Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Glycemic Control, Cardiovascular Risk Factors, Individualized Dietary Plan (IDP)
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.
Detailed 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.
Interventions
BEHAVIORALIndividualized 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).
BEHAVIORALUsual care
Standard dietary advice as per the current clinical practice.
Sponsors
Khyber Medical University Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | Baseline to 3 months. | 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). |
| Acceptability - Recruitment Rate | Enrollment to study completion (6 months) | Assesses acceptability via recruitment rate, calculated as: Formula: (Number of participants completing 3 month follow-up) ÷ (Number of randomized participants) × 100. |
| Change in Glycemic Control (HbA1c) | Baseline to 3 months | 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%. |
Countries
Pakistan
Outcome results
None listed