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

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

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-08-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a parallel-group, randomized, open-label feasibility trial with two arms: an intervention group receiving individualized dietary plans (IDPs) and a control group receiving standard dietary advice. Participants (n=122) will be randomly assigned using simple random sampling, with no masking (open-label) due to the nature of dietary interventions. The study will assess feasibility through adherence (PDAQ scores) and acceptability (recruitment rates), while secondary outcomes include changes in HbA1c, cholesterol, and BMI over 3 months. The design ensures practical evaluation of IDPs in a real-world clinical setting at Diabetes Hospital Peshawar.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study with no masking (blinding) of participants, care providers, investigators, or outcomes assessors. The nature of the dietary intervention makes blinding impractical, as both the individualized meal plans and standard advice require active participation and awareness from patients and providers. However, objective laboratory measures (HbA1c, cholesterol) will be used to minimize bias in outcome assessment. The study acknowledges potential performance bias due to the lack of masking but prioritizes real-world applicability in evaluating the feasibility of personalized nutrition for diabetes management.

Study Groups

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Individualized Dietary Plan (IDP) Group

Participants in this arm will receive a personalized dietary plan (IDP) tailored by a dietitian based on their BMI, glycemic levels, age, and lifestyle. The IDP includes Low-glycemic index foods (lentils, whole grains, barley), High-fiber foods (vegetables, cereals), Healthy fats (fish, walnuts, olive oil), Restricted high-sugar foods (rice, potatoes) and saturated fats (fried foods), Adherence will be monitored weekly using the Perceived Dietary Adherence Questionnaire (PDAQ) over 10 weeks.

Group Type EXPERIMENTAL

Individualized Dietary Plan (IDP) for Type 2 Diabetes

Intervention Type BEHAVIORAL

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).

Standard Care Group

Participants will receive conventional dietary advice for diabetes management (non-personalized), as routinely provided at the Diabetes Hospital and Research Centre Peshawar. This includes general guidelines on carbohydrate intake, portion control, and avoidance of sugary foods, without individualized adjustments.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Standard dietary advice as per the current clinical practice.

Interventions

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Individualized Dietary Plan (IDP) for Type 2 Diabetes

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).

Intervention Type BEHAVIORAL

Usual care

Standard dietary advice as per the current clinical practice.

Intervention Type BEHAVIORAL

Other Intervention Names

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Personalized Nutrition Therapy, Medical Nutrition Therapy (MNT), Diabetes-Specific Meal Plan

Eligibility Criteria

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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.