Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP®): A Feasibility Study

Study Overview
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Brief Summary
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Ramadan fasting is an important event for Muslims. During Ramadan, all healthy Muslims are asked to abstain from food and drink throughout the day and eat only during daybreak (also know as Sahur in Malay/Arabic language) and after sunset (also know as Iftar in Malay/Arabic language). Patients with type 2 diabetes (T2DM) can be exempted from fasting but most of them do not perceive themselves as sick, and they continue to fast. With so many Muslims with diabetes choosing to fast, there is an immediate need for evidence-based nutrition practice guidelines. This study is conducted to determine the feasibility of implementing the Ramadan Nutrition Plan named My Dia-RNP that is also incorporating diabetes-specific nutrition formula on dietary adherence and acceptability in patients with type 2 diabetes mellitus. We hypothesized that My Dia-RNP is feasible to be practiced by patients with type 2 diabetes.

Detailed Description
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In Malaysia, average fasting duration is about 14 hours which could potentially cause hypoglycemia, hyperglycemia, ketoacidosis, and dehydration among people with diabetes. Also, Ramadan triggers a prime dietary change leading to increased risk of nutritional issues from improper eating habits and reduction in physical activity level (Hamdy et al., 2016). Ramadan fasting, therefore, represents a challenge to both patients and healthcare professionals (HCPs) including dietitians. Ramadan Nutrition Plan (RNP) has recently published by the International Diabetes Federation (IDF) and the Diabetes and Ramadan (DAR) International Alliance IDF-DAR guidelines. The goal is to provide comprehensive guidance on nutrition practice during Ramadan. However, its feasibility in the real clinical scenarios warrants further investigation. Besides, the use of a diabetes-specific nutrition formula (Nutren Untuk Diabetik®) has been shown beneficial in improving blood glucose control and managing body weight as well as enhancing the nutrient adequacy among people with diabetes (Hamdy and Barakatun-Nisak 2016). While the benefits have been well established, no study has explored its potential during Ramadan. Malaysia Diabetes-Ramadan Nutrition Plan (My Dia-RNP) is proposed to determine the feasibility of implementing the RNP and to incorporate the diabetes-specific nutrition formula (Nutren Untuk Diabetik®) during Ramadan on dietary adherence and acceptability in patients with type 2 diabetes mellitus.

Official Title
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Effects of Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP) on Adherence, Acceptability, Efficacy Potential and Quality of Life in Patients With Type 2 Diabetes Mellitus: A Feasibility Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Nutrition Intervention based on My Dia-RNP
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Muslim patients aged > 18 years old Have a confirmed diagnosis of T2D for at least 6 months BMI > 18.5 but < 40 kg/m2 HbA1c of > 6.5% but < 10% On a stabilised dose of oral anti-diabetes agents (OAD) for the past 2 months prior to the study Willing to fast for at least 15 days during Ramadan Exclusion Criteria: History of hypoglycaemia leading to hospitalization during the previous Ramadan Liver disease Abnormal liver function test or renal profiles On insulin injection Reported abnormal thyroid stimulating hormones Use of medications known to effect lipid or glucose metabolism such as steroid Pregnancy or the desire to become pregnant in the next 3 months On any weight loss program or weight loss medications History of cancer undergoing active treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to two groups in parallel for the duration of the study based on their choice
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: My Dia-RNP<br>In the My Dia-RNP group, participants will undergo the pre-RNP assessment 2 weeks before Ramadan. They will be given a nutrition education based on the Ramadan Nutrition Plan Guide published by IDF-DAR Practical Guidelines. They will also be asked to incorporate diabetes-specific nutrition formula (Nutren untuk Diabetik®) within the prescribed calories before Ramadan period to help them familiarise with a dietary change. | Other: Nutrition Intervention based on My Dia-RNP<br>* Subjects in this group will be advised to follow My Dia-RNP and to incorporate diabetes-specific formula (Nutren®Untuk Diabetik)<br>|
| Active Comparator: Usual Care<br>Participant in this group will continue in a usual care (UC) group. They will receive dietary advice based on the Practical Guide to Diabetes Management in Ramadan produced by Ministry of Health (2015). | Other: Usual Care<br>* Subjects in the group continue with the usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants completed the study | The ability and likelihood to complete a study successfully with the aim to achieve at least 80% of the study retention rates. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants adhered to the intervention | Dietary adherence refers to the ability of the participants to adhere to the selected group. This study aims to achieve the completeness of Ramadan Diaries and the able to consume diabetes-specific nutrition formula (Nutren® untuk Diabetik) for at least 75% during the study period. | 12 weeks | 
| Efficacy potential on the rate of hypoglycemia | Changes in rate of hypoglycemia during Ramadan | 12 weeks | 
| Efficacy potential on the fructosamine level | Changes in fructosamine levels | 4 weeks | 
| Efficacy potential on fasting glucose | Changes in fasting blood glucose levels | 12 weeks | 
| Efficacy potential on glycemic control | Changes in HbA1c levels | 12 weeks | 
| Efficacy potential on functional status | Changes in hand grip strength | 12 weeks | 
| Efficacy potential on body mass index | Changes in body mass index | 12 weeks |