RADAR Rheumatoid Arthritis Exclusion Diet

RADAR Rheumatoid Arthritis Exclusion Diet
An Online Randomised Controlled Trial
Amanda Burls1, Amy Price2, Paresh Jobanputra3, Jose Emparanza4
City University, 2University of Oxford, 3University of Birmingham,
4University Hospital Donostia · Clinical Epidemiology and Research
1
Background
Available reviews of gluten free
diets report low quality evidence
and small studies. Benefits may
come from lower calories or be
complicated by the relapsing/
remitting nature of the disease.
People with rheumatiod arthritis
(RA) are keenly interested in lifestyle and dietary changes which
may improve their disease. A
large randomized controlled trial
with sound methodology and
public involvement is the best way
to answer the question"Does a
gluten-free (GF) diet reduce RA
symptoms".
4. GF and CR combination to test
for interaction
Conditions other than dietary are
the same for all groups.
Outcome Measures
● Online BMI Calculator
● Printable electronic forms
to record food intake and
symptoms, RAPID3
● Personal weight scale
● PROMIS®
Aims & Objectives
To answer the question: Does
eating a GF diet improve the
symptoms of RA? The objective
of this research is to run a selfrecruited randomized online
patient preference comprehensive
cohort trial in English and Spanish
to investigate whether a GF diet
improves the symptoms of active
(RA) compared to water or a
restricted calorie (RC) diet.
Population
Adults: normal, overweight and
obese with RA.
Interventions
Collaborate ThinkWell
Http://ithinkwell.org
[email protected]
Trial Design
Option-1 RADAR is a pragmatic
six-month online RCT factorial
design to find if there are benefits
of a GF diet for those with active
rheumatoid arthritis.
Participant arms will alter their diet
as assigned by the computer for
180 days. Prior to this a 14 day
feasibility trial will be completed. A
convenience sample will confirm
symptoms with their physicians.
1. GF participants consume only
gluten-free products calories
are unrestricted.
2. RC diet calculated as to
caloric needs at present weight
and activity levels minus 500
calories per day.
3. The control group will drink 8
glasses of water.
Option-2 If GF efficacy is oversold
in the media we will engage
a modified Wennberg design
(PLOT-M) and learn to what
extent randomization rather than
choice influences bias.
Participants are randomized to
preference or randomization.
Preference participants choose
their treatment. Control
participants are assigned
treatment based on
randomization. All groups are
analyzed to assess the impact of
patient preference on outcomes.
Participants are followed-up
in the same way whether they
accept or reject randomization.
A and B will be estimated in
those accepting randomization
followed by separate estimates
of A and B in the preference
group. Analysis will be based on
these subgroups and all effect
sizes will be recorded. PLOT-M
enables parallel tracks of a trial to
run concurrently, one as patient
preference and the other as an
RCT.
Study Analysis
Quantitative methods will be web
based, plus we use qualitative and
embedded methods, particpants
will contribute to qualitative
analysis. Embedded research
will be a collaborative project with
Zooniverse and Oxford Internet
Institute.
References
Hagen KB, Byfuglien MG, Falzon L, Olsen SU,
Smedslund G (2009) Dietary interventions for
rheumatoid arthritis. Cochrane Database Syst
Rev 21: CD006400 (2009).
Rheumatoid arthritis; National clinical guideline
for management and treatment in adults.
Doi:ISBN 978-1-86016-359-3 (2009)