"Effects of High-Calorie Diets VS High-Calorie Formulas on Weight Gain in Children With Congenital Heart Disease " ((CHD))
"Effects of High-Calorie Diet vs High-Calorie Formula on Weight Gain and Clinical Outcomes Among Children With Congenital Heart Disease"
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.
Study Overview
Status
Detailed Description
Children with congenital heart disease (CHD) are at high risk of growth failure and malnutrition due to a combination of increased metabolic demands and feeding difficulties. Despite advancements in surgical and medical management, undernutrition remains a persistent challenge and can negatively affect recovery, development, and long-term health outcomes. While most nutritional intervention studies focus on infants or the immediate postoperative period, older children with CHD-particularly those aged 1 to 5 years-remain an understudied group, despite ongoing nutritional risks.
This study addresses a critical gap in pediatric cardiac care by evaluating whether targeted nutritional strategies, such as high-calorie diets and specialized pediatric formulas, can support better weight gain and overall health in this population. The intervention is designed to be practical and feasible, combining enriched natural foods and commercially available high-calorie formulas tailored to children with increased energy needs.
By comparing standard care with enhanced nutritional interventions over an 8-week period, this randomized controlled trial aims to provide evidence on effective, non-invasive nutritional approaches for improving the health and development of underweight children with CHD. The results are expected to inform clinical nutrition guidelines and support individualized care plans for pediatric cardiology patients.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: aryan najmadin, B.Sc nursing
- Phone Number: 07501949549
- Email: aryan.najmadin88@gmail.com
Study Contact Backup
- Name: Dr.nazar Ramadhan, assist prof
- Phone Number: 07504946398
- Email: nazar.othman@hum.edu.krd
Study Locations
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Erbil, Iraq, 44001
- Cardiac center Pediatric Cardiology Unit and Nutrition Clinic
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Contact:
- Phone Number: 07510755848
- Email: cardiaccenter2007@gmail.com
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Principal Investigator:
- aryan najmadin, BSc
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Erbil, Iraq, 44001
- Pediatric Cardiology Unit, Cardiac Center
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Contact:
- Phone Number: 07500166362
- Email: nursing@hum.edu.krd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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.
Other Names:
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.
Other Names:
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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.
|
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.
Other Names:
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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From baseline (week 0) to week 8 after the start of the dietary intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Parental Knowledge Improvement
Time Frame: Measured at baseline and at week 8.
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Change in caregivers' knowledge about nutrition and feeding practices for children with CHD, assessed via pre- and post-intervention questionnaires.
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Measured at baseline and at week 8.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: aryan najmadin, BSc, Hawler Medical University
- Study Director: nazar ramadhan, assist prof, hawler medical university college of nursing
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Nutrition Disorders
- Heart Diseases
- Body Weight
- Body Weight Changes
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Malnutrition
- Heart Defects, Congenital
- Weight Gain
- Diet, Food, and Nutrition
- Physiological Phenomena
- Nutritional Physiological Phenomena
- Health Services
- Health Care Facilities Workforce and Services
- Child Health Services
- Community Health Services
- Preventive Health Services
- Population Characteristics
- Health Status
- Demography
- Early Intervention, Educational
- Nutritional Status
Other Study ID Numbers
- ANNasradin
- U1111-1339-0340 (Other Identifier: WHO Universal Trial Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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