Feasibility Of Individualized Dietary Plan (Idp) On Glycemic Control And Total Cholestrol In Diabetic Patients At Diabetes Hospital And Research Centre Peshawar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnant women (to exclude gestational diabetes).
- •Patients with conditions preventing dietary adherence (severe comorbidities).
结局指标
主要结局
Adherence
时间窗: 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
时间窗: 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)
时间窗: 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%.
次要结局
未报告次要终点
研究者
Dr Khalid Rahman
Director IPHSS
Khyber Medical University Peshawar