Effect of Low Carbohydrate Diet and Physical Activity on HbA1c outcomes Among Diabetic and Prediabetic teaching professionals- A Randomized controlled trial

Topic: Effect of Low Carbohydrate Diet and Physical Activity on HbA1c outcomes Among Diabetic and Prediabetic teaching professionals- A Randomized controlled trial

Introduction:

Type 2 Diabetes mellitus is a chronic condition with a major impact on the lives and well-being of individuals, families, and communities worldwide.

The International Diabetes Federation (IDF) estimates that there are 72.9 million people with diabetes in India in 2017, which is projected to rise to 134.3 million by the year 2045.

Insulin resistance and impaired beta cell function are core defects in type 2 diabetes responsible for the pathophysiological disturbances leading to hyperglycemia, dyslipidemia and hypertension.

 Diagnostic criteria for diabetes:

Fasting plasma glucose mg/dl

2-hour post 75 g glucose 200 mg/dl

Glycated Hemoglobin (HbA1c) %

Random plasma glucose 200 mg/dl

Operational definition:

Type 2 Diabetes with HbA1c level

Prediabetes with HbA1c level 5.7- 6.4%

Low carbohydrate diet range of my study is daily consumption of carbohydrate less than 200 g/day.

The physical activity of my study indicates brisk walking for 30-45 minutes/day for a period of 6 months.

Aim:

Effectiveness of behavioral intervention in promoting Low Carbohydrate Diet and Physical activity among diabetic and prediabetic teaching professionals.

Objective:

Among the diabetic and prediabetic teaching professionals in selected colleges of Puducherry

To compare the HbA1c level in both control and intervention group before and after intervention.

To study and compare the effectiveness of low carbohydrate diet and routine physical activity among control and intervention group before and after intervention.

Methodology:

Study design: Open label Randomized Controlled Trial.

Study setting:  The study will be conducted in Engineering and Arts & Science colleges of Puducherry.

Study participants:  Teaching faculties of Engineering and Arts & Science college will be selected as per the inclusion criteria.

Sample Size Estimation:

Based on the study done by Kirsten et al, considering P1 as 53% and P2 as 32% with 95% Confidence level and 80% power we estimated the sample size to be 168 by using the formula,

n = (Zα/2+Zβ)2 * (p1(1-p1)+p2(1-p2)) / (p1-p2)2

Data collection:

An announcement will be made in the colleges regarding the study. After getting the consent, all the eligible participants will be screened.

A pretested, validated questionnaire will be used to gather information regarding the Socio Demographic characteristics of study population such as name, age, sex, occupation, place of residency, education, socio economic status, anthropometry, diabetic status, drug history, personal history and mental history.

Method of data collection:

study will be explained after which a written informed consent is taken.

Direct face to face interview conducted using structured questionnaire.

Blood investigation for HbA1c at 0 and 6 months will be done.

Expected outcome:

This study will find out that low carbohydrate diet and physical activity will show improvement in controlling glycemia in individuals with diabetes and prediabetes and their HbA1c remission.

Difference in HbA1c outcome between control and intervention group will be analyzed.