Subject selection

Used Mass Awareness Programs of BADAS

Awareness Day 28 February – the day of establishment of BADAS
Service Day 6 September – the demise day of Prof. Ibrahim
United Nations Day 14 November

Organized screening programs in different location

Subjects from diabetes hospitals and centers

A. BIRDEM
B: NHN
1. MPL-Ibrahim GH
2. Wari Center
3. SK-Ibrahim GH
4. Shuborno IGH
5. Mirpur Center
6. Nawab Garden Center
7. Shamoli Center
8. Naya Palton Executive Center

Please mouse over on the pictures for details

Manpower recruitment and training

  • Doctors (12)
  • Nutritionists (4)
  • Diabetes Educators(8)
  • Ophthalmologists (4)
  • Admin officer (4)

Six days intensive training including practice session was conducted separately for quantitative and qualitative enumerators.

Study design and intervention

  • Study design- prospective intervention trail
  • Sample size – 1800
  • Intervention groups- 6
    • Lifestyle (300)
    • Metformin (300)
    • Glibenclamide (300)
    • Lifestyle + Metformin (300)
    • Lifestyle + Glibenclamide (300)
    • Control (300)

Flow Diagram of the Sampling Technique

Schematic Figure of the Study Procedure

Flow Diagram of Study Design

Baseline and follow up data collection

Structured Interview (SI):
Food Behaviour Questionnaire:
Physical Activities Questionnaire:
Anthropometric Measurement:.
Weight, height and waist measurement
Investigations done (at baseline and then at 9 months and 18 months time.)

  • OGTT (F and 2h after 75g Glucose drink)
  • Lipid Profile
  • HbA1c
  • Serum Creatinine
  • SGPT
  • Urine R/M/E
  • ECG

All investigations and consultations are free of cost

Intervention Session

Serial Visits Duration Tasks
1 Initial screening 2 -3 hours Blood tests only
2 Inclusion 0 weeks 2 -3 hours Counseling and Motivation
3 2 weeks after inclusion 1 hour Motivation and counseling
4 At 4 weeks 1 hour Motivation and counseling
5 At 3 months 1 hour Reinforcement and counseling
6 At 6 months 1 hour Reinforcement and counseling
7 At 9 months 3 hours Motivation and Blood Test
8 At 12 months 1 hour Reinforcement and counseling
9 At 15 months 1 hour Reinforcement and counseling
10 At 18 months 3 hours Motivation and Blood Tests

Intervention

Diet modification : diet chart according to individuals BMI

  • Obese (≥ 25 kg/m2) = IBW x 20
  • Overweight ( 23 to 24.9 kg/m2) = IBW x 25
  • Normal weight ( 18.5 to 22.9 kg/m2) = IBW x 30
  • Under-wt (<18.5 kg/m2) = IBW x 35
  • Prescribe food will follow the 60%, 15% and 25% of carbohydrate, protein and fat distribution respectively.

Physical activity:

  • at least 30 minutes walking at 3 to 4 kilometers per hour rate, which can produce sweating within 5 to 10 minutes of starting time.

Drug intervention:

  • 500 mg metformin twice daily will be prescribed for intervention.
  • 1 mg glibenclamide once daily will be prescribed for intervention.

Methods and specification of the machines for the various biological tests

Test Sample Method Specification of Machine
Measurement Type Name of the analyzer
OGTT
  • FPG
  • 2h AG
Venous
Plasma
Glucose oxidase End point Dimension RxL
Max
(Made in )
T-Chol Serum CHOD- End point Do
Tg Serum GPO- End point Do
Serum Direct Enzymatic End point Do
Serum Direct Enzymatic/
Precipitation Method
End point Do
SGPT Serum Kinetic Rate Do
S.Creatinine Serum Kinetic Rate Do
Urine R/M/E Spot Urine Turbidimetric End point Do
HbA1C Whole blood HPLC Colorimetric/
Turbidimetric
Variant Hemoglobin Testing System
ECG 12 lead ECG Kenz ECG 110 (Made in )

Time Frame

Description/ Time in quarterly→ Duration in quarter 1 2 3 4 5 6 7 8 9
Finalize the methodology and field assessment  1
Training  1
Screening 1
Baseline information collection 1
Intervention tool development and baseline assessment 1
Intervention 2
Follow up assessment 1
Intervention 2
Final follow up assessment 1
Report writing 2