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

NCT07030543 | Completed DMC

• 1 other identifier: KMU/DIR/CTU/2024/016
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Glycemic Control; Cardiovascular Risk Factors; Individualized Dietary Plan (IDP)

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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%.

  Baseline to 3 months

Study Arms (2)

Individualized Dietary Plan (IDP) Group

EXPERIMENTAL

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.

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

Standard Care Group

ACTIVE COMPARATOR

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.

Behavioral: Usual care

Interventions

Individualized Dietary Plan (IDP) for Type 2 Diabetes 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).

Also known as: Personalized Nutrition Therapy, Medical Nutrition Therapy (MNT), Diabetes-Specific Meal Plan

Individualized Dietary Plan (IDP) Group

Usual care BEHAVIORAL

Standard dietary advice as per the current clinical practice.

Standard Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women (to exclude gestational diabetes).
• Patients with conditions preventing dietary adherence (severe comorbidities).

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Diabetes Hospital and Research Centre

Peshawar, Khyber Pakhtunkhwa, 25100, Pakistan

Location

Related Publications (3)

• Mottalib A, Salsberg V, Mohd-Yusof BN, Mohamed W, Carolan P, Pober DM, Mitri J, Hamdy O. Effects of nutrition therapy on HbA1c and cardiovascular disease risk factors in overweight and obese patients with type 2 diabetes. Nutr J. 2018 Apr 7;17(1):42. doi: 10.1186/s12937-018-0351-0.

  PMID: 29626933 BACKGROUND

• Aamir AH, Ul-Haq Z, Mahar SA, Qureshi FM, Ahmad I, Jawa A, Sheikh A, Raza A, Fazid S, Jadoon Z, Ishtiaq O, Safdar N, Afridi H, Heald AH. Diabetes Prevalence Survey of Pakistan (DPS-PAK): prevalence of type 2 diabetes mellitus and prediabetes using HbA1c: a population-based survey from Pakistan. BMJ Open. 2019 Feb 21;9(2):e025300. doi: 10.1136/bmjopen-2018-025300.

  PMID: 30796126 BACKGROUND

• American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.

  PMID: 30559228 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Inosine Diphosphate; Nutrition Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Therapeutics

Study Officials

• Aisha Naz, MPH

  Khyber Medical Univeristy Peshawar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director IPHSS

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: February 1, 2025
• Primary Completion: July 10, 2025
• Study Completion: August 29, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available 6 months after study completion (final publication). Shared data will remain accessible for 5 years via the repository.
• Access Criteria: Data will be available to qualified researchers with a methodologically sound proposal approved by an independent review committee. Requestors must sign a data use agreement outlining ethical restrictions.

Locations

PA (1)