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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aisha Naz, MPH | Khyber Medical Univeristy Peshawar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Hospital and Research Centre | Peshawar | Khyber Pakhtunkhwa | 25100 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29626933 | Background | 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. | |
| 30796126 | 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. |
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Individual participant data (IPD) that underlie the results reported in this study will be shared with qualified researchers to support reproducibility and further scientific inquiry. This includes:
Baseline characteristics (age, sex, BMI, HbA1c, cholesterol levels)
Adherence scores (PDAQ questionnaire results)
Outcome measures (HbA1c, total cholesterol, fasting blood sugar at 3-month follow-up)
Data will become available 6 months after study completion (final publication).
Shared data will remain accessible for 5 years via the repository.
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.
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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.
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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.
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| Usual care | Behavioral | Standard dietary advice as per the current clinical practice. |
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| 30559228 | 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. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007290 | Inosine Diphosphate |
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D007292 | Inosine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D013812 | Therapeutics |
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