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Investigating and comparing the effectiveness of a mindfulness-based intervention along with standard treatment compared to standard treatment alone on the food craving trait in overweight and obese individuals with mild to moderate anxiety and/or depression: a randomized controlled trial.

Protocol summary

Study aim
Investigating the effectiveness of a mindfulness-based intervention on the food craving trait in overweight and obese individuals with mild to moderate anxiety and/or depression
Design
Two arm parallel group randomized trial including 60 patients in total. The list created by the random allocation software will be used for randomization.
Settings and conduct
This study will be in the form of a randomized controlled trial. The study will be conducted on overweight and obese people referred to the special nutrition clinic of Al-Zahra Hospital, Isfahan. Individuals, after obtaining written informed consent, will be randomly assigned to one of the control or intervention groups. All will receive the standard treatment. In addition to the standard treatment, the participants in the intervention group will receive the audio course. There is no possibility of blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: BMI>=25, mild to moderate anxiety or depression Exclusion criteria: Candidates for bariatric surgery, previous regular use of mindfulness-based techniques
Intervention groups
Control group: Receives the standard treatment, which includes a normal caloric restriction diet tailored to the person, which is determined by a nutritionist, based on factors such as the person's nutritional status, the amount of overweight and obesity, and underlying diseases. Intervention group: In addition to the standard treatment, participants in the intervention group will receive a 14-day training course including audio files of maximum 10-15 minutes on mindfulness and mindful eating.
Main outcome variables
The main result will be the amount of food craving trait

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210507051204N2
Registration date: 2024-01-09, 1402/10/19
Registration timing: prospective

Last update: 2024-01-09, 1402/10/19
Update count: 0
Registration date
2024-01-09, 1402/10/19
Registrant information
Name
Sayed Amirhossein Allameh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3229 5351
Email address
sahallameh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the effectiveness of a mindfulness-based intervention along with standard treatment compared to standard treatment alone on the food craving trait in overweight and obese individuals with mild to moderate anxiety and/or depression: a randomized controlled trial.
Public title
Investigating the effectiveness of mindfulness on the food craving trait
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
BMI>=25 Mild to moderate anxiety or depression: according to the DASS-21 questionnaire, a score of 7 to 12 in men and 9 to 14 in women for the depression subscale, or a score of 6 to 11 in men and 8 to 12 in women for the anxiety subscale Access to a smart phone and the ability to use it to receive and use the files related to study Having sufficient literacy (reading and writing) to complete forms and questionnaires Living in Isfahan city or nearby towns and villages Willingness to participate in the study
Exclusion criteria:
Being a candidate for bariatric surgery History of bariatric surgery in the last 18 months Age less than 18 or more than 65 years Having mental disabilities, blindness or deafness Being treated in other centers or participating in other similar studies Having a history of acute psychological diseases such as major depression, bulimia, anorexia, suicide or suicidal thoughts, schizophrenia, acute personality disorders, severe anxiety and depression, panic disorder and drug addiction. History of hospitalization due to psychological diseases History of diseases affecting appetite and weight gain/loss such as hypo/hyperthyroidism, liver cirrhosis, uncontrolled metabolic diseases, immune diseases and malignancy Taking drugs that have a significant effect on metabolism or appetite, such as corticosteroids, psychiatric drugs, and hormonal drugs Previous familiarity with and regular use of mindfulness-based techniques (more than or equal to three times a week, each time 10 minutes or more) Pregnant or lactating women Not willing to participate in the study or withdrawing from cooperation at any stage of the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization will be done in blocks with blocks of 4, where the strata are obesity and overweight. The order of assigning people to groups will be determined based on the list generated by "Random Allocation" software, and people will be assigned to one of two intervention or control groups based on this list. The main interventionist is not aware of the order created by this list, and after the decision to enter a person into the study, the list is checked by another researcher, who then informs the main researcher of the individual's group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Scien
Street address
Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Sciences and Health Services, Hezar Jarib Ave.
City
اصفهان
Province
Isfehan
Postal code
8174673461
Approval date
2024-01-03, 1402/10/13
Ethics committee reference number
IR.MUI.PHANUT.REC.1402.055

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Food craving-trait score from FCQ-T-r questionnaire
Timepoint
The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files.
Method of measurement
FCQ-T-r questionnaire

Secondary outcomes

1

Description
binge eating
Timepoint
The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files.
Method of measurement
Binge eating scale questionnaire

2

Description
anxiety level
Timepoint
The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files.
Method of measurement
Anxiety subscale of 21 question version of depression-anxiety-stress scale questionnaire

3

Description
depression level
Timepoint
The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files.
Method of measurement
Depression subscale of 21 question version of depression-anxiety-stress scale questionnaire

4

Description
Mindful eating level
Timepoint
The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files.
Method of measurement
Mindful-Eating questionnaire

5

Description
Mindfulness level
Timepoint
The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files.
Method of measurement
Philadelphia mindfulness scale questionnaire

6

Description
satisfaction level regarding the therapy
Timepoint
The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files.
Method of measurement
visual analogue scale

7

Description
body mass index
Timepoint
The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files.
Method of measurement
weight in kilograms divided by height in meters squared

8

Description
weight
Timepoint
The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files.
Method of measurement
body analyzer

9

Description
body composition
Timepoint
The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files.
Method of measurement
body analyzer

Intervention groups

1

Description
Control group: will receive standard treatment, which includes a normal caloric restriction diet tailored to the individual, which is determined by a nutritionist based on factors such as the individual's nutritional status, degree of overweight and obesity, and underlying diseases.
Category
Treatment - Other

2

Description
Intervention group: In addition to the standard treatment, will receive a 14-day course including audio files of maximum 10-15 minutes including training related to mindfulness and mindful eating. Participants will be asked to listen to these files daily and apply the skills taught throughout the day. The educational topics will include a concept section and a mindful eating section. Topics in the concepts section include Mindfulness-introduction, Present moment awareness, Acceptance and non-judgment, Body scan, Decentralization, Beginner's mind, Gratitude and Self-acceptance. Topics in the Mindful Eating section include Mindful Eating-Introduction, Mindful snack, Connection to Food, Types of Hunger, Satiety Cues, and Coping with Food Cravings.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Gholamreza Askari
Street address
Alzahra hospital, Soffeh Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
nfsrc@nutr.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza askari
Street address
Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Amirhossein Allameh
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Security Research Center, Faculty of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hazarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3179
Email
sahallameh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zeinab Mokhtari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Security Research Center, Faculty of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hazarjarib Street
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
zeinab_mokhtary@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Amirhossein Allameh
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Security Research Center, Faculty of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hazarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3179
Email
sahallameh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after individuals were unidentified
When the data will become available and for how long
After results publication
To whom data/document is available
Everyone
Under which criteria data/document could be used
For further studies
From where data/document is obtainable
Dr. Zeinab Mokhtari, Assistant Professor of Nutritional Sciences, Food Security Research Center, Isfahan University of Medical Sciences E-mail: mokhtari@nutr.mui.ac.ir
What processes are involved for a request to access data/document
Contacting Dr. Zeinab Mokhtari via email
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