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PROTO-study: Prevention of undernutrition in community dwelling older adults


- candidate number22179
- NTR NumberNTR5184
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-mei-2015
- Secondary IDswc2010-023;  VU project nr./ ZonMw 200320004
- Public TitlePROTO-study: Prevention of undernutrition in community dwelling older adults
- Scientific TitleHigh risk for undernutrition, now what? Development and evaluation of an intervention for the prevention of undernutrition in high-risk older persons receiving home care
- ACRONYMPROTO (PReventie Ondervoeding Thuiswonende Ouderen)
- hypothesisBy tackling the underlying determinants, we might slow down of prevent undernutrition in community dwelling older adults.
- Healt Condition(s) or Problem(s) studiedMalnutrition, Community-dwelling, Body-weight, SPPB
- Inclusion criteriaHigh risk undernutrition/undernourished
65 years or older
community dwelling
- Exclusion criteriaMMSE <18
terminal patients (prognosis <6 months)
not able to stand on weighing scale
not able to understand Dutch language
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2013
- planned closingdate31-aug-2015
- Target number of participants180
- InterventionsStep by step action plan to act on the underlying determinants of undernutrition
- Primary outcomebody weight (Kg)
physical functioning (SPPB)
ADL (Barthel Index)
- Secondary outcomeGait speed (SPPB)
Mid-upper arm circumference (Cm)
Hand grip strength
Quality of life (SF12)
Utility (EQ-5D)
- TimepointsMeasurments will take place at baseline, after 3 months and after 6 months follow-up
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES M. Visser
- CONTACT for SCIENTIFIC QUERIES M. Visser
- Sponsor/Initiator Vrije Universiteit Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publicationsvan der Pols-Vijlbrief R, Wijnhoven HA, Schaap LA, Terwee CB, Visser M. Determinants of protein-energy malnutrition in community-dwelling older adults: A systematic review of observational studies. Ageing research reviews. 2014;18C:112-31.
- Brief summaryThis intervention consists of a step-by-step action plan to identify and tackle the underlying determinants of undernutrition. The aim of this intervention trial is to prevent or slow down undernutrition as determined by the health care worker using the SNAQ65+ in community dwelling older adults. the second goal is to determine the cost-effectiveness of this intervention with changes in body weight as primary endpoint.
- Main changes (audit trail)
- RECORD7-mei-2015 - 2-jul-2015


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