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Trial registered on ANZCTR


Registration number
ACTRN12619001586101
Ethics application status
Approved
Date submitted
22/08/2019
Date registered
18/11/2019
Date last updated
18/11/2019
Date data sharing statement initially provided
18/11/2019
Date results information initially provided
18/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
To compare the effectiveness of usual care versus best practice nutritional support in treating malnutrition in Chronic Obstructive Pulmonary Disease (COPD).
Scientific title
The effectiveness of best practice nutrition and dietetic care on clinical and patient-centered outcomes in outpatients with chronic obstructive pulmonary disease (COPD).
Secondary ID [1] 296394 0
None
Universal Trial Number (UTN)
U1111-1230-6089
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 310158 0
Malnutrition 314529 0
Condition category
Condition code
Respiratory 308908 308908 0 0
Chronic obstructive pulmonary disease
Diet and Nutrition 312876 312876 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietetic intervention was provided to malnourished COPD patients who were divided into two groups – the control group (Group A) and the intervention group (Group B).

In Group B, participants received the routine dietetic intervention as described below with one difference:
- Instead of being recommended to buy the Sustagen Hospital formula they were given 6x840g tins after the initial and the 6 week interventions. Flavours offered were chocolate, vanilla and neutral.
- Adherence to the programme was measured by measuring the amount of Sustagen left after 6 weeks. It was calculated that one tin of Sustagen would last one week. Six tins were given to patients and those who attended clinic appointments were asked how many tins they had left. Participants visited at home who had Sustagen left over after 6 weeks were given sufficient to last the next 6 weeks.


Intervention code [1] 312739 0
Treatment: Other
Comparator / control treatment
- Dietetic intervention was provided to malnourished COPD patients who were divided into two groups – the control group (Group A) and the intervention group (Group B). Participants in Group A received the routine dietetic intervention as stated below. Participants in Group B received the same intervention with one exception, they were given a free 12 week supply of Sustagen Hospital Formula (Sustagen HF).
- Patients were seen by the same chronic disease dietitian (>10 years’ experience) four times: the initial appointment then at 6, 12 and 26 weeks. Each appointment lasted 1 hour.
- The appointments took place face-to-face in clinic at the community health centre or at the patient’s home if housebound.
- At the initial appointment height was measured using a stadiometer and at every appointment the patient was weighed using the same digital scale.
- Participants received individualised counselling on diet modification to a high protein, high energy diet. Diet resources for high protein, high energy diet used were obtained from the Nutrition Education Materials Online (NEMO) website (https://www.health.qld.gov.au/nutrition/patients) which consists of resources which are evidence-based and reviewed on a regular basis.
- They were recommended to purchase Sustagen HF and consume two drinks daily. The recommendation was to mix the Sustagen HF powder with full cream milk however this depended on individual taste preference with some preferring to mix the powder in water.
- Adherence to the high protein, high energy recommendations was through a 24 hour diet recall which was reviewed at every appointment. It included assessment of adherence to Sustagen HF.
- Standard dietetic intervention followed the Nutrition Care Process (ADIME format: nutrition assessment, diagnosis, intervention, monitoring and evaluation).
- The protein and energy requirements were calculated to promote weight gain and preserve muscle mass/ promote muscle gain as follows:
Energy: 30-35kCal/kg (125-145kJ/kg)
Protein: 1.2-1.5g/kg
The above recommendation is evidence based and follows NEMO recommendations (https://www.health.qld.gov.au/nutrition/clinicians# - under “Nutrition Support”).

Control group
Active

Outcomes
Primary outcome [1] 307878 0
Nutritional status analysed by assessing energy intake using 24 hour recall.
Timepoint [1] 307878 0
Baseline, 6, 12 weeks (primary end-point) post enrolment.
Primary outcome [2] 321485 0
Weight status by using digital scale.
Timepoint [2] 321485 0
Baseline, 6, 12 weeks (primary end-point) post enrolment.
Primary outcome [3] 321805 0
Nutritional status analysed by assessing protein intake using 24 hour recall.
Timepoint [3] 321805 0
Baseline, 6, 12 weeks (primary end-point) post enrolment.
Secondary outcome [1] 370415 0
Quality of life assessed by the St Georges Respiratory Questionnaire.
Timepoint [1] 370415 0
Baseline, 6, 12 weeks post-intervention commencement.
Secondary outcome [2] 375088 0
Body Mass Index (BMI) for assessment of malnutrition status
This was assessed by using a Seca digital scale and height stadiometer.
Timepoint [2] 375088 0
Baseline, 6, 12 weeks post-intervention commencement.
Secondary outcome [3] 376969 0
Hand grip strength for assessment of muscle mass.
This was assessed by using a dynamometer.
Timepoint [3] 376969 0
Baseline, 6 and 12 weeks.

Eligibility
Key inclusion criteria
• Confirmed diagnosis of COPD: forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than the lower limit of normal with a smoking history of 10 pack years or more.
• Currently stable i.e. not receiving antibiotic or steroid treatment for an infective
• exacerbation of COPD within the last 4 weeks
• At nutritional risk: Malnutrition Screening Tool score greater than or equal to 2.
• Competent to provide written informed consent and able to answer questions
• Able to achieve nutritional requirements orally
Minimum age
18 Years
Maximum age
84 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Requirement for tube feeding or parenteral nutrition
• Currently receiving, or within the last 4 weeks, oral nutritional supplements
• Palliative care
• Conditions that could result in weight loss (chronic renal disease requiring dialysis,
liver failure, known malignancy)
• Currently participating in another research trial
• Already under the care of a dietitian

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were allocated according to central randomisation by computer
Allocation was concealed until the time of the appointment. The dietitian was required to know how the participant was allocated immediately prior to the appointment in order to know if they were to be given free Sustagen HF or recommended to buy it.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The target sample size was 100 in each treatment arm in order to achieve the statistical power to detect differences in the primary (protein and energy intake, weight) and secondary (quality of life) outcomes. In malnourished outpatients with COPD minimum important clinical differences/changes in weight (+2.0kg) and quality of life (St George's Respiratory Questionnaire -4.0 score) were used from the published literature. Power calculations were done using SamplePower 2 aiming for 80% power determined by SPSS version 23.0 (SPSS Inc, Chicago, Illinois, USA) and statistical significance set at p < 0.05. Due to recruitment difficulties power calculations were also conducted for 40 versus 40 outpatients, a difference in SGRQ total score of 3.79 SD 6 (4 represents minimally important clinical difference) between the two groups was required to achieve 80% power.
Statistical analysis: all outpatients who completed the intervention were included in the final analysis. Tests included one-way analysis of variance (ANOVA) comparing differences between the two groups, paired-sample t-tests to compare within group changes and regression analysis exploring the independent effect of nutritional treatment, adjustment for known confounders.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/04/2015
Date of last participant enrolment
Anticipated
Actual
28/12/2016
Date of last data collection
Anticipated
Actual
8/06/2017
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12252 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [2] 12253 0
Logan Hospital - Meadowbrook
Recruitment hospital [3] 12254 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 24438 0
4108 - Coopers Plains
Recruitment postcode(s) [2] 24439 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 24440 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 24461 0
4113 - Eight Mile Plains
Recruitment postcode(s) [5] 24462 0
4077 - Inala

Funding & Sponsors
Funding source category [1] 301002 0
Hospital
Name [1] 301002 0
Metro South Health
Country [1] 301002 0
Australia
Primary sponsor type
Hospital
Name
Metro South Health
Address
199 Ipswich Rd
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 300588 0
Hospital
Name [1] 300588 0
Brisbane South Chronic Disease
Address [1] 300588 0
51 McKechnie Drive
Eight Mile Plains QLD 4113
Country [1] 300588 0
Australia
Other collaborator category [1] 280408 0
University
Name [1] 280408 0
Queensland University of Technology
Address [1] 280408 0
2 George St
Brisbane City QLD 4000
Country [1] 280408 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301758 0
Metro South Hospital and Health Service Human Research Ethics Office
Ethics committee address [1] 301758 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland,
Australia, 4102
Ethics committee country [1] 301758 0
Australia
Date submitted for ethics approval [1] 301758 0
03/02/2014
Approval date [1] 301758 0
12/09/2014
Ethics approval number [1] 301758 0
HREC/14/QPAH/274

Summary
Brief summary
To implement and evaluate the effectiveness of nutrition and dietetic intervention in improving clinical and patient-centred outcomes in COPD outpatients at nutritional risk.
Hypothesis: Dietary modification and oral nutritional support (ONS) is clinically more effective than dietary modification alone in the management of malnutrition in COPD.
Study Design: Parallel randomised control trial.
Intervention: The intervention involved 4 individual appointments with a dietitian ranging from 30-60minutes in length at initial, 6 and 12 weeks with a follow up at 26 weeks. Over the intervention phase the participants were given individualised dietary advice to improve energy and protein intake using either food modification and fortification (control group) or oral nutritional supplements (intervention group).

Outcome measures
• Dietary intake will be collected using 24 hour food recall to assess changes in energy
and protein intake.
• The St George’s Respiratory Questionnaire will provide an assessment of respiratory
health status and quality of life.
• Body Mass Index (BMI) for assessment of malnutrition status
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88002 0
Dr Peter Collins
Address 88002 0
School of Human Movement and Nutrition Sciences
Level 2, Connell Building
26 Blair Drive
The University of Queensland
Brisbane Qld 4072 Australia
Country 88002 0
Australia
Phone 88002 0
+61 7 3138 3360
Fax 88002 0
Email 88002 0
[email protected]
Contact person for public queries
Name 88003 0
Dr Peter Collins
Address 88003 0
School of Human Movement and Nutrition Sciences
Level 2, Connell Building
26 Blair Drive
The University of Queensland
Brisbane Qld 4072 Australia
Country 88003 0
Australia
Phone 88003 0
+61 7 3138 3360
Fax 88003 0
Email 88003 0
[email protected]
Contact person for scientific queries
Name 88004 0
Dr Peter Collins
Address 88004 0
School of Human Movement and Nutrition Sciences
Level 2, Connell Building
26 Blair Drive
The University of Queensland
Brisbane Qld 4072 Australia
Country 88004 0
Australia
Phone 88004 0
+61 7 3138 3360
Fax 88004 0
Email 88004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical clearance was not obtained for this.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.