Impact of Nutrition Counselling on Multiple Sclerosis Patients Nutritional Status: Randomized Controlled Clinical Trial

Background: Faulty dietary habits and overnutrition are prevalent among Egyptian multiple sclerosis (MS) patients who do not receive nutrition care as part of treatment. This study was conducted to explore the impact of nutrition counselling on the nutritional status of MS patients. Methods: : A single-blinded, parallel randomized controlled clinical trial (RCT) was conducted at Kasr Alainy MS Unit (KASMU) on 120 Eligible MS patients from September 2019 to February 2020. Patients were randomly allocated to either Nutrition counseling intervention group (IG) or control group (CG). Allocation concealment was done by sequentially numbered opaque sealed envelopes. All patients were assessed initially then followed the KASMU standard management protocol for the study period. Only patients in the IG underwent initial teaching sessions followed by monthly evaluation (nutrition counseling). All patients were assessed at the end of end of 3 month follow up period. Sociodemographic data was gathered through a structured interview. Nutritional status was assessed anthropometrically, by 24-hour recall and by Malnutrition Universal Screening Tool (MUST). The 2 groups were compared initially and at the end of follow-up. Analysis of covariance (ANCOVA) was used to analyze the difference between the two arms in quantitative outcomes. Chi-squared or Fisher's exact tests, and Mann-Whitney U test were used in quantitative outcomes. The alpha value (α) was set at 5%. Both Intention To Treat (INT) and Perprotocol (PP) analyses were performed. Results: : At baseline assessment, the prevalence of overweight and obesity was 31.7% and 32.5% respectively, mean body mass index (BMI) was 27.7 ± 5.7 kg/m 2 . The mean waist circumference was 93.5±11.9 and 99.2±13.1 cm for males and females, respectively. About 27.3% of males and 83.9% of females showed abdominal obesity. After 3 months of counseling, weight, BMI, waist circumference, food consumption and nutrient intake and adequacy significantly improved in the IG (p<0.05). Conclusion: Nutrition counselling significantly improved anthropometric measurements, food consumption, nutrient intake and adequacy. The study was registered on ClinicalTrial.gov and was given a code (NCT04217564).