"Effects of High-Calorie Diets VS High-Calorie Formulas on Weight Gain in Children With Congenital Heart Disease "

Summary

This study is a randomized controlled trial designed to evaluate the effects of high-calorie diets and specialized nutritional formulas on weight gain and clinical outcomes in underweight children aged 1 to 5 years with congenital heart disease (CHD). Children with CHD often experience growth failure due to increased energy needs and feeding difficulties, which can negatively impact their recovery, development, and overall health.

Seventy-five children will be randomly assigned to one of three groups: a control group receiving a standard diet, a group receiving a high-calorie diet made from energy-dense foods, and a third group receiving both the high-calorie diet and a specialized high-calorie pediatric formula. The study will measure changes in weight, appetite, feeding tolerance, and other growth indicators over an 8-week period. The goal is to determine whether enhanced nutritional support can improve weight gain and health outcomes in this high-risk population.

Conditions

• Weight Gain
• Body Mass Index
• Pediatric Nutrition
• Congenital Heart Disease
• Undernutrition

Interventions

DIETARY_SUPPLEMENT

High-Calorie Specialized Nutritional Formula

This intervention involves providing a commercially available pediatric formula specially designed for children with congenital heart disease. The formula is enriched with additional calories and protein to meet the increased metabolic demands of this population. Intake volumes will be tailored to each child's caloric needs and feeding tolerance, with regular monitoring by a pediatric dietitian to ensure adherence and minimize gastrointestinal side effects.

BEHAVIORAL

education program

This behavioral intervention consists of a structured education program aimed at primary caregivers of children aged 1-5 years with congenital heart disease (CHD) who are underweight. The program's goal is to improve caregivers' knowledge and practices related to child nutrition to promote healthy weight gain and growth. The program includes six weekly sessions (45-60 minutes each) covering topics such as understanding CHD's impact on nutrition, age-appropriate dietary needs, high-calorie feeding strategies using home ingredients, safe use of specialized formulas, practical feeding techniques, and methods for monitoring progress. Teaching methods involve lectures, group discussions, hands-on demonstrations, role-playing, visual aids, and provision of educational materials like meal plans, growth charts, and formula preparation guides. The intervention emphasizes practical skills and ongoing caregiver support to enhance feeding practices and child health outcomes.

DIETARY_SUPPLEMENT

High-Calorie Diet

This intervention involves educating caregivers of children aged 1-5 years with congenital heart disease (CHD) on implementing a high-calorie diet to promote healthy weight gain and growth. Caregivers are taught how to prepare calorie-dense meals using commonly available home ingredients, including healthy fats, full-fat dairy, powdered milk, and nutrient-rich foods such as eggs, meat, and legumes. The program includes practical guidance on meal enrichment, feeding schedules, safe use of specialized high-calorie formulas, and strategies to manage feeding difficulties. Caregivers receive tools such as recipe cards, sample meal plans, growth monitoring charts, and support through interactive sessions to ensure effective application of the diet.

Sponsors & Collaborators

• Aryan Najmadin Nasradin

  lead OTHER

Principal Investigators

• aryan najmadin, BSc · Hawler Medical University

• nazar ramadhan, assist prof · hawler medical university college of nursing

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-17

Primary Completion

2026-06-01

Completion

2026-06-01

Countries

• Iraq

Study Locations