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IRCT20230316057733N1 IRCT 2023-08-18 Larestan University of Medical Sciences Effect of balanced low calorie diet on depression score The effect of a balanced low-calorie diet on depression score evaluated by Beck questionnaire in overweight and obese patients 2023-08-23 anticipated 78 Complete https://irct.ir/trial/69202 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. N/A Overweight and Obesity. The current study is a 12-week randomized clinical trial with the overall goal of determining the effects of a low-calorie balanced diet on depression score based on Beck's standard questionnaire, anthropometry and body composition in overweight and obese patients. The patients will be recruited among the outpatients living in Lar city with overweight and obesity (BMI≥27) referring to Nutrition and Diet therapy Center of Larestan University of Medical Sciences with easy non-probability sampling method and based on the inclusion criteria. Written informed consent forms for participation in the trial will be obtained from all participants. The patients will be provided with a balanced weight loss diet based on individual indicators (height, weight, gender and physical activity level) and Harris-Benedict equation by subtracting 500 kcal/day from their estimated energy requirements for weight maintenance. Moreover, the participants will be asked to complete a study questionnaire, which included questions regarding their demographic and socioeconomic characteristics (age, sex, occupation, education level, marital status, and family history of Diabetes Mellitus(DM), Hypertension(HTN) and Cardio Vascular Diseases(CVD)) The participants will be also asked not to change their physical activity levels, and avoid starting to take any medicine or nutritional supplement or changing their food habits during the follow-up period. Patients following up in order to check them in terms of adherence to the diet, answering their questions and preventing samples from falling will be also done every week by phone and also by visiting patients once every two weeks. Also, to check the state of mood of the participants in the study, Beck's standard depression questionnaire will be used at the beginning and end of the intervention. Weight, height, and waist and hip circumferences (WC; HC) of subjects will be measured based upon standard protocol at the time they will be enrolled in the study (to the nearest 0.1 Kg and 0.5 cm for weight, height, WC and HC respectively). Both WC and HC were measured using a flexible non-elastic tape above the iliac crests and at the maximal buttocks, respectively. Body mass index (BMI), defined as weight (kg) divided by square of height (m2), was then calculated from these measures. Moreover, the indicators related to body composition (body fat mass) are calculated using the following formula: Body fat%: (1.2×BMI) + (0.23×age)- (10.8× g) g = 0 for women g= 1 for men. No - There is not a plan to make this available Justification or reason for not sharing IPD is No plan to release it
public Somayeh Yousai
Larestan University Of Medical Sciences,behind the Larestan Grand Market,Karmand St,North Ghadir Blvd,Shahr_eJadid,Larestan,Fars,Iran.
Larestan Iran (Islamic Republic of) 7153675541 +98 71 5225 5512 s_yousai@yahoo.com Larestan University of Medical Sciences scientific Somayeh Yousai
Larestan University Of Medical Sciences,behind the Larestan Grand Market,Karmand St,North Ghadir Blvd,Shahr_eJadid,Larestan,Fars,Iran.
larestan Iran (Islamic Republic of) 7153675541 +98 71 5225 5512 s_yousai@yahoo.com Larestan University of Medical Sciences Iran (Islamic Republic of) Age between 20-60 years BMI>27 Depression score evaluated by Beck questionnaire>13 Willingness to participate in the study 20 years 60 years Both Pregnancy and Lactation Taking anti depressant drugs Taking multi vitamins and minerals Having any severe systemic disease, endocrine or metabolic disorders Having been on a weight loss diet for the past 6 months Professional athlete E66.9 Obesity, unspecified Lifestyle The current study is a 12-week randomized clinical trial with the overall goal of determining the effects of a low-calorie balanced diet on depression score based on Beck's standard questionnaire, anthropometry and body composition in overweight and obese patients. The patients will be recruited among the outpatients living in Lar city with overweight and obesity (BMI≥27) referring to Nutrition and Diet therapy Center of Larestan University of Medical Sciences with easy non-probability sampling method and based on the inclusion criteria. Written informed consent forms for participation in the trial will be obtained from all participants. The patients will be provided with a balanced weight loss diet based on individual indicators (height, weight, gender and physical activity level) and Harris-Benedict equation by subtracting 500 kcal/day from their estimated energy requirements for weight maintenance. Moreover, the participants will be asked to complete a study questionnaire, which included questions regarding their demographic and socioeconomic characteristics (age, sex, occupation, education level, marital status, and family history of Diabetes Mellitus(DM), Hypertension(HTN) and Cardio Vascular Diseases(CVD)) The participants will be also asked not to change their physical activity levels, and avoid starting to take any medicine or nutritional supplement or changing their food habits during the follow-up period. Patients following up in order to check them in terms of adherence to the diet, answering their questions and preventing samples from falling will be also done every week by phone and also by visiting patients once every two weeks. Also, to check the state of mood of the participants in the study, Beck's standard depression questionnaire will be used at the beginning and end of the intervention. Weight, height, and waist and hip circumferences (WC; HC) of subjects will be measured based upon standard protocol at the time they will be enrolled in the study (to the nearest 0.1 Kg and 0.5 cm for weight, height, WC and HC respectively). Both WC and HC were measured using a flexible non-elastic tape above the iliac crests and at the maximal buttocks, respectively. Body mass index (BMI), defined as weight (kg) divided by square of height (m2), was then calculated from these measures. Moreover, the indicators related to body composition (body fat mass) are calculated using the following formula: Body fat%: (1.2×BMI) + (0.23×age)- (10.8× g) g = 0 for women g= 1 for men Decreasing in depression score. Timepoint: In the beginning and the end of the study. Method of measurement: Beck questionnaire. Weight. Timepoint: Every 2 weeks. Method of measurement: Scale. Larestan University of Medical Sciences Approved 2022-11-07 Ethics committee of Larestan University of Medical Sciences Larestan University Of Medical Sciences,behind the Larestan Grand Market,Karmand St,North Ghadir Blvd,Shahr_eJadid,Larestan,Fars,Iran. Larestan Fars Iran (Islamic Republic of)