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. 2021 Dec 21;2021(12):CD002008. doi: 10.1002/14651858.CD002008.pub5

Schilp 2013.

Study characteristics
Methods RCT.
Parallel design with 2 arms.
Duration: 6 months.
Location: the Netherlands.
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).
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.
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.
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.
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.