Multidimensional Individualized Nutritional Therapy for Individuals with Severe COPD

NCT04873856 | Completed

• 1 other identifier: MINDNUT NOH
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Health-related quality of life; Nutrition; Mental health; Functional capacity; Anthropometry

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life

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

  1 and 3 months after baseline

Secondary Outcomes (12)

• Weight

  1 and 3 months after baseline

• Body mass index

  1 and 3 months after baseline

• Hand grip strength

  1 and 3 months after baseline

• Lower body strength

  1 and 3 months after baseline

• Number of unplanned acute hospitalizations

  1 and 3 months after baseline

Other Outcomes (12)

• Total protein intake

  1 and 3 months after baseline

• Difference in protein requirement and protein intake

  1 and 3 months after baseline

• Total energy intake

  1 and 3 months after baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention contains: 1. individual nutritional plan 2. regular contact 3. friendly reminder/informal caregiver and 4. weight dairy.

Dietary Supplement: Intervention

Control Group

NO INTERVENTION

Standard of care

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Rigshospitalet, Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (1)

• Hegelund MH, Ritz C, Nielsen TL, Olsen MF, Soborg C, Braagaard L, Molgaard C, Krogh-Madsen R, Lindegaard B, Faurholt-Jepsen D. Multidimensional individualized nutritional therapy for individuals with severe chronic obstructive pulmonary disease: study protocol for a registry-based randomized controlled trial. Trials. 2023 Feb 6;24(1):86. doi: 10.1186/s13063-023-07099-1.

  PMID: 36747276 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Psychological Well-Being

Interventions

Methods

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Birgitte Lindegaard, MD, PhD

  Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital, 3400 Hillerød, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 5, 2021
• Study Start: May 21, 2021
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: November 18, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)