(Pakistan Diabetes Prevention Program PDPP)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-15

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Intervention versus Control

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

life style intervention arm

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.

Group Type OTHER

Life style intervention

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes