Locher 2013.
Study characteristics | ||
Methods | RCT (stratified by gender and BMI). Duration: 60 days. Location: USA. |
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Participants |
Inclusion: older adults receiving Medicare home health services, > 65 years, homebound, able to communicate, living in a private residence, experiencing either an acute or chronic illness, undereating. Exclusion: cognitive impairment (< 8/10 Short Portable MSQ), terminal illness, cancer diagnosis within past 5 years, end‐stage renal disease, tube feed, dependence on ventilator. Diagnosis: acute or chronic illness. Number randomised: 40 participants, but 34 included in analyses (intervention group n = 18, control group n = 16). Attrition: 6/40 but reasons not described. Gender split: 6/34 (18%) male, 28/34 (82%) female. Age: mean (SD) years 81.4 (8.2). Nutritional status: 15.2% BMI < 18.5. |
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Interventions |
Intervention: participants received dietary advice in the form of B‐NICE (behavioural nutrition intervention), self management education approaches to guide participants and carers to improve caloric intake. Control: participants received no dietary advice in the form of standard care. |
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Outcomes | Body weight, caloric intake. | |
Publication details |
Language: English. Funding: National Institutes of Health/National Institute on Aging. Publication status: peer‐reviewed journal. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "randomly assigned…using stratified blocked randomisation". Judgement, insufficient information on method of randomisation. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) Clinical outcomes | Unclear risk | No clinical outcomes assessed. |
Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | No functional outcomes assessed. |
Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | Quote: "research interviewers collecting outcomes data were blinded to group assignment". Absence of performance blinding might have influenced assessment of nutritional intake. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "This was a social behavioural intervention therefore not possible to blind participants or study personnel to group assignment." Not blinded and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Knowledge of group allocation might have influenced collection of food intake data, therefore some outcome assessment might have been influenced by absence of performance bias. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "40 participants randomised and 34 included in the analyses". Group allocation and reasons for attrition not described therefore insufficient information to make a judgement. |
Selective reporting (reporting bias) | Unclear risk | Published protocol identified. Planned outcomes, energy intake and weight at 60 days and 6 months, and fidelity outcomes. Only data at 60 days reported and fidelity outcomes not reported. Outcome data are reported without SDs, therefore data requested from authors. |
Other bias | Unclear risk | Baseline characteristics not presented but in the text "the randomisation schedule was successful in balancing for both gender and BMI". Judged as unclear because insufficient information on all characteristics likely to influence differences in outcomes. |