Clinical trial NCT04217564: Nutritional Counselling for Patients at Kasr AlAiny Multiple Sclerosis Clinic: an Intervention Study
Official title: Nutritional Counselling for Patients at Kasr AlAiny Multiple Sclerosis Clinic: an Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of quality of life of MS patients: 36-SF
timeFrame: 3 months
measure: Change of nutritional status of MS patients
timeFrame: 3 months
Secondary outcomes:
measure: Change of the disease progression.
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Prof. Zeinab Emam Mohamed Afifi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Egyptian National Nutrition Institute
name: Prof. Nebal Abdel Rahman Aboul-Ella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Associate professor. Amr Hassan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Dr. Marwa Rashad Salem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Dr. Asmaa Farrag El-Sayed Othman, Msc
role: PRINCIPAL_INVESTIGATOR
References: