(Pakistan Diabetes Prevention Program PDPP)

Aga Khan University

Status: Completed

Conditions: Prediabetic State & High Risk Individuals on the Basis of Diabetes Risk Score

Treatments: Behavioral: Life style intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01530165

DS10-A5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,564 patients

Sex: All

Ages: 30 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,564 participants in 2 patient groups

Standard

No Intervention group

Description:

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.

life style intervention arm

Other group

Description:

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.

Treatment:

Behavioral: Life style intervention