Nutritional Counselling for Patients at Kasr AlAiny Multiple Sclerosis Clinic: an Intervention Study (AlAiny)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nutritional counselling
Sponsored by

About this trial
This is an interventional supportive care trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
MS patients diagnosed with any of the following disease subtypes:
- Relapsing Remitting MS (RRMS)
- Secondary Progressive MS (SPMS)
- Primary Progressive MS (PPMS)
- Patients finished their secondary school education, its equivalents or higher education.
Exclusion Criteria:
- Patients in MS relapse.
- Known diabetes mellitus patients.
- Known malabsorption syndrome patients.
- Known allergic patients to some food items such as milk and wheat.
- Patients who underwent bariatric surgeries.
- Patients on special diets.
- Patients receiving drugs that affect the appetite e.g. psychotropic drugs.
Sites / Locations
- Faculty of medicine, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04217564
Brief Title
Nutritional Counselling for Patients at Kasr AlAiny Multiple Sclerosis Clinic: an Intervention Study
Acronym
AlAiny
Official Title
Nutritional Counselling for Patients at Kasr AlAiny Multiple Sclerosis Clinic: an Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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:
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.
Session 2: follow up and reemphasize the instruction.
Session 3: follow up and reemphasize the instruction.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All attending patients will be checked for the inclusion and exclusion criteria. Eligible patients 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of quality of life of MS patients: 36-SF
Description
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.
Time Frame
3 months
Title
Change of nutritional status of MS patients
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change of the disease progression.
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
MS patients diagnosed with any of the following disease subtypes:
Relapsing Remitting MS (RRMS)
Secondary Progressive MS (SPMS)
Primary Progressive MS (PPMS)
Patients finished their secondary school education, its equivalents or higher education.
Exclusion Criteria:
Patients in MS relapse.
Known diabetes mellitus patients.
Known malabsorption syndrome patients.
Known allergic patients to some food items such as milk and wheat.
Patients who underwent bariatric surgeries.
Patients on special diets.
Patients receiving drugs that affect the appetite e.g. psychotropic drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Zeinab Emam Mohamed Afifi, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Nebal Abdel Rahman Aboul-Ella, MD
Organizational Affiliation
Egyptian National Nutrition Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Associate professor. Amr Hassan, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Marwa Rashad Salem, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Asmaa Farrag El-Sayed Othman, Msc
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, Cairo University
City
Cairo
ZIP/Postal Code
11731
Country
Egypt
12. IPD Sharing Statement
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Nutritional Counselling for Patients at Kasr AlAiny Multiple Sclerosis Clinic: an Intervention Study
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