object: Effect of education of dietary healthy eating index on serum levels of inflammation markers in oboes women. This study is a randomized, single-blind,single center clinical trial with control group. inclusion criteria: women with body mass index (BMI) ≥ 30; having an initial HEI score < 80, under conditions of weight stability for at least 3 month; and subject satisfaction. Exclusion criteria: chronic disease (diabetes, cardiovascular disease,…); being active in exercise or weight reduction programs; taking weight loss medications;taking drugs that are known to affect the immune system; consumption of nutritional supplements at least 6 month before sampling; alcohol consumption; vegan diet; smoking and lack of subject follow-up . sixty obese women (BMI>30) were randomly divided into two groups, education group and control (non-education) group;individuals in education group will receive all recommendations concerning the healthy eating and healthy diet through receiving training package and having small group training sessions (12 sessions) conducted by a registered dietitian for 3 months. The control group won't receive the nutrition education program. The primary expected outcomes are changes in HEI score and serum concentration of inflammatory markers (adiponectin, TNF-a, hs-CRP)compared with baseline in the intervention group and the control before and after of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062610181N4
Registration date:2014-06-28, 1393/04/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-28, 1393/04/07
Registrant information
Name
Fatemeh Heidari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
haidari-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arvand International Division of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education of dietary healthy eating index on serum levels of inflammation markers in oboes women.
Public title
Effect of education of dietary healthy eating index on serum levels of inflammation markers in oboes women.
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: women with body mass index (BMI) ≥ 30; having an initial HEI score < 80, under conditions of weight stability for at least 3 month; and subject satisfaction. Exclusion criteria: chronic disease (diabetes, cardiovascular disease,…); being active in exercise or weight reduction programs; taking weight loss medications;taking drugs that are known to affect the immune system; consumption of nutritional supplements at least 6 month before sampling; alcohol consumption; vegan diet; smoking and lack of subject follow-up
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz
City
Ahvaz
Postal code
Approval date
2012-10-13, 1391/07/22
Ethics committee reference number
ETH-9115
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Healthy Eating Index
Timepoint
Before and after intervention
Method of measurement
Scoring method defined by the USDA
2
Description
Adiponectin
Timepoint
Before and after intervention
Method of measurement
Enzymatic
3
Description
TNF- α
Timepoint
Before and after intervention
Method of measurement
Enzymatic
4
Description
hs-CRP
Timepoint
Before and after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
weight
Timepoint
Before and after intervention
Method of measurement
scale
2
Description
height
Timepoint
Before and after intervention
Method of measurement
meter
3
Description
Waist circumference
Timepoint
Before and after intervention
Method of measurement
Non-elastic meter
4
Description
Body Mass Index(BMI)
Timepoint
Before and after intervention
Method of measurement
mathematics
5
Description
Waist to hip ratio (WHR)
Timepoint
Before and after intervention
Method of measurement
mathematics
6
Description
Percent of body fat mass
Timepoint
Before and after intervention
Method of measurement
Body state set
Intervention groups
1
Description
Intervention group/ Training sessions about healthy diet and HEI recommendations in small groups (12 sessions) for 3 months
Category
Other
2
Description
control group/ Without nutrition education program
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences (Health and Nutrition Clinic of Ahvaz)
Full name of responsible person
Dr Majid Mohammad Shahi
Street address
School of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Golestan St, ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arvand International Division of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Bahram Abdali
Street address
Education section, Arvand International Division of Ahvaz Jundishapur University of Medical Sciences , Opposite the international airport of Abadan, Parastar Square, Abadan, Khuzestan,Iran
City
Abadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arvand International Division of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Majid Mohammad Shahi
Position
PhD of Nutrition sciences/Assistant Professor
Other areas of specialty/work
Street address
School of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1373 8253
Fax
Email
mohamadshahi-m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Majid Mohammad Shahi
Position
PhD of Nutrition sciences/Assistant professor
Other areas of specialty/work
Street address
School of Paramedicine, Ahvaz Jundishapur University of Medical Sciences , Golestan St, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1373 8253
Fax
Email
mohamadshahi-m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Fatemeh Haidari
Position
PhD of Nutrition sciences/Associated Professor
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences , Golestan St, ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1373 8253
Fax
Email
haidari58@gmail.comhaidari-f@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)