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 Peshawar

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Individualized Dietary Plan (IDP) for Type 2 Diabetes; Behavioral: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT07030543

KMU/DIR/CTU/2024/016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Individualized Dietary Plan (IDP) Group

Experimental group

Description:

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.

Treatment:

Behavioral: Individualized Dietary Plan (IDP) for Type 2 Diabetes

Standard Care Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual care