None listed
Conditions
Brief summary
Chronic obstructive pulmonary disease (COPD) is a prevalent and serious condition predicted to become the third leading cause of death worldwide by 2030. Patients with COPD often suffer from weight loss and malnutrition, which is associated with poor prognosis. Nutrition interventions in COPD patients are often based on nutritional supplements, yet evidence to support the role of dietary counseling is lacking. Very few studies have investigated COPD related malnutrition or explored appropriate solutions to improve the nutrition status of Vietnamese COPD outpatients. In addition until recently, all of the published evidence for nutritional support in COPD has been in Western COPD population. Sugawara et al. have recently published but this is the first study in an Asian population and no intervention study to date have included Vietnamese patients. This research will explore the malnutrition prevalence among Vietnamese COPD patients at the National Lung Hospital and assess the impact of tailored nutrition counseling on: (1) Knowledge, attitudes, and behaviors of patients related to dietary intake; and thus (2) nutrition status, functional outcomes and quality of life among COPD outpatients who are at risk of malnutrition in Vietnam. To address the research aims, preliminary work was undertaken with a smaller sample of patients to collect dietary intake data to inform the development of nutrition counseling materials and to pre-test data collection forms. Following this preliminary work, recruitment for the RCT was undertaken. Malnourished patients were enrolled and randomly assigned to intervention and control groups. Patients in the intervention group were received one tailored nutrition counseling session per month for 3 months. The content of tailored counseling session was based on the eating habits, dietary intake of the patient, and other characteristics of socio-demography or disease status. Patients in the control group were received a nutrition handbook in addition to usual care at the COPD management clinic. The research is expected to provide the first scientific evidence regarding the role of a tailored nutrition counseling intervention among COPD malnutrition patients in Vietnam. It is hoped the research findings will significantly contribute to the future management of malnutrition in Vietnamese COPD patients. Therefore, it would support the development of appropriate ways to improve the nutrition status and thus the quality of life among COPD patients in Vietnam, and also in other resource-limited countries.
Interventions
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.
Sponsors
Study design
Eligibility
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
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