecting drugs; hypothyroidism; pregnancy; diabetes
Intervention groups
Experimental group 1:Mindfulness- based eating awareness training (MB-EAT) will be held in the form of group training.
Experimental group 2:In addition to MB-EAT the behavioral goals will be set for daily meditation, calorie counting, and physical activity.
Control group:They will receive information on obesity and overweight, weight loss guidelines and goal setting based on these weight loss guidelines.
Main outcome variables
Weight
biological indicators ( Chol; TG; HDL; LDL; FBS; waist circumference and BMI
Psychological indicators: (life based on weight self-efficacy; eating behavior; conscious mind eating and difficulty in regulating emotion)
Behavioral indicators: (Calorie counting; physical activity and healthy eating)
General information
Reason for update
Acronym
MB_EAT
IRCT registration information
IRCT registration number:IRCT20200919048767N1
Registration date:2020-11-18, 1399/08/28
Registration timing:registered_while_recruiting
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Mona Jassemi Zergani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2641 9061
Email address
mjassemi@yhoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of mindfulness- based eating awareness training (MB-EAT) and its integration with the implementation intentions on weight loss and biological, psychological and behavioral indices in women with obesity
Public title
Effect of mindfulness training on weight loss
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
BMI ≥ 25
Gender: Female
Age:20 years and older
Education: Diploma and higher.
Exclusion criteria:
Receive concomitant psychotherapy or other regular weight loss and exercise programs
Use of psychotropic or weight-affecting drugs.
Having a mental disorder
Hypothyroidism
Pregnancy
Diabetes
Age
From 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
1. After equalizing people in weight, age and waist circumference, we put them in three groups.
2. Each intervention is named with the English letters A, B, C.
3. Write the letters A, B, C inside the three envelopes and mix them so that it is not clear what is in each envelope.
4.By asking one person from each category to enter the study, we tell them to take one of the envelopes randomely and according to the letter, that person will be placed in one of the groups.
5.For the fourth to sixth participants, we repeat step 4, and then for the next three people, etc., until the required number of samples is completed in all three groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Implamentation intention is integrated with mindfulness-based eating awareness training as a program to implement the goals of change.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Nursing and Midwifery, Karaj Azad University
Street address
Faculty of Nursing and Midwifery, Islamic Azad University, Karaj, Rajai Shahr
City
Karaj
Province
Alborz
Postal code
1998669711
Approval date
2020-09-16, 1399/06/26
Ethics committee reference number
IR.IAU.K.REC.1399.028
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Weight
Timepoint
Before the study and after that (3 months later) and 3 and 6 months later for follow-up
Method of measurement
weight of digital scales
Secondary outcomes
1
Description
Cholesterol
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
Blood samples after 12 hours of fasting using laboratory kits
2
Description
Triglycerid
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
Blood samples after 12 hours of fasting using laboratory kits
3
Description
High density lipoprotein(HDL)
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
Blood samples after 12 hours of fasting using laboratory kits
4
Description
low density lipoprotein(LDL)
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
Blood samples after 12 hours of fasting using laboratory kits
5
Description
Fasting blood sugar(FBS)
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
Blood samples after 12 hours of fasting using laboratory kits
6
Description
Waist circumference
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
The narrowest waist area with tape measure (accuracy 0.5 cm)
7
Description
self-efficacy
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
weight efficacy lifestyle questionnaire
8
Description
Eating behavior
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
Three Factor Eating Questionnaire
9
Description
Mindful eating
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
Mindful Eating Questionnaire
10
Description
Emotional eating
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
Difficulties in Emotion Regulation Scale( (DERS)
11
Description
Calorie counting
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
check list
12
Description
physical activity
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
check list
13
Description
Healthy diet
Timepoint
Before the intervention and 3 and 6 months after the intervention
Method of measurement
check list
Intervention groups
1
Description
Intervention group 1: Mindful based eating awareness training will be done for 12 sessions, one session per week and each session for 2 and a half hours according to the training instructions. Participants will be introduced to the concepts of inner wisdom and outer wisdom. Inner wisdom, wise use of: Awareness of physical hunger and fullness, eating triggers, emotions and thoughts/ Self-acceptance. Outer Wisdom: wise use of nutrition and calories/activity-exercise Information. At the end of each session, group participants are asked to practice the trained techniques to turn this knowledge into a wisdom and become a lifestyle.
Category
Lifestyle
2
Description
Intervention group 2: This group, just like experimental group 1 receives mindfulness-based eating awareness training. At the end of each session, they are asked to do the practices and techniques they have learned to become a lifestyle, according to implementation Intention, the therapist will write a practical plan for how to count calories, healthy eating and physical activity, and asks them to have a high commitment to performing these three components on a daily basis and to report their practice virtually.
Category
Lifestyle
3
Description
Control group: Simultaneously with the experimental groups, they will receive information about obesity and overweight. After the end of the intervention and follow-up; to observe the treatment ethics, the intervention will be performed for this group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar haspital
Full name of responsible person
Habibeh Taghavi
Street address
No. 30, 24 metri Ave., Saadat Abad.،Tehran
City
Karaj
Province
Alborz
Postal code
1998669711
Phone
+98 21 2641 9061
Fax
Email
mjassemi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Reza Seirafi
Street address
No. 30, 24 metri Ave., Saadat Abad., Tehran
City
Karaj
Province
Alborz
Postal code
1998669711
Phone
+98 21 2641 9061
Email
mjassemi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mona Jassemi Zergani
Position
Student of health psychology (Phd)
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
NO. 30, Mohammadali Keshaverz Ave; Saadat Abad.
City
Tehran
Province
Tehran
Postal code
1998669711
Phone
+98 21 2641 9061
Fax
Email
mjassemi@yhoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mona Jassemi Zergani
Position
Student of health psychology (Phd)
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
NO. 30, Mohammadali Keshaverz Ave; Saadat Abad.
City
Tehran
Province
Tehran
Postal code
1998669711
Phone
+98 21 2641 9061
Fax
Email
mjassemi@yhoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mona Jassemi Zergani
Position
Student of health psychology (Phd)
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
NO. 30, Mohammadali Keshaverz Ave; Saadat Abad.
City
Tehran
Province
Tehran
Postal code
1998669711
Phone
009822649061
Fax
Email
mjassemi@yhoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available