Research with human participants

Overview of medical research in the Netherlands

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

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON26104

Source

Nationaal Trial Register

Brief title

PROTO (PReventie Ondervoeding Thuiswonende Ouderen)

Health condition

Eng:
undernutrition, community-dwelling, determinants, body-weight, MUAC, SPPB

NL:
Ondervoeding, thuiswonende ouderen, determinanten, lichaanmgewicht, bovenarmomtrek, SPPB

Sponsors and support

Primary sponsor :
VU University, Amsterdam
Source(s) of monetary or material Support :
ZonMw, 200320004

Intervention

Outcome measures

Primary outcome

body weight (Kg)

physical functioning (SPPB)

ADL (Barthel Index)

Secondary outcome

Gait speed (SPPB)

Mid-upper arm circumference (Cm)

Hand grip strength

Quality of life (SF12)

Utility (EQ-5D)

Background summary

This 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.

Study objective

By tackling the underlying determinants, we might slow down of prevent undernutrition in community dwelling older adults.

Study design

Measurments will take place at baseline, after 3 months and after 6 months follow-up

Intervention

Step by step action plan to act on the underlying determinants of undernutrition

Public
M. Visser
VUMC
De Boelelaan 1085
Amsterdam 1081 HV
The Netherlands
+31 (0)20 598 9282
marjolein.visser@falw.vu.nl
Scientific
M. Visser
VUMC
De Boelelaan 1085
Amsterdam 1081 HV
The Netherlands
+31 (0)20 598 9282
marjolein.visser@falw.vu.nl

Inclusion criteria

High risk undernutrition/undernourished

65 years or older

community dwelling

Exclusion criteria

MMSE <18

terminal patients (prognosis <6 months)

not able to stand on weighing scale

not able to understand Dutch language

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
180
Type :
Actual

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL5045
NTR-old NTR5184
Other VU project nr./ ZonMw 200320004 : wc2010-023;

Summary results

van 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.