Determination of the effect of balanced low calorie diet on depression score evaluated by Beck questionnaire in overweight and obese patients
Design
Clinical trial وwithout control group design of 78 participants, with simple random sampling method and table of random numbers, have been enrolled between December 2022 and June 2023, and have been following for 3months
Settings and conduct
The samples required for the present study are selected from among the outpatients referred to the nutrition and diet therapy clinic who meet the criteria for entering the study using non-probability sampling method.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 20-60 years
BMI>27
Depression score evaluated by Beck questionnaire>13
Willingness to participate in the study
Exclusion criteria:
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
Intervention groups
The group receives a balanced low-calorie diet
Main outcome variables
Weight loss
Decreasing in depression score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230316057733N1
Registration date:2023-08-18, 1402/05/27
Registration timing:prospective
Last update:2023-08-18, 1402/05/27
Update count:0
Registration date
2023-08-18, 1402/05/27
Registrant information
Name
Maryam Ranjbar Zahedani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5226 9320
Email address
m.ranjbar@larums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a balanced low-calorie diet on depression score evaluated by Beck questionnaire in overweight and obese patients
Public title
Effect of balanced low calorie diet on depression score
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-60 years
BMI>27
Depression score evaluated by Beck questionnaire>13
Willingness to participate in the study
Exclusion criteria:
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
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Larestan University of Medical Sciences
Street address
Larestan University Of Medical Sciences,behind the Larestan Grand Market,Karmand St,North Ghadir Blvd,Shahr_eJadid,Larestan,Fars,Iran.
City
Larestan
Province
Fars
Postal code
7153675541
Approval date
2022-11-07, 1401/08/16
Ethics committee reference number
IR.LARUMS.REC.1401.010
Health conditions studied
1
Description of health condition studied
Overweight and Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Decreasing in depression score
Timepoint
In the beginning and the end of the study
Method of measurement
Beck questionnaire
2
Description
Weight
Timepoint
Every 2 weeks
Method of measurement
Scale
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition and Diet therapy Center of Larestan University of Medical Sciences
Full name of responsible person
Somayeh Yousai
Street address
Larestan University Of Medical Sciences,Behind the Larestan Grand Market,Karmand St,North Ghadir Blvd,Shahr_eJadid,Larestan,Fars,Iran.
City
Larestan
Province
Fars
Postal code
7153675541
Phone
+98 917 192 8520
Email
s_yousai@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Salmanpoor
Street address
Larestan University Of Medical Sciences,behind the Larestan Grand Market,Karmand St,North Ghadir Blvd,Shahr_eJadid,Larestan,Fars,Iran.
City
Larestan
Province
Fars
Postal code
7153675541
Phone
+98 71 5225 5512
Email
s_yousai@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
Somayeh Yousai
Position
Assistant Professor in Nutrition Science
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Larestan University Of Medical Sciences,behind the Larestan Grand Market,Karmand St,North Ghadir Blvd,Shahr_eJadid,Larestan,Fars,Iran.
City
Larestan
Province
Fars
Postal code
7153675541
Phone
+98 71 5225 5512
Email
s_yousai@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Somayeh Yousai
Position
Assistant Professor in Nutrition Science
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Larestan University Of Medical Sciences,behind the Larestan Grand Market,Karmand St,North Ghadir Blvd,Shahr_eJadid,Larestan,Fars,Iran.
City
larestan
Province
Fars
Postal code
7153675541
Phone
+98 71 5225 5512
Email
s_yousai@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Maryam Ranjbar Zahedani
Position
Assistant Professor in Nutrition Science
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Larestan University Of Medical Sciences,behind the Larestan Grand Market,Karmand St,North Ghadir Blvd,Shahr_eJadid,Larestan,Fars,Iran.
City
Larestan
Province
Fars
Postal code
7153675541
Phone
+98 71 5225 5512
Email
ranjbarmaryam29@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No plan to release it
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
No plan to release it
When the data will become available and for how long
No plan to release it
To whom data/document is available
No plan to release it
Under which criteria data/document could be used
No plan to release it
From where data/document is obtainable
No plan to release it
What processes are involved for a request to access data/document