"Effects of High-Calorie Diets VS High-Calorie Formulas on Weight Gain in Children With Congenital Heart Disease "
"Effects of High-Calorie Diet vs High-Calorie Formula on Weight Gain and Clinical Outcomes Among Children With Congenital Heart Disease"
2 other identifiers
interventional
75
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2026
CompletedStudy Start
First participant enrolled
April 17, 2026
CompletedFirst Posted
Study publicly available on registry
April 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
April 29, 2026
April 1, 2026
2 months
April 17, 2026
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean weight gain (kg) from baseline to 8 weeks
Average change in body weight (in kilograms) from baseline (start of the study) to the end of the 8-week intervention period, measured using standardized calibrated scales.
From baseline (week 0) to week 8 after the start of the dietary intervention.
Secondary Outcomes (1)
Parental Knowledge Improvement
Measured at baseline and at week 8.
Study Arms (3)
High-Calorie Diet Group
EXPERIMENTALParticipants 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.
High-Calorie Diet + Specialized Formula Group
EXPERIMENTALParticipants 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.
Control Group - Standard Diet (No Intervention) Group
NO INTERVENTIONParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Children aged 1 to 5 years.
- Diagnosed with congenital heart disease (confirmed by echocardiography).
- Underweight (weight-for-age below the 10th percentile).
- Medically stable and eligible for oral or enteral feeding.
- Informed consent obtained from a parent.
You may not qualify if:
- Children with genetic syndromes known to affect growth (e.g., Down syndrome).
- Children with gastrointestinal conditions impairing nutrient absorption.
- Children who had cardiac surgery within the last 4 weeks.
- Presence of severe organ failure (renal, hepatic, etc.).
- Children on parenteral nutrition.
- Families unlikely to adhere to follow-up or dietary instructions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cardiac center Pediatric Cardiology Unit and Nutrition Clinic
Erbil, 44001, Iraq
Pediatric Cardiology Unit, Cardiac Center
Erbil, 44001, Iraq
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
aryan najmadin, BSc
Hawler Medical University
- STUDY DIRECTOR
nazar ramadhan, assist prof
hawler medical university college of nursing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This study is open-label, meaning that both the participants (children and their caregivers) and the researcher are aware of the dietary intervention assigned. Due to the nature of nutritional interventions-different diets and formulas-blinding is not feasible. All outcomes will be assessed objectively to minimize bias.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Research Nurse
Study Record Dates
First Submitted
April 17, 2026
First Posted
April 27, 2026
Study Start
April 17, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
Currently, the plan for sharing individual participant data (IPD) is under development. Once finalized, the plan will outline which data elements will be shared, such as de-identified participant-level data, relevant metadata, and supporting documentation. Data sharing will be conducted in accordance with ethical standards and applicable regulations to protect participant confidentiality. Access to the data may be granted to qualified researchers upon reasonable request and subject to data use agreements.