Multidimensional Individualized Nutritional Therapy for Individuals with Severe COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2023-06-14

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

Intervention contains:

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

Group Type EXPERIMENTAL

Intervention

Intervention Type 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.

Control Group

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No