None listed
Conditions
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
Interventions
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 progr
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.
Sponsors
Metro South Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 84 Years
Healthy volunteers
No
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
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
Outcome results
None listed