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

Sponsor
Aryan Najmadin Nasradin
Study ID
NCT07552688
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
1 Year - 5 Years
Healthy Volunteers
Not accepted

Interventions

  • High-Calorie Specialized Nutritional Formula — DIETARY_SUPPLEMENT
    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.
  • education program — BEHAVIORAL
    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.
  • High-Calorie Diet — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

First listed
Apr 27, 2026
Start date
Apr 17, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-Calorie Diet Group
    Participants in this group will receive a diet enriched with additional calories through natural, energy-dense foods such as added oils, mashed avocados, and fortified cereals. The diet aims to exceed the child's estimated daily caloric needs to promote weight gain.
  • Experimental: High-Calorie Diet + Specialized Formula Group
    Participants in this group will receive the same high-calorie natural diet as Group 2, plus a commercially available specialized pediatric formula designed to meet increased energy and protein requirements in children with congenital heart disease. Formula amounts will be tailored to individual needs and tolerability.
  • No Intervention: Control Group - Standard Diet (No Intervention) Group
    Participants receive a standard diet appropriate for their age and clinical condition, without any additional calorie enrichment or specialized formulas. This group serves as the baseline for comparison.

Primary Outcome Measure

Mean weight gain (kg) from baseline to 8 weeks [ Time Frame: From baseline (week 0) to week 8 after the start of the dietary intervention. ]

Central Contacts

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