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Comparison the effectiveness of lifestyle modification interventions ( nutrition and physical activity) in comparison with lifestyle education on nutritional behaviors, physical activity, anthropometric measurements, fasting blood sugar and serum lipid profile in the adults aged 40-60 years

Protocol summary

Summary
The aim of this study is to evaluate the effectiveness of nutrition and physical activity interventions in comparison with education in the population of 40- 60 years old of Amirkola; which will be conducted with random sampling of participants referring to the health center of Amirkola. Enrolled participants will be allocated randomly in the three groups: highly-intensive intervention group, low- intensive intervention group and education group. The sample size is 300. Highly-intensive intervention includes weekly group-training about nutrition and physical activity, individualized nutrition counseling, providing educational materials and weekly free aerobic exercises. Low- intensive intervention includes weekly group-training about nutrition, individualized nutrition counseling and providing educational materials. The third group (control group) will not participate in weekly group-training classes and will receive only educational packages related to the study. Lifestyle status (based on Health-Promoting Life Style Profile questionnaire), nutritional and physical activity behaviors (based on Food Recall questionnaire and the Iranian version of International Physical Activity Questionnaire), besides body mass index, waist, neck, buttock and arm circumferences, body fat, blood pressure, fasting blood glucose and serum lipids will be examined before and after the intervention.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015070423055N1
Registration date: 2016-02-05, 1394/11/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-02-05, 1394/11/16
Registrant information
Name
Simin Mouodi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0624
Email address
s.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison the effectiveness of lifestyle modification interventions ( nutrition and physical activity) in comparison with lifestyle education on nutritional behaviors, physical activity, anthropometric measurements, fasting blood sugar and serum lipid profile in the adults aged 40-60 years
Public title
Comparison the effectiveness of lifestyle modification interventions
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria: Age 40-60 years; Living in Amirkola Babol; Desire to participate in the study, fill out and sign the informed consent form of the research Exclusion Criteria: Unable to read and write; Pregnancy or child breast feeding; Severe physical or mental disease which make them disable; Probable migration from Amirkola in 10 months
Age
From 40 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization in study population will be performed with random allocation of subjects in the age group of 40- 60 years old in the three groups by random numbers table.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrooz Avenue, Babol
City
Babol
Postal code
4136747176
Approval date
2015-06-02, 1394/03/12
Ethics committee reference number
mubabol.rec.1394.45

Health conditions studied

1

Description of health condition studied
Life-style (Factors influencing health status and contact with health services)
ICD-10 code
Z40,Z41,Z4
ICD-10 code description
Persons encountering health services for specific procedures and health care

Primary outcomes

1

Description
Life style status
Timepoint
Before ( 0 week) and after the intervention (16th week)
Method of measurement
HPLP-II questionnaire (Health-Promoting Life Style Profile-II)

2

Description
Main dietary pattern
Timepoint
Before ( 0 week) and after the intervention (16th week)
Method of measurement
Food Recall Questionnaire

3

Description
Physical activity status
Timepoint
Before ( 0 week) and after the intervention (16th week)
Method of measurement
IPAQ:International Physical Activity Questionnaire

Secondary outcomes

1

Description
Anthropometric measures
Timepoint
Before (0 week) and after the intervention (16 th week)
Method of measurement
Physical examination

2

Description
Blood pressure
Timepoint
Before (0 week) and after the intervention (16 th week)
Method of measurement
Physical examination

3

Description
Fasting blood glucose
Timepoint
Before ( 0 week) and after the intervention (16 th week)
Method of measurement
Blood sample

4

Description
Serum lipid profile
Timepoint
Before ( 0 week) and after the intervention (16 th week)
Method of measurement
Blood sample

Intervention groups

1

Description
Intervention group 1: For 4 months (16 weeks), weekly group training about nutrition and physical activity, individualized nutrition counseling, providing educational materials and weekly free aerobic exercises. The content of nutrition classes is adapted from nutritional principles which Ministry of Health and Medical Education of Iran has released. The trainer is an expert nutritionist. The duration of each class is 45 minutes, classes will be taken as group discussion and approximate number of participants is 25-30 persons.
Category
Lifestyle

2

Description
Intervention group 2: For 16 weeks, weekly group training about nutrition and physical activity, individualized nutrition counseling and providing educational materials.
Category
Lifestyle

3

Description
Control group: Only educational package included booklet, CD, pamphlet and papers about lifestyle especially improving nutrition and physical activity.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
population lab of Amirkola
Full name of responsible person
Seyed Reza Hosseini
Street address
Research center, Amirkola
City
Amirkola

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Babol University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia
Street address
Ganjafrooz Avenue, Babol
City
Babol
Grant name
دانشگاه علوم پزشکی و خدمات بهداشتی درمانی بابل
Grant code / Reference number
2786 research code
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Babol 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
Babol University of Medical Sciences
Full name of responsible person
Simin Mouodi
Position
MD, MPH
Other areas of specialty/work
Street address
Ganjafrooz Avenue, Babol University of Medical Sciences, Babol
City
Babol
Postal code
4136747176
Phone
+98 11 3219 0624
Fax
+98 11 3219 0624
Email
dr.mouodi@gmail.com
Web page address
mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyed Reza Hosseini
Position
Specialist in Social Medicine, Associate Professor
Other areas of specialty/work
Street address
Ganjafrooz Ave, Babol University of Medical Sciences, Babol
City
Babol
Postal code
4136747176
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
dr.mouodi@gmail.com
Web page address
mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Simin Mouodi
Position
MD, MPH
Other areas of specialty/work
Street address
Ganjafrooz Avenue, Babol University of Medical Sciences, Babol
City
Babol
Postal code
4136747176
Phone
+98 11 3219 0624
Fax
+98 11 3219 0624
Email
dr.mouodi@gmail.com
Web page address
mubabol.ac.ir

Sharing plan

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