Feasibility Of Individualized Dietary Plan (Idp) On Glycemic Control And Total Cholestrol In Diabetic Patients At Diabetes Hospital And Research Centre Peshawar

Khyber Medical University Peshawar122 enrolled

Overview

This study aims to test whether a personalized meal plan (Individualized Dietary Plan, IDP) is practical and helpful for adults with type 2 diabetes in Peshawar, Pakistan. We want to see if patients can follow the IDP for 10 weeks and if it improves their blood sugar control and cholesterol levels. About 122 participants will be randomly assigned to either the IDP group (receiving customized diet advice) or a standard care group. We will measure their weight, blood sugar (HbA1c), cholesterol, and other health markers at the start and after 3 months. Results will show if a larger study is feasible in our local community.

Type 2 diabetes prevalence in Pakistan is high (16.98%), yet standardized dietary advice is often given without considering individual factors like age, weight, or lifestyle. Evidence shows nutrition therapy improves glycemic control, but no studies have tested personalized dietary plans in Pakistan's local population. This feasibility trial addresses this gap by evaluating the practicality of implementing IDPs at the Diabetes Hospital and Research Centre Peshawar.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

122

Conditions

Type 2 Diabetes Mellitus

Interventions

Individualized Dietary Plan (IDP) for Type 2 DiabetesBEHAVIORAL

This study evaluates the feasibility of an Individualized Dietary Plan (IDP), a structured, patient-tailored nutrition intervention designed to improve glycemic control and lipid profiles in adults with Type 2 Diabetes Mellitus (T2DM).

Usual careBEHAVIORAL

Standard dietary advice as per the current clinical practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults ≥18 years with physician-diagnosed Type 2 Diabetes Mellitus. * Receiving care at Diabetes Hospital and Research Centre Peshawar. * Willing to comply with dietary interventions and follow-up. Exclusion Criteria: * Pregnant women (to exclude gestational diabetes). * Patients with conditions preventing dietary adherence (severe comorbidities).

Outcomes

Primary Outcomes

Adherence

Measures participant adherence to the IDP using the Perceived Dietary Adherence Questionnaire (PDAQ). The scoring of the questionnaire are as follows: Good Adherence: Score ≥70 (consistent adherence over 10 weeks). Poor Adherence: Score 45-69 (inconsistent adherence over 7-9 weeks).

Time frame: Baseline to 3 months.

Acceptability - Recruitment Rate

Assesses acceptability via recruitment rate, calculated as: Formula: (Number of participants completing 3 month follow-up) ÷ (Number of randomized participants) × 100.

Time frame: Enrollment to study completion (6 months)

Change in Glycemic Control (HbA1c)

Measures difference in HbA1c levels (reflecting 3-month average blood glucose) between IDP and control groups. The threshold of glycemic control are as follows: Normal: \<7%. Abnormal: ≥7%.

Time frame: Baseline to 3 months