The effect of DASH (dietary approaches to stop hypertension) diet on anthropometric indices, blood pressure and Urinary sodium-to-potassium ratio in overweight and obese school children
Determining the effect of the DASH diet (Dietary Solution for Blood Pressure Control) on anthropometric indicators, blood pressure, and the ratio of sodium to potassium in the urine of overweight and obese elementary school children.
Design
This research is a double-blind randomized clinical trial. Participants: the ages of 8-12 years with a body mass index above the 85th percentile are selected from primary schools in Dezful city.
Settings and conduct
At the beginning and end of the study, the anthropometric indicators and blood pressure of each child are measured. A random urine sample will also be taken to measure sodium, potassium and creatinine levels. For the diet therapy group, DASH diet is considered. Also, before the start of the study, at the end of the first month and at the end of the study, a food record book with a food frequency questionnaire will be given to each child, and their parents will be asked to record all the food and drinks that they eat during these 3 days. Express the amount they have consumed along with the amount of household units.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the ages of 8-12 years, body mass index above the 85th percentile. Exclusion criteria: children suffering from heart problems, kidney problems, thyroid disorders or hormonal disorders and diabetes.
Intervention groups
There will be two intervention and control groups in the study. The intervention group includes people who receive the DASH diet and the control group does not receive a diet.
Main outcome variables
Anthropometric indicators, blood pressure, sodium, potassium and urine creatinine
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20240623062229N1
Registration date:2024-06-30, 1403/04/10
Registration timing:prospective
Last update:2024-06-30, 1403/04/10
Update count:0
Registration date
2024-06-30, 1403/04/10
Registrant information
Name
Reza Norouzirad
Name of organization / entity
Dezful University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 9532
Email address
norouzirad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of DASH (dietary approaches to stop hypertension) diet on anthropometric indices, blood pressure and Urinary sodium-to-potassium ratio in overweight and obese school children
Public title
The effect of DASH (dietary approaches to stop hypertension) diet on anthropometric indices, blood pressure and Urinary sodium-to-potassium ratio in overweight and obese school children
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index above the 85th percentile
Exclusion criteria:
Suffering from heart and kidney problems, thyroid disorders or hormonal disorders and diabetes, use of other diet and special medicines such as weight-reducing and blood pressure medicines
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, people are selected using the convenience sampling method, and the distribution of people between groups is done in a blocked randomization manner.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the following researchers were blinded according to the mentioned method:
- A researcher assigns each participant to groups-blocks based on a random method. This was done after generating random codes.
- A researcher who performs anthropometric measurements and records the data. During the first and second visit, he records the information in a form that is nameless and has a code.
- A researcher who performs data analysis. All of them are blind to the study.
- Based on the alphabet letters assigned to each person, and in a place separate from the above researchers, the health care provider delivers the diet method sheet to the person accompanying the child and explains it completely.
The person accompanying the child does not know the type of diet (the meaning of the name of the diet) and which group they are in (intervention or control), but anyway, because they have already filled out the consent form and seen the diet sheet, guess what They are a group, it is not difficult for them. But they clearly know what study they have participated in and have already filled out the informed consent form.
The researcher who performs the anthropometric measurements is independent of the health care provider who explains the diet to the child's companion. And therefore, they record the data in anonymous sheets that have random codes assigned to each person. He never asks the child or his companion about the type of diet he had.
The data analyst researcher analyzes the data based on the code assigned to each person and does not know whether group A or B is the intervention or the control group.
The data safety and monitoring committee, which includes the PI and one other principal investigator who also prepares the draft of the article, has access to all data after the analysis is completed, but is independent of the health care provider and measurement investigator and data recorder and analysis. are given and therefore do not interfere in the implementation.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Dezful University of Medical Sciences
Street address
No. 17, Shora st. between Aref and Dehghan
City
Dezful
Province
Khouzestan
Postal code
6461884476
Approval date
2023-05-05, 1402/02/15
Ethics committee reference number
IR.DUMS.REC.1402.003
Health conditions studied
1
Description of health condition studied
Obesity and overweight
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Anthropometric indices
Timepoint
Start and end of study
Method of measurement
Using scales, meters, and calipers
2
Description
blood pressure
Timepoint
Start and end of study
Method of measurement
Mercury blood pressure measuring device
3
Description
Urine sodium and potassium
Timepoint
Start and end of study
Method of measurement
Using a film photometer
4
Description
Creatinine
Timepoint
Start and end of study
Method of measurement
Using Jaffe's method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dash diet
Category
N/A
2
Description
Control group: No diet
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers, schools
Full name of responsible person
Reza Norouzirad
Street address
No. 17, Shora St. between Aref and Dehghan
City
Dezful
Province
Khouzestan
Postal code
6461884476
Phone
+98 61 4252 3857
Email
norouzirad@gmail.com
Web page address
https://www.dums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Mohammad Amin Bahmanesh
Street address
Dezful University of Medical Sciences, next to the traffic department, Azadegan Blvd
No. 24, Arabi St., Endocrine Sciences Research Institute
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2241 2500
Fax
+98 21 2243 9981
Email
zahrabahadoran@yahoo.com
Web page address
http://emrc.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Reza Norouzirad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
No. 17, Shora St. between Aref and Dehghan St., Dezful, Iran
City
Dezful
Province
Khouzestan
Postal code
6461884476
Phone
+98 61 4242 9532
Fax
Email
norouzirad@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
All anonymized analyzed data will be published in the form of articles or abstracts in a peer-reviewed journal.
When the data will become available and for how long
After completing the study and publishing the results in the form of an article
To whom data/document is available
Everyone has access to the data published in the article. For other raw data, a reasonable request from the responsible administrator and in coordination with the University Ethics Committee may be possible.
Under which criteria data/document could be used
Other statistical analyzes except what is printed in the article.
From where data/document is obtainable
Corresponding author, Reza Norouzirad
What processes are involved for a request to access data/document
With the request of the responsible executive and the approval of the ethics committee, the desired data will be provided.