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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
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| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional counselling | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
MS patients diagnosed with any of the following disease subtypes:
Patients finished their secondary school education, its equivalents or higher education.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Cairo University | Cairo | 11731 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36691061 | Derived | Afifi Z, Hassan A, Abdelrahman N, El Sayed A, Salem M. Impact of nutrition counseling on anthropometry and dietary intake of multiple sclerosis patients at Kasr Alainy Multiple Sclerosis Unit, Cairo, Egypt 2019-2020: randomized controlled clinical trial. Arch Public Health. 2023 Jan 23;81(1):11. doi: 10.1186/s13690-022-01013-y. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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.
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |