An interventional study of A structured follow-up with a tailored made nutritional plan and a parent empowerment program in Malnutrition, Child, sponsored by Erasmus Medical Center. Recruiting at 6 sites in Netherlands. Open to participants aged 7 Days to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
The goal of this stepped wedge cluster randomized trial is to compare nutritional care after discharge to an intervention in children term born - 18 years old discharged with newly initiated nutritional care.
The main question it aims to answer is:
To investigate whether a tailored nutritional care follow-up program in children who are being discharged from the hospital with nutritional support improves nutritional intake and status as well as feeding behavior and quality of life (QoL) in children and their parents. Furthermore, the effect on parental stress, anxiety, depression, and post-traumatic stress (PTSD) as well as QoL will be assessed with and without a tailored nutritional care follow-up program
All subjects, both in the usual care and intervention group, will be treated with the standard nutritional protocols of these individual hospitals during hospitalization. After hospital discharge, the treatments of the intervention and the control group will entail the procedures as described below.
Intervention group The intervention consists of a tailored nutritional follow-up plan, including a parent empowerment program, made by a multidisciplinary support team (primarily responsible clinician, dietician, psychologist and, if indicated, a speech therapist). At discharge and follow-up at 6, 12 and 18 weeks after discharge, food diaries (including growth) and questionnaires* relating to feeding behaviour and parental stress are filled out by parents/caregivers.
One week before the planned outpatient visit of the patient and their parents, questionnaires will be sent with preferred software available in ErasmusMC ICT infrastructure through e-mail. The findings gathered from these nutritional data and questionnaires will be visualized on a dashboard (visible to parents and the caregivers) to discuss and help resolve the most relevant problems with the parents during the follow-up moments. During the outpatient visit, the growth and body composition of the child will also be assessed.
The nutritional support team will discuss the outcomes of the questionnaires and make tailored advice based on the problems parents have reported. The dietician will discuss this tailored advice with the children and/or parents based on the growth, the nutritional intake of the child, and the problems parents have reported regarding the feeding behaviour of the child and their parental distress. Subsequently, the dietician will provide recommendations and psychoeducation to parents and/or patients in order to improve the nutritional status.
At 6 months after discharge follow/up measurements such as, growth, duration and frequency of nutritional support, food diary, feeding behaviour of the child, QoL of the child, parental stress and QoL will be gathered.
Evaluation and treatment other than follow-up at 6, 8 and 12 weeks after discharge with one of the health care professionals are on indication and data will not be collected.
The intervention differs from the usual care, because follow-up is at standard time periods. In the usual care this is not regulated. Nutritional support is given in a multidisciplinary team including a psychologist, but in the pilot study we saw collaboration with the pediatrician and speech therapist only. In the intervention we also focuses on parenteral stress, which is new and different from usual care.
Usual care group Nutritional advice in the usual care group will be given after discharge and follow-up according to standard practices. At 6 months after discharge an evaluation will be done equal to the intervention group. To collect information about the number of readmissions to the hospital and reason of admission, visits to a health-care provider, and growth parameters parents are asked to fill in a logbook to collect this data between discharge and 6 months follow-up. This method has been chosen because these are parameters that are difficult to remember at the visit 6 months after discharge.
167 studies on the registry are indexed under Child Nutrition Disorders; 36 are open to participants now.
This study's planned enrollment of 260 is below the median of 402 across 132 interventional studies indexed under Child Nutrition Disorders.
Browse Child Nutrition Disorders studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The usual care as given at that moment in that hospital. The group to compare the intervention with.
The intervention consists of a tailored nutritional follow-up plan, including a parent empowerment program, made by a multidisciplinary support team (primarily responsible clinician, dietician, psychologist and, if indicated, a speech therapist). At discharge and follow-up at 6, 12 and 18 weeks after discharge, food diaries (including growth) and questionnaires\* relating to feeding behaviour and parental stress are filled out by parents/caregivers.
Other: A structured follow-up with a tailored made nutritional plan and a parent empowerment program
The goal is a structured follow-up after discharge. Parents need to fill in questionnaires about eating behavior en feeding difficulties about their child. They also need to fill in a questionnaire about their stress. Together with their nutritional intake (3-days food diary) and growth a tailor-made nutritional plan is made. All the information I showed in a dashboard and discussed it with their dietitian. Who discusses this information in a multi-disciplinary team (pediatrician, psychologist and if needed a speech therapist).
Weight
in kilograms, cm and z-scores
Time frame: From enrollment until 6 months after discharge
Height
in meters and z-scores
Time frame: From enrollment until 6 months after discharge
Head circumference
in centimeters and z-scores
Time frame: From enrollment until 6 months after discharge
Mid-upper arm circumference
in centimeters and z-scores
Time frame: From enrollment until 6 months after discharge
Length in children <2 years of age
in centimeters and z-scores
Time frame: From enrollment until 6 months after discharge
Body composition
Fat mass, Fat free mass
Time frame: From enrollment until 6 months after discharge
Duration and frequency of nutritional support
Time (weeks), frequency per day
Time frame: From enrollment until 6 months after discharge
Dependency on nasogastric tube feeding
Yes/No and intermitted or portions
Time frame: From enrollment until 6 months after discharge
Nutritional requirements and intake
Energy as kcal/day and kcal/kg
Time frame: From enrollment until 6 months after discharge
Nutritional requirements and intake
Protein as gram/day and gram/kg
Time frame: From enrollment until 6 months after discharge
Nutritional requirements and intake
Fluids as ml/day and ml/kg
Time frame: From enrollment until 6 months after discharge
Nutritional requirements and intake
Total mineral an vitamin intake percentage of ADH
Time frame: From enrollment until 6 months after discharge
Feeding behaviour of the child
Questionnnaire CEBQ/BEBQ
Time frame: From enrollment until 6 months after discharge
Feeding behaviour of the child
Questionnnaire MCH-FS
Time frame: From enrollment until 6 months after discharge
Parental stress
Questionnaire LTO
Time frame: From enrollment until 6 months after discharge
Parental stress
Questionnaire PROMIS
Time frame: From enrollment until 6 months after discharge
Quality of Life of children and parents
Questionnaire CHU9D
Time frame: From enrollment until 6 months after discharge
Cost-effectiveness of tailored nutritional care
Questionnaire iMCQ
Time frame: From enrollment until 6 months after discharge
Cost-effectiveness of tailored nutritional care
Questionnaire iPCQ
Time frame: From enrollment until 6 months after discharge
Barriers and facilitators of implementation of the multidisciplinary support team
Interviews with parents and health care professionals
Time frame: After the intervention
Plan to share: Yes — De-identified participant data may be made available for legitimate scientific purposes upon reasonable request, subject to review by the NutriCAD steering group, a data sharing agreement, institutional approval, and applicable privacy regulations
Supporting information: Study protocol, Analytic code
Time frame: Expected availablity june 2027
Access criteria: De-identified participant data may be made available for legitimate scientific purposes upon reasonable request, subject to review by the NutriCAD steering group, a data sharing agreement, institutional approval, and applicable privacy regulations
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.