Protocol summary

Study aim
Comparison and determination the effects of high-fat and low-carbohydrate diet with Standard diet on body composition, appetite, and anthropometric measurements in overweight and obese children
Design
The clinical trial has two intervention groups, parallel groups, single blind and randomized.
Settings and conduct
Demographic questionnaire was used to measure social status, IPAQ-short form (The International Physical Activity Questionnaire) form was used to measure physical activity and The Appetite and Diet Assessment Tool(ADAT) and self-reported score were used to assess appetite. The three-day food record are filled out by the parents or children. Weight measurement is measured with a digital scale with 100 grams accuracy .  The individual's height is measured with 0.5 cm accuracy . Waist and hip circumference is measured using a meter. Body composition is assessed with a Body impedance analysis (BIA). Diet sheet with supplementary recommendations to be given to the participant. To measure adherence each week, we will ask the person about their diet performing. Blinding: The evaluator is not aware of the participant's diet. location: Shiraz, Namazi Square, Imam Reza Clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 9-18 years BMI for age above 85th percentile Exclusion criteria: Having a specific diet
Intervention groups
Control group: Low fat and high carbohydrate diet (Standard diet) (25% of total energy as fat, 20% of total energy as protein and 55% of total energy as carbohydrate) Intervention group: High-fat, low-carbohydrate diet (55% of total energy as fat, 20% of total energy as protein , and 25% of total energy as carbohydrate)
Main outcome variables
Height, weight, BMI, waist-to-hip ratio, waist circumference, hip circumference, appetite, adipose tissue, lean tissue, interstitial water

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191121045464N1
Registration date: 2020-07-06, 1399/04/16
Registration timing: registered_while_recruiting

Last update: 2020-07-06, 1399/04/16
Update count: 0
Registration date
2020-07-06, 1399/04/16
Registrant information
Name
Mohaddeseh Hasanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3648 0127
Email address
hasanzade-m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of high-fat and low-carbohydrate weight loss diet with standard weight loss diet on body composition, appetite and anthropometric measurements in overweight and obese children
Public title
Comparison of the effects of two weight loss diets (High fat diet and Standard diet)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI(Body mass index) for age above 85th percentile Parents' consent to participate in the project
Exclusion criteria:
BMI (body mass index) for age is normal
Age
From 9 years old to 18 years old
Gender
Female
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals using the Permuted Block Randomization method will be divided into two groups. To create a random sequence in the block randomization approach, the website http://www.sealedenvelopepe.com will be used. The project methodologist is also given a random sequence to hide the allocation concealment. Then, the researcher communicates with the mentioned people based on the order of the participants entering the study and communicates with the said person about the random allocation of the participants to the study and asks about the random allocation of the participant to the specific group. For each intervention, a number (multi-digit code) is defined and entered on the envelope according to the random sequence created.
Blinding (investigator's opinion)
Single blinded
Blinding description
The trial is planned in such a way that the evaluator of weight and body composition does not understand which of the two groups (High-fat weight loss diet and Standard weight loss diet) belong to the participant.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences Central Building, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-12-12, 1398/09/21
Ethics committee reference number
IR.TUMS.VCR.REC.1398.694

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Children's body mass index percentile
Timepoint
The first week and the sixth week
Method of measurement
Body weight in kilogram divided by the square of the height in meters

2

Description
Individual weight with minimum clothing and no shoes with 0.1 kg accuracy
Timepoint
The first week and the sixth week
Method of measurement
Scale

3

Description
Children's height in standing position without shoes with 0.5 accuracy
Timepoint
The first week and the sixth week
Method of measurement
Stadiometer

4

Description
Waist circumference measurement in the midline between the lower rib and the upper part of the iliac bone
Timepoint
The first week and the sixth week
Method of measurement
Meter

5

Description
Measuring the most articulated part of the hip
Timepoint
The first week and the sixth week
Method of measurement
Meter

6

Description
Waist to hip ratio
Timepoint
The first week and the sixth week
Method of measurement
Waist circumference divided by hip circumference

7

Description
Appetite score by ADAT questionnaire(The Appetite and Diet Assessment Tool)
Timepoint
The first week and the sixth week
Method of measurement
ADAT questionnaire(The Appetite and Diet Assessment Tool)

8

Description
Fat mass measured by Bioelectrical Impedance Analysis (BIA)with minimal clothing and no shoes
Timepoint
The first week and the sixth week
Method of measurement
Bioelectrical Impedance Analysis

9

Description
Lean body mass measured by Bioelectrical Impedance Analysis with minimal clothing and no shoes
Timepoint
The first week and the sixth week
Method of measurement
Bioelectrical Impedance Analysis (body weight - fat mass)

10

Description
Interstitial water measured by Bioelectrical Impedance Analysis with minimal clothing and no shoes
Timepoint
The first week and the sixth week
Method of measurement
Bioelectrical Impedance Analysis

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: High fat and low carbohydrate (55% of total energy as fat, 20% of total energy as protein 25% of total energy as carbohydrate ) and the amount of diet energy is 500 kcal below the individual requirement .Everyone will also be given dietary advice.The duration of the diet will be 6 weeks
Category
Treatment - Other

2

Description
Control group: Standard diet (55% of total energy as carbohydrate, 20% of total energy as protein 25% of total energy as fat ) and the amount of diet energy is 500 kcal below the individual requirement .Everyone will also be given dietary advice.The duration of the diet will be 6 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
کلینیک زیبا آفرین
Full name of responsible person
محدثه حسن زاده
Street address
4th floor,Kasra Building,Ordibehesht Ave,Mulla Sadra Street
City
Shiraz
Province
Fars
Postal code
7134684499
Phone
+98 71 3648 0127
Email
mahdishealth@outlook.com
Web page address
http://mahdishealth.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Mahmoodi
Street address
6th Floor, School of Nutrition and Dietetics, Hojjat Doust Alley, Naderi St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5805
Email
m-mahmoudi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohaddeseh Hasanzadeh
Position
Student of Master of science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.207 ,18/2 Ave. , Besat Blvd.
City
Shiraz
Province
Fars
Postal code
7183613317
Phone
+98 71 3648 0127
Fax
Email
hasanzade-m@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohaddeseh Hasanzadeh
Position
Student of Master of science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.207 ,18/2 Ave. , Besat Blvd.
City
Shiraz
Province
Fars
Postal code
7183613317
Phone
+98 71 3648 0127
Fax
Email
hasanzade-m@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohaddeseh Hasanzadeh
Position
Student of Master of science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.207 ,18/2 Ave. , Besat Blvd.
City
Shiraz
Province
Fars
Postal code
7183613317
Phone
+98 71 3648 0127
Fax
Email
hasanzade-m@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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