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

Cairo University (CU)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Nutritional counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT04217564

MD-57-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Intervention group

Experimental group

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.

Treatment:

Behavioral: Nutritional counselling

Control group

No Intervention group

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.