Protocol summary

Summary
Objectives: To determine the quality of working life in the male employees using dietary management. This study is an interventional study with two groups (100 members in intervention group with low-calorie low-fat diet and 100 members in control group with low-calorie low-carb diet). Allocation to the groups was nonrandom. Study population: 25_65 years employees in Assaluyeh with abdominal obesity. Sampling has been done according to some matching variables (Age, sex, height, weight, prior diet). Interventions: the subjects followed a common diet food for 1_2 weeks before the intervention processes and regimes training. Then they were divided into two groups. Inclusion criteria: male; aged 25_65 years; with abdominal obesity; working in Assaluyeh; willingness to cooperate. Exclusion criteria: not be willing to cooperate; developing a particular disease. The sample size is 200 people. Interventions: providing low-calorie low-fat diet education to 100 members in intervention group and followed the low-calorie low-Carb diet education to 100 members in control group during 6 months. The primary outcome of this study was losing weight and individuals’ health improvements. The final outcome was quality of working life.

General information

Acronym
_
IRCT registration information
IRCT registration number: IRCT2017022032690N1
Registration date: 2017-06-11, 1396/03/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
Aliye Basiri
Name of organization / entity
School of Management and Medical Information, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 0779
Email address
a_basiri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-05-09, 1395/02/20
Expected recruitment end date
2016-11-05, 1395/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the quality improvement of working life among 25_65 years male petrochemical company employees using dietary management
Public title
The effect of diet on the quality of working life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: male; aged 25_65 years; having abdominal obesity; working in Assaluyeh; willingness to having cooperation. Exclusion criteria: not having willingness to cooperate; developing a particular disease.
Age
From 25 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study is based on a dietary and questionnaire of quality of working life.

Secondary Ids

1

Registry name
_
Secondary trial Id
_
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Boulevard، Shiraz
City
Shiraz
Postal code
71348-14336
Approval date
2017-01-22, 1395/11/03
Ethics committee reference number
IR.SUMS.REC.1395.172

Health conditions studied

1

Description of health condition studied
Localized adiposity
ICD-10 code
E65
ICD-10 code description
Localized adiposity

2

Description of health condition studied
Obesity, unspecified
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS

Primary outcomes

1

Description
Quality of working life
Timepoint
Baseline_4 months later (end of study)
Method of measurement
Walton's Quality of working life Questionnaire

Secondary outcomes

1

Description
Liver function tests (SGOT- SGPT- ALKPH )
Timepoint
Baseline_4 months later (end of study)
Method of measurement
Laboratory tests of blood samples

2

Description
Blood pressure
Timepoint
Baseline_4 months later (end of study)
Method of measurement
Millimeters of mercury using mercury manometer

3

Description
Lipid tests (CHOL- TG- HDL- LDL )
Timepoint
Baseline_4 months later (end of study)
Method of measurement
Laboratory tests of blood samples

4

Description
body mass index ( BMI )
Timepoint
Baseline_4 months later (end of study)
Method of measurement
Weight (Kilogram )/ Height ( Meter )_ Scale/ Measuring tape

5

Description
Weight
Timepoint
Baseline_4 months later (end of study)
Method of measurement
By weight_ Scale

6

Description
Waist
Timepoint
Baseline_4 months later (end of study)
Method of measurement
In meters_ Measuring tape

7

Description
Blood glucose level tests ( FBS- BS )
Timepoint
Baseline_4 months later (end of study)
Method of measurement
Laboratory tests of blood samples

Intervention groups

1

Description
Intervention group 1: Offering low-fat, low-calorie diet :2 2-hour training sessions to transfer information in the field of nutrition for each individual according to his/her needs by nutrition expert; Calculate the energy of low-fat low-calorie diet; Changing the diet to a low-fat low-calorie diet (60% carbohydrate, 20% fat and 20% protein); Follow-up for 4 months.
Category
Lifestyle

2

Description
Intervention group 2: Offering low-carbohydrate, low-calorie diet: 2 2-hour training sessions to transfer information in the field of nutrition for each individual according to his/her needs by nutrition expert; Calculate the energy of low-carb low-calorie diet; Changing the diet to a low-carb low-calorie diet (45% carbohydrate, 35% fat and 25% protein); Follow-up for 4 months.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr Petrochemical Company
Full name of responsible person
Reza Ghasemi _ Expert Nutrition Sciences_ scientist dietitian; Morteza Mansouri_ Master of Environme
Street address
Mehr Petrochemical Company، Phase 2 Petrochemical، Special Economic Zone Pars، Assaluyeh، Bushehr
City
Assaluyeh

2

Recruitment center
Name of recruitment center
Arya Sasol Polymer Company
Full name of responsible person
Ali Zeinabi_ PHD in Nutrition_ nutritionist
Street address
Arya Sasol Polymer Company, Pars Special Economic Energy Zone, Assaluyeh, Bushehr, Iran
City
Assaluyeh

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research of Shiraz University of Medical Sciences
Full name of responsible person
Syed Basir Hashemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Boulevard‌‌‌, Shiraz, Iran
City
Shiraz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Shiraz 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
Faculty of Nutrition and Food Science _ Shiraz University of Medical Sciences
Full name of responsible person
Mousa Salehi
Position
PHD in nutrition education_ Associate Professor
Other areas of specialty/work
Street address
School of Public Health Nutrition, Zahra Street, Shiraz, Iran
City
Shiraz
Postal code
71645-111
Phone
+98 71372510015
Fax
+98 71 3725 7288
Email
schealth@sums.ac.ir; salehi@sums.ac.ir
Web page address
http://scnutrition.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Health Care Management & Informatics School, Shiraz University of Medical Sciences
Full name of responsible person
Omid Barati
Position
PHD in Health Services Management
Other areas of specialty/work
Street address
Health Care Management & Informatics School, Almas Building, Alley 29, Qasrodasht Ave, Shiraz,Iran
City
shiraz
Postal code
71336-54361
Phone
+98 71 3234 0779
Fax
+98 71 3234 0039
Email
omidbarati40@gmail.com
Web page address
http://mgsch.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Health Care Management & Informatics School, Shiraz University of Medical Sciences
Full name of responsible person
Ramin Ravangard
Position
PHD in Health Services Management, assistant professor
Other areas of specialty/work
Street address
Health Care Management & Informatics School, Almas Building, Alley 29, Qasrodasht Ave, Shiraz, Iran
City
Shiraz
Postal code
71336-54361
Phone
+98 71323407746
Fax
-
Email
ra_ravangard@yahoo.com
Web page address
http://mgsch.sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...