UndernutritionMEDIALIMENCT06330025
Exploring Food Rejection Dispositions as Potential Risk Factors for Undernutrition in Hospitalized Children Aged 2 to 8
An observational study of Undernutrition, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Undernutrition affects over 30% of hospitalized children in France, with 10% severely malnourished yet only half of the cases are diagnosed. Undernutrition deteriorates children's health during hospital stays, weakening immunity and hindering recovery. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Undernutrition
- What is being tested?
- Children between 2 and 8 years, without medical treatments or pathologies impacting food intake and his parents
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2024to 29 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 8 years
- All sexes
- Child
Study population: Study population will include patients between 2 and 8 years admitted to hospitalization for at least 48 hours in a children hospital located in Lyon-France.
Who may be able to join
- child aged between 2 and 8 years (2 years ≤ age ≤ 8 years)
- child admitted to hospitalization for a minimum duration of 48 hours
Who cannot join
- regularly hospitalized children who come for routine check-ups, thus having repeated exposures to hospital meals
- children with pathologies or treatments causing a significant reduction in their food consumption (perioperative fasting, loss of appetite, nausea, vomiting, etc.)
- children with brain injuries, post-traumatic disorders, sensory deficits, digestive pathologies, severe organ failures (respiratory, cardiac, hepatic, renal)
- children admitted to intensive care units
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MEasuring and Overcoming Nutritional DIfficulties in Hospitalized Children
Undernutrition affects over 30% of hospitalized children in France, with 10% severely malnourished yet only half of the cases are diagnosed. Undernutrition deteriorates children's health during hospital stays, weakening immunity and hindering recovery. Children suffering from acute malnutrition can stay in the hospital 45% longer than non-malnourished patients.
One of the primary causes of malnutrition is the reduction in children's food intake. Several researchers have emphasized that the young age of patients is associated with reduced food intake. For example, data on 923 children aged 1 day to 16 years indicates that patients under 8 years old are at a higher risk of undernutrition than older children.
Read more
The MEDIC project aims to investigate if increased food rejection dispositions contribute to reduced food intake in hospitalized children. Food rejections are typically observed between 2 and 8 years. Some children are more challenging and eat only a few different foods, while others try everything. Around the age of 2, children become more selective about the foods they consume. This is largely due to two common dispositions in young children: food neophobia and food pickiness. Food neophobia is defined as the reluctance to eat or even try foods that appear new, whereas food pickiness is defined as the rejection of a substantial number of familiar foods, including foods previously tasted. Both pickiness and neophobia have been associated with a significant reduction in food consumption (especially of vegetables), a decrease in food variety, and less enjoyment derived from food. A study showed that children aged 2 to 5 were twice as likely to be underweight if they were picky eaters.
Studies have shown that the socioeconomic status has a significant impact on food rejection in children. For instance, longitudinal studies reveal a higher proportion of picky eaters in low-income families. Parental education was also found to be inversely associated with children's food rejection levels.
The MEDIC project seeks to assess health inequalities by studying the impact of food rejection dispositions on the nutritional status of children in pediatric services. A qualitative study supports the notion that food rejection is heightened during the hospitalization: half of the parents of hospitalized children interviewed reported that foods accepted outside the hospital were rejected in the ward. Parents indicated that their child's food preferences were more limited, and they only alternated between a few foods after entering the hospital. According to the majority of interviewed nurses, children refuse any food other than that provided by parents.
The research hypotheses of the MEDIC project focus on understanding the moderating effects of food rejection dispositions and socioeconomic backgrounds on children's food intake during hospitalization. Two hypotheses are formulated: (H1) the pre-hospitalization food rejection levels predict the amount of food consumed during the hospital stay, and (H2) children from disadvantaged socioeconomic backgrounds are more likely to refuse food during their hospital stay than those from more advantaged backgrounds. To test these hypotheses, parents of children aged 2 to 8 will complete questionnaires on food rejection dispositions upon admission, and food consumption (in grams and calories) will be assessed through weighing and photographs of meal trays taken 48 hours (± 24 hours) post-admission. The project aims to shed light on the complexities of childhood malnutrition, addressing social inequalities and contributing valuable insights for interventions and public health policy.
- Conditions
- Undernutrition
- Being tested
- Children between 2 and 8 years, without medical treatments or pathologies impacting food intake and his parents
- Keywords
- Undernutrition, Food intake, Hospitalization, Children, Food rejection, Food neophobia, Food pickiness, Social inequalities
- Medical subject headings
- Malnutrition, Avoidant Restrictive Food Intake Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children between 2 and 8 years, without medical treatments or pathologies impacting food intake and his parentsOther
The group comprises 102 children aged between 2 and 8 years, hospitalized for at least 48 hours and their parents. The children's pathologies and medical treatments should not influence their food intake.
What is being measured
The primary outcome is the main question the study is designed to answer.
Grams of hospital meals consumed by the patients at lunch
To assess the impact of the intensity of food refusal on children's food intake, the investigators will examine the regression coefficient between food refusal scores, measured by the questionnaire completed by one of the patient's parents, and food intake in grams during the lunch 48 hours (± 24 hours) post-admission..
Measured: Day 2
Calories of hospital meals consumed by the patients at lunch, 48 hours after their admission to the hospital.
To assess the impact of the intensity of food refusal on children's food intake, the investigators will examine the regression coefficient between food refusal scores, measured by the questionnaire completed by one of the patient's parents, and food intake in calories during the lunch 48 hours (± 24 hours) post-admission.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start10 Jul 2024
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330025
- Sponsor's protocol ID
- 69HCL23_1180
- Acronym
- MEDIALIME
- Status last verified
- Nov 2025
- First submitted
- 11 Mar 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Restier L, Duclos A, Jarri L, Touzet S, Denis A, Occelli P, Kassai-Koupai B, Lachaux A, Loras-Duclaux I, Colin C, Peretti N. Incorrect evaluation of the frequency of malnutrition and of its screening in hospitalized children by health care professionals. J Eval Clin Pract. 2015 Oct;21(5):958-62. doi: 10.1111/jep.12412. Epub 2015 Jul 23.
PubMed 26202860Joosten KF, Zwart H, Hop WC, Hulst JM. National malnutrition screening days in hospitalised children in The Netherlands. Arch Dis Child. 2010 Feb;95(2):141-5. doi: 10.1136/adc.2008.157255. Epub 2009 May 3.
PubMed 19414435Mehta NM, Corkins MR, Lyman B, Malone A, Goday PS, Carney LN, Monczka JL, Plogsted SW, Schwenk WF; American Society for Parenteral and Enteral Nutrition Board of Directors. Defining pediatric malnutrition: a paradigm shift toward etiology-related definitions. JPEN J Parenter Enteral Nutr. 2013 Jul;37(4):460-81. doi: 10.1177/0148607113479972. Epub 2013 Mar 25.
PubMed 23528324Aurangzeb B, Whitten KE, Harrison B, Mitchell M, Kepreotes H, Sidler M, Lemberg DA, Day AS. Prevalence of malnutrition and risk of under-nutrition in hospitalized children. Clin Nutr. 2012 Feb;31(1):35-40. doi: 10.1016/j.clnu.2011.08.011. Epub 2011 Sep 25.
PubMed 21945311White M, Dennis N, Ramsey R, Barwick K, Graham C, Kane S, Kepreotes H, Queit L, Sweeney A, Winderlich J, Wong See D, Littlewood R. Prevalence of malnutrition, obesity and nutritional risk of Australian paediatric inpatients: a national one-day snapshot. J Paediatr Child Health. 2015 Mar;51(3):314-20. doi: 10.1111/jpc.12709. Epub 2014 Aug 15.
PubMed 25123425Dovey TM, Staples PA, Gibson EL, Halford JC. Food neophobia and 'picky/fussy' eating in children: a review. Appetite. 2008 Mar-May;50(2-3):181-93. doi: 10.1016/j.appet.2007.09.009. Epub 2007 Sep 29.
PubMed 17997196Levene IR, Williams A. Fifteen-minute consultation: The healthy child: "My child is a fussy eater!". Arch Dis Child Educ Pract Ed. 2018 Apr;103(2):71-78. doi: 10.1136/archdischild-2016-311787. Epub 2017 Aug 8.
PubMed 28790134Pliner P, Hobden K. Development of a scale to measure the trait of food neophobia in humans. Appetite. 1992 Oct;19(2):105-20. doi: 10.1016/0195-6663(92)90014-w.
PubMed 1489209Taylor CM, Wernimont SM, Northstone K, Emmett PM. Picky/fussy eating in children: Review of definitions, assessment, prevalence and dietary intakes. Appetite. 2015 Dec;95:349-59. doi: 10.1016/j.appet.2015.07.026. Epub 2015 Jul 29.
PubMed 26232139Galloway AT, Lee Y, Birch LL. Predictors and consequences of food neophobia and pickiness in young girls. J Am Diet Assoc. 2003 Jun;103(6):692-8. doi: 10.1053/jada.2003.50134.
PubMed 12778039Dubois L, Farmer AP, Girard M, Peterson K. Preschool children's eating behaviours are related to dietary adequacy and body weight. Eur J Clin Nutr. 2007 Jul;61(7):846-55. doi: 10.1038/sj.ejcn.1602586. Epub 2006 Dec 20.
PubMed 17180152Tharner A, Jansen PW, Kiefte-de Jong JC, Moll HA, van der Ende J, Jaddoe VW, Hofman A, Tiemeier H, Franco OH. Toward an operative diagnosis of fussy/picky eating: a latent profile approach in a population-based cohort. Int J Behav Nutr Phys Act. 2014 Feb 10;11:14. doi: 10.1186/1479-5868-11-14.
PubMed 24512388Vereecken CA, Keukelier E, Maes L. Influence of mother's educational level on food parenting practices and food habits of young children. Appetite. 2004 Aug;43(1):93-103. doi: 10.1016/j.appet.2004.04.002.
PubMed 15262022Skolin I, Wahlin YB, Broman DA, Koivisto Hursti UK, Vikstrom Larsson M, Hernell O. Altered food intake and taste perception in children with cancer after start of chemotherapy: perspectives of children, parents and nurses. Support Care Cancer. 2006 Apr;14(4):369-78. doi: 10.1007/s00520-005-0904-6. Epub 2006 Jan 28.
PubMed 16633841
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEasuring and Overcoming Nutritional DIfficulties in Hospitalized Children
- ClinicalTrials.gov ID
- NCT06330025
- Acronym / sponsor ID
- MEDIALIME / 69HCL23_1180
- Conditions
- Undernutrition
- Keywords
- Undernutrition, Food intake, Hospitalization, Children, Food rejection, Food neophobia, Food pickiness, Social inequalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 26 Mar 2024 (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.
Undernutrition affects over 30% of hospitalized children in France, with 10% severely malnourished yet only half of the cases are diagnosed. Undernutrition deteriorates children's health during hospital stays, weakening immunity and hindering recovery. Children suffering from acute malnutrition can stay in the hospital 45% longer than non-malnourished patients.
One of the primary causes of malnutrition is the reduction in children's food intake. Several researchers have emphasized that the young age of patients is associated with reduced food intake. For example, data on 923 children aged 1 day to 16 years indicates that patients under 8 years old are at a higher risk of undernutrition than older children.
The MEDIC project aims to investigate if increased food rejection dispositions contribute to reduced food intake in hospitalized children. Food rejections are typically observed between 2 and 8 years. Some children are more challenging and eat only a few different foods, while others try everything. Around the age of 2, children become more selective about the foods they consume. This is largely due to two common dispositions in young children: food neophobia and food pickiness. Food neophobia is defined as the reluctance to eat or even try foods that appear new, whereas food pickiness is defined as the rejection of a substantial number of familiar foods, including foods previously tasted. Both pickiness and neophobia have been associated with a significant reduction in food consumption (especially of vegetables), a decrease in food variety, and less enjoyment derived from food. A study showed that children aged 2 to 5 were twice as likely to be underweight if they were picky eaters.
Studies have shown that the socioeconomic status has a significant impact on food rejection in children. For instance, longitudinal studies reveal a higher proportion of picky eaters in low-income families. Parental education was also found to be inversely associated with children's food rejection levels.
The MEDIC project seeks to assess health inequalities by studying the impact of food rejection dispositions on the nutritional status of children in pediatric services. A qualitative study supports the notion that food rejection is heightened during the hospitalization: half of the parents of hospitalized children interviewed reported that foods accepted outside the hospital were rejected in the ward. Parents indicated that their child's food preferences were more limited, and they only alternated between a few foods after entering the hospital. According to the majority of interviewed nurses, children refuse any food other than that provided by parents.
The research hypotheses of the MEDIC project focus on understanding the moderating effects of food rejection dispositions and socioeconomic backgrounds on children's food intake during hospitalization. Two hypotheses are formulated: (H1) the pre-hospitalization food rejection levels predict the amount of food consumed during the hospital stay, and (H2) children from disadvantaged socioeconomic backgrounds are more likely to refuse food during their hospital stay than those from more advantaged backgrounds. To test these hypotheses, parents of children aged 2 to 8 will complete questionnaires on food rejection dispositions upon admission, and food consumption (in grams and calories) will be assessed through weighing and photographs of meal trays taken 48 hours (± 24 hours) post-admission. The project aims to shed light on the complexities of childhood malnutrition, addressing social inequalities and contributing valuable insights for interventions and public health policy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- Study population will include patients between 2 and 8 years admitted to hospitalization for at least 48 hours in a children hospital located in Lyon-France.
Key inclusion criteria (2 listed)
- child aged between 2 and 8 years (2 years ≤ age ≤ 8 years)
- child admitted to hospitalization for a minimum duration of 48 hours
Key exclusion criteria (4 listed)
- regularly hospitalized children who come for routine check-ups, thus having repeated exposures to hospital meals
- children with pathologies or treatments causing a significant reduction in their food consumption (perioperative fasting, loss of appetite, nausea, vomiting, etc.)
- children with brain injuries, post-traumatic disorders, sensory deficits, digestive pathologies, severe organ failures (respiratory, cardiac, hepatic, renal)
- children admitted to intensive care units
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 |
|---|---|---|
| Children between 2 and 8 years, without medical treatments or pathologies impacting food intake and his parentsThe group comprises 102 children aged between 2 and 8 years, hospitalized for at least 48 hours and their parents. The children's pathologies and medical treatments should not influence their food intake. | Other | – |
Primary outcome
Grams of hospital meals consumed by the patients at lunch
Time frame: Day 2
To assess the impact of the intensity of food refusal on children's food intake, the investigators will examine the regression coefficient between food refusal scores, measured by the questionnaire completed by one of the patient's parents, and food intake in grams during the lunch 48 hours (± 24 hours) post-admission..
Calories of hospital meals consumed by the patients at lunch, 48 hours after their admission to the hospital.
Time frame: Day 2
To assess the impact of the intensity of food refusal on children's food intake, the investigators will examine the regression coefficient between food refusal scores, measured by the questionnaire completed by one of the patient's parents, and food intake in calories during the lunch 48 hours (± 24 hours) post-admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 26202860Restier L, Duclos A, Jarri L, Touzet S, Denis A, Occelli P, Kassai-Koupai B, Lachaux A, Loras-Duclaux I, Colin C, Peretti N. Incorrect evaluation of the frequency of malnutrition and of its screening in hospitalized children by health care professionals. J Eval Clin Pract. 2015 Oct;21(5):958-62. doi: 10.1111/jep.12412. Epub 2015 Jul 23.
- Background: PubMed 19414435Joosten KF, Zwart H, Hop WC, Hulst JM. National malnutrition screening days in hospitalised children in The Netherlands. Arch Dis Child. 2010 Feb;95(2):141-5. doi: 10.1136/adc.2008.157255. Epub 2009 May 3.
- Background: PubMed 23528324Mehta NM, Corkins MR, Lyman B, Malone A, Goday PS, Carney LN, Monczka JL, Plogsted SW, Schwenk WF; American Society for Parenteral and Enteral Nutrition Board of Directors. Defining pediatric malnutrition: a paradigm shift toward etiology-related definitions. JPEN J Parenter Enteral Nutr. 2013 Jul;37(4):460-81. doi: 10.1177/0148607113479972. Epub 2013 Mar 25.
- Background: PubMed 21945311Aurangzeb B, Whitten KE, Harrison B, Mitchell M, Kepreotes H, Sidler M, Lemberg DA, Day AS. Prevalence of malnutrition and risk of under-nutrition in hospitalized children. Clin Nutr. 2012 Feb;31(1):35-40. doi: 10.1016/j.clnu.2011.08.011. Epub 2011 Sep 25.
- Background: PubMed 25123425White M, Dennis N, Ramsey R, Barwick K, Graham C, Kane S, Kepreotes H, Queit L, Sweeney A, Winderlich J, Wong See D, Littlewood R. Prevalence of malnutrition, obesity and nutritional risk of Australian paediatric inpatients: a national one-day snapshot. J Paediatr Child Health. 2015 Mar;51(3):314-20. doi: 10.1111/jpc.12709. Epub 2014 Aug 15.
- Background: PubMed 17997196Dovey TM, Staples PA, Gibson EL, Halford JC. Food neophobia and 'picky/fussy' eating in children: a review. Appetite. 2008 Mar-May;50(2-3):181-93. doi: 10.1016/j.appet.2007.09.009. Epub 2007 Sep 29.
- Background: PubMed 28790134Levene IR, Williams A. Fifteen-minute consultation: The healthy child: "My child is a fussy eater!". Arch Dis Child Educ Pract Ed. 2018 Apr;103(2):71-78. doi: 10.1136/archdischild-2016-311787. Epub 2017 Aug 8.
- Background: PubMed 1489209Pliner P, Hobden K. Development of a scale to measure the trait of food neophobia in humans. Appetite. 1992 Oct;19(2):105-20. doi: 10.1016/0195-6663(92)90014-w.
- Background: PubMed 26232139Taylor CM, Wernimont SM, Northstone K, Emmett PM. Picky/fussy eating in children: Review of definitions, assessment, prevalence and dietary intakes. Appetite. 2015 Dec;95:349-59. doi: 10.1016/j.appet.2015.07.026. Epub 2015 Jul 29.
- Background: PubMed 12778039Galloway AT, Lee Y, Birch LL. Predictors and consequences of food neophobia and pickiness in young girls. J Am Diet Assoc. 2003 Jun;103(6):692-8. doi: 10.1053/jada.2003.50134.
- Background: PubMed 17180152Dubois L, Farmer AP, Girard M, Peterson K. Preschool children's eating behaviours are related to dietary adequacy and body weight. Eur J Clin Nutr. 2007 Jul;61(7):846-55. doi: 10.1038/sj.ejcn.1602586. Epub 2006 Dec 20.
- Background: PubMed 24512388Tharner A, Jansen PW, Kiefte-de Jong JC, Moll HA, van der Ende J, Jaddoe VW, Hofman A, Tiemeier H, Franco OH. Toward an operative diagnosis of fussy/picky eating: a latent profile approach in a population-based cohort. Int J Behav Nutr Phys Act. 2014 Feb 10;11:14. doi: 10.1186/1479-5868-11-14.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undernutrition, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grams of hospital meals consumed by the patients at lunch (time frame: Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06330025, which also lists 14 linked publications.
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 4 Dec 2025.