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

NCT ID: NCT04217564

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-06-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Nutritional counselling

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutritional counselling

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Farrag El-Sayed Othman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. Zeinab Emam Mohamed Afifi, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Prof. Nebal Abdel Rahman Aboul-Ella, MD

Role: PRINCIPAL_INVESTIGATOR

Egyptian National Nutrition Institute

Associate professor. Amr Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Dr. Marwa Rashad Salem, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Dr. Asmaa Farrag El-Sayed Othman, Msc

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of medicine, Cairo University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 36691061 (View on PubMed)

Other Identifiers

MD-57-2019

Identifier Type: -

Identifier Source: org_study_id