Multidimensional Individualized Nutritional Therapy for Individuals with Severe COPD (MINDNUT)

Multidimensional INDividualized NUTritional Therapy for Individuals with Severe Chronic Obstructive Pulmonary Disease

Individuals with severe chronic pulmonary disease often life isolated with a high burden of symptoms. Nutritional risk and low quality of life are common, and both associated with increased societal cost and poor prognosis. COPD is a complex and progressive disease with changing clinical states that influences nutritional status and quality of life in different ways. The primary aim is to improve quality of life for individuals with severe COPD.

120 individuals are recruited from the outpatient clinic at Nordsjællands Hospital in Denmark to a randomized controlled trial with two parallel groups (intervention and control). The intervention will last for 3 months comprising four elements including nutritional plan, regular contact, informal caregiver/friendly reminder and a weight dairy.

We expect that the intervention will improve quality of life, nutritional status and prognosis.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Dietary supplement: Intervention

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Nordsjællands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 35 years
• Severe COPD defined as GOLD grade 2 group B or D OR GOLD grade 3 and 4 group ABCD
• Able to eat orally
• Live in own home
• Speak Danish or English
• Undernourished OR at risk of undernutrition defined as BMI ≤ 21 kg/m2 if < 70 years and BMI <22 kg/m2 if ≥70 years OR BMI 21-25 kg/m2 plus nutritional risk (nutritional risk screening score ≥3) if <70 years and BMI 22-25 kg/m2 plus nutritional risk if ≥70 years
• Stable phase

CHANGE: Undernourished OR at risk of undernutrition (a maximum BMI of 25 kg/m2) determined by Nutritional Risk Screening 2002 or Mini Nutritional Assessment Short Form according to the protocol published in Trials.

Exclusion Criteria:

• Active solid cancer" defined as cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months or hematological cancer that is not in complete remission
• Unable to sign informed consent e.g. due to severe dementia.
• Severe chronic renal failure defined as estimated glomerular filtration rate < 30 mL/min./1.73 m2 (ICD-10 codes N18.4 and N18.5
• Severe alcohol abuse (ICD-10 codes F10.2 and K70.x).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intervention contains: individual nutritional plan; regular contact; friendly reminder/informal caregiver and; weight dairy.	Dietary supplement: Intervention; The four dimensions of MINDNUT are described below: Nutritional plan: is conducted in collaboration with the participant based on nutritional registration and information about routines and habits to reach a daily protein target of 1.5 g/kg/day. The nutritional plan is adjusted at the regular contact, and nutritional supplementation will be handed out to the participant. Friendly reminder/informal caregiver: is a friendly reminder that encourage the participant to follow the nutritional plan and to ask for support (a note to hang on the refrigerator). The informal caregiver is a person with close contact to the participant. Regular contacts: The participant will be contacted on regular basis (with an interval of 7-14 days) via phone and besides nutritional plan, this conversation will be used to talk about well-being, compliance and potential side-effects. Weight diary: participants is instructed in keeping a weight diary which include registration of a daily weight.
No Intervention: Control Group; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	Will be measured using the EQ-5D-5L	1 and 3 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Measured using an electronic scale (TANITA DC 430 SMA, TANITA, Denmark) to the nearest 0.1 kg	1 and 3 months after baseline
Body mass index	Calculated as weight (kg)/height (m2)	1 and 3 months after baseline
Hand grip strength	Measured using handdynanometer	1 and 3 months after baseline
Lower body strength	Measured using 30 second stand chair test	1 and 3 months after baseline
Number of unplanned acute hospitalizations	Obtained from patient files	1 and 3 months after baseline
Number of days in hospital	Obtained from patient files	1 and 3 months after baseline
Number of acute unplanned visits to emergency ward (<6 hours)	Obtained from patient files	1 and 3 months after baseline
Number of contacts to outpatient clinic (visits and phone calls)	Obtained from patient files	up to 3 months after baseline
Disease specific quality of life	Obtained using COPD Assessment test (CAT). CAT contains 8 items with a scoring range of 0-40. The total score indicate the impact level COPD has on the everyday life ranging from low to very high. A total score of 5 is referred to the upper limit of normal in healthy non-smokers, a total score <10 indicate low impact, 10-20 indicate medium impact, whereas >20 and >30 indicate high and very high impact, respectively.	1 and 3 months after baseline
Mortality	will be obtained from patient files	up to 3 months after baseline
Fat-free mass	Measured using bioelectrical impedance analysis	1 and 3 months after baseline
Fat mass	Measured using bioelectrical impedance analysis	1 and 3 months after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total protein intake	Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams	1 and 3 months after baseline
Difference in protein requirement and protein intake	Intake measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams adnd requirements is calculated as 1.5 g/kg/day.	1 and 3 months after baseline
Total energy intake	Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in kalories.	1 and 3 months after baseline
Difference in energy requirement and energy intake	Intake measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in kalories. Requirements calculated as 30 kcal/kg/day if goal is weight maintenance and 45 kcal kg/day if goal is weight gain	1 and 3 months after baseline
Upper arm circumference	Measured using a measuring tape to the nearest 0.1 cm	1 and 3 months after baseline
Hip circumference	Measured using a measuring tape to the nearest 0.1 cm	1 and 3 months after baseline
Waist circumference	Measured using a measuring tape to the nearest 0.1 cm	1 and 3 months after baseline
Number of exacerbations	Obtained from patient files supplemented with self-reported information	1 and 3 months after baseline
Oxygen therapy	Self-reported. The participant is asked if he/she is currently using home oxygen.	1 and 3 months after baseline
Anxiety and depression	Measured using Hospital Anxiety and Depression Scale. The scale contains two subscales to evaluate risk of anxiety and depression. Each subscale contains 7 items with a total score from 0-21. Risk of anxiety and depression are based on a total score ≥8.	1 and 3 months
Physical activity (subjective)	Measured using the physical activity and vial signs questionnaire	1 and 3 months after baseline
Physical activity (objective)	Measured using accelerometers (Activity AX3, Newcastle, United Kingdom)	7 days from 1- months follow-up and 7 days from 3 months follow-up

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Collaborators: Rigshospitalet, Denmark; University of Copenhagen
• Investigators: Principal Investigator: Birgitte Lindegaard, MD, PhD, Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital, 3400 Hillerød, Denmark

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): June 14, 2023

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Nutrition; Chronic obstructive pulmonary disease; Mental health; Health-related quality of life; Anthropometry; Functional capacity
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: MINDNUT NOH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No