Plain English Summary
Background and study aims
Noncommunicable disorders (NCDs) are long-term diseases that are not passed from person to person. NCDs include heart disease, cancer, lung disease and diabetes. This study is a long-term community-based programme which aims to evaluate lifestyle modification interventions to prevent or postpone the development of NCDs.
Who can participate?
Residents of District 13 of Tehran, aged 3 years and over
What does the study involve?
Participating areas are randomly allocated to either the intervention or the control group. Residents in the intervention areas receive interventions that aim to improve their lifestyle (e.g., diet, smoking and exercise) through education, leaflets, brochures, school programme alterations, and treating patients with NCD risk factors. Data is collected every 3 years to assess the effects of the different interventions on the prevalence of NCDs in the intervention areas as compared to the control areas, where residents do not receive the interventions.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Research Institute for Endocrine Sciences (Iran)
When is the study starting and how long is it expected to run for?
March 1999 to March 2020
Who is funding the study?
1. National Research Council, Ministry of Health (Iran)
2. Research Institute for Endocrine Sciences (Iran)
Who is the main contact?
Prof Fereidoun Azizi
azizi@endocrine.ac.ir
Study website
Contact information
Type
Scientific
Contact name
Prof Fereidoun Azizi
ORCID ID
Contact details
Research Institute for Endocrine Sciences
No 24 Parvaneh Avenue
Yaman Street
Velenjak
Tehran
19395-4763
Iran
+98 (0)21 2240 9309
azizi@endocrine.ac.ir
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Prevention of non-communicable disease in a population in nutrition transition: Tehran Lipid and Glucose Study Phase II
Acronym
TLGS II
Study hypothesis
The Tehran Lipid and Glucose Study (TLGS) is a long term integrated community-based programme for prevention of non-communicable disorders (NCD) by development of a healthy lifestyle and reduction of NCD risk factors. The primary research goal is an evaluation of the feasibility and effectiveness of lifestyle modification interventions in preventing or postponing the development of NCD risk factors and outcomes in a population in nutrition transition. Secondary research goals include determining differences in the prevalence of major NCD risk factors and outcomes between intervention and control groups with special focus on angina pectoris, myocardial infarction, cerebrovascular events, diabetes mellitus, hypertension and dyslipidaemia.
Ethics approval(s)
The National Research Council of the Islamic Republic of Iran (ref: 121); performed with the approval of the Human Research Review Committee of the Endocrine Research Centre, Shahid Beheshti University (MC).
Study design
Randomised community intervention (controlled field trial)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Community
Study type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Non-communicable diseases (NCD)
Intervention
Primary, secondary and tertiary interventions were designed based on specific target groups including school children, housewives, and high-risk persons. Officials of various sectors such as health, education, municipality, police, media, traders and community leaders were actively engaged as decision makers and collaborators. Interventional strategies were based on lifestyle modifications in diet, smoking and physical activity through face-to-face education, leaflets and brochures, school programme alterations, training volunteers as health team and treating patients with NCD risk factors. Collection of demographic, clinical and laboratory data will be repeated every 3 years to assess the effects of different interventions in the intervention group as compared to control group.
Intervention type
Behavioural
Primary outcome measure
Major NCD risk factors including the following:
1. Glucose disorders (oral glucose tolerance test, fasting blood sugar)
2. Dyslipidaemia: serum total cholesterol, triglycerides, low density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C)
3. Obesity: a body mass index (BMI) of 25 to 29.9 kg/m^2 in adults is considered as overweight and a BMI equal to or more than 30 kg/m^2 is defined as obesity. Obesity and overweight in children and adolescents are defined according to international cut-off points for body mass index. Truncal obesity is defined as a waist-hip ratio (WHR) more than 0.95 in adult men and more than 0.8 in adult women.
4. Smoking, assessed by a 110-item questionnaire and Modifiable Activity Questionnaire (MAQ)
5. Hypertension (HTN)
6. Level of physical activity, assessed by a 110-item questionnaire and Modifiable Activity Questionnaire (MAQ)
7. Nutritional status, assessed by interviews
The primary outcomes are assessed every 3 years.
Secondary outcome measures
1. Any significant medical events
2. Mortality
The secondary outcomes are assessed annually.
Overall study start date
01/03/1999
Overall study end date
01/03/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Individuals aged 3 years and over, either sex
2. Residents of the District 13 of Tehran
3. Under the coverage of three medical health centres, selected using multistage cluster random sampling method
4. Agree for all members of each family, including those not having risk factors, to be enrolled
Participant type(s)
All
Age group
Other
Sex
Both
Target number of participants
15,005 (5,630 cases for intervention group)
Participant exclusion criteria
Mentally disabled persons
Recruitment start date
01/03/1999
Recruitment end date
01/03/2020
Locations
Countries of recruitment
Iran
Study participating centre
Research Institute for Endocrine Sciences
Tehran
19395-4763
Iran
Sponsor information
Organisation
Research Institute for Endocrine Sciences (Iran)
Sponsor details
No 24 Parvaneh Avenue
Yaman Street
Velenjak
Tehran
19395-4763
Iran
+98 (0)21 2243 2500 or 2240 9309
azizi@endocrine.ac.ir
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Research Council, Ministry of Health (Iran)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Research Institute for Endocrine Sciences (Iran)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 15/06/2000 | Yes | No | ||
| Results article | results | 01/01/2002 | Yes | No | |
| Results article | results | 14/11/2007 | Yes | No | |
| Results article | assessment of alternative definitions results | 01/05/2008 | Yes | No | |
| Results article | nested case control study results | 05/06/2008 | Yes | No | |
| Results article | prospective study results | 01/10/2008 | Yes | No | |
| Results article | anthropometric parameter results | 01/11/2008 | Yes | No | |
| Results article | nutritional intervention results | 01/11/2008 | Yes | No | |
| Protocol article | phase II protocol | 25/01/2009 | Yes | No | |
| Results article | results | 01/06/2010 | Yes | No | |
| Results article | results | 01/02/2018 | Yes | No |