Effect of Artificial Intelligence on Nutritional Status of Children Post Cardiac Surgery

NCT04782635 | Completed

• 1 other identifier: AlShifaTrustEye
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the study will be to assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group.To assess usefulness of diet related mobile application in comparison to usual care group.To identify diet related problems among children post cardiac surgery in both groups (usual care group and intervention group ).

Conditions

Post-cardiac Surgery

Outcome Measures

Primary Outcomes (5)

• Weight changes

  observe the Weight changes , weight for age , Z score weight for age in both groups

  2 months

• Caloric intake

  Check the average calories intake consumed in both groups

  2 months

• Proteins intake

  Check the average proteins consumed in both groups

  2 months

• Mobile application usage

  Patients will be asked whether the language used in application on a likert scale ranging from very easy to very difficult , handling application will be ranging from very easy to very difficult, cost effectiveness will be ranging from yes to very costly, Visual cues in application will be ranged from useful to difficult to understand, Recipes in application will be ranged from being Useful to not useful, Meal reminders will be ranged from being useful to irritating

  2 months

• nutritional issues

  Patient will be inquired regarding the episodes of vomiting, diarrhea, loss of appetite and other nutritional related problems

  2 months

Secondary Outcomes (4)

• carbohydrates intake

  2 months

• fats intake

  2 months

• Vitamins intake

  2 months

• Minerals intake

  2 months

Study Arms (2)

AI group

EXPERIMENTAL

* Care givers will be selected through permuted block. * They will be explained the procedure of intervention and written consent will be asked. * Mobile application will be installed in their mobile. * They will be explained the working of mobile application * Application will make a standard diet plan for the child according to the requirements of the child * Then the child will use the application for one month. * After one month patient will visit the doctor for routine checkup, during the visit patient will be asked for the usefulness of the application. * Nutritional status of the patient will be monitored including weight, height, clinical signs, dietary history and will be updated in application. * Then patient will follow the application for one month * After another one month patient will visit the doctor for routine checkup, during the visit patient will be asked for the usefulness of the application and nutritional status will be measured

Device: mobile based application

usual care group

OTHER

* Caregivers (Mothers/fathers/guardians) will be selected through permuted block. * Patient weight, height, clinical signs will be noted. * Caregivers will be handed over pamphlet regarding dietary instructions on discharge. * After one month patient will visit the doctor for routine checkup, during the visit nutritional status of the patient will be checked and noted including weight, height, clinical signs and dietary history. * Patient will leave hospital with no added dietary instruction. * After one month patient will visit the doctor for routine checkup, during the visit nutritional status of the patient will be checked and noted weight, height, clinical sign, and dietary history.

Behavioral: Pamphlet

Interventions

mobile based application DEVICE

Application basic function would be support and improve nutrition status of children. Personalization of goals and challenges, daily intake of calories, carbohydrates, proteins, fats, minerals and vitamins will be tracked, food logging, food tracking, meal and supplement reminders, recipes, visual cues (remaining calories) will be notified, episodes of vomiting, meals missed, diarrhea, nausea will be recorded , meal planned according to the food preferences of child, food composition table, nutrition blogs and articles

AI group

Pamphlet BEHAVIORAL

A pamphlet which will be provide knowledge to the patients

usual care group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of age 2-12 (early and middle childhood) years will be included in the study.
• Surgeries within first and second class of RACHS score are included in the study.
• Patients with smart phones and internet facilities are included in the study.
• Patients with caregivers who can read English are included in the study
• Patients discharged from the hospital will be selected

You may not qualify if:

• Patients with multiple congenital abnormalities and surgeries without an RACHS score are excluded.
• Patient who will be rehospitalized will be excluded from the research

Sponsors & Collaborators

• Al-Shifa Trust Eye Hospital: lead

Study Sites (2)

Armed Forces Institute of Cardiology and National Institute of Heart Disease

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Maryam Zahid

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (2)

• Zahid M, Sughra U, Mumtaz S, Hassan M. Improving nutritional status of children using artificial intelligence-based mobile application postsurgery: randomised controlled trial. BMJ Nutr Prev Health. 2023 Dec 2;6(2):367-373. doi: 10.1136/bmjnph-2023-000645. eCollection 2023.

  PMID: 38618548 DERIVED

• Zahid M, Sughra U. Development of a protocol for conducting a randomized control trial on effects of artificial intelligence on nutritional status of children post cardiac surgery. J Pak Med Assoc. 2022 May;72(5):908-911. doi: 10.47391/JPMA.3751.

  PMID: 35713054 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 4, 2021
• Study Start: March 25, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 3, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-08

Locations

PA (2)