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Completed

NCT Number: NCT04873856

Multidimensional Individualized Nutritional Therapy for Individuals with Severe COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intervention

Dietary Supplement

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.

Primary outcomes

  1. Health-related quality of life

    Time frame: 1 and 3 months after baseline

    Will be measured using the EQ-5D-5L

Secondary outcomes

  1. Weight

    Time frame: 1 and 3 months after baseline

    Measured using an electronic scale (TANITA DC 430 SMA, TANITA, Denmark) to the nearest 0.1 kg

  2. Body mass index

    Time frame: 1 and 3 months after baseline

    Calculated as weight (kg)/height (m2)

  3. Hand grip strength

    Time frame: 1 and 3 months after baseline

    Measured using handdynanometer

  4. Lower body strength

    Time frame: 1 and 3 months after baseline

    Measured using 30 second stand chair test

  5. Number of unplanned acute hospitalizations

    Time frame: 1 and 3 months after baseline

    Obtained from patient files

  6. Number of days in hospital

    Time frame: 1 and 3 months after baseline

    Obtained from patient files

  7. Number of acute unplanned visits to emergency ward (<6 hours)

    Time frame: 1 and 3 months after baseline

    Obtained from patient files

  8. Number of contacts to outpatient clinic (visits and phone calls)

    Time frame: up to 3 months after baseline

    Obtained from patient files

  9. Disease specific quality of life

    Time frame: 1 and 3 months after baseline

    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.

  10. Mortality

    Time frame: up to 3 months after baseline

    will be obtained from patient files

  11. Fat-free mass

    Time frame: 1 and 3 months after baseline

    Measured using bioelectrical impedance analysis

  12. Fat mass

    Time frame: 1 and 3 months after baseline

    Measured using bioelectrical impedance analysis

Other outcomes

  1. Total protein intake

    Time frame: 1 and 3 months after baseline

    Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams

  2. Difference in protein requirement and protein intake

    Time frame: 1 and 3 months after baseline

    Intake measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams adnd requirements is calculated as 1.5 g/kg/day.

  3. Total energy intake

    Time frame: 1 and 3 months after baseline

    Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in kalories.

  4. Difference in energy requirement and energy intake

    Time frame: 1 and 3 months after baseline

    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

  5. Upper arm circumference

    Time frame: 1 and 3 months after baseline

    Measured using a measuring tape to the nearest 0.1 cm

  6. Hip circumference

    Time frame: 1 and 3 months after baseline

    Measured using a measuring tape to the nearest 0.1 cm

  7. Waist circumference

    Time frame: 1 and 3 months after baseline

    Measured using a measuring tape to the nearest 0.1 cm

  8. Number of exacerbations

    Time frame: 1 and 3 months after baseline

    Obtained from patient files supplemented with self-reported information

  9. Oxygen therapy

    Time frame: 1 and 3 months after baseline

    Self-reported. The participant is asked if he/she is currently using home oxygen.

  10. Anxiety and depression

    Time frame: 1 and 3 months

    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.

  11. Physical activity (subjective)

    Time frame: 1 and 3 months after baseline

    Measured using the physical activity and vial signs questionnaire

  12. Physical activity (objective)

    Time frame: 7 days from 1- months follow-up and 7 days from 3 months follow-up

    Measured using accelerometers (Activity AX3, Newcastle, United Kingdom)

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Collaborators

  • Rigshospitalet, Denmark
  • University of Copenhagen

Registry information

Official study title

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

Acronym: MINDNUT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 5, 2021
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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