An interventional study of Life style intervention in Prediabetic State & High Risk Individuals on the Basis of Diabetes Risk Score, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged 30 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention
The Karachi-based Pakistan Diabetes Prevention Study aims to address key issues in the prevention of type 2 diabetes. Approximately 20,000 people From four communities will be screened for diabetes risk factors using a non-invasive diabetes risk-score system. Those found to be at increased risk will be given an oral glucose tolerance test. People who, after the oral glucose tolerance test, are identified as having prediabetes or normal but with risk factors such as raised BMI and/or history of hypertension will have the opportunity to take part in the Pakistan Diabetes Prevention Study lifestyle intervention. This consists of culturally adjusted preventive strategies focusing on diet and physical activity in real-life settings. Another important aspect of this trial will be to assess the impact of urban planning on the prevalence of obesity and diabetes.
The aim of this study is to translate the life style intervention project to prevent diabetes into real life settings in Karachi, Pakistan, home to one sixth of the world's population.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 1,564 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.
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-Adult men and women between 30-64 years of age
Exclusion Criteria:
Pre diabetics randomized to control arm will receive standard life style advice which is given to all pre diabetics seeking medical advice. Group counselling (30 min to 1 hour) will be provided to participants enrolled in control arm in which they will attend one group class at baseline where they will be given basic information on diabetes prevention , weight loss, diet, and exercise consitent with expert recommendations for a healthy life style inclusing losing 5-10% of their excess body weight to reduce their calorie and fat intake and exercising at least 150 minutes per week.
This arm would be given aggressive life style intervention in comparison to standard (control) arm. The intervention would consist of nutritional and physical activity advice. Consists of 5 sessions during the two years course of follow up. Three sessions in the first year (intensive phase), two sessions (maintenance phase) in second year. Overall sessions have a theme with simple selected theoretical background information. Sessions are to be interactive. Selected handouts and pamphlets are given after the session. Teaching material is both available in English and Urdu (local) language.
Behavioral: Life style intervention
The main goals of intervention will focus mainly on: Weight reduction ≥ 5% , moderate intensity physical activity ≥ 30 min daily, dietary fat \<30 proportion of total energy, saturated fat \<10%, Fiber ≥ 15g/1,000 kcal There will be 9 sessions during the two years course of follow-up
Incidence of Type 2 Diabetes
Incidence of type 2 diabetes based on OGTT, diagnosed by WHO criteria at interim and end of an intervention.
Time frame: 2 yrs
Components of Metabolic syndrome
To assess the difference in incidence of components of metabolic syndrom which includes waist circumference, dyslipidimia, blood pressure etc between control and intervention arm after 2 years of lifestyle intervention.
Time frame: 2 years
The impact of city planning on prevalence of obesity and type 2 diabetes
The communities will be divided according to number and accessibility of parks. The community with large number of parks will be compared with community with no parks and then change in incidence of diabetes and obesity after 2 years of lifestyle intervention will be assessed and compared between two communities. By this it would be feasible to convince local authorities to incorporate this into their agenda for future urban design.
Time frame: 2 years
Plan to share: Undecided
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Aga Khan University