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Comparison of the effectiveness of low-calorie diet alone and in combination with cognitive-behavioural therapy intervention to reduce weight self-stigma on diet adherence and anthropometric indices in adult women with obesity and weight self-stigma: a randomized clinical trial

Protocol summary

Study aim
Comparison of the effectiveness of low-calorie diet alone and combined with cognitive-behavioural therapy intervention on diet adherence and anthropometric indices in adult women with obesity and weight self-stigma
Design
Clinical trial with control group, with parallel groups, non blinded, randomized on 120 samples. The site www.sealedenvelope.com will be used for randomization.
Settings and conduct
The location of the study will be Dr. Keshavarz's nutrition and diet therapy clinic in Tehran. The study population is adult women with obesity and weight self-stigma. This study won't be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study and sign a written consent form; Age between 18 and 50 years; BMI between 30 and 40 Kg/m2; Confirmation of weight self-stigma by questionnaire Exclusion criteria: suffering from certain diseases or a severe condition that affects the study results; Receiving specialized psychological counselling to reduce weight self-stigma in the last three months.
Intervention groups
The intervention group will receive cognitive-behavioral therapy to reduce self-stigma along with the weight loss diet, and the control group will receive the weight-loss diet alone.
Main outcome variables
Weight self-stigma; weight-loss diet adherence; weight; Waist circumference; Hip circumference; Fat mass; Fat free mass; Body water

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140907019082N12
Registration date: 2023-11-25, 1402/09/04
Registration timing: retrospective

Last update: 2023-11-25, 1402/09/04
Update count: 0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Mahdieh Abbasalizad Farhangi
Name of organization / entity
Department of Community Nutrition School of Nutrition
Country
Iran (Islamic Republic of)
Phone
+98 413357580
Email address
abbasalizadm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-17, 1402/05/26
Expected recruitment end date
2023-10-18, 1402/07/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of low-calorie diet alone and in combination with cognitive-behavioural therapy intervention to reduce weight self-stigma on diet adherence and anthropometric indices in adult women with obesity and weight self-stigma: a randomized clinical trial
Public title
Effect of weight self-stigma reduction intervention on obesity treatment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and sign a written consent form Age between 18 and 50 years Body mass index (BMI) between 30 and 40 Kg/m2 Confirmation of weight self-stigma by questionnaire
Exclusion criteria:
Suffering from certain diseases or a serious condition (such as bulimia) that affects the results of the study Receive specialized psychological counseling to treat weight self-stigma in the last 3 months
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be included in the study through availability sampling from the nutrition and diet therapy clinic and will be divided into intervention and control groups using simple randomization and will be matched based on age, BMI, and the use of supplements or drugs. In this study, we will use block randomization. The size of all the blocks is the same and we will have blocks of size 4 in this two-group experiment. For randomization, www.sealedenvelope.com website is used, which can generate random sequences in addition to simple randomization by blocking method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with a random sequence (Sequentially numbered, sealed, opaque envelopes) in which in this method each random sequence is recorded on a card and the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of the participant is revealed.
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
ٍEthics committee of Nutrition Faculty, Tabriz University of Medical Sciences
Street address
Nutrition Faculty, Tabriz University of Medical Sciences, Attar Street, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2023-10-02, 1402/07/10
Ethics committee reference number
IR.TBZMED.REC.1402.498

Health conditions studied

1

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

2

Description of health condition studied
weight self-stigma
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Weight self-stigma score using WBIS questionnaire
Timepoint
assessment of weight self-stigma score at the beginning, day 30, 60 and 120 of the study
Method of measurement
assessment of weight self-stigma score with the Weight Bias Internalization Scale (WBIS) questionnaire

2

Description
adherence percentage to weight loss diet
Timepoint
Measuring percentage of adherence to weight loss diet at the beginning, day 30, 60 and 120 of the study
Method of measurement
Measuring the percentage of adherence to the weight loss diet using the method of Pedro et al. (2009)

Secondary outcomes

1

Description
General mental health
Timepoint
At the beginning, on the 30th, 60th and 120th day of the study
Method of measurement
GHQ-28 questionnaire

2

Description
the intake of energy, micronutrients and macronutrients
Timepoint
At the beginning, on the 30th, 60th and 120th day of the study
Method of measurement
FFQ questionnaire and 3-day food record

3

Description
weight
Timepoint
At the beginning, on the 30th, 60th and 120th day of the study
Method of measurement
With the InBody 230 device

4

Description
height
Timepoint
At the beginning of the study
Method of measurement
seca stadiometer

5

Description
waist circumference
Timepoint
At the beginning, on the 30th, 60th and 120th day of the study
Method of measurement
tape measure

6

Description
hip circumference
Timepoint
At the beginning, on the 30th, 60th and 120th day of the study
Method of measurement
tape measure

7

Description
fat mass
Timepoint
At the beginning, on the 30th, 60th and 120th day of the study
Method of measurement
With the InBody 230 device

8

Description
fat-free mass
Timepoint
At the beginning, on the 30th, 60th and 120th day of the study
Method of measurement
With the InBody 230 device

9

Description
body water
Timepoint
At the beginning, on the 30th, 60th and 120th day of the study
Method of measurement
With the InBody 230 device

Intervention groups

1

Description
Intervention group: providing a monthly weight-loss diet in the form of a 30% reduction of the total daily caloric requirement calculated by the Mifflin st jeor formula (minimum calorie prescribed diet is 1200 kcal) and with the ratio of macronutrients in the form of 15-18% protein, 50-53% carbohydrates and 30-32% fat, along with the provision of cognitive-behavioral intervention to reduce self-stigma by a psychologist in the form of weekly group therapy sessions, using PowerPoint, for 12 weeks with CBT technique, providing a summary of the group therapy sessions in the form of a pamphlet at the end of each session and providing the content of the group therapy sessions through a phone call to absentees.
Category
Behavior

2

Description
Control group: receiving only the weight-loss diet as the same of intervention group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Keshavarz Nutrition and Diet Therapy Clinic
Full name of responsible person
Dr. Seyed Ali Keshavarz
Street address
No. 3, Fifth Alley, North Kargar St., Tehran
City
Tehran
Province
Tehran
Postal code
۵۱۶۶۶۱۴۷۱۱
Phone
+98 41 3335 7580
Email
abbasalizadm@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Ostad Rahimi
Street address
Nutrition Faculty, Tabriz University of Medical Sciences, AttarSstreet, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahdieh Abbasalizad Farhangi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Sciences, Attar Neishaboory St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 413357580
Fax
+98 41 3334 4280
Email
abbasalizadm@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahdieh Abbasalizad Farhangi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Sciences, Attar Neishaboory St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 413357580
Fax
+98 41 3334 4280
Email
abbasalizadm@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahdieh Abbasalizad Farhangi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Sciences, Attar Neishaboory St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 413357580
Fax
+98 41 3334 4280
Email
abbasalizadm@tbzmed.ac.ir

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
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