NHS Low Calorie Diet Pilot Programme Guidance & Aims
NH
S
E
ng
l
a
n
d
a
n
d
NH
S
I
m
p
r
o
v
e
m
e
n
t
N
H
S
L
o
w
C
a
l
o
r
i
e
D
i
e
t
P
i
l
o
t
P
r
o
g
r
a
m
m
e
G
u
i
d
a
n
c
e
f
o
r
G
P
p
r
a
c
t
i
c
e
s
a
n
d
r
e
f
e
r
r
e
r
s
|
24
t
h
J
u
l
y
2020
•
T
h
e
D
i
R
E
C
T
t
r
i
a
l
(
2017
)
t
e
s
t
e
d
a
l
ow
c
a
l
o
r
i
e
d
i
e
t
(
L
CD
)
,
t
o
t
a
l
d
i
e
t
r
ep
l
a
c
e
m
e
n
t
(
T
D
R
)
app
r
oa
ch
i
n
peop
l
e
w
i
t
h
T
y
p
e
2
D
i
abe
t
e
s
w
i
t
h
i
n
6
y
ea
r
s
o
f
d
i
ag
n
o
s
i
s
t
o
a
c
h
i
e
v
e
w
e
i
g
h
t
l
o
ss
a
n
d
r
e
m
i
ss
i
o
n
o
f
d
i
abe
t
e
s
•
O
n
t
h
e
f
i
r
st
da
y
o
f
s
t
a
r
t
i
n
g
T
D
R
,
a
l
l
g
l
u
c
o
se
-
l
o
w
e
r
i
n
g
age
n
t
s
a
n
d
B
P
-
l
o
w
e
r
i
n
g
age
n
t
s
w
e
r
e
s
t
oppe
d
•
A
t
1
y
ea
r
,
46
%
o
f
peop
l
e
i
n
t
h
e
i
n
t
e
r
v
e
n
t
i
o
n
g
r
o
u
p
a
c
h
i
e
v
e
d
r
e
m
i
ss
i
o
n
(
a
s
de
f
i
n
e
d
i
n
t
h
e
t
r
i
a
l
)
,
c
o
m
pa
r
e
d
t
o
4
%
i
n
t
h
e
c
o
n
t
r
o
l
g
r
o
u
p
•
W
e
i
g
h
t
l
o
ss
w
a
s
s
t
r
o
n
g
l
y
a
ss
o
c
i
a
t
e
d
w
i
t
h
a
c
h
i
e
v
e
m
e
n
t
o
f
r
e
m
i
ss
i
o
n
.
T
h
e
2
y
ea
r
da
t
a
s
h
o
w
e
d
t
h
a
t
64
%
o
f
peop
l
e
w
i
t
h
≥
10
kg
l
o
ss
a
t
2
y
ea
r
s
w
e
r
e
i
n
r
e
m
i
ss
i
o
n
,
c
o
m
pa
r
e
d
t
o
29
%
o
f
peop
l
e
w
i
t
h
5
-
10
kg
w
e
i
g
h
t
l
o
ss
a
n
d
5
%
o
f
peop
l
e
w
i
t
h
<
5
kg
w
e
i
g
h
t
l
o
ss
•
W
h
i
l
e
D
i
R
E
C
T
u
s
e
d
nu
r
s
e
s
o
r
d
i
e
t
i
c
i
a
n
s
t
o
p
r
o
v
i
d
e
be
h
a
v
i
o
u
r
a
l
s
u
ppo
r
t
,
t
h
e
D
R
O
P
L
E
T
t
r
i
a
l
(
2018
)
s
h
o
w
e
d
t
h
a
t
s
i
m
i
l
a
r
w
e
i
g
h
t
l
oss
o
u
t
c
o
m
e
s
t
o
D
i
R
E
C
T
c
o
u
l
d
b
e
a
c
h
i
e
v
e
d
u
s
i
n
g
a
t
r
a
i
n
e
d
w
o
r
k
f
o
r
ce
o
f
n
o
n
-
h
ea
l
t
h
ca
r
e
p
r
o
f
e
ss
i
o
n
a
l
s
t
o
de
l
i
v
e
r
t
h
e
be
h
a
v
i
o
u
r
a
l
s
u
ppo
r
t
e
l
e
m
e
n
t
s
o
f
t
h
e
L
C
D
i
n
t
e
r
v
e
n
t
i
o
n
•
T
h
e
NH
S
i
s
r
unn
i
n
g
p
i
l
o
t
s
t
o
o
ff
e
r
t
h
i
s
i
n
t
e
r
v
e
n
t
i
o
n
a
t
sc
a
l
e
,
i
n
t
h
e
r
ea
l
w
o
r
l
d
•
P
eop
l
e
e
l
i
g
i
b
l
e
f
o
r
t
h
e
s
e
r
v
i
ce
w
i
l
l
b
e
s
u
ppo
r
t
e
d
t
o
l
o
se
w
e
i
g
h
t
,
i
m
p
r
o
v
e
g
l
y
c
ae
m
i
c
pa
r
a
m
e
t
e
r
s
a
n
d
po
t
e
n
t
i
a
ll
y
a
c
h
i
e
v
e
r
e
m
i
s
s
i
o
n
o
f
T
y
p
e
2
D
i
abe
t
e
s
•
E
v
e
n
i
f
r
e
m
i
ss
i
o
n
i
s
n
o
t
a
c
h
i
e
v
ed
,
peop
l
e
a
c
h
i
e
v
i
n
g
w
e
i
g
h
t
l
o
ss
a
r
e
l
i
k
e
l
y
t
o
be
n
e
f
i
t
f
r
o
m
i
m
p
r
o
v
e
m
e
n
t
s
i
n
g
l
y
c
ae
m
i
a
a
n
d
c
a
r
d
i
o
m
e
t
abo
l
i
c
r
i
sk
f
a
c
t
o
r
s
•
E
a
ch
NH
S
L
C
D
P
i
l
o
t
s
i
t
e
h
a
s
bee
n
i
n
v
o
l
v
e
d
i
n
c
h
oo
s
i
n
g
a
de
l
i
v
e
r
y
m
ode
l
a
n
d
h
a
s
bee
n
pa
r
t
o
f
t
h
e
c
o
mm
e
r
c
i
a
l
p
r
o
c
e
ss
o
f
s
e
l
e
c
t
i
n
g
a
p
r
o
v
i
de
r
NH
S
E
ng
l
a
n
d
a
n
d
NH
S
I
m
p
r
o
v
e
m
e
n
t
|
Ba
c
k
gro
u
nd
NH
S
E
ng
l
a
n
d
a
n
d
NH
S
I
m
p
r
o
v
e
m
e
n
t
•
T
ot
a
l
diet
re
p
lac
e
m
ent
ref
e
rs
to
an
ap
p
ro
a
ch
wh
e
re
us
u
al
fo
o
ds
are
re
p
lac
e
d
with
a
m
icro
n
utri
e
n
t
-re
p
lete
for
m
ula
t
ed
diet
•
T
he
T
DR
pr
o
du
c
ts
us
u
ally
take
the
form
of
sh
a
kes
or
s
ou
p
s,
ho
w
ev
e
r
ot
h
er
pr
o
du
c
t
for
m
s
are
av
a
ila
b
le
•
When
used
as
intended
and
no
other
foods
are
consu
m
ed,
the
total
daily
calorie
intake
on
the
T
DR
phase
of
the
NHS
LCD
Pilots
is
around
80
0
-900
kcals
•
T
ho
u
gh
ot
h
er
ap
p
ro
a
ch
e
s
su
c
h
as
low
cal
o
rie
die
t
s
with
‘re
a
l
fo
o
ds’
m
ay
b
e
eff
e
ctive
for
so
m
e
pe
o
ple,
the
str
o
ng
e
st
evi
d
en
c
e
-
ba
s
e
in
ac
h
ievi
n
g
Ty
p
e
2
Dia
b
et
e
s
re
m
issi
o
n
thr
o
ugh
no
n
-sur
g
ical
m
ea
n
s
is
curr
e
ntly
with
T
DR
ap
p
ro
a
ch
e
s
|
W
hat
is
low
c
alorie
die
t
,
t
o
t
al
diet
repl
a
c
e
m
en
t
?
NH
S
E
ng
l
a
n
d
a
n
d
NH
S
I
m
p
r
o
v
e
m
e
n
t
•
R
e
du
c
t
i
o
n
in
w
e
i
gh
t
o
f
S
e
r
v
i
c
e
U
s
e
r
s
a
n
d
m
a
i
n
t
e
n
a
n
c
e
o
f
w
e
i
gh
t
l
o
s
s
a
c
h
i
e
v
e
d
•
A
c
h
i
e
v
e
m
e
n
t
o
f
r
e
m
i
ss
i
o
n
o
f
T
y
p
e
2
d
i
a
b
e
t
e
s
/
r
e
du
c
e
d
g
l
y
c
ae
m
i
c
p
a
r
a
m
e
t
e
r
s
•
R
e
du
c
t
i
o
n
in
m
e
d
i
c
a
t
i
o
n
u
s
a
g
e
•
B
u
i
l
d
t
h
e
e
v
i
d
e
n
c
e
b
a
s
e
a
r
o
un
d
t
h
e
e
ff
e
c
t
i
v
e
n
e
s
s
o
f
d
i
ff
e
r
e
n
t
d
e
l
i
v
e
r
y
a
pp
r
oa
c
h
e
s
t
o
t
h
e
l
o
w
c
a
l
o
r
ie
d
i
e
t
(
L
CD
)
,
t
o
t
a
l
d
i
e
t
r
e
p
l
a
c
e
m
e
n
t
(
T
DR
)
i
n
t
e
r
v
e
n
t
i
o
n
,
s
u
c
h
a
s
o
n
e
-
t
o
-
o
n
e
o
r
g
r
o
u
p
s
e
ss
i
on
s
,
a
n
d
e
v
i
d
e
n
c
e
a
r
o
un
d
i
m
p
a
c
t
in
d
i
ff
e
r
e
n
t
d
e
m
o
g
r
a
ph
i
c
g
r
o
up
s
|
Ai
m
s
of
t
he
NH
S
L
C
D
Pro
g
ra
m
m
e
Pilo
t
s
NH
S
E
ng
l
a
n
d
a
n
d
NH
S
I
m
p
r
o
v
e
m
e
n
t
•
R
e
f
e
rr
a
l
s
t
o
t
h
e
L
C
D
se
r
v
i
c
e
w
il
l
b
e
f
r
o
m
G
P
p
r
a
c
t
i
ce
s
•
T
h
r
e
e
p
ha
se
s
t
o
t
h
e
i
n
t
e
r
v
e
n
t
i
o
n
:
•
T
o
t
a
l
D
i
e
t
R
ep
l
a
c
e
m
e
n
t
:
1
2
w
ee
k
s
•
F
oo
d
r
e
-
i
n
tr
od
u
c
t
i
o
n
:
4
-
6
w
ee
k
s
•
W
e
i
g
h
t
m
a
i
n
t
e
nan
c
e
:
U
n
t
i
l
1
2
m
o
n
t
h
s
•
A
r
esc
u
e
p
r
o
t
oco
l
(
w
i
t
h
4
w
ee
k
s
f
u
l
l
o
r
p
a
rt
i
a
l
T
DR
)
i
s
a
v
a
il
a
b
l
e
i
f
p
a
rt
i
c
i
p
an
t
r
eg
a
i
n
s
≥
2
k
g
w
e
i
g
h
t
a
f
t
e
r
T
D
R
p
ha
s
e
•
T
h
e
r
e
i
s
n
o
d
i
r
ec
t
cos
t
t
o
p
a
t
i
e
n
t
s
(
i
.
e
.
t
h
e
y
d
o
n
o
t
p
a
y
f
o
r
t
h
e
T
D
R
p
r
od
u
c
t
s
)
|
O
v
er
v
iew
of
t
he
Pro
g
ra
m
m
e
•
A
t
the
ti
m
e
of producing
this
slide
deck,
there
was
no
definition
of
re
m
ission
stated
in
relevant
N
I
CE
Guidance
or
consensus
international
definition.
Differ
e
nt
definitions
of
re
m
ission
have
been
proposed
by
the
A
BCD,
A
DA
and
E
A
CD
•
I
n
the
absence
of
a
consensus
internation
a
l
definition,
the
E
x
pert
A
dvisory
Group
for
the
NHS
LCD
Pilot
Progra
mm
e
agreed
the
below
definition
for
the
purpose
of
the
NHS
LCD
Pilots.
T
his
m
ay
be
reviewed
in
light
of
an
international
consens
u
s
definiti
o
n
o
r
new
national
guidance:
•
R
e
m
i
s
s
i
o
n
h
a
s
b
e
e
n
a
c
h
i
e
v
e
d
w
h
e
n
H
b
A
1
c
<
4
8
m
m
o
l
/
m
o
l
(
o
r
F
P
G
<
7
m
m
o
l
/
l
i
f
H
b
A
1
c
i
s
n
o
t
c
l
i
n
i
c
a
l
l
y
s
u
i
t
a
b
l
e
)
h
a
s
b
e
e
n
m
a
i
n
t
a
i
n
e
d
f
o
r
a
t
l
e
a
s
t
6
m
o
n
t
h
s
,
o
f
f
a
l
l
g
l
u
c
o
s
e
-
l
o
w
e
r
i
n
g
a
g
e
n
t
s
•
I
dentifying
re
m
ission
therefore
requires
checking
of
Hb
A
1c
levels
(or
FPG
if
Hb
A
1c
is
not
clinically
suitable)
at
least
6
m
o
n
ths
ap
a
rt,
with
no
glucos
e
-low
e
ri
n
g
ag
e
nts
us
e
d
during
this
int
e
rval
NH
S
E
ng
l
a
n
d
a
n
d
NH
S
I
m
p
r
o
v
e
m
e
n
t
|
D
e
f
ini
t
ion
of
R
e
m
i
ss
ion
•
M
a
k
e
c
l
e
a
r
t
o
p
a
t
i
e
n
t
s
t
h
a
t
a
c
h
i
e
v
e
m
e
n
t
o
f
r
e
m
i
s
s
i
o
n
d
o
e
s
n
o
t
m
e
a
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The NHS Low Calorie Diet Programme aims to help people through total diet replacement to achieve weight loss, remission of Type 2 Diabetes, and reduced medication usage. The programme focuses on delivering effective interventions, building evidence, and supporting individuals in achieving and maintaining positive health outcomes.
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NHS Low Calorie Diet Pilot Programme Guidance for GP practicesand referrers 24th July 2020 NHSEngland and NHSImprovement |
Background The DiRECTtrial (2017) tested a low calorie diet (LCD),total dietreplacement (TDR) approachin people withType 2 Diabetes within 6 years of diagnosis to achieve weight loss and remissionof diabetes On the first day of starting TDR, all glucose-lowering agents and BP-lowering agents were stopped At 1 year, 46% of people in the intervention group achieved remission(as defined in the trial), compared to 4% in the control group Weight loss was strongly associated with achievement of remission.The 2 year data showed that 64% of people with 10kg loss at 2 years were in remission, compared to 29% of people with 5-10kg weight loss and 5% of people with <5kg weight loss While DiRECTused nurses or dieticians to provide behavioural support, the DROPLETtrial (2018) showed that similarweight loss outcomes to DiRECT could be achieved using a trained workforce of non-healthcare professionals to deliver the behavioural support elements of the LCD intervention The NHS isrunning pilots to offer this intervention at scale, in the real world People eligible for the service will be supported to lose weight, improve glycaemic parameters and potentially achieve remission of Type 2 Diabetes Even if remission is not achieved, people achieving weight loss are likely to benefit from improvements in glycaemia and cardiometabolic riskfactors Each NHS LCD Pilot site has been involved in choosing a delivery model and has been part of the commercialprocess of selecting a provider NHSEngland and NHSImprovement |
What is low calorie diet, total diet replacement? Totaldiet replacementrefersto an approachwhereusual foodsare replacedwith a micronutrient-repleteformulateddiet TheTDRproductsusuallytakethe form of shakesor soups,however otherproductforms are available Whenused as intendedand no other foodsare consumed,the total daily calorieintake on theTDRphaseof the NHS LCD Pilots is around800-900kcals Thoughotherapproachessuchaslow calorie dietswith real foods may be effectivefor some people,the strongestevidence- base in achievingType2 Diabetesremissionthroughnon-surgicalmeansis currentlywith TDRapproaches NHSEngland and NHSImprovement |
Aims of the NHS LCD Programme Pilots Reductionin weight of Service Users andmaintenance of weight loss achieved Achievement of remissionofType 2 diabetes / reducedglycaemic parameters Reductionin medication usage Build the evidence base around the effectivenessofdifferentdelivery approachesto the low caloriediet (LCD),total diet replacement (TDR)intervention, such as one-to-oneor group sessions,and evidence around impact in differentdemographic groups NHSEngland and NHSImprovement |
Overview of the Programme Referralsto the LCD service will be from GP practices Three phases to the intervention: Total Diet Replacement:12 weeks Foodre-introduction: 4-6 weeks Weightmaintenance: Until 12 months Arescueprotocol(with 4 weeks full or partial TDR) is available if participant regains 2kg weight after TDRphase There is no directcostto patients (i.e. they do not pay forthe TDR products) NHSEngland and NHSImprovement |
Definition of Remission At the time of producingthisslide deck,there was no definitionof remission statedin relevantNICE Guidanceor consensus internationaldefinition.Differentdefinitionsof remissionhave beenproposedby theABCD,ADAand EACD In the absenceof a consensusinternationaldefinition,theExpertAdvisory Groupfor the NHSLCD Pilot Programme agreedthe belowdefinitionfor the purposeof the NHSLCD Pilots.Thismay be reviewedin light of an international consensusdefinitionornew nationalguidance: Remission has been achieved when HbA1c < 48mmol/mol (or FPG < 7mmol/l if HbA1c is not clinically suitable) has been maintained for at least 6 months, off all glucose-lowering agents Identifyingremission thereforerequirescheckingofHbA1c levels(or FPGif HbA1c is not clinicallysuitable)at least6 months apart, with no glucose-loweringagentsusedduringthis interval NHSEngland and NHSImprovement |
Remission of Type 2 Diabetes Make clear to patients that achievement of remission does not mean they have been cured - use the term remission The mechanism of remission is thought to be the removal of excess fat from the liver and pancreas, allowing these organs to potentially return to normal physiological function in maintaining optimal blood glucose regulation Weight gain above an individual s personal fat threshold for Type 2 Diabetes - the body weight at which physiological processes for regulating glucose levels are sufficiently deranged to result in diabetes-range glycaemic parameters is likely to result in active Type 2 Diabetes and the according risks of developing complications It is therefore essential that anyone referred to the NHS LCD programme commits to attending diabetes review / monitoring appointments when offered, regardless of whether remission has been achieved Ongoing review and monitoring should be offered in line with usual care for people with Type 2 diabetes NHSEngland and NHSImprovement |
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