A randomized controlled trial protocol for the introduction of a multidisciplinary individualized nutritional intervention in children with cerebral palsy

Ruzha Pancheva; Stanka A Fitneva; Rositsa Chamova; Dimitar Marinov; Albena Toneva; Stanislava Hadzhieva; Rozalina Braykova; Nikoleta Yoncheva; Stefka Tsvetanova; Silviya Nikolova; Natalya Usheva; Koen Huysentruyt; Karina Dimova; Yana Bocheva; Stanislava Pavlova; Petya Hristanova

doi:10.1016/j.conctc.2024.101343

A randomized controlled trial protocol for the introduction of a multidisciplinary individualized nutritional intervention in children with cerebral palsy

Contemp Clin Trials Commun. 2024 Aug 7:41:101343. doi: 10.1016/j.conctc.2024.101343. eCollection 2024 Oct.

Authors

Ruzha Pancheva^{1

2}, Stanka A Fitneva³, Rositsa Chamova^{1

2}, Dimitar Marinov^{1

2}, Albena Toneva^{1

2}, Stanislava Hadzhieva^{1

2}, Rozalina Braykova^{1

2}, Nikoleta Yoncheva⁴, Stefka Tsvetanova⁴, Silviya Nikolova^{2

5}, Natalya Usheva^{2

5}, Koen Huysentruyt⁶, Karina Dimova⁷, Yana Bocheva⁷, Stanislava Pavlova⁸, Petya Hristanova⁸

Affiliations

¹ Department of Hygiene and Epidemiology, Faculty of Public Health, Medical University "Prof. Dr Paraskev Stoyanov", Varna, Bulgaria.
² Research Group NutriLect, Department of Neuroscience, Research Institute, Medical University "Prof. Dr. Paraskev Stoyanov", Varna, Bulgaria.
³ Department of Psychology, Queen's University, Kingston, Canada.
⁴ Karin Dom Foundation, Varna, Bulgaria.
⁵ Department of Social Medicine and Healthcare Organization, Faculty of Public Health, Medical University "Prof. Dr Paraskev Stoyanov", Varna, Bulgaria.
⁶ Department of Paediatric Gastroenterology, UZ Brussel, Vrije Universiteit Brussel (VUB), Brussels, Belgium.
⁷ Department of Clinical Laboratory, Medical University "Prof. Dr. Paraskev Stoyanov", Varna, Bulgaria.
⁸ Department of Speech Therapy and Medical Pedagogics, Faculty of Public Health, Medical University "Prof. Dr Paraskev Stoyanov", Varna, Bulgaria.

Abstract

Introduction: Children with Cerebral Palsy (CP) encounter substantial nutritional challenges that impair their health and quality of life. Despite the importance of nutrition in managing CP and the recognition of physiological, behavioral, and social causes of malnutrition, research on the effectiveness of individualized nutritional interventions developed and supported by multidisciplinary teams is scarce.

Aim: The study will evaluate the impact of an individualized nutritional intervention developed and supported by a multidisciplinary team on the anthropometric outcomes and overall health of children with CP.

Methods: A single-center, randomized controlled trial, conducted at the Medical University of Varna, Bulgaria, will enroll 100 children aged 2-12 years and diagnosed with CP. Participants will be randomly assigned to either an intervention group, receiving comprehensive structured dietary assessment and individualized nutrition plan developed by a multidisciplinary team of experts, or to a standard care group. Outcomes assessed will focus on anthropometric measures of nutritional status, but also include health outcomes, child development and clinical assessments, and quality of life indicators.

Ethics: Ethical approval for this study has been obtained from the Medical Ethics Committee at the Medical University of Varna (Protocol No. 134 dated 20.07.2023).

Conclusion: This study will assess the benefits of a multidisciplinary, individualized nutritional intervention for children with CP. The findings will have implications for clinical guidelines and interventions aiming to improve their care and quality of life.

Keywords: Cerebral palsy; Individualized; Intervention; Multidisciplinary; Nutrition.