Administrative information
Title {1} | Multidimensional individualized nutritional therapy for individuals with severe chronic obstructive pulmonary disease – study protocol for a randomized controlled trial MINDNUT |
Trial registration {2a and 2b} | ClinicalTrials, NCT04873856 |
Protocol version {3} | Version 3 December 13, 2021 |
Funding {4} | Grosserer L. F. Foghts Fond Axel Muusfeldts Fond The Research Council at Copenhagen University Hospital, North Zealand, Denmark |
Author details {5a} |
Maria H. Hegelund,
Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark Christian Ritz, National Institute of Public Health, Copenhagen, Denmark Thyge L. Nielsen, Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark Christian Mølgaard, Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark Mette Frahm Olsen, Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark Christian Søborg, Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark Lone Braagaard, Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark Rikke Krogh-Madsen, Department of infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark Center for Physical Activity Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark Birgitte Lindegaard, Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark Center for Physical Activity Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark Daniel Faurholt-Jepsen, Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark |
Name and contact information for the trial sponsor {5b} |
Daniel Faurholt-Jepsen
,
daniel.faurholt-jepsen@regionh.dk + 45 26 74 12 42 |
Role of sponsor {5c} | The sponsor is involved in study design, data collection, data management, data analysis, interpretation of the results and in deciding which journals manuscripts will be submitted to. The funder will have no role in study design, data collection, data management, data analysis, interpretation of the results and in deciding which journals manuscripts will be submitted to |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
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≥ 35 years
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Severe COPD defined as GOLD grade 2 group B or D OR GOLD grade 3 and 4 group ABCD [15]
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Able to eat orally
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Live in own home
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Speak Danish or English
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Undernourished (BMI < 18.5 kg/m.2) OR at risk of undernutrition (a maximum BMI of 25 kg/m2) determined by Nutritional Risk Screening 2002 (NRS2002) or Mini Nutritional Assessment short form (MNA-SF)
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Stable phase
-
“Active solid cancer” defined as cancer diagnosed within the previous 6 months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within 6 months or hematological cancer that is not in complete remission [16].
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Unable to sign informed consent, e.g., due to severe dementia.
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Severe chronic renal failure defined as estimated glomerular filtration rate < 30 mL/min./1.73 m2 (ICD-10 codes N18.4 and N18.5).
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Severe alcohol abuse (ICD-10 codes F10.2 and K70.x).
-
Lost to follow-up
-
Withdrawal
Daily management
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Public and patient involvement
Nutritionally augmented standard of care
-
Nutritional plan is developed and adjusted with the participant based on nutritional registration, information about routines and habits and nutritional preferences to reach a daily protein target of 1.5 g protein/kg/day [17] and individual energy requirements of 30–45 kcal/kg/day [17]. The nutritional plan is adjusted at the regular contacts. The nutritional plan may include supplementation with energy and protein-rich products and during the intervention period, a document summarizing tools and advices are provided.
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Regular contacts are phone calls from the project coordinator every 7–14th day to talk about the nutritional plan, well-being, adherence, or potential side effects.
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Adherence support is provided through the regular contact and a friendly reminder that encourages the participant to follow the nutritional plan and to ask for support (a note to hang on the refrigerator).
-
Weight diary is a daily registration of weight.
Standard of care
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome
Secondary outcomes
Other outcomes
Participant timeline {13}
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
Assessments | Specific measurements |
Timepoint
|
Mean/median
|
Percent/proportion
|
Type of variable
| ||
---|---|---|---|---|---|---|---|
Baseline
|
1 mo
|
3 mos
| |||||
Primary outcome
| |||||||
Health-related quality of life | EQ-5D-5L | x | x | x | x | Numerical | |
Secondary outcomes
| |||||||
Hospitalizations | Acute hospitalizations (all causes) | x | x | x | Numerical | ||
Days in hospital | Number of days in hospital (all causes) | x | x | x | Numerical | ||
Other hospital contacts | Acute hospital contacts < 6 h | x | x | x | Numerical | ||
Contact to the outpatient clinic | Contact to the outpatient clinic via phone or visit | x | x | x | Numerical | ||
Mortality | Mortality (number of deaths) | x | x | x | Binomial | ||
Disease-specific quality of life | COPD Assessment Test | x | x | x | x | Numerical | |
Anxiety and depression | Hospital Acquired Depression Scale | x | x | x | x | Binomial | |
Muscle strength | Grip strength | x | x | x | x | Numerical | |
Muscle endurance | 30-s chair stand test | x | x | x | x | Numerical | |
Fat-free mass | Bioelectrical impedance analysis | x | x | x | x | Numerical | |
Fat mass | Bioelectrical impedance analysis | x | x | x | x | Numerical | |
Weight | Electronic scale | x | x | x | x | Numerical | |
Body mass index | Weight (kg)/height(m2) | x | x | x | x | x | Numerical/categorical |
Other outcomes
| |||||||
Hip circumference | Measuring tape | x | x | x | x | Numerical | |
Waist circumference | Measuring tape | x | x | x | x | Numerical | |
Mid-upper arm circumference | Measuring tape | x | x | x | x | Numerical | |
Exacerbation history | Number of exacerbations | x | x | x | x | Numerical | |
Oxygen therapy | Yes/no | x | x | x | x | Binomial | |
General physical activity level | Physical Activity Vital Sign | x | x | x | x | Numerical | |
Physical activity level | AX3 accelerometers | x | x | x | Numerical | ||
Protein intake | 24-h recall | x | x | x | Numerical | ||
Energy intake | 24-h recall | x | x | x | Numerical | ||
Difference between energy requirement and intake | 24-h recall | x | x | x | Numerical | ||
Difference between protein requirement and intake | 24-h recall | x | x | x | Numerical |