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IRCT20140907019082N12 IRCT 2023-11-25 Tabriz University of Medical Sciences Effect of weight self-stigma reduction intervention on obesity treatment 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 2023-08-17 anticipated 120 Complete https://irct.ir/trial/71348 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A Condition 1: obesity. Condition 2: weight self-stigma. Intervention 1: 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. Intervention 2: Control group: receiving only the weight-loss diet as the same of intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is not planned yet
public Mahdieh Abbasalizad Farhangi
Tabriz University of Medical Sciences, Attar Neishaboory St.
Tabriz Iran (Islamic Republic of) 5166614711 +98 413357580 abbasalizadm@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mahdieh Abbasalizad Farhangi
Tabriz University of Medical Sciences, Attar Neishaboory St.
Tabriz Iran (Islamic Republic of) 5166614711 +98 413357580 abbasalizadm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 50 years Female 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 E66 Overweight and obesity Behavior Treatment - Other 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. Control group: receiving only the weight-loss diet as the same of intervention group 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. 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). General mental health. Timepoint: At the beginning, on the 30th, 60th and 120th day of the study. Method of measurement: GHQ-28 questionnaire. 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. Weight. Timepoint: At the beginning, on the 30th, 60th and 120th day of the study. Method of measurement: With the InBody 230 device. Height. Timepoint: At the beginning of the study. Method of measurement: seca stadiometer. Waist circumference. Timepoint: At the beginning, on the 30th, 60th and 120th day of the study. Method of measurement: tape measure. Hip circumference. Timepoint: At the beginning, on the 30th, 60th and 120th day of the study. Method of measurement: tape measure. Fat mass. Timepoint: At the beginning, on the 30th, 60th and 120th day of the study. Method of measurement: With the InBody 230 device. 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. Body water. Timepoint: At the beginning, on the 30th, 60th and 120th day of the study. Method of measurement: With the InBody 230 device. Tabriz University of Medical Sciences Approved 2023-10-02 ٍEthics committee of Nutrition Faculty, Tabriz University of Medical Sciences Nutrition Faculty, Tabriz University of Medical Sciences, Attar Street, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)