Hospitalized Adult PatientsADDUCENCT07730996
A Dietitian-Driven Unified Nutritional Care Model (ADDUCE)
A study testing Dietitian-driven nutritional care model and Current practice nutritional care in people with Hospitalized Adult Patients and Inpatient Internal Medicine Patients, run by Gødstrup Hospital at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to learn whether a new way of organising hospital nutrition care can improve outcomes for adults who are admitted to medical wards and are at risk of malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalized Adult Patients, Inpatient Internal Medicine Patients, Haematologic Disease
- What is being tested?
- Dietitian-driven nutritional care model and Current practice nutritional care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Aug 2026to 16 May 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Admitted to a participating medical ward during the study period
- First eligible admission during the study period
- For the prospectively enrolled cohort:
- Age 18 years or older
- Newly admitted
Show all 9Show fewer
- Expected hospital stay until at least day 3 after admission
- Able to speak and understand Danish
- Able to provide written informed consent
Who cannot join
- Terminally ill patients with short expected survival
- Patients admitted to an isolation room at the time of recruitment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn whether a new way of organising hospital nutrition care can improve outcomes for adults who are admitted to medical wards and are at risk of malnutrition.
The main questions it aims to answer are:
Read more
- Does having clinical dietitians take primary responsibility for nutrition care shorten hospital stay?
- Does this approach improve nutritional intake, nutritional status, quality of life, and patient satisfaction?
- Does this approach lower healthcare costs compared with current practice?
Researchers will compare the new nutrition care model with current practice. In current practice, nursing staff are mainly responsible for nutrition screening and nutrition care planning, while clinical dietitians are involved only when requested. In the new model, clinical dietitians are part of the ward team and take primary responsibility for identifying patients at nutritional risk, planning nutritional care, and providing nutritional treatment.
Participants will:
- Receive either the current nutrition care approach or the new dietitian-led nutrition care approach, depending on when they are admitted to the ward
- Complete questionnaires about their nutritional status, quality of life, and daily activities during their hospital stay and about 30 days later
- Have information collected during their hospital stay and from their medical records, including nutritional intake, body weight, length of hospital stay, hospital readmissions, and other health outcomes
The study will be conducted on three medical wards at Gødstrup Hospital. All wards will start with current practice and will gradually change to the new nutrition care model during the study period. Researchers will compare outcomes before and after the new model is introduced.
Read the detailed description
Disease-related malnutrition is common among hospitalised medical patients and is associated with prolonged hospital stay, poorer clinical outcomes, reduced quality of life, and increased healthcare costs. Although evidence-based guidelines recommend systematic nutritional risk screening and nutritional treatment, implementation in routine clinical practice remains inconsistent. In many healthcare systems, including Denmark, responsibility for nutritional risk screening and nutritional care planning is primarily assigned to nursing staff, while clinical dietitians are typically involved only following referral.
The ADDUCE trial (A Dietitian-Driven Unified Nutritional Care Model) evaluates an alternative organisational model for delivering hospital nutritional care. The intervention is based on systematic integration of clinical dietitians into ward teams, with dietitians assuming primary responsibility for nutritional risk screening, nutritional assessment, nutritional care planning, and individualised nutritional treatment in close collaboration with nursing staff. Dietitians are present on the wards daily, participate in routine ward activities, and proactively identify patients requiring nutritional care rather than relying solely on referrals.
The study uses a stepped-wedge cluster-randomised controlled design conducted across three medical wards at Gødstrup Hospital, Denmark. All participating wards begin in the control condition, representing current clinical practice. The intervention is then introduced sequentially across wards in a randomised order until all wards have implemented the dietitian-driven model. This design allows each ward to contribute data under both control and intervention conditions while facilitating implementation at ward level.
Approximately 216 participants will be prospectively recruited and enrolled for detailed data collection, including nutritional intake, body weight, nutritional status, quality of life, patient satisfaction, and other clinical and patient-reported outcomes. In addition, routinely collected hospital data from all eligible patients admitted to participating wards during the study period will be used to evaluate length of hospital stay and hospital readmissions. The enrolled cohort will provide detailed clinical information that supports adjusted analyses of secondary outcomes.
The purpose of the study is to determine whether a dietitian-driven model of nutritional care can improve patient outcomes and healthcare efficiency compared with current practice. The study also aims to evaluate whether earlier identification and treatment of patients at nutritional risk can contribute to more systematic nutritional care in hospital settings.
- Conditions
- Hospitalized Adult Patients, Inpatient Internal Medicine Patients, Haematologic Disease, Pulmonary Diseases, Infectious Diseases, Gastroenterology
- Being tested
- Dietitian-driven nutritional care model, Current practice nutritional care
- Keywords
- Disease-related malnutrition, Nutritional risk, Nutritional care, Clinical dietitian, Nutritional risk screening, Medical inpatients, Health services research, Interdisciplinary care, Hospital nutrition, Nutrition, Stepped-wedge cluster randomised trial
- Medical subject headings
- Hematologic Diseases, Lung Diseases, Communicable Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietitian-driven nutritional care modelBehavioural
Clinical dietitians are integrated into the ward team and assume primary responsibility for systematic nutritional risk screening, nutritional assessment, nutritional care planning, follow-up, and nutritional treatment. Dietitians identify patients requiring nutritional care without waiting for referral and collaborate with nursing staff and other clinicians to provide coordinated nutritional care during hospital admission.
Current practice nutritional careOther
Nutritional care delivered according to existing ward procedures, with nursing staff primarily responsible for nutritional risk screening and nutritional care planning and clinical dietitians involved following referral or consultation.
| Study group | Role | What they receive |
|---|---|---|
| Dietitian-driven nutritional care model | Experimental | Clinical dietitians are integrated into the ward team and assume primary responsibility for nutritional risk screening, nutritional care planning, follow-up, and nutritional treatment. Nutritional care is delivered in close collaboration with nursing staff according to a predefined model of care. Receives: Behavioral: Dietitian-driven nutritional care model |
| Current practice | Active comparator | Nutritional risk screening and nutritional care are delivered according to existing ward procedures. Nursing staff are primarily responsible for nutritional risk screening and nutritional care, while clinical dietitians are involved following referral or consultation as needed. Receives: Other: Current practice nutritional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Length of hospital stay, defined as the time from hospital admission to hospital discharge. Length of stay will be calculated in hours from electronic health record time stamps and expressed in days (hours/24). Assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Measured: Through study completion, an average of 5 days
Hospital re-admissions
Number of hospital readmissions after discharge from the index admission, assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Measured: 30 days, 90 days
Secondary outcomes (9)
Days alive and out of hospital
Days alive and out of hospital after index admission. Assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Measured: 30 days, 90 days
Mortality
Assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Measured: 30 days, 90 days
Daily energy intake
Energy intake (kJ/day) expressed as a percentage of estimated energy requirements, assessed in the prospectively recruited cohort of approximately 216 enrolled participants. Energy intake will be estimated using a 24-hour dietary recall conducted as a structured interview with the participant, supported by data from the hospital electronic meal ordering system and the electronic administration records for enteral and parenteral nutrition.
Measured: Day 1-3
Daily protein intake
Protein intake (g/day) expressed as a percentage of estimated protein requirements, assessed in the prospectively recruited cohort of approximately 216 enrolled participants. Protein intake will be estimated using a 24-hour dietary recall conducted as a structured interview with the participant, supported by data from the hospital electronic meal ordering system and the electronic administration records for enteral and parenteral nutrition.
Measured: Day 1-3
Health-related quality of life (EQ-5D-5L)
Health-related quality of life assessed using the EQ-5D-5L in the prospectively recruited cohort of approximately 216 enrolled participants. The EQ-5D-5L is a self-administered questionnaire that measures health status across five dimensions and includes a health utility index score. Participants may receive assistance from the data collector if needed. Higher index scores indicate better health-related quality of life.
Measured: Day 2, day 30
Nutritional risk
Nutritional risk assessed using the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) in the prospectively recruited cohort of approximately 216 enrolled participants. The PG-SGA SF is completed by the participant as a self-administered questionnaire, with assistance from the data collector if required to facilitate completion. The questionnaire assesses weight history, food intake, nutrition impact symptoms, and functional capacity. Higher scores indicate greater nutritional risk.
Measured: Day 2, day 30
Nutritional risk screening completed
Proportion of eligible patients who undergo nutritional risk screening during hospital admission, assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Measured: Throughout study completion, an average of 5 days
Nutritional care plan documented
Proportion of eligible patients with a documented nutritional care plan during hospital admission, assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Measured: Throughout study completion, an average of 5 days
Clinical dietitian involvement
Proportion of eligible patients with documented involvement of a clinical dietitian during hospital admission, assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Measured: Throughout study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start11 Aug 2026
- Primary completion16 May 2027 (estimated)
- Study completion16 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized Adult PatientsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a stepped-wedge cluster-randomised design. Three medical wards are randomised to the order in which they transition from current practice to the intervention. All wards begin in the control condition and sequentially cross over to the intervention condition at predefined time points until all wards have implemented the intervention.
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Dietetic Association, NIDO Research Foundation, Health Research Foundation of Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Marianne Boll Kristensen, RD, PhD, Principal investigator, Department of Nutrition, Gødstrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730996
- Sponsor's protocol ID
- ADDUCE-2026
- Acronym
- ADDUCE
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to GDPR
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dietitian-Driven Unified Nutritional Care Model (ADDUCE)
- ClinicalTrials.gov ID
- NCT07730996
- Acronym / sponsor ID
- ADDUCE / ADDUCE-2026
- Conditions
- Hospitalized Adult Patients, Inpatient Internal Medicine Patients, Haematologic Disease, Pulmonary Diseases, Infectious Diseases, Gastroenterology
- Keywords
- Disease-related malnutrition, Nutritional risk, Nutritional care, Clinical dietitian, Nutritional risk screening, Medical inpatients, Health services research, Interdisciplinary care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Collaborators
- The Danish Dietetic Association, NIDO Research Foundation, Health Research Foundation of Central Denmark Region
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 16 May 2027 (estimated)
- Study completion
- 16 May 2027 (estimated)
- First posted
- 28 Jul 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.
The goal of this clinical trial is to learn whether a new way of organising hospital nutrition care can improve outcomes for adults who are admitted to medical wards and are at risk of malnutrition.
The main questions it aims to answer are:
- Does having clinical dietitians take primary responsibility for nutrition care shorten hospital stay?
- Does this approach improve nutritional intake, nutritional status, quality of life, and patient satisfaction?
- Does this approach lower healthcare costs compared with current practice?
Researchers will compare the new nutrition care model with current practice. In current practice, nursing staff are mainly responsible for nutrition screening and nutrition care planning, while clinical dietitians are involved only when requested. In the new model, clinical dietitians are part of the ward team and take primary responsibility for identifying patients at nutritional risk, planning nutritional care, and providing nutritional treatment.
Participants will:
- Receive either the current nutrition care approach or the new dietitian-led nutrition care approach, depending on when they are admitted to the ward
- Complete questionnaires about their nutritional status, quality of life, and daily activities during their hospital stay and about 30 days later
- Have information collected during their hospital stay and from their medical records, including nutritional intake, body weight, length of hospital stay, hospital readmissions, and other health outcomes
The study will be conducted on three medical wards at Gødstrup Hospital. All wards will start with current practice and will gradually change to the new nutrition care model during the study period. Researchers will compare outcomes before and after the new model is introduced.
Detailed description
Disease-related malnutrition is common among hospitalised medical patients and is associated with prolonged hospital stay, poorer clinical outcomes, reduced quality of life, and increased healthcare costs. Although evidence-based guidelines recommend systematic nutritional risk screening and nutritional treatment, implementation in routine clinical practice remains inconsistent. In many healthcare systems, including Denmark, responsibility for nutritional risk screening and nutritional care planning is primarily assigned to nursing staff, while clinical dietitians are typically involved only following referral.
The ADDUCE trial (A Dietitian-Driven Unified Nutritional Care Model) evaluates an alternative organisational model for delivering hospital nutritional care. The intervention is based on systematic integration of clinical dietitians into ward teams, with dietitians assuming primary responsibility for nutritional risk screening, nutritional assessment, nutritional care planning, and individualised nutritional treatment in close collaboration with nursing staff. Dietitians are present on the wards daily, participate in routine ward activities, and proactively identify patients requiring nutritional care rather than relying solely on referrals.
The study uses a stepped-wedge cluster-randomised controlled design conducted across three medical wards at Gødstrup Hospital, Denmark. All participating wards begin in the control condition, representing current clinical practice. The intervention is then introduced sequentially across wards in a randomised order until all wards have implemented the dietitian-driven model. This design allows each ward to contribute data under both control and intervention conditions while facilitating implementation at ward level.
Approximately 216 participants will be prospectively recruited and enrolled for detailed data collection, including nutritional intake, body weight, nutritional status, quality of life, patient satisfaction, and other clinical and patient-reported outcomes. In addition, routinely collected hospital data from all eligible patients admitted to participating wards during the study period will be used to evaluate length of hospital stay and hospital readmissions. The enrolled cohort will provide detailed clinical information that supports adjusted analyses of secondary outcomes.
The purpose of the study is to determine whether a dietitian-driven model of nutritional care can improve patient outcomes and healthcare efficiency compared with current practice. The study also aims to evaluate whether earlier identification and treatment of patients at nutritional risk can contribute to more systematic nutritional care in hospital settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a stepped-wedge cluster-randomised design. Three medical wards are randomised to the order in which they transition from current practice to the intervention. All wards begin in the control condition and sequentially cross over to the intervention condition at predefined time points until all wards have implemented the intervention.
| Arm | Type | Receives |
|---|---|---|
| Dietitian-driven nutritional care model | Experimental | Behavioral: Dietitian-driven nutritional care modelClinical dietitians are integrated into the ward team and assume primary responsibility for nutritional risk screening, nutritional care planning, follow-up, and nutritional treatment. Nutritional care is delivered in close collaboration with nursing staff according to a predefined model of care. |
| Current practice | Active comparator | Other: Current practice nutritional careNutritional risk screening and nutritional care are delivered according to existing ward procedures. Nursing staff are primarily responsible for nutritional risk screening and nutritional care, while clinical dietitians are involved following referral or consultation as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older
- Admitted to a participating medical ward during the study period
- First eligible admission during the study period
- Age 18 years or older
- Newly admitted
Key exclusion criteria (2 listed)
- Terminally ill patients with short expected survival
- Patients admitted to an isolation room at the time of recruitment
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 |
|---|---|---|
| Dietitian-driven nutritional care modelClinical dietitians are integrated into the ward team and assume primary responsibility for systematic nutritional risk screening, nutritional assessment, nutritional care planning, follow-up, and nutritional treatment. Dietitians identify patients requiring nutritional care without waiting for referral and collaborate with nursing staff and other clinicians to provide coordinated nutritional care during hospital admission. | Behavioural | Dietitian-driven nutritional care model |
| Current practice nutritional careNutritional care delivered according to existing ward procedures, with nursing staff primarily responsible for nutritional risk screening and nutritional care planning and clinical dietitians involved following referral or consultation. | Other | Current practice |
Primary outcome
Length of hospital stay
Time frame: Through study completion, an average of 5 days
Length of hospital stay, defined as the time from hospital admission to hospital discharge. Length of stay will be calculated in hours from electronic health record time stamps and expressed in days (hours/24). Assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Hospital re-admissions
Time frame: 30 days, 90 days
Number of hospital readmissions after discharge from the index admission, assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
9 secondary outcomes
Days alive and out of hospital
Time frame: 30 days, 90 days
Mortality
Time frame: 30 days, 90 days
Daily energy intake
Time frame: Day 1-3
Daily protein intake
Time frame: Day 1-3
Health-related quality of life (EQ-5D-5L)
Time frame: Day 2, day 30
Nutritional risk
Time frame: Day 2, day 30
Nutritional risk screening completed
Time frame: Throughout study completion, an average of 5 days
Nutritional care plan documented
Time frame: Throughout study completion, an average of 5 days
Clinical dietitian involvement
Time frame: Throughout study completion, an average of 5 days
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 31 Aug 2026.
- Individual participant dataSharing planned: No. Due to GDPR
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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.
Marianne Boll Kristensen, RD, PhD principal investigator
Department of Nutrition, Gødstrup Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietitian-driven nutritional care model and Current practice nutritional care in people with Hospitalized Adult Patients and Inpatient Internal Medicine Patients, run by Gødstrup Hospital at 1 site in Denmark.
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 9 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. 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 Denmark. 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 Marianne Boll Kristensen, RD, PhD (+4581441015, maboki@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Through study completion, an average of 5 days). 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?
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 31 Aug 2026.