Condition category
Not Applicable
Date applied
11/10/2008
Date assigned
27/11/2008
Last edited
05/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

http://endocrine.ac.ir/English/study.aspx

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Community

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/1999

Overall trial end date

01/03/2020

Reason abandoned

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

All

Age group

Other

Gender

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

Trial 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

http://endocrine.ac.ir

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2000 rationale and design in
Azizi F, Rahmani M, Emami, H, Majid M. Tehran lipid and glucose study (TLGS): rationale and design. CVD Prevention 2000; 3:50-3.
2. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12643001
3. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17999777
4. 2008 nutritional intervention results in http://www.ncbi.nlm.nih.gov/pubmed/18349527
5. 2008 anthropometric parameter results in http://www.ncbi.nlm.nih.gov/pubmed/18772585
6. 2008 nested case control study results in http://www.ncbi.nlm.nih.gov/pubmed/18533046
7. 2008 assessment of alternative definitions results in http://www.ncbi.nlm.nih.gov/pubmed/18282630
8. 2008 prospective study results in http://www.ncbi.nlm.nih.gov/pubmed/18068961
9. 2009 phase II protocol in http://www.ncbi.nlm.nih.gov/pubmed/19166627
10. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20494239

Publication citations

  1. Results

    Azizi F, Rahmani M, Emami H, Mirmiran P, Hajipour R, Madjid M, Ghanbili J, Ghanbarian A, Mehrabi Y, Saadat N, Salehi P, Mortazavi N, Heydarian P, Sarbazi N, Allahverdian S, Saadati N, Ainy E, Moeini S, Cardiovascular risk factors in an Iranian urban population: Tehran lipid and glucose study (phase 1)., Soz Praventivmed, 2002, 47, 6, 408-426.

  2. Results

    Hosseinpanah F, Rambod M, Azizi F, Population attributable risk for diabetes associated with excess weight in Tehranian adults: a population-based cohort study., BMC Public Health, 2007, 7, 328, doi: 10.1186/1471-2458-7-328.

  3. Nutritional intervention results

    Mirmiran P, Ramezankhani A, Hekmatdoost A, Azizi F, Effect of nutrition intervention on non-communicable disease risk factors among Tehranian adults: Tehran Lipid and Glucose Study., Ann. Nutr. Metab., 2008, 52, 2, 91-95, doi: 10.1159/000121364.

  4. Anthropometric parameter results

    Bozorgmanesh MR, Hadaegh F, Padyab M, Mehrabi Y, Azizi F, Temporal changes in anthropometric parameters and lipid profile according to body mass index among an adult Iranian urban population., Ann. Nutr. Metab., 2008, 53, 1, 13-22, doi: 10.1159/000152869.

  5. Nested case control study results

    Tohidi M, Harati H, Hadaegh F, Mehrabi Y, Azizi F, Association of liver enzymes with incident type 2 diabetes: A nested case control study in an Iranian population., BMC Endocr Disord, 2008, 8, 5, doi: 10.1186/1472-6823-8-5.

  6. Assessment of alternative definitions results

    Hadaegh F, Ghasemi A, Padyab M, Tohidi M, Azizi F, The metabolic syndrome and incident diabetes: Assessment of alternative definitions of the metabolic syndrome in an Iranian urban population., Diabetes Res. Clin. Pract., 2008, 80, 2, 328-334, doi: 10.1016/j.diabres.2008.01.003.

  7. Prospective study results

    Mirmiran P, Noori N, Azizi F, A prospective study of determinants of the metabolic syndrome in adults., Nutr Metab Cardiovasc Dis, 2008, 18, 8, 567-573, doi: 10.1016/j.numecd.2007.06.002.

  8. Phase II protocol

    Azizi F, Ghanbarian A, Momenan AA, Hadaegh F, Mirmiran P, Hedayati M, Mehrabi Y, Zahedi-Asl S, , Prevention of non-communicable disease in a population in nutrition transition: Tehran Lipid and Glucose Study phase II., Trials, 2009, 10, 5, doi: 10.1186/1745-6215-10-5.

  9. Results

    Harati H, Hadaegh F, Momenan AA, Ghanei L, Bozorgmanesh MR, Ghanbarian A, Mirmiran P, Azizi F, Reduction in incidence of type 2 diabetes by lifestyle intervention in a middle eastern community., Am J Prev Med, 2010, 38, 6, 628-636.e1, doi: 10.1016/j.amepre.2010.03.003.

Additional files

Editorial Notes

05/04/2016: Plain English summary added.