MyDia-RNP: Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP®): A Feasibility Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: Nutrition Intervention based on My Dia-RNP
Subjects in this group will be advised to follow My Dia-RNP and to incorporate diabetes-specific formula (Nutren®Untuk Diabetik)
|
| Active Comparator: 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). |
Other: Usual Care
Subjects in the group continue with the usual care
|
Outcome Measures
Primary Outcome Measures
- Rate of participants completed the study [12 weeks]
The ability and likelihood to complete a study successfully with the aim to achieve at least 80% of the study retention rates.
Secondary Outcome Measures
- Rate of participants adhered to the intervention [12 weeks]
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.
- Efficacy potential on the rate of hypoglycemia [12 weeks]
Changes in rate of hypoglycemia during Ramadan
- Efficacy potential on the fructosamine level [4 weeks]
Changes in fructosamine levels
- Efficacy potential on fasting glucose [12 weeks]
Changes in fasting blood glucose levels
- Efficacy potential on glycemic control [12 weeks]
Changes in HbA1c levels
- Efficacy potential on functional status [12 weeks]
Changes in hand grip strength
- Efficacy potential on body mass index [12 weeks]
Changes in body mass index
Eligibility Criteria
Criteria
Inclusion Criteria:
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All Muslim patients aged > 18 years old
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Have a confirmed diagnosis of T2D for at least 6 months
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BMI > 18.5 but < 40 kg/m2
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HbA1c of > 6.5% but < 10%
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On a stabilised dose of oral anti-diabetes agents (OAD) for the past 2 months prior to the study
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Willing to fast for at least 15 days during Ramadan
Exclusion Criteria:
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History of hypoglycaemia leading to hospitalization during the previous Ramadan
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Liver disease
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Abnormal liver function test or renal profiles
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On insulin injection
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Reported abnormal thyroid stimulating hormones
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Use of medications known to effect lipid or glucose metabolism such as steroid
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Pregnancy or the desire to become pregnant in the next 3 months
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On any weight loss program or weight loss medications
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History of cancer undergoing active treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universiti Putra Malaysia | Serdang | Selangor | Malaysia | 43400 |
Sponsors and Collaborators
- Universiti Putra Malaysia
- Nestle Health Science
- Joslin Diabetes Center
Investigators
- Principal Investigator: Barakatun-Nisak Mohd Yusof, PhD, Universiti Putra Malaysia
- Principal Investigator: Wan Zul Haikal Hafiz Wan Zukiman, Mmed, Universiti Putra Malaysia
- Principal Investigator: Noraida Omar, PhD, Universiti Putra Malaysia
- Principal Investigator: Zalina Abu Zaid, PhD, Universiti Putra Malaysia
- Principal Investigator: Azrina Azlan, PhD, Universiti Putra Malaysia
- Principal Investigator: Firdaus Mamat @ Mukhtar, PhD, Universiti Putra Malaysia
- Principal Investigator: Norhasmah Sulaiman, PhD, Universiti Putra Malaysia
- Principal Investigator: Siti NurA'syura Adznam, PhD, Universiti Putra Malaysia
- Principal Investigator: Nur Maziah Hanum Osman, Master, Universiti Putra Malaysia
- Principal Investigator: Nor Farahain Yahya, Degree, Universiti Putra Malaysia
- Principal Investigator: Osama Hamdy, MD, PhD, Joslin Diabetes Centre
Study Documents (Full-Text)
None provided.More Information
Publications
- Babineaux SM, Toaima D, Boye KS, Zagar A, Tahbaz A, Jabbar A, Hassanein M. Multi-country retrospective observational study of the management and outcomes of patients with Type 2 diabetes during Ramadan in 2010 (CREED). Diabet Med. 2015 Jun;32(6):819-28. doi: 10.1111/dme.12685. Epub 2015 Apr 10.
- Bujang MA, Ismail M, Hatta NKBM, Othman SH, Baharum N, Lazim SSM. Validation of the Malay version of Diabetes Quality of Life (DQOL) Questionnaire for Adult Population with Type 2 Diabetes Mellitus. Malays J Med Sci. 2017 Aug;24(4):86-96. doi: 10.21315/mjms2017.24.4.10. Epub 2017 Aug 18.
- Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000 Sep 16;321(7262):694-6.
- Hamdy O, Barakatun-Nisak MY. Nutrition in Diabetes. Endocrinol Metab Clin North Am. 2016 Dec;45(4):799-817. doi: 10.1016/j.ecl.2016.06.010. Review.
- Hassanein M, Al-Arouj M, Hamdy O, Bebakar WMW, Jabbar A, Al-Madani A, Hanif W, Lessan N, Basit A, Tayeb K, Omar M, Abdallah K, Al Twaim A, Buyukbese MA, El-Sayed AA, Ben-Nakhi A; International Diabetes Federation (IDF), in collaboration with the Diabetes and Ramadan (DAR) International Alliance. Diabetes and Ramadan: Practical guidelines. Diabetes Res Clin Pract. 2017 Apr;126:303-316. doi: 10.1016/j.diabres.2017.03.003. Epub 2017 Mar 12. Review.
- Jadviscokova T, Fajkusova Z, Pallayova M, Luza J, Kuzmina G. Occurence of adverse events due to continuous glucose monitoring. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2007 Dec;151(2):263-6.
- Lee JY, Wong CP, Tan CSS, Nasir NH, Lee SWH. Telemonitoring in fasting individuals with Type 2 Diabetes Mellitus during Ramadan: A prospective, randomised controlled study. Sci Rep. 2017 Aug 31;7(1):10119. doi: 10.1038/s41598-017-10564-y.
- Lee JY, Wong CP, Tan CSS, Nasir NH, Lee SWH. Type 2 diabetes patient's perspective on Ramadan fasting: a qualitative study. BMJ Open Diabetes Res Care. 2017 May 8;5(1):e000365. doi: 10.1136/bmjdrc-2016-000365. eCollection 2017.
- Lee SWH, Lee JY, Tan CSS, Wong CP. Strategies to Make Ramadan Fasting Safer in Type 2 Diabetics: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials and Observational Studies. Medicine (Baltimore). 2016 Jan;95(2):e2457. doi: 10.1097/MD.0000000000002457. Review.
- Lessan N, Hannoun Z, Hasan H, Barakat MT. Glucose excursions and glycaemic control during Ramadan fasting in diabetic patients: insights from continuous glucose monitoring (CGM). Diabetes Metab. 2015 Feb;41(1):28-36. doi: 10.1016/j.diabet.2014.11.004. Epub 2014 Dec 10.
- Salti I, Bénard E, Detournay B, Bianchi-Biscay M, Le Brigand C, Voinet C, Jabbar A; EPIDIAR study group. A population-based study of diabetes and its characteristics during the fasting month of Ramadan in 13 countries: results of the epidemiology of diabetes and Ramadan 1422/2001 (EPIDIAR) study. Diabetes Care. 2004 Oct;27(10):2306-11.
- MyDia-RNP study