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Trial registered on ANZCTR


Registration number
ACTRN12618000625279
Ethics application status
Approved
Date submitted
27/03/2018
Date registered
20/04/2018
Date last updated
20/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of Individualized Dietary Counseling in Treating Malnutrition in Vietnamese Outpatients with Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
The effectiveness of Individualized Dietary Counseling in Treating Malnutrition in Vietnamese Outpatients with Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 294274 0
Nil known
Universal Trial Number (UTN)
U1111-1210-4756
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 306961 0
Malnutrition 306962 0
Condition category
Condition code
Diet and Nutrition 306058 306058 0 0
Other diet and nutrition disorders
Respiratory 306515 306515 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Among COPD patients visiting the CMU, those who were classified as malnourished and met the inclusion criteria would be invited to take part in the RCT study. A baseline assessment for all participants in the RCT was performed, including:
- Nutrition assessment (SGA)
- Quality of life (SGRQ)
- Anthropometry: BMI, mid-arm circumference (MAC), triceps skinfold (TSF),
- Muscle strength: handgrip strength (HGS), sniff nasal inspiratory pressure (SNIP)
- 24-hour recall dietary intake
After that, all these patients were randomly assigned to one of two groups. The intervention group received tailored nutrition counseling session once a month for 3 months by the principal researcher. The control group received a written nutrition handbook only one time after the baseline assessment without any explanation of the handbook’s content.The handbook used in this study was developed basing on results from a pilot survey that aimed to explore the characteristics of dietary intake of COPD outpatients in Vietnam. A team of nutritionist and dietitian experts from Vietnam and Australia had involved in the development of detail contents and all messages.

All the patients in the intervention group received tailored dietary advice basing on their weight, energy requirement and current dietary intake as well as their food preference. The dietary history interview contained questions regarding frequency of foods consumed, portion sizes, current usual meal pattern. Patients were also interviewed about their home environment, who prepared the food, who made the food purchasing, socio-economic status, and food-related problems. It was also noted whether the patient or a caregiver had noticed any changes in food intake during the last months. The answer to these questions made it possible to personalize the dietary advice given and also made those easier to follow for the patient. The results from the dietary history interview consisted the background for the individual dietary advice given to the patients in the intervention group. Nutrition recommendations for COPD were used as the background for estimation of energy requirements. One of the aims of the dietary advice was to give the patient an adequate intake of energy and protein, in order to give a maximal effect of reducing malnutrition. Forli (2005) suggested a patient with COPD would need an energy intake of 44kcal/kg to obtain a weight gain of 2kg that has been proved to improve the prognosis or clinical outcomes. Patients in the intervention group of this present study were recommended to eat breakfast, lunch, dinner and three snacks every day (morning tea, afternoon tea, and bed-time meal). Foods rich in protein and energy were suggested and information on fortifying their meals by natural and friendly means was also given. These patients were advised to increase their intake of meat, poultry, fish, eggs, dairy products and fat as of their preference in the consideration of its Availability, Accessibility and Affordability for the patients’ real life (“3A principle” for dietary advice).
All tailored nutritional counseling packet included:
- Information about malnutrition in COPD, its risk factors, and sequences;
- Education about diet and average energy requirement for COPD patient;
- Perceived susceptibility and intensity including the statistics on this subject, the cause of malnutrition consequences, applying of motivation methods, explaining the risk of disregarding the diet and energy intake. Emphasizing the controllable nature of malnutrition and introducing the method;
- Benefit and obstacles of nutritional diet, proposing methods to increase patient’s knowledge about nutritional diet;
- Information about the current nutrition status of the participant, methods to improve the malnutrition status by alternating the current diet. A dietary plan would be developed and discussed;
- Anticipate potential barriers and provide solutions to decrease perceived barriers;
- A tailored information regarding dietary protein and energy intake and a recipe model with specific diet tips to add in calories in the patient’s daily meals.

The tailored nutrition counseling intervention consisted of three 30 to 45-minute sessions, presented via leaflets and face to face counseling using the “question and answer” method. The “question and answer” method was used to encourage the participants to get involved in the process and to make sure that they were paying attention. All the key contents of the counseling session, as well as its update information in each patient visit, were noted in the patient’s medical registration book (So Y Ba) which the patients would keep and bring in with them in each visit at the CMU. A leaflet that suited to the patient nutrition condition providing all key messages to help to improve his/her dietary intake was delivered to the patient at the end of the counseling session. No other effort to enhance the effects of counseling such as phone call or email was applied in this study because the researcher respected the routine daily activity at the CMU and wanted to explore an effective and sustainable integration for this nutrition care activity in the real context.
The goal of tailored dietary advice was to prevent further weight loss, promote weight gain and reduce adverse clinical outcomes. Each individual dietary plan was developed based on the discussion between the dietitian and the patient to enhance its feasibility. All the potential barriers were discussed to find suitable solutions.
Previous studies have suggested the effectiveness of nutrition advice after three months of intervention and its sustainability for a long time after the intervention period among COPD patients. Therefore, in this present study, three months of nutrition counseling intervention were chosen to evaluate the role of tailored dietary advice in improving health-related outcomes among COPD Patient in Vietnam.
During three months of intervention, all patients in both groups presented at the CMU one time per month as per the clinic’s regulation and the appointment date with their treating doctors. At each visit time, patients in the intervention group continued receiving individual dietary advice and all patients in both group were measured relevant outcome variables as mentioned in the baseline assessment (except SGRQ). After three months, all the patients in both groups were repeated all the assessments as in the baseline (including SGRQ).

The dietary intake and all tailored nutrition counseling sessions were performed by the principal researcher who is a trained medical doctor with additional training in dietary methodologies. All other measurements were performed by the CMU's nurses who were trained prior to the study's commencement.
Intervention code [1] 300566 0
Treatment: Other
Comparator / control treatment
All participants in the control group were assessed at the baseline, and at week 4, 8 and 12 of the following up, including:
1. Checking the medical notes as well as taking the history of weight change, dietary intake and any gastrointestinal symptom followed by a physical examination which looks at the muscle and fat distribution.
2. The dietary intake was assessed by asking about all food and drink the subjects consumed during the 24 hour period (using the 24hr recall form) as well as their eating habits in the last 12 months (using the Food Frequency Questionnaire).
3. Muscle strength measurements: the handgrip strength (HGS) and the respiratory muscle strength (SNIP) were measured by a squeezing hard on a machine and sniffing into a machine.
4. The body weight, height, mid-arm circumference and arm skinfold were measured.

They had also received a written nutrition handbook only one time (after the baseline assessment) without any explanation of the handbook’s content. The handbook used in this study was developed basing on results from a pilot survey that aimed to explore the characteristics of dietary intake of COPD outpatients in Vietnam. A team of nutritionist and dietitian experts from Vietnam and Australia had involved in the development of detail contents and all messages.

The handbook covered following contents:
1. How breathing works and why healthy muscles are important
2. Why think about food when having COPD and what happens if underweight
3. How to increase the calories and protein in daily diets
4. Some nutrition concerns when having COPD and solutions

The dietary intake was assessed by the principal researcher who is a trained medical doctor with additional training in dietary methodologies. All other measurements were performed by the CMU's nurses who were trained prior to the study's commencement.
Control group
Active

Outcomes
Primary outcome [1] 305088 0
Energy intake (Kcal per day): measured by the 24hour dietary intake recall tool
Timepoint [1] 305088 0
Baseline [primary timepoint], and at 4, 8 and 12 weeks [primary timepoint] post commencement of intervention
Primary outcome [2] 305090 0
Protein intake (g per day): measured by the 24hour dietary intake recall tool
Timepoint [2] 305090 0
Baseline [primary timepoint], and at 4, 8 and 12 weeks [primary timepoint] post commencement of intervention
Secondary outcome [1] 344131 0
Body weight (Kg) was measured to the nearest 0.1kg in light clothing and barefoot using a digital weighing scale.
Timepoint [1] 344131 0
Baseline, and at 4, 8 and 12 weeks after the intervention commencement
Secondary outcome [2] 344132 0
Quality of life assessed using SGRQ-COPD questionnaire
Timepoint [2] 344132 0
Baseline and 12 weeks after the intervention commencement
Secondary outcome [3] 344133 0
Inspiratory muscle strength assessed by the sniff nasal inspiratory pressure (SNIP)
Timepoint [3] 344133 0
Baseline, and at 4, 8 and 12 weeks after the intervention commencement
Secondary outcome [4] 345622 0
Mid-arm circumference (MAC) was measured with a single standard measuring tape and arm was bare. All measures were taken on left arms.
Timepoint [4] 345622 0
Baseline, and at 4, 8 and 12 weeks post commencement of intervention
Secondary outcome [5] 345625 0
Triceps skinfold (TSF): a skinfold caliper was used to measure TSF.
Timepoint [5] 345625 0
Baseline, and at 4, 8 , and 12 weeks post commencement of intervention
Secondary outcome [6] 345626 0
Hand-grip strength (HGS) was measured by the same dynamometer for all participants
Timepoint [6] 345626 0
Baseline, and at 4, 8, and 12 weeks post commencement of intervention.

Eligibility
Key inclusion criteria
- 18 years or older
- Being diagnosed as COPD (FEV1 <80% predicted and FEV1/FVC <0.7)
- Agree to participate in this study
- In stable COPD condition (minimum 4 weeks since last exacerbation at the recruitment time)
- Being identified as malnourished by the Subjective Global Assessment tool
- Vietnamese-speaking and able to communicate verbally
- Being able to give informed consent
- Being ambulatory
- Being contactable (active phone number, email or home address)

An exacerbation is defined as a worsening of respiratory function that required non-scheduled or emergency visits to a physician or hospital for additional treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Exacerbation in the last 4 weeks at the time of recruitment
- Patients with a history of surgery or trauma within 3 months of the study
- Patients with a history of a myocardial infarction within 3 months of the study
- Patients with concomitant disease that might alter nutritional status: cirrhosis, uncontrolled diabetes, chronic renal, thyroid disease, malabsorption syndrome, hepatic failure, renal failure, or heart failure
- Malignancy
- Pregnancy
- Being involved in drug trials, weight reducing programs or dieting
- Non-ambulatory
- Cognitive impairment

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To investigate whether tailored nutrition counseling could help to improve dietary intake, nutrition status and quality of life among COPD malnutrition outpatients, the target sample in this present study would be 60 patients in each group (including 30% drop out rate).

All participants who have been randomized and entered the intervention need to be included in the analysis in the condition to which they have been assigned, regardless of whether they complete the trial or not. This is known as the intent to treat analysis principle.

Prior to any analysis steps, data will be cleaned, checked for errors or missing values. Continuous data will be checked for normality of distribution and non-normally distributed data will be transformed where possible.

Descriptive analysis will be undertaken to give summary descriptions for core variables and other measure variables, which are calculated in term of percentage, mean, standard deviation (SD), median, range, 95% confident interval (95% CI), frequency and percentage.

For continuous variables, data will be presented as mean (SD) when normally distributed and median range when distributed as skewed. Frequency and percentage will be used for categorical variables.

An independent samples t-test is conducted to explore the relationship between each continuous outcome variable and the dichotomous independent variables. A one-way ANOVA test is applied to explore the relationship between each continuous outcome variable and the categorical independent variables except dichotomous independent variables.

A chi-square test is used to explore the relationship between each categorical outcome variable and the categorical independent variables. Bivariate correlations were conducted for continuous independent variables correlating with dependent variables, either continuous or categorical. A Pearson correlation is used when both independent and dependent variables are normally distributed and continuous data.

After bivariate analysis, a general linear model for continuous dependent variables and binary logistic regression for dichotomous dependent variables is conducted to control the covariates of each outcome variable. Scatter plots will be used to determine the shape of relationship before applying linear regression. Comorbid status and severity of exacerbations will be assessed as potential confounders using multiple regression analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/05/2017
Date of last participant enrolment
Anticipated
Actual
3/07/2017
Date of last data collection
Anticipated
Actual
20/10/2017
Sample size
Target
120
Accrual to date
Final
123
Recruitment outside Australia
Country [1] 9664 0
Viet Nam
State/province [1] 9664 0
Hanoi

Funding & Sponsors
Funding source category [1] 298911 0
Government body
Name [1] 298911 0
Department of Foreign Affairs and Trade, Australian Embassy, Vietnam
Country [1] 298911 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
149 Victoria Park Rd, Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 298125 0
None
Name [1] 298125 0
Address [1] 298125 0
Country [1] 298125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299853 0
University Human Research Ethics Committee, NHMRC Registered Committee Number EC00171
Ethics committee address [1] 299853 0
Ethics committee country [1] 299853 0
Australia
Date submitted for ethics approval [1] 299853 0
29/09/2016
Approval date [1] 299853 0
30/11/2016
Ethics approval number [1] 299853 0
1600000959

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2490 2490 0 0
/AnzctrAttachments/374680-QUT ETHICS APPROVAL CERT 1600000959.pdf (Ethics approval)

Contacts
Principal investigator
Name 81778 0
Prof Danielle Gallegos
Address 81778 0
School of Exercise and Nutrition Science, Faculty of Health, Queensland University of Technology, 149 Victoria Park Rd, Kelvin Grove QLD 4059
Country 81778 0
Australia
Phone 81778 0
+61 7 3138 5799
Fax 81778 0
+61 7 3138 3980
Email 81778 0
danielle.gallegos@qut.edu.au
Contact person for public queries
Name 81779 0
Danielle Gallegos
Address 81779 0
School of Exercise and Nutrition Science, Faculty of Health, Queensland University of Technology, 149 Victoria Park Rd, Kelvin Grove QLD 4059
Country 81779 0
Australia
Phone 81779 0
+61 7 3138 5799
Fax 81779 0
+61 7 3138 3980
Email 81779 0
danielle.gallegos@qut.edu.au
Contact person for scientific queries
Name 81780 0
Ha Thanh Nguyen
Address 81780 0
Room A110, O block-A wing, School of Exercise and Nutrition Science, Faculty of Health, Queensland University of Technology, 149 Victoria Park Rd, Kelvin Grove QLD 4059
Country 81780 0
Australia
Phone 81780 0
+61 7 3138 9199
Fax 81780 0
Email 81780 0
thanhha.nguyen@hdr.qut.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseNutritional status, dietary intake, and health-related quality of life in outpatients with COPD.2019https://dx.doi.org/10.2147/COPD.S181322
N.B. These documents automatically identified may not have been verified by the study sponsor.