(Pakistan Diabetes Prevention Program PDPP)

Not Applicable

Completed

• Conditions: Prediabetic State & High Risk Individuals on the Basis of Diabetes Risk Score
• Interventions: Behavioral: Life style intervention

• Registration Number: NCT01530165
• Lead Sponsor: Aga Khan University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-11-21
• Study Start: 2011-12-15
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-09
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1564

Inclusion Criteria

-Adult men and women between 30-64 years of age

Exclusion Criteria

• Diagnosed type 1 or type 2 diabetes
• Pregnancy or presence of chronic disease rendering survival for three years unlikely
• Any psychological or physical disability to interfere with participation in the study
• Ischemic heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
life style intervention arm	Life style intervention	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Type 2 Diabetes	2 yrs	Incidence of type 2 diabetes based on OGTT, diagnosed by WHO criteria at interim and end of an intervention.

Secondary Outcome Measures

Name	Time	Method
Components of Metabolic syndrome	2 years	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.
The impact of city planning on prevalence of obesity and type 2 diabetes	2 years	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.

Trial Locations

Locations (1)

The Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan