Intervention phase of the Tehran Lipid and Glucose Study (TLGS phase II)

ISRCTN ISRCTN52588395
DOI https://doi.org/10.1186/ISRCTN52588395
Secondary identifying numbers N/A
Submission date
11/10/2008
Registration date
27/11/2008
Last edited
20/11/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Fereidoun Azizi
Scientific

Research Institute for Endocrine Sciences
No 24 Parvaneh Avenue
Yaman Street
Velenjak
Tehran
19395-4763
Iran

Phone +98 (0)21 2240 9309
Email azizi@endocrine.ac.ir

Study information

Study designRandomised community intervention (controlled field trial)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePrevention of non-communicable disease in a population in nutrition transition: Tehran Lipid and Glucose Study Phase II
Study acronymTLGS II
Study hypothesisThe 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).
ConditionNon-communicable diseases (NCD)
InterventionPrimary, 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 typeBehavioural
Primary outcome measureMajor 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 measures1. Any significant medical events
2. Mortality

The secondary outcomes are assessed annually.
Overall study start date01/03/1999
Overall study end date01/03/2020

Eligibility

Participant type(s)All
Age groupOther
SexBoth
Target number of participants15,005 (5,630 cases for intervention group)
Participant inclusion criteria1. 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 exclusion criteriaMentally disabled persons
Recruitment start date01/03/1999
Recruitment end date01/03/2020

Locations

Countries of recruitment

  • Iran

Study participating centre

Research Institute for Endocrine Sciences
Tehran
19395-4763
Iran

Sponsor information

Research Institute for Endocrine Sciences (Iran)
University/education

No 24 Parvaneh Avenue
Yaman Street
Velenjak
Tehran
19395-4763
Iran

Phone +98 (0)21 2243 2500 or 2240 9309
Email azizi@endocrine.ac.ir
Website http://endocrine.ac.ir
ROR logo "ROR" https://ror.org/01kpm1136

Funders

Funder type

Government

National Research Council, Ministry of Health (Iran)

No information available

Research Institute for Endocrine Sciences (Iran)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

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

Editorial Notes

20/11/2018: Publication reference added.
05/04/2016: Plain English summary added.