Schilp 2013.
Study characteristics | ||
Methods | RCT. Parallel design with 2 arms. Duration: 6 months. Location: the Netherlands. |
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Participants |
Inclusion criteria: adults aged > 65 years, home‐dwelling, non‐institutionalized, undernourished (SNAQ65+). Exclusion criteria: MMSE < 18, unable to stand on the weighing scale. Number randomised: 146 participants (intervention group,n = 72; control group, n = 74). Attrition: 127 participants completed the 6 months examination: intervention group, n = 62 (86 %); control group, n = 65 (88 %). The reasons for dropout were withdrawal (intervention group n = 5; control group n = 6), death (intervention group n = 3; control group n = 0) and health problems (intervention group n = 2; control group n = 3). Gender split: 52 males, 94 females. Age: mean (SD), intervention 80.6 (7.5) years; control 80.5 (7.5) years. Nutritional status: n (%) meeting SNAQ criteria for undernutrition, intervention weight loss ≥ 4 kg/6 months 23(32), MUAC < 25 cm 35 (49), both 14 (19); control weight loss ≥ 4 kg/6 months 26 (35), MUAC < 25 cm 37 (50), both 11 (15). |
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Interventions |
Intervention: participants received dietary advice plus ONS if required in the form of dietary counselling from a team of 18 qualified trained dietitians, aiming to achieve adequate protein and energy intake, preferably by regular foods and beverages. Control: participants received no dietary advice and no ONS in the form of usual care, no referral to a dietitian but provided with a standard brochure of the Netherlands Nutrition Centre with general information about healthy eating habits. |
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Outcomes | Body weight*, physical performance, handgrip strength*, energy intake*, protein intake*, fat‐free mass* as costs* were assessed at baseline, after 3 months and 6 months and QoL* after 6 months. | |
Publication details |
Language: English. Funding: the Ministry of Health, Welfare and Sports of the Netherlands. Publication status: peer‐reviewed journal. |
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Notes | To avoid bias of potential prescription of vitamin D as part of the dietetic treatment, all participants were prescribed a combined calcium (1000 mg calcium carbonate) plus vitamin D (800 IU cholecalciferol) supplement by their general practitioner if this was not already used. Analyses were derived from GEE; mean changes were re‐calculated from the data set by one of researchers of the group. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: Block randomisation by the primary investigator within 1 day of baseline examination using the website www.randomization.com. Participants recruited at an outpatient clinic department were randomised with a separate scheme, because they were expected to be more severely undernourished. |
Allocation concealment (selection bias) | Low risk | Random allocation to either the intervention group or the control group was individually performed in blocks of 4 and 6 by using the website www.randomization.com |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | The study was unblinded. However, this is unlikely to influence clinical outcomes. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | Quote: Participants, researcher and research assistants were no longer blinded for the intervention assignment from this point [=after randomization]. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | Quote: Participants, researcher and research assistants were no longer blinded for the intervention assignment from this point [=after randomisation]. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | 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 | Judged to be unclear, as low risk for clinical outcomes and high risk for functional and nutritional outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | After 3 months 8 participants in the intervention group and 9 participants in the control group were lost to follow‐up (withdrawn, health problems or death), after months another 2 participants in the intervention group (withdrawn, health problems) and 0 participants in the control group were lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | Protocol identified Dutch Trial Register NTR 1808, all planned outcomes with the exception of the secondary outcomes MUAC and supplementation with calcium and vitamin D were reported. |
Other bias | Low risk | Baseline characteristics were similar between groups and there were no statistically significant differences in baseline characteristics between participants who discontinued early and study completers. |