Aim: The Life style promotion project (LPP) is a long term community-based project for prevention and control of non-communicable diseases (NCDs). In this project, the healthy lifestyle promotion plan will be implemented by the health policy agenda of East Azerbaijan province. This study is a community based intervention trial for measuring performance of healthy lifestyle promotion plan.
Design and methods: This study is a prospective follow-up research in which data recollection will be performed every 2 years after the intervention initiated. The healthy lifestyle promotion interventions are as follows: 1 Running at least 30 training courses of healthy lifestyle during one year in health centers, each for 1 hour (healthy eating, nutrition for prevention and control of non-communicable diseases, mental health) and running healthy lifestyle campaigns (reducing salt, sugar and oil intake, increasing dairy products intake, increasing physical activity level, reducing anxiety and smoking) each for 2 months using banners, posters and pamphlets. Theses programs will be implemented by the health policy agenda of East Azerbaijan province. A total of 3000 participants with aged 15-65 years will be enrolled to evaluate the impact of healthy life style interventions. Data will be collected based on interviews, physical assessments, and anthropometric measurements by visiting households via a team of health experts based on cluster sampling. The research primary goal is determining differences in the prevalence of major NCDs risk factors and outcomes before and after healthy life style intervention.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016070428787N1
Registration date:2016-07-25, 1395/05/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-25, 1395/05/04
Registrant information
Name
Leila Nikniaz
Name of organization / entity
Tabriz health services management research center
Country
Iran (Islamic Republic of)
Phone
+98 41 3655 2890
Email address
nikniazl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tabriz University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of life style promotion plan on non-communicable diseases and associated behavioral and clinical risk factors
Public title
Evaluation the effectiveness of life style promotion plan on non-communicable diseases
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: adults aged between 15 - 64 years; having Iranian nationality
Exclusion criteria: adults with severe chronic illness requiring bed rest; physical disability; mental disability; the presence of communication barriers; pregnant women
Age
From 15 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
3000
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Ave., Tabriz
City
Tabriz
Postal code
Approval date
2015-02-09, 1393/11/20
Ethics committee reference number
1394.383
Health conditions studied
1
Description of health condition studied
non communicable diseases
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
non communicable diseases
Timepoint
every 2 years
Method of measurement
questionnaires,hospital records and biomedical assessment
Secondary outcomes
1
Description
Risk factors of noncommunicable diseases
Timepoint
every 2 years
Method of measurement
questionnaires,Antheropometeric examinations and biomedical assessment
Intervention groups
1
Description
Running at least 30 training courses of healthy lifestyle during one year in health centers, each for 1 hour (healthy eating , nutrition for prevention and control of non-communicable diseases, mental health )
Running healthy lifestyle campaigns (reducing salt, sugar and oil intake, increasing dairy products intake, increasing physical activity level, reducing anxiety and smoking) each for 2 months using banners, posters and pamphlets
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Households in East Azerbaijan province
Full name of responsible person
Leila Nikniaz
Street address
NPMC, Tavanir exit, Pasdaran highway, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hussein Abdollahi
Street address
Tabriz University of Medical Sciences, Daneshgah Ave., Tabriz
City
Tabriz
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,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Leila Nikniaz
Position
PhD/ َAssistant professor
Other areas of specialty/work
Street address
NPMC, Tavanir exit, Pasdaran highway, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3655 2890
Fax
Email
nikniazleila@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Leila Nikniaz
Position
PhD/ Assistant professor
Other areas of specialty/work
Street address
NPMC, Tavanir exit, Pasdaran highway, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3655 2890
Fax
Email
nikniazleila@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Leila Nikniaz
Position
PhD/ Assistant professor
Other areas of specialty/work
Street address
NPMC, Tavanir exit, Pasdaran highway, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3655 2890
Fax
Email
nikniazleila@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)