Nutritional Counselling for Patients at Kasr AlAiny Multiple Sclerosis Clinic: an Intervention Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

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.
    

Intervention name(s): Nutritional counselling
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Supportive Care