| Methods |
Method of randomisation: envelope prepared by statistician‐ allocation concealment: A
Assessor blinding: not reported
Intention to treat: for some outcomes
Lost to follow‐up: 42 withdrawn (unclear which arm)
Timing of intervention: 8 weeks from baseline visit within 7 days after discharge from hospital
Length of follow‐up: 6 months |
| Participants |
Location: North Staffordshire Hospital NHS trust, Hammersmith NHS Trust and Newcastle upon Tyne Hospital NHS Trust (4 Hospitals)
100 patients
Inclusion criteria: female elderly malnourished patients newly discharged from hospital, aged 65 years or older, BMI<20, or <25 with documented evidence of weight loss of at least 10% of body weight in the last 6 months prior to the study period or 5% of more in the last 3 months prior to the study period. Score of 7 or more on the abbreviated mental test.
Exclusion criteria: Incapable of taking supplements to provide a minimum of 600 kcal/day, not able to be weighed standing, intolerant of any of the ingredients in the study supplements, history of diabetes, hyperglycaemia or chronic renal failure, requiring Parenteral Nutrition or Enteral feeds as a sole source of nutrition or had been prescribed supplements during the last week of their hospital stay. Informed consent.
Sex: 55 female, 25 male |
| Interventions |
a: The choice of one or more nutritional supplements: Ensure Plus tetrapak, Enlive tetrapak, Formance pudding or Ensure Bar, Abbott Laboratories Ltd. Supplements 600‐1000 kcal aim to increase to ideal body weight 0.5kg/ week based on Schofield equations
b: Routine care
Allocated: 51/49
Assessed: 32/26 (weight) |
| Outcomes |
Main outcomes: mortality
Functional status ‐ Handgrip, health related quality of life, requirement for health and social care services, health care costs
Additional outcomes: Anthropometric indices ‐ weight change, %AMC change, dietary intake change |
| Notes |
Classified as malnourished, unwell, acute admission and in the community
Commercial trial |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
