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RecruitingNCT07730996ADDUCEUpdated Aug 31, 2026

A Dietitian-Driven Unified Nutritional Care Model (ADDUCE)

An interventional study of Dietitian-driven nutritional care model and Current practice nutritional care in Hospitalized Adult Patients, Inpatient Internal Medicine Patients and Haematologic Disease, sponsored by Gødstrup Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Gødstrup Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Hospitalized Adult Patients
  • Inpatient Internal Medicine Patients
  • Haematologic Disease
  • Pulmonary Diseases
  • Infectious Diseases
  • Gastroenterology
  • Renal Diseases

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
03

In context

Hematologic Diseases

609 studies on the registry are indexed under Hematologic Diseases; 108 are open to participants now.

This study's planned enrollment of 216 is above the median of 50 across 410 interventional studies indexed under Hematologic Diseases.

Browse Hematologic Diseases studies →

Lead sponsor

Gødstrup Hospital is the lead sponsor of 24 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

For routinely collected hospital data:

Inclusion Criteria:

  • 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:

Inclusion Criteria:

  • Age 18 years or older
  • Newly admitted
  • Expected hospital stay until at least day 3 after admission
  • Able to speak and understand Danish
  • Able to provide written

Exclusion Criteria:

  • Terminally ill patients with short expected survival
  • Patients admitted to an isolation room at the time of recruitment
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
216 participants (estimated)

Study arms

  • Experimental
    Dietitian-driven nutritional care model

    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.

    Behavioral: Dietitian-driven nutritional care model

  • Active comparator
    Current practice

    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.

    Other: Current practice nutritional care

Interventions

  • BehavioralDietitian-driven nutritional care model

    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.

  • OtherCurrent practice nutritional care

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 5 days

  2. 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.

    Time frame: 30 days, 90 days

Secondary outcomes

  1. 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.

    Time frame: 30 days, 90 days

  2. Mortality

    Assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.

    Time frame: 30 days, 90 days

  3. 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.

    Time frame: Day 1-3

  4. 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.

    Time frame: Day 1-3

  5. 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.

    Time frame: Day 2, day 30

  6. 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.

    Time frame: Day 2, day 30

  7. 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.

    Time frame: Throughout study completion, an average of 5 days

  8. 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.

    Time frame: Throughout study completion, an average of 5 days

  9. 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.

    Time frame: Throughout study completion, an average of 5 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Due to GDPR

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07730996
Lead sponsor
Gødstrup Hospital
Collaborators
The Danish Dietetic Association, NIDO Research Foundation, Health Research Foundation of Central Denmark Region
Responsible party
Sponsor
First posted
Jul 28, 2026
Start date
Aug 11, 2026
Primary completion
May 16, 2027 (estimated)
Completion
May 16, 2027 (estimated)
Last update
Aug 31, 2026

Study contacts

Marianne Boll Kristensen, RD, PhD
Contact
maboki@rm.dk
+4581441015
Lone Viggers, RD, MSc.
Contact
lonvig@rm.dk
+4578434500
Marianne Boll Kristensen, RD, PhD
principal investigator · Department of Nutrition, Gødstrup Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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