Nutritional Counselling for Patients at Kasr AlAiny Multiple Sclerosis Clinic: an Intervention Study (AlAiny)

Eligible Multiple sclerosis patients attending Kasr AlAiny Multiple Sclerosis Clinic will be randomly allocated to either the intervention or control group by randomized block design.

Patients in the 2 groups will be initially assessed. Those in the intervention group will receive a counselling session then instructed on the subsequent follow up dates. Those in the control group will not receive nutritional counselling during the study period but will be instructed to attend for final assessment by the end of the study. Apart from counselling, patients will receive the same care from the clinic medical staff. After the final assessment the control group will be invited to receive the nutritional counselling material to gain its suspected benefits.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Nutritional counselling

Detailed Description

The socioeconomic characteristics, quality of life, the disability status using the EDSS (Expanded Disability Status Scale) and the nutritional status of the patients will be assessed for both the intervention group and the control group. A booklet in Arabic language which contains the instruction to be fulfilled will be delivered for each patient in the intervention group at the first session.Also, a diet plan will be tailored for each patient at the first visit. Myplate model will be adopted and the concept of food groups with healthy choices from each group will be illustrated. Dietary records will be included to check the adherence of the patients to the instructions. Each patient of the intervention group will receive 4 sessions 4 weeks apart according to settled appointments to check the adherence of the patient to the nutrition plan and to answer any question of the patients as the following:

1. Session 1: the nutritional counselling based on the nutritional assessment will be conducted. A booklet that contains the whole instructions and dietary records will be provided to help remembering information and record their application of the plan.
2. Session 2: follow up and reemphasize the instruction.
3. Session 3: follow up and reemphasize the instruction.
4. Session 4: the final assessment. If the patient failed to attend the unit for session 2 and 3, the investigator will follow up him/her via a phone/mobile call instead. A "WhatsApp" group will be created and all patients who have smart phones and "WhatsApp" accounts will be added to the group. Messages will be sent to the patients through this group to stimulate patient adherence to healthy diet.

After 3 month of the first visit all patients ( the intervention group and the control group) will be assessed again for quality of life, disability status and nutritional status.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11731
    • Faculty of medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. MS patients diagnosed with any of the following disease subtypes:

   • Relapsing Remitting MS (RRMS)
   • Secondary Progressive MS (SPMS)
   • Primary Progressive MS (PPMS)
2. Patients finished their secondary school education, its equivalents or higher education.

Exclusion Criteria:

1. Patients in MS relapse.
2. Known diabetes mellitus patients.
3. Known malabsorption syndrome patients.
4. Known allergic patients to some food items such as milk and wheat.
5. Patients who underwent bariatric surgeries.
6. Patients on special diets.
7. Patients receiving drugs that affect the appetite e.g. psychotropic drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will receive a counselling session then instructed on the subsequent follow up dates and final assessment by the end of the study.	Behavioral: Nutritional counselling; Nutritional counselling based on the nutritional assessment will be conducted. A booklet that contains the whole instructions and dietary records will be provided to help remembering information and record their application of the plan.
No Intervention: Control group; The control group will not receive nutritional counselling during the study period but will be instructed to attend for final assessment by the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of quality of life of MS patients: 36-SF	Measured by the 36-item short form survey instrument (36-SF) Arabic version. Scores are from 0 to 100. A higher score indicates better health.	3 months
Change of nutritional status of MS patients	Measured by the Malnutrition Universal Screening Tool (MUST). Scores are either 0: Low risk of malnutrition Or 1: Medium risk of malnutrition Or ≥ 2: High risk of malnutrition	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the disease progression.	Measured by the Expanded Disability Status Scale (EDSS). EDSS scores range between 0 and 10 in 0.5 unit increments. Scores increase when the severity of the disability increases.	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Prof. Zeinab Emam Mohamed Afifi, MD, Cairo University; Principal Investigator: Prof. Nebal Abdel Rahman Aboul-Ella, MD, Egyptian National Nutrition Institute; Principal Investigator: Associate professor. Amr Hassan, MD, Cairo University; Principal Investigator: Dr. Marwa Rashad Salem, MD, Cairo University; Principal Investigator: Dr. Asmaa Farrag El-Sayed Othman, Msc, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): March 18, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MD-57-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No