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

NCT04217564 | Completed DMC

• 1 other identifier: MD-57-2019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Change of the disease progression.

  3 months

Study Arms (2)

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.

Behavioral: Nutritional counselling

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.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MS patients diagnosed with any of the following disease subtypes:
• Relapsing Remitting MS (RRMS)
• Secondary Progressive MS (SPMS)
• Primary Progressive MS (PPMS)
• Patients finished their secondary school education, its equivalents or higher education.

You may not qualify if:

• Patients in MS relapse.
• Known diabetes mellitus patients.
• Known malabsorption syndrome patients.
• Known allergic patients to some food items such as milk and wheat.
• Patients who underwent bariatric surgeries.
• Patients on special diets.
• Patients receiving drugs that affect the appetite e.g. psychotropic drugs.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, 11731, Egypt

Location

Related Publications (1)

• 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.

  PMID: 36691061 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 3, 2020
• Study Start: January 1, 2020
• Primary Completion: March 18, 2020
• Study Completion: June 30, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

EG (1)