Comparing the effectiveness of teaching adaptive coping strategies in combination with diet and diet alone on the success rate in reducing weight and waist circumference in obese women​

Determining the effectiveness of teaching adaptive coping strategies along with diet on weight loss and waist circumference in obese women

A clinical trial with a control group, with parallel groups, without blinding, randomized with blocks of size 2 based on 2 variables of age and body mass index, on 64 patients. Block randomization will be used for randomization.

Place of study: Nutrition Clinic of Ghaem Hospital, Mashhad; Population: Obese women with a BMI of 25-40 who meet the inclusion criteria; Blinding: Blinding is not done in this study.

Inclusion criteria: women aged 18 to 45 years old living in Mashhad; BMI equal to 25-40 kg/m2; Having a regular menstrual cycle. Exclusion criteria: use of medications to control blood sugar or lipids; pregnancy or planning to become pregnant in the next 6 months; breastfeeding; participating in a competitive sport; Abnormal concentration of thyroid hormone, use of psychiatric drugs, psychiatric disorders

Intervention group: a group that we teach adaptive coping strategies in 6 one-hour sessions along with diet and meal plan. We also teach about changing bad eating habits and behaviors and replacing them with good ones. Control group: the group to which we only give diet and food plan.

Waist circumference, hip circumference, BMI, body fat percentage

Due to the fact that this study is only conducted on women, it is not necessary to establish gender equality in the two intervention and control groups, but to maintain the equality of people in terms of age and BMI, we use the block randomization method. For this purpose, it is necessary to use 4 blocks in the following order. When 4 women signed the informed consent to participate in the study, according to their age and BMI, they will be placed in one of the following 4 categories, then each one will be randomly and secretly assigned to one of the two intervention or control groups: BMI ≥ 25 & Age <49; BMI<25 & Age <49; BMI ≥ 25 & Age≥49; BMI<25 & Age≥49. In this way, we have tried not to have a significant difference in the number of people in the two groups in terms of BMI and Age, and in this way, the effect of these two important confounding variables on the outcome will be moderated.

Data including anthropometric indices and body composition analysis are considered in this study. To release the data in a de-identified form, the data of individuals will be based on ID so that individuals are de-identified when analyzing the data.

The access period starts 4 months after the publication of the results

Nutritionists and researchers

To access the data and documents, he must obtain permission from the researchers of this project, and to access the data of this study, the individual must give a written commitment that he will only use the data for research purposes and will not disclose the personal information of people in any way.

Sara Alizadeh Moghaddam with email address saraalizadehmoqaddam@gmail.com

Permission must first be obtained from the data owner or the relevant licensor to access data and documents. Conditions and restrictions may accompany access to data and documents. For example, access to data and documents may require a non-disclosure agreement to be signed or a guarantee that the data and documents will only be used for research purposes. It takes 4 months to obtain permission and access to data.

To access the data and documents, he must obtain permission from the researchers of this project, and to access the data of this study, the individual must give a written commitment that he will only use the data for research purposes and will not disclose the personal information of people in any way. It takes about 3 months for permission and approval from the researchers, and after that, the person can access the data.