An interventional study of High-Calorie Specialized Nutritional Formula and education program in Weight Gain, Body Mass Index and Pediatric Nutrition, sponsored by Aryan Najmadin Nasradin. Not yet recruiting at 2 sites in Iraq. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Aryan Najmadin Nasradin · Not applicable, Interventional, and Treatment
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.
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.
317 studies on the registry are indexed under Weight Gain; 48 are open to participants now.
This study's planned enrollment of 75 is close to the median of 83 across 251 interventional studies indexed under Weight Gain.
Browse Weight Gain studies →This is the only study on the registry with Aryan Najmadin Nasradin as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: education program · Dietary Supplement: High-Calorie Diet
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.
Dietary Supplement: High-Calorie Specialized Nutritional Formula · Behavioral: education program
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.
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.
Also known as: Nutrition and Feeding Support Program for Children with Congenital Heart Disease (CHD)
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.
Also known as: High-Calorie Formula
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.
Time frame: From baseline (week 0) to week 8 after the start of the dietary intervention.
Parental Knowledge Improvement
Change in caregivers' knowledge about nutrition and feeding practices for children with CHD, assessed via pre- and post-intervention questionnaires.
Time frame: Measured at baseline and at week 8.
Plan to share: Yes — 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.
Supporting information: Study protocol
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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