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
试验速览
- 阶段
- 不适用
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Rate of participants completed the study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •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
排除标准
- •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
研究组 & 干预措施
Usual Care
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).
干预措施: Usual Care (Other)
My Dia-RNP
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.
干预措施: Nutrition Intervention based on My Dia-RNP (Other)
结局指标
主要结局
Rate of participants completed the study
时间窗: 12 weeks
The ability and likelihood to complete a study successfully with the aim to achieve at least 80% of the study retention rates.
次要结局
- Efficacy potential on functional status(12 weeks)
- Efficacy potential on body mass index(12 weeks)
- Efficacy potential on the fructosamine level(4 weeks)
- Efficacy potential on fasting glucose(12 weeks)
- Efficacy potential on glycemic control(12 weeks)
- Rate of participants adhered to the intervention(12 weeks)
- Efficacy potential on the rate of hypoglycemia(12 weeks)
研究者
Barakatun Nisak Bt Mohd Yusof
Associate Professor
Universiti Putra Malaysia