Weight GainNCT07552688
"Effects of High-Calorie Diets VS High-Calorie Formulas on Weight Gain in Children With Congenital Heart Disease "
A study testing High-Calorie Specialized Nutritional Formula, education program and High-Calorie Diet in people with Weight Gain and Body Mass Index, run by Aryan Najmadin Nasradin at 2 sites in Iraq.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Weight Gain, Body Mass Index, Pediatric Nutrition
- What is being tested?
- High-Calorie Specialized Nutritional Formula, education program and High-Calorie Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesIraq
- Study dates
- 17 Apr 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq2 sites
Cardiac center Pediatric Cardiology Unit and Nutrition Clinic
Erbil, 44001
07510755848, cardiaccenter2007@gmail.com
aryan najmadin, BSc
Pediatric Cardiology Unit, Cardiac Center
Erbil, 44001
07500166362, nursing@hum.edu.krd
About this study
Official title: "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.
Read the 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.
- Conditions
- Weight Gain, Body Mass Index, Pediatric Nutrition, Congenital Heart Disease, Undernutrition
- Being tested
- High-Calorie Specialized Nutritional Formula, education program, High-Calorie Diet
- Keywords
- BMI, Nutritional Status, Growth and Development, Pediatric Nursing
- Medical subject headings
- Weight Gain, Heart Defects, Congenital, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Calorie Specialized Nutritional FormulaDietary 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 programBehavioural
Also called Nutrition and Feeding Support Program for Children with Congenital Heart Disease (CHD)
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 DietDietary supplement
Also called High-Calorie Formula
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 group | Role | What they receive |
|---|---|---|
| High-Calorie Diet Group | Experimental | 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. Receives: Behavioral: education program; Dietary Supplement: High-Calorie Diet |
| High-Calorie Diet + Specialized Formula Group | Experimental | 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. Receives: Dietary Supplement: High-Calorie Specialized Nutritional Formula; Behavioral: education program |
| Control Group - Standard Diet (No Intervention) Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (week 0) to week 8 after the start of the dietary intervention.
Secondary outcomes (1)
Parental Knowledge Improvement
Change in caregivers' knowledge about nutrition and feeding practices for children with CHD, assessed via pre- and post-intervention questionnaires.
Measured: Measured at baseline and at week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start17 Apr 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- articipants will be randomly assigned to one of three groups. Each group will receive a different dietary intervention: a standard diet, a high-calorie diet made with natural energy-dense foods, or a high-calorie diet combined with a specialized pediatric formula. All groups will be followed simultaneously over an 8-week period to compare the effects of these interventions on weight gain and clinical outcomes.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aryan Najmadin Nasradin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aryan Najmadin Nasradin, Hawler Medical University
- Investigators
- aryan najmadin, BSc, Principal investigator, Hawler Medical Universitynazar ramadhan, assist prof, Study director, hawler medical university college of nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552688
- Sponsor's protocol ID
- ANNasradin
- Other IDs
- U1111-1339-0340
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effects of High-Calorie Diet vs High-Calorie Formula on Weight Gain and Clinical Outcomes Among Children With Congenital Heart Disease"
- ClinicalTrials.gov ID
- NCT07552688
- Acronym / sponsor ID
- ANNasradin
- Conditions
- Weight Gain, Body Mass Index, Pediatric Nutrition, Congenital Heart Disease, Undernutrition
- Keywords
- BMI, Nutritional Status, Growth and Development, Pediatric Nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Aryan Najmadin NasradinUniversity, hospital or other
- Study start
- 17 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- articipants will be randomly assigned to one of three groups. Each group will receive a different dietary intervention: a standard diet, a high-calorie diet made with natural energy-dense foods, or a high-calorie diet combined with a specialized pediatric formula. All groups will be followed simultaneously over an 8-week period to compare the effects of these interventions on weight gain and clinical outcomes.
| Arm | Type | Receives |
|---|---|---|
| High-Calorie Diet Group | Experimental | Behavioral: education program, Dietary Supplement: High-Calorie DietParticipants 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 | Experimental | Dietary Supplement: High-Calorie Specialized Nutritional Formula, Behavioral: education programParticipants 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 intervention | –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. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Calorie Specialized Nutritional FormulaThis 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. | Dietary supplement | High-Calorie Diet + Specialized Formula Group |
| education programAlso: Nutrition and Feeding Support Program for Children with Congenital Heart Disease (CHD)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. | Behavioural | High-Calorie Diet + Specialized Formula Group, High-Calorie Diet Group |
| High-Calorie DietAlso: High-Calorie FormulaThis 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. | Dietary supplement | High-Calorie Diet Group |
Primary outcome
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.
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.
1 secondary outcome
Parental Knowledge Improvement
Time frame: Measured at baseline and at week 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
aryan najmadin, BSc principal investigator
Hawler Medical University
nazar ramadhan, assist prof study director
hawler medical university college of nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Calorie Specialized Nutritional Formula, education program and High-Calorie Diet in people with Weight Gain and Body Mass Index, run by Aryan Najmadin Nasradin at 2 sites in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact aryan najmadin, B.Sc nursing (07501949549, aryan.najmadin88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.