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The	
  Ea'ng	
  Behavior	
  Ques'onnaire	
  ©,	
  
	
  a	
  Novel	
  Clinical	
  Examina'on	
  
ASBP	
  Spring	
  Conference	
  2014	
  
Philadelphia	
  
Ed	
  J.	
  Hendricks,	
  M.D.,	
  FASBP	
  
	
  
Background	
  -­‐	
  I	
  
When	
  asked	
  “What	
  is	
  the	
  effect	
  of	
  the	
  drug	
  ?”	
  
obese	
  pa'ents	
  treated	
  with	
  an'-­‐obesity	
  drugs	
  
offer	
  a	
  wide	
  variety	
  of	
  answers	
  such	
  as:	
  
•  “I	
  don’t	
  eat	
  as	
  much.”	
  
•  “I	
  can	
  stop	
  ea'ng.”	
  
•  “I	
  don’t	
  	
  graze	
  all	
  day	
  and	
  night.”	
  
•  “I’m	
  not	
  hungry	
  as	
  soon	
  as	
  I	
  stop	
  ea'ng.”	
  
•  “I’m	
  normal”	
  (in	
  respect	
  to	
  ea'ng).	
  
Background	
  -­‐	
  II	
  
1.  Obese	
  pa'ents	
  have	
  ea'ng	
  behaviors	
  that	
  
have	
  led	
  to	
  weight	
  gain.	
  
2.  An'-­‐obesity	
  drugs	
  change	
  ea'ng	
  behaviors	
  
inducing	
  compara've	
  hypophagia.	
  
3.  Treatment-­‐induced	
  ea'ng	
  behavior	
  changes	
  
are	
  proximate	
  to	
  weight	
  loss.	
  
4.  Simplis'c	
  descrip'ons,	
  but	
  if	
  true	
  we	
  
hypothesize	
  that	
  a	
  metric	
  of	
  ea'ng	
  behavior	
  
could	
  be	
  a	
  useful	
  clinical	
  tool.	
  
Measurements	
  of	
  Behavior	
  
•  Method:	
  provide	
  s'mulus	
  –	
  measure	
  reac'on.	
  
•  Measurement	
  of	
  reac'on	
  can	
  be	
  done	
  either	
  
by	
  tes'ng	
  administrator/observer	
  or	
  by	
  test	
  
subject.	
  	
  
•  The	
  la`er	
  method,	
  termed	
  psychometric	
  scale	
  
tes'ng,	
  is	
  more	
  widely	
  used.	
  
•  Psychometric	
  tes'ng	
  can	
  be	
  confounded	
  
because	
  the	
  measurements	
  depend	
  on	
  a	
  
subjec've	
  assessment	
  by	
  the	
  person	
  tested.	
  
Test	
  Desirable	
  Characteris'cs	
  
•  Discriminate	
  between	
  untreated	
  and	
  treated	
  
pa'ents.	
  
•  Good	
  test	
  re-­‐test	
  reliability.	
  
•  Rapid	
  test	
  comple'on	
  by	
  pa'ent.	
  
•  Rapid	
  test	
  assessment	
  by	
  clinician.	
  
•  Real	
  number,	
  parametric	
  data;	
  not	
  ordinal	
  or	
  
non-­‐parametric	
  data.	
  	
  
•  Ques'ons	
  relate	
  to	
  treatment-­‐induced	
  changes.	
  
Some	
  Scales	
  of	
  Ea'ng	
  Behavior	
  
•  Three	
  Factor	
  Ea'ng	
  Ques'onnaire	
  (TFEQ)	
  
– Stunkard	
  1985	
  
•  Food	
  Preference	
  Ques'onnaire	
  (FPQ)	
  
– Geiselman	
  1998	
  
•  Food-­‐Craving	
  Inventory	
  (FCI)	
  
– White	
  2002	
  
•  Power	
  of	
  Food	
  Scale	
  (PFS)	
  
– Lowe	
  2009	
  
Disadvantages	
  of	
  Previous	
  Scales	
  
•  Ques'ons	
  do	
  not	
  necessarily	
  relate	
  to	
  
treatment-­‐induced	
  changes.	
  
•  Designed	
  for	
  laboratory	
  tes'ng.	
  
•  Lengthy	
  tes'ng	
  process.	
  
•  Evalua'on	
  of	
  results	
  'me-­‐consuming.	
  	
  
•  Lickert-­‐like	
  answer	
  structure	
  producing	
  
ordinal,	
  non-­‐parametric	
  data.	
  
•  Non-­‐parametric	
  sta's'cal	
  analysis.	
  
EBQ	
  Design	
  
•  Ques'ons	
  taken	
  from	
  pa'ent	
  descrip'ons	
  of	
  
drug	
  effects.	
  
•  Ques'ons	
  phrased	
  in	
  simple	
  sentences.	
  
•  Visual	
  Analog	
  Scale;	
  parametric	
  data.	
  	
  
•  Pa'ents	
  answer	
  ques'ons	
  by	
  marking	
  a	
  100	
  
millimeter	
  line	
  under	
  each	
  ques'on.	
  
•  Scored	
  by	
  measuring	
  mm	
  from	
  lej	
  end.	
  
•  Ques'on	
  8,	
  reverse;	
  measured	
  from	
  right	
  end.	
  
VAS	
  Scale	
  
EBQ	
  Ques'ons	
  
•  1.	
  Are	
  you	
  preoccupied	
  with	
  thoughts	
  of	
  food	
  
or	
  ea'ng?	
  
•  2.	
  Do	
  you	
  eat	
  to	
  comfort	
  yourself?	
  	
  
•  3.	
  Do	
  you	
  crave	
  any	
  specific	
  foods?	
  
•  4.	
  Once	
  you	
  start	
  ea'ng,	
  do	
  you	
  find	
  it	
  hard	
  to	
  
stop?	
  	
  
•  5.	
  Do	
  you	
  find	
  it	
  difficult	
  to	
  s'ck	
  to	
  an	
  ea'ng	
  
plan?	
  	
  
EBQ	
  Ques'ons	
  
•  6.	
  Do	
  you	
  eat	
  rapidly,	
  more	
  rapidly	
  than	
  those	
  
around	
  you?	
  	
  
•  7.	
  Do	
  you	
  “graze”	
  or	
  eat	
  con'nually	
  during	
  
any	
  part	
  of	
  a	
  24-­‐hour	
  day?	
  
•  8.	
  Are	
  you	
  in	
  control	
  of	
  your	
  ea'ng?	
  	
  (Reverse)	
  
•  9.	
  Do	
  you	
  eat	
  more	
  when	
  under	
  stress?	
  	
  
•  10.	
  Do	
  you	
  eat	
  more	
  during	
  highly	
  emo'onal	
  
'mes?	
  	
  
Study	
  Design	
  
•  Observa'onal	
  prospec've	
  study.	
  
•  Non-­‐randomized;	
  pa'ents	
  allowed	
  to	
  select	
  
treatment	
  program.	
  
•  Non-­‐blinded;	
  physician	
  and	
  pa'ent	
  	
  
completely	
  aware	
  of	
  treatment	
  details.	
  
•  Sta's'cal	
  analysis:	
  
– Normally	
  distributed	
  data	
  è	
  T-­‐test.	
  
– Non-­‐normal	
  data	
  è	
  Wilcoxen	
  signed	
  ranks	
  test	
  
Study	
  Treatment	
  Methods	
  	
  
•  Diet	
  	
  
–  	
  VLCKD,	
  Very	
  Low	
  Carbohydrate	
  Ketogenic	
  Diet	
  
–  Protein	
  1.5-­‐2.0	
  g/ideal	
  wt./day	
  
–  ≤	
  40	
  g	
  carbohydrate/day	
  
•  Behavior	
  Modifica'on	
  
–  One-­‐on-­‐one	
  pa'ent	
  and	
  prac''oner	
  at	
  every	
  
encounter	
  
–  Focus	
  on	
  ea'ng	
  and	
  exercise	
  behaviors	
  
•  Pharmacotherapy	
  	
  
–  Phentermine	
  mono-­‐therapy	
  
TREATMENT	
  EXPECTATIONS	
  
Study	
  treatment	
  methods	
  are	
  standard	
  prac'ce	
  in	
  the	
  private	
  prac'ce	
  
seqng	
  where	
  this	
  study	
  was	
  conducted.	
  Treatment	
  results	
  with	
  this	
  
method	
  have	
  been	
  published	
  previously:	
  Hendricks	
  EJ,	
  et	
  al.	
  Obesity	
  
(Silver	
  Spring)	
  2011;19:	
  2351-­‐2360.	
  
	
  
-­‐45.0%	
  
-­‐40.0%	
  
-­‐35.0%	
  
-­‐30.0%	
  
-­‐25.0%	
  
-­‐20.0%	
  
-­‐15.0%	
  
-­‐10.0%	
  
-­‐5.0%	
  
0.0%	
  
5.0%	
  
1	
  
8	
  
15	
  
22	
  
29	
  
36	
  
43	
  
50	
  
57	
  
64	
  
71	
  
78	
  
85	
  
92	
  
99	
  
106	
  
113	
  
120	
  
127	
  
134	
  
141	
  
148	
  
155	
  
162	
  
169	
  
Percent	
  Weight	
  Loss	
   Individual	
  PaBent	
  Weight	
  Loss	
  at	
  52	
  Weeks	
  
Hendricks,	
  Obesity	
  2011;	
  19:2351-­‐2360.	
  
-­‐120	
  
-­‐100	
  
-­‐80	
  
-­‐60	
  
-­‐40	
  
-­‐20	
  
0	
  
20	
  
1	
   5	
   9	
   13	
   17	
   21	
   25	
   29	
   33	
   37	
   41	
   45	
   49	
   53	
   57	
   61	
   65	
   69	
   73	
   77	
   81	
   85	
   89	
   93	
   97	
  101	
  105	
  109	
  113	
  117	
  121	
  125	
  129	
  133	
  137	
  141	
  145	
  149	
  153	
  157	
  161	
  165	
  169	
  173	
  
1	
  Year	
  Wt.	
  Loss	
  Pounds	
  	
  
N	
  =	
  175	
  
Mean	
  Weight	
  Loss	
  =	
  40	
  pounds	
  
Std.	
  Dev.	
  =	
  25	
  
Hendricks,	
  Obesity	
  2011;	
  19:2351-­‐2360.	
  
0	
  
5	
  
10	
  
15	
  
20	
  
25	
  
30	
  
35	
  
40	
  
45	
  
Number	
  of	
  PaBents	
  
Loss	
  -­‐	
  Pounds	
  
1	
  Year	
  Weight	
  Loss	
  DistribuBon	
  	
  
Variability	
  of	
  Response	
  to	
  Roux-­‐en-­‐Y	
  
Gastric	
  Bypass	
  
Hatoum,	
  J	
  Clin	
  Endocrinol	
  Metab	
  2011;	
  96:	
  E1630.	
  
-­‐30.0	
  
-­‐25.0	
  
-­‐20.0	
  
-­‐15.0	
  
-­‐10.0	
  
-­‐5.0	
  
0.0	
  
week	
   1	
   2	
   3	
   4	
   8	
   12	
   26	
   40	
   52	
  
%	
  Weight	
  Loss	
  	
  
Phentermine	
  +	
  VLCKD	
  Treated	
  1	
  Year	
  
%	
  Weight	
  Loss	
  
Hendricks,	
  Obesity	
  2011;	
  19:2351-­‐2360	
  
Systolic	
  BP	
  mm	
  Hg	
  
-­‐30.0	
  
-­‐25.0	
  
-­‐20.0	
  
-­‐15.0	
  
-­‐10.0	
  
-­‐5.0	
  
0.0	
  
%	
  Weight	
  loss	
  	
  
Phentermine	
  +	
  VLCKD	
  then	
  LCD	
  Treated	
  8	
  Years	
  
Systolic	
  BP	
  mm	
  Hg	
  
%	
  Weight	
  Loss	
  
Average	
  Weight	
  Loss	
  vs.	
  Rx	
  Week	
  
Week	
   %	
   Lbs.	
  
1	
   -­‐3.2	
   -­‐6.8	
  
2	
   -­‐5.0	
   -­‐10.6	
  
3	
   -­‐6.4	
   -­‐13.8	
  
4	
   -­‐8.0	
   -­‐17.2	
  
8	
   -­‐12.0	
   -­‐25.8	
  
Week	
   %	
   Lbs.	
  
12	
   -­‐15.1	
   -­‐32.6	
  
26	
   -­‐18.9	
   -­‐41.5	
  
40	
   -­‐18.7	
   -­‐42.0	
  
52	
   -­‐17.6	
   -­‐39.7	
  
104	
   -­‐12.7	
   -­‐28.8	
  
STUDY	
  DATA	
  
Study	
  Pa'ent	
  Selec'on	
  
•  Type	
  A:	
  New	
  pa'ents	
  star'ng	
  VLCKD	
  and	
  
phentermine.	
  
•  Type	
  B:	
  Previous	
  pa'ents,	
  restar'ng	
  VLCKD	
  
and	
  phentermine	
  ajer	
  a	
  treatment	
  hiatus.	
  
•  Type	
  C:	
  Current	
  pa'ents,	
  LCD	
  +	
  drug,	
  
treatment	
  sa'sfactory,	
  no	
  change	
  needed.	
  
•  Type	
  D:	
  Current	
  pa'ents,	
  LCD	
  +	
  drug,	
  
treatment	
  unsa'sfactory,	
  change	
  needed.	
  
Criteria	
  for	
  Rx	
  Altera'on	
  
•  Rx	
  Change	
  Needed:	
  
– Weight	
  loss	
  less	
  than	
  expected	
  
– Weight	
  plateau	
  reached	
  sooner	
  than	
  expected	
  
– Weight	
  increase	
  on	
  maintenance	
  
– Drug	
  “doesn’t	
  work	
  as	
  well	
  as	
  before.”	
  
•  No	
  Rx	
  Change	
  Needed	
  
– Expected	
  weight	
  loss	
  achieved	
  
– Stable	
  maintenance	
  
Study	
  Demographics	
  
•  Pa'ents	
  Tested:	
  374	
  
•  Female	
  86%;	
  Male	
  14%	
  
•  Weight	
  196.2	
  (±45.4)	
  pounds	
  
•  BMI	
  33.2	
  (±6.0)	
  Kg/m2	
  
•  Race	
  %:	
  	
  
White/Hispanic/Black/Asian:	
  92/6/1/1	
  	
  
Long-­‐term	
  Phentermine	
  Rx	
  Dura'on	
  
PaBent	
   N	
   MEAN	
  
(YRS)	
  
RANGE	
  (YRS)	
  
A	
   58	
   N.A.	
   N.A.	
  
B,	
  C,	
  D	
   316	
   6.0	
   0.1	
  –	
  20.5	
  
Prior	
  Report	
  (1)	
   117	
   8.4	
   1.1	
  –	
  21.1	
  
Prior	
  Report	
  (2)	
   269	
   -­‐	
   0.25	
  –	
  12.0	
  
(1)  Hendricks,	
  Int	
  J	
  Obes	
  2014;	
  38:	
  292-­‐298.	
  
(2)  Hendricks,	
  Obesity	
  2011;	
  19:2351-­‐2360	
  
Normal	
  Distribu'on	
  
Small	
  Overlap	
  
ê	
  
0	
  
5	
  
10	
  
15	
  
20	
  
25	
  
30	
  
35	
  
5	
   15	
   25	
   35	
   45	
   55	
   65	
   75	
   85	
   95	
  
Number	
  of	
  PaBents	
   DistribuBon	
  of	
  EBQ	
  Scores	
  
Untreated	
  
N	
  =	
  217	
  
Mean	
  (SD)	
  
62.0	
  (13.6)	
  
Treated	
  
N	
  =	
  197	
  
Mean	
  (SD)	
  
36.9	
  (15.7)	
  
Ini'al	
  EBQ	
  Scores	
  (P1)	
  
PaBent	
  Type	
   N	
   Mean	
  (SD)	
   T-­‐Test:	
  vs	
  	
  
Type	
  A	
  
A	
  –	
  New,	
  
Untreated	
  
58	
   60.8	
  (10.4)	
   	
  	
  
B	
  -­‐	
  Restart	
  ajer	
  
Treatment	
  hiatus	
  
159	
   62.4	
  (14.5)	
   0.4305	
  
C	
  -­‐	
  Treated	
  
No	
  change	
  needed	
  	
  
92	
   39.3	
  (14.7)	
   1.8	
  x	
  10-­‐17	
  
D	
  –	
  Treated,	
  
change	
  needed	
  
65	
   55.0	
  (14.2)	
   0.0114	
  
EBQ	
  Scores	
  P1	
  vs	
  P2	
  
PaBent	
  
Type	
  	
  
N	
  	
   P1	
  
Mean	
  
(SD)	
  
P2	
  
Mean	
  
(SD)	
  
Δ1-­‐2	
  
(P1-­‐P2)	
  
T-­‐test	
  	
  
P1	
  v	
  P2	
  
P	
  =	
  
A.	
  New	
   43	
   61.3	
  
(±11.0)	
  
28.1	
  
(±15.9)	
  
33.2	
  
(±17.4)	
  
1.6x10-­‐18	
  
B.	
  
Restart	
  
60	
   65.1	
  
(±14.2)	
  
40.1	
  
(±14.8)	
  
24.9	
  
(±18.4)	
  
4.7x10-­‐16	
  
C.	
  no	
  
change	
  
29	
   37.4	
  
(±11.5)	
  
39.5	
  
(±11.9)	
  
-­‐2.1	
  
(±8.9)	
  
0.4970	
  
D.	
  need	
  
change	
  
24	
   59.8	
  
(±13.8)	
  
40.3	
  
(±15.8)	
  
19.5	
  
(±15.2)	
  
3.8x10-­‐5	
  
Days	
  Between	
  P1	
  &	
  P2	
  EBQ	
  
PaBent	
  Type	
   Interval	
  	
  (SD)	
   Rx	
  Plan	
  
A.	
  New	
  Pa'ent	
  	
   11.4	
  (±	
  7.2)	
   7	
  
B.	
  Old	
  pa'ent,	
  
previously	
  treated	
  
20.1	
  (±	
  13.1)	
   7	
  -­‐	
  14	
  
C.	
  Under	
  Treatment,	
  
no	
  change	
  needed	
  	
  
56.6	
  (±	
  23.8)	
   90	
  
D.	
  Under	
  Treatment,	
  
change	
  needed	
  
22.5	
  (±	
  12.3)	
   30	
  
Single	
  Ques'on	
  T-­‐test	
  P1	
  vs	
  P2	
  
QuesBon	
   P	
  
1	
   2	
  x	
  10-­‐9	
  
2	
   4	
  x	
  10-­‐14	
  
3	
   1	
  x	
  10-­‐13	
  
4	
   1	
  x	
  10-­‐13	
  
5	
   1	
  x	
  10-­‐11	
  
6	
   4	
  x	
  10-­‐6	
  
QuesBon	
   P	
  
7	
   2	
  x	
  10-­‐11	
  
8	
   1	
  x	
  10-­‐9	
  
9	
   4	
  x	
  10-­‐10	
  
10	
   1	
  x	
  10-­‐10	
  
Rejected*	
   0.03	
  
Rejected*	
   0.20	
  
*These	
  two	
  ques'ons	
  from	
  ini'al	
  EBQ	
  were	
  deleted.	
  
Example	
  Case:	
  Type	
  A	
  	
  
•  J.M.	
  49	
  year-­‐old	
  W	
  male	
  
•  Wt.	
  275.2	
  pounds	
  
•  Ht.	
  69”	
  
•  W.C.	
  46.5”	
  
•  Fat	
  %	
  41	
  
•  BMI	
  41	
  
•  VLCKD	
  +	
  Phentermine	
  37.5	
  mg/day	
  
•  Rx	
  Dura'on:	
  5	
  months,	
  -­‐56.8	
  lbs.,	
  -­‐20.6%	
  	
  
0	
  
-­‐8.8	
  
-­‐10.8	
  
-­‐14.3	
  
-­‐17.2	
  
-­‐20.6	
  
0	
  
-­‐8.2	
  
-­‐12.2	
  
-­‐15.1	
  
-­‐17.2	
  
-­‐18.1	
  
-­‐25	
  
-­‐20	
  
-­‐15	
  
-­‐10	
  
-­‐5	
  
0	
  
0	
   1	
   2	
   3	
   4	
   5	
  
%	
  Weight	
  loss	
  	
  
Months	
  
J.M.	
  vs.	
  Avg.	
  %	
  Weight	
  Loss	
  through	
  5	
  months	
  
JM	
  
AVG	
  
EBQ	
  61	
  	
  	
  	
  	
  EBQ	
  22	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  EBQ	
  19	
  	
  	
  	
  	
  	
  	
  	
  EBQ	
  12	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  EBQ	
  17	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  EBQ	
  12	
  
1	
  Week=	
  22	
  
Average	
  Pa'ent	
  Wt.	
  Loss	
  by	
  month	
  from:	
  
Hendricks,	
  Obesity	
  2011;	
  19:2351-­‐2360.	
  
Example	
  Case:	
  Type	
  B	
  	
  
•  M.L.	
  46	
  year-­‐old	
  H	
  female	
  
•  Wt.	
  157.6	
  pounds	
  
•  Ht.	
  61”	
  
•  W.C.	
  36”	
  
•  Fat	
  %	
  52	
  
•  BMI	
  29,	
  (Prior	
  high	
  31)	
  
•  VLCKD	
  +	
  Phentermine	
  37.5	
  mg/day	
  
•  Rx	
  Dura'on:	
  3	
  months,	
  -­‐30	
  lbs.,	
  -­‐17.4%	
  	
  
0	
  
-­‐8.0	
   -­‐12.2	
  
-­‐15.1	
  
0	
  
-­‐3.5	
  
-­‐12.9	
  
-­‐17.4	
  
-­‐25	
  
-­‐20	
  
-­‐15	
  
-­‐10	
  
-­‐5	
  
0	
  
0	
   1	
   2	
   3	
  
%	
  Weight	
  loss	
  	
  
Months	
  
M.L.	
  vs.	
  AVG	
  %	
  Weight	
  loss	
  through	
  3	
  Months	
  
AVG	
  
Pt	
  ML	
  
EBQ	
  60	
  
1	
  Week=	
  32	
  
EBQ	
  43	
   EBQ	
  42	
   EBQ	
  50	
  
Average	
  Pa'ent	
  Wt.	
  Loss	
  by	
  month	
  from:
Hendricks,	
  Obesity	
  2011;	
  19:2351-­‐2360.	
  
Example	
  Case:	
  Type	
  C	
  	
  
•  S.A.	
  70	
  year-­‐old	
  W	
  female	
  
•  Wt.	
  172.2	
  pounds	
  
•  Ht.	
  60”	
  
•  W.C.	
  42”	
  
•  Fat	
  %	
  52	
  
•  BMI	
  34	
  
•  VLCKD	
  +	
  Phentermine	
  37.5	
  mg/day	
  
•  Rx	
  Dura'on:	
  8	
  months,	
  -­‐22.3	
  lbs.,	
  -­‐13.5%	
  	
  
0	
  
-­‐3.4	
  
-­‐5.3	
  
-­‐7.5	
  
-­‐9.6	
  
-­‐9.9	
  
-­‐12.0	
   -­‐12.3	
  
-­‐13.5	
  
0	
  
-­‐8.0	
  
-­‐12.2	
  
-­‐15.1	
  
-­‐17.2	
  
-­‐18.1	
  
-­‐18.8	
   -­‐18.8	
   -­‐18.9	
  
-­‐25	
  
-­‐20	
  
-­‐15	
  
-­‐10	
  
-­‐5	
  
0	
  
0	
   1	
   2	
   3	
   4	
   5	
   6	
   7	
   8	
  
%	
  Weight	
  loss	
  	
  
Months	
  
S.A.	
  vs.	
  Avg.	
  %	
  Weight	
  Loss	
  through	
  8	
  Months	
  	
  
EBQ:	
  	
  31	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  35	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  33	
  	
  
-­‐22.3	
  #	
  
Average	
  Pa'ent	
  Wt.	
  Loss	
  by	
  month	
  from:	
  
Hendricks,	
  Obesity	
  2011;	
  19:2351-­‐2360.	
  
EBQ	
  Comments	
  
•  Scores	
  dependent	
  on	
  pa'ent’s	
  observa'ons.	
  
•  Some	
  pa'ents	
  poor	
  at	
  self-­‐observa'on.	
  
•  Inappropriate	
  in	
  our	
  hands	
  for	
  5%	
  of	
  pa'ents.	
  
•  Some	
  untreated	
  pa'ents	
  present	
  with	
  low	
  
scores.	
  
•  Low	
  EBQ	
  score	
  may	
  occur	
  in	
  untreated	
  pa'ents	
  
who	
  have	
  dieted	
  previously.	
  
•  Pa'ents	
  treated	
  with	
  diet	
  alone	
  some'mes	
  have	
  
high	
  Δ1-­‐2	
  
Clinical	
  usefulness	
  of	
  EBQ	
  
•  Useful	
  as	
  ancillary	
  metric	
  of	
  treatment	
  
effec'veness.	
  
•  Scores	
  <	
  50	
  suggest	
  treatment	
  is	
  effec've	
  	
  
•  Large	
  EBQ	
  Δ1-­‐2	
  suggests	
  good	
  Rx	
  effect.	
  
•  Scores	
  >	
  50	
  suggest	
  no	
  or	
  ineffec've	
  
treatment	
  
•  Increases	
  pa'ent	
  awareness	
  of	
  Rx	
  effects.	
  
•  Could	
  improve	
  long-­‐term	
  Rx	
  compliance?	
  
EBQ	
  Summary	
  &	
  Conclusions	
  
•  Discriminates	
  treated	
  from	
  untreated	
  pts.	
  
•  Good	
  test-­‐retest	
  reliability.	
  	
  
•  Low	
  scores	
  persist	
  for	
  years	
  in	
  con'nuously	
  
treated	
  pts.	
  with	
  good	
  response.	
  
•  High	
  or	
  increasing	
  scores	
  are	
  one	
  indica'on	
  
treatment	
  	
  altera'on	
  should	
  be	
  considered.	
  
•  Tes'ng	
  and	
  scoring	
  can	
  be	
  accomplished	
  
usually	
  in	
  <	
  3	
  minutes.	
  
Comments	
  
•  These	
  data	
  suggest	
  the	
  EBQ	
  deserves	
  further	
  
inves'ga'on.	
  
•  The	
  EBQ	
  has	
  not	
  yet	
  been	
  validated.	
  
•  Prac''oners	
  are	
  encouraged	
  to	
  use	
  the	
  EBQ,	
  
and	
  to	
  assist	
  with	
  further	
  inves'ga'ons.	
  
•  The	
  Ea'ng	
  Behavior	
  Ques'onnaire©	
  is	
  
available	
  from	
  the	
  Obesity	
  Treatment	
  
Founda'on.	
  
Some	
  Ques'ons	
  for	
  Future	
  Research	
  	
  
•  Does	
  high	
  EBQ	
  Δ1-­‐2	
  indicate	
  a	
  good	
  6	
  month	
  
weight	
  loss	
  (i.e.	
  is	
  the	
  pa'ent	
  a	
  responder)?	
  
•  What	
  are	
  EBQ	
  Δ1-­‐2	
  values	
  for	
  other	
  drugs?	
  
•  Why	
  	
  do	
  some	
  pa'ents	
  have	
  low	
  ini'al	
  
scores?	
  
•  Can	
  the	
  EBQ	
  be	
  used	
  to	
  jus'fy	
  drug	
  or	
  dose	
  
changes?	
  
•  Does	
  high	
  EBQ	
  Δ1-­‐2	
  occur	
  with	
  all	
  treatments?	
  
This	
  EBQ	
  study	
  was	
  funded	
  by	
  the	
  ASBP.	
  
	
  
With	
  Thanks	
  to	
  Study	
  Collaborators:	
  
	
  
Frank	
  L.	
  Greenway,	
  MD	
  
Professor	
  and	
  Director	
  of	
  Outpa'ent	
  Clinic	
  
Pennington	
  Biomedical	
  Research	
  Center	
  
Louisiana	
  State	
  University	
  
Baton	
  Rouge,	
  LA	
  
	
  
Stacy	
  L.	
  Schmidt,	
  PhD	
  
Director,	
  Obesity	
  Treatment	
  Founda'on	
  
	
  
Yelena	
  Istra'y	
  
Student,	
  Pre-­‐medicine	
  	
  
Sierra	
  College,	
  
Rocklin,	
  CA	
  
	
  
Margaret	
  (Mia)	
  J.	
  Hendricks	
  
Student,	
  Psychology	
  
Pepperdine	
  University	
  
Malibu,	
  CA	
  
	
  
	
  

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The Eating Behavior Questionnaire of Hendricks & Obesity Treatment Foundation

  • 1. The  Ea'ng  Behavior  Ques'onnaire  ©,    a  Novel  Clinical  Examina'on   ASBP  Spring  Conference  2014   Philadelphia   Ed  J.  Hendricks,  M.D.,  FASBP    
  • 2. Background  -­‐  I   When  asked  “What  is  the  effect  of  the  drug  ?”   obese  pa'ents  treated  with  an'-­‐obesity  drugs   offer  a  wide  variety  of  answers  such  as:   •  “I  don’t  eat  as  much.”   •  “I  can  stop  ea'ng.”   •  “I  don’t    graze  all  day  and  night.”   •  “I’m  not  hungry  as  soon  as  I  stop  ea'ng.”   •  “I’m  normal”  (in  respect  to  ea'ng).  
  • 3. Background  -­‐  II   1.  Obese  pa'ents  have  ea'ng  behaviors  that   have  led  to  weight  gain.   2.  An'-­‐obesity  drugs  change  ea'ng  behaviors   inducing  compara've  hypophagia.   3.  Treatment-­‐induced  ea'ng  behavior  changes   are  proximate  to  weight  loss.   4.  Simplis'c  descrip'ons,  but  if  true  we   hypothesize  that  a  metric  of  ea'ng  behavior   could  be  a  useful  clinical  tool.  
  • 4. Measurements  of  Behavior   •  Method:  provide  s'mulus  –  measure  reac'on.   •  Measurement  of  reac'on  can  be  done  either   by  tes'ng  administrator/observer  or  by  test   subject.     •  The  la`er  method,  termed  psychometric  scale   tes'ng,  is  more  widely  used.   •  Psychometric  tes'ng  can  be  confounded   because  the  measurements  depend  on  a   subjec've  assessment  by  the  person  tested.  
  • 5. Test  Desirable  Characteris'cs   •  Discriminate  between  untreated  and  treated   pa'ents.   •  Good  test  re-­‐test  reliability.   •  Rapid  test  comple'on  by  pa'ent.   •  Rapid  test  assessment  by  clinician.   •  Real  number,  parametric  data;  not  ordinal  or   non-­‐parametric  data.     •  Ques'ons  relate  to  treatment-­‐induced  changes.  
  • 6. Some  Scales  of  Ea'ng  Behavior   •  Three  Factor  Ea'ng  Ques'onnaire  (TFEQ)   – Stunkard  1985   •  Food  Preference  Ques'onnaire  (FPQ)   – Geiselman  1998   •  Food-­‐Craving  Inventory  (FCI)   – White  2002   •  Power  of  Food  Scale  (PFS)   – Lowe  2009  
  • 7. Disadvantages  of  Previous  Scales   •  Ques'ons  do  not  necessarily  relate  to   treatment-­‐induced  changes.   •  Designed  for  laboratory  tes'ng.   •  Lengthy  tes'ng  process.   •  Evalua'on  of  results  'me-­‐consuming.     •  Lickert-­‐like  answer  structure  producing   ordinal,  non-­‐parametric  data.   •  Non-­‐parametric  sta's'cal  analysis.  
  • 8. EBQ  Design   •  Ques'ons  taken  from  pa'ent  descrip'ons  of   drug  effects.   •  Ques'ons  phrased  in  simple  sentences.   •  Visual  Analog  Scale;  parametric  data.     •  Pa'ents  answer  ques'ons  by  marking  a  100   millimeter  line  under  each  ques'on.   •  Scored  by  measuring  mm  from  lej  end.   •  Ques'on  8,  reverse;  measured  from  right  end.  
  • 10.
  • 11.
  • 12.
  • 13. EBQ  Ques'ons   •  1.  Are  you  preoccupied  with  thoughts  of  food   or  ea'ng?   •  2.  Do  you  eat  to  comfort  yourself?     •  3.  Do  you  crave  any  specific  foods?   •  4.  Once  you  start  ea'ng,  do  you  find  it  hard  to   stop?     •  5.  Do  you  find  it  difficult  to  s'ck  to  an  ea'ng   plan?    
  • 14. EBQ  Ques'ons   •  6.  Do  you  eat  rapidly,  more  rapidly  than  those   around  you?     •  7.  Do  you  “graze”  or  eat  con'nually  during   any  part  of  a  24-­‐hour  day?   •  8.  Are  you  in  control  of  your  ea'ng?    (Reverse)   •  9.  Do  you  eat  more  when  under  stress?     •  10.  Do  you  eat  more  during  highly  emo'onal   'mes?    
  • 15. Study  Design   •  Observa'onal  prospec've  study.   •  Non-­‐randomized;  pa'ents  allowed  to  select   treatment  program.   •  Non-­‐blinded;  physician  and  pa'ent     completely  aware  of  treatment  details.   •  Sta's'cal  analysis:   – Normally  distributed  data  è  T-­‐test.   – Non-­‐normal  data  è  Wilcoxen  signed  ranks  test  
  • 16. Study  Treatment  Methods     •  Diet     –   VLCKD,  Very  Low  Carbohydrate  Ketogenic  Diet   –  Protein  1.5-­‐2.0  g/ideal  wt./day   –  ≤  40  g  carbohydrate/day   •  Behavior  Modifica'on   –  One-­‐on-­‐one  pa'ent  and  prac''oner  at  every   encounter   –  Focus  on  ea'ng  and  exercise  behaviors   •  Pharmacotherapy     –  Phentermine  mono-­‐therapy  
  • 17. TREATMENT  EXPECTATIONS   Study  treatment  methods  are  standard  prac'ce  in  the  private  prac'ce   seqng  where  this  study  was  conducted.  Treatment  results  with  this   method  have  been  published  previously:  Hendricks  EJ,  et  al.  Obesity   (Silver  Spring)  2011;19:  2351-­‐2360.    
  • 18. -­‐45.0%   -­‐40.0%   -­‐35.0%   -­‐30.0%   -­‐25.0%   -­‐20.0%   -­‐15.0%   -­‐10.0%   -­‐5.0%   0.0%   5.0%   1   8   15   22   29   36   43   50   57   64   71   78   85   92   99   106   113   120   127   134   141   148   155   162   169   Percent  Weight  Loss   Individual  PaBent  Weight  Loss  at  52  Weeks   Hendricks,  Obesity  2011;  19:2351-­‐2360.  
  • 19. -­‐120   -­‐100   -­‐80   -­‐60   -­‐40   -­‐20   0   20   1   5   9   13   17   21   25   29   33   37   41   45   49   53   57   61   65   69   73   77   81   85   89   93   97  101  105  109  113  117  121  125  129  133  137  141  145  149  153  157  161  165  169  173   1  Year  Wt.  Loss  Pounds     N  =  175   Mean  Weight  Loss  =  40  pounds   Std.  Dev.  =  25   Hendricks,  Obesity  2011;  19:2351-­‐2360.  
  • 20. 0   5   10   15   20   25   30   35   40   45   Number  of  PaBents   Loss  -­‐  Pounds   1  Year  Weight  Loss  DistribuBon    
  • 21. Variability  of  Response  to  Roux-­‐en-­‐Y   Gastric  Bypass   Hatoum,  J  Clin  Endocrinol  Metab  2011;  96:  E1630.  
  • 22. -­‐30.0   -­‐25.0   -­‐20.0   -­‐15.0   -­‐10.0   -­‐5.0   0.0   week   1   2   3   4   8   12   26   40   52   %  Weight  Loss     Phentermine  +  VLCKD  Treated  1  Year   %  Weight  Loss   Hendricks,  Obesity  2011;  19:2351-­‐2360   Systolic  BP  mm  Hg  
  • 23. -­‐30.0   -­‐25.0   -­‐20.0   -­‐15.0   -­‐10.0   -­‐5.0   0.0   %  Weight  loss     Phentermine  +  VLCKD  then  LCD  Treated  8  Years   Systolic  BP  mm  Hg   %  Weight  Loss  
  • 24. Average  Weight  Loss  vs.  Rx  Week   Week   %   Lbs.   1   -­‐3.2   -­‐6.8   2   -­‐5.0   -­‐10.6   3   -­‐6.4   -­‐13.8   4   -­‐8.0   -­‐17.2   8   -­‐12.0   -­‐25.8   Week   %   Lbs.   12   -­‐15.1   -­‐32.6   26   -­‐18.9   -­‐41.5   40   -­‐18.7   -­‐42.0   52   -­‐17.6   -­‐39.7   104   -­‐12.7   -­‐28.8  
  • 26. Study  Pa'ent  Selec'on   •  Type  A:  New  pa'ents  star'ng  VLCKD  and   phentermine.   •  Type  B:  Previous  pa'ents,  restar'ng  VLCKD   and  phentermine  ajer  a  treatment  hiatus.   •  Type  C:  Current  pa'ents,  LCD  +  drug,   treatment  sa'sfactory,  no  change  needed.   •  Type  D:  Current  pa'ents,  LCD  +  drug,   treatment  unsa'sfactory,  change  needed.  
  • 27. Criteria  for  Rx  Altera'on   •  Rx  Change  Needed:   – Weight  loss  less  than  expected   – Weight  plateau  reached  sooner  than  expected   – Weight  increase  on  maintenance   – Drug  “doesn’t  work  as  well  as  before.”   •  No  Rx  Change  Needed   – Expected  weight  loss  achieved   – Stable  maintenance  
  • 28. Study  Demographics   •  Pa'ents  Tested:  374   •  Female  86%;  Male  14%   •  Weight  196.2  (±45.4)  pounds   •  BMI  33.2  (±6.0)  Kg/m2   •  Race  %:     White/Hispanic/Black/Asian:  92/6/1/1    
  • 29. Long-­‐term  Phentermine  Rx  Dura'on   PaBent   N   MEAN   (YRS)   RANGE  (YRS)   A   58   N.A.   N.A.   B,  C,  D   316   6.0   0.1  –  20.5   Prior  Report  (1)   117   8.4   1.1  –  21.1   Prior  Report  (2)   269   -­‐   0.25  –  12.0   (1)  Hendricks,  Int  J  Obes  2014;  38:  292-­‐298.   (2)  Hendricks,  Obesity  2011;  19:2351-­‐2360  
  • 30. Normal  Distribu'on   Small  Overlap   ê  
  • 31. 0   5   10   15   20   25   30   35   5   15   25   35   45   55   65   75   85   95   Number  of  PaBents   DistribuBon  of  EBQ  Scores   Untreated   N  =  217   Mean  (SD)   62.0  (13.6)   Treated   N  =  197   Mean  (SD)   36.9  (15.7)  
  • 32. Ini'al  EBQ  Scores  (P1)   PaBent  Type   N   Mean  (SD)   T-­‐Test:  vs     Type  A   A  –  New,   Untreated   58   60.8  (10.4)       B  -­‐  Restart  ajer   Treatment  hiatus   159   62.4  (14.5)   0.4305   C  -­‐  Treated   No  change  needed     92   39.3  (14.7)   1.8  x  10-­‐17   D  –  Treated,   change  needed   65   55.0  (14.2)   0.0114  
  • 33. EBQ  Scores  P1  vs  P2   PaBent   Type     N     P1   Mean   (SD)   P2   Mean   (SD)   Δ1-­‐2   (P1-­‐P2)   T-­‐test     P1  v  P2   P  =   A.  New   43   61.3   (±11.0)   28.1   (±15.9)   33.2   (±17.4)   1.6x10-­‐18   B.   Restart   60   65.1   (±14.2)   40.1   (±14.8)   24.9   (±18.4)   4.7x10-­‐16   C.  no   change   29   37.4   (±11.5)   39.5   (±11.9)   -­‐2.1   (±8.9)   0.4970   D.  need   change   24   59.8   (±13.8)   40.3   (±15.8)   19.5   (±15.2)   3.8x10-­‐5  
  • 34. Days  Between  P1  &  P2  EBQ   PaBent  Type   Interval    (SD)   Rx  Plan   A.  New  Pa'ent     11.4  (±  7.2)   7   B.  Old  pa'ent,   previously  treated   20.1  (±  13.1)   7  -­‐  14   C.  Under  Treatment,   no  change  needed     56.6  (±  23.8)   90   D.  Under  Treatment,   change  needed   22.5  (±  12.3)   30  
  • 35. Single  Ques'on  T-­‐test  P1  vs  P2   QuesBon   P   1   2  x  10-­‐9   2   4  x  10-­‐14   3   1  x  10-­‐13   4   1  x  10-­‐13   5   1  x  10-­‐11   6   4  x  10-­‐6   QuesBon   P   7   2  x  10-­‐11   8   1  x  10-­‐9   9   4  x  10-­‐10   10   1  x  10-­‐10   Rejected*   0.03   Rejected*   0.20   *These  two  ques'ons  from  ini'al  EBQ  were  deleted.  
  • 36. Example  Case:  Type  A     •  J.M.  49  year-­‐old  W  male   •  Wt.  275.2  pounds   •  Ht.  69”   •  W.C.  46.5”   •  Fat  %  41   •  BMI  41   •  VLCKD  +  Phentermine  37.5  mg/day   •  Rx  Dura'on:  5  months,  -­‐56.8  lbs.,  -­‐20.6%    
  • 37. 0   -­‐8.8   -­‐10.8   -­‐14.3   -­‐17.2   -­‐20.6   0   -­‐8.2   -­‐12.2   -­‐15.1   -­‐17.2   -­‐18.1   -­‐25   -­‐20   -­‐15   -­‐10   -­‐5   0   0   1   2   3   4   5   %  Weight  loss     Months   J.M.  vs.  Avg.  %  Weight  Loss  through  5  months   JM   AVG   EBQ  61          EBQ  22                    EBQ  19                EBQ  12                    EBQ  17                    EBQ  12   1  Week=  22   Average  Pa'ent  Wt.  Loss  by  month  from:   Hendricks,  Obesity  2011;  19:2351-­‐2360.  
  • 38. Example  Case:  Type  B     •  M.L.  46  year-­‐old  H  female   •  Wt.  157.6  pounds   •  Ht.  61”   •  W.C.  36”   •  Fat  %  52   •  BMI  29,  (Prior  high  31)   •  VLCKD  +  Phentermine  37.5  mg/day   •  Rx  Dura'on:  3  months,  -­‐30  lbs.,  -­‐17.4%    
  • 39. 0   -­‐8.0   -­‐12.2   -­‐15.1   0   -­‐3.5   -­‐12.9   -­‐17.4   -­‐25   -­‐20   -­‐15   -­‐10   -­‐5   0   0   1   2   3   %  Weight  loss     Months   M.L.  vs.  AVG  %  Weight  loss  through  3  Months   AVG   Pt  ML   EBQ  60   1  Week=  32   EBQ  43   EBQ  42   EBQ  50   Average  Pa'ent  Wt.  Loss  by  month  from: Hendricks,  Obesity  2011;  19:2351-­‐2360.  
  • 40. Example  Case:  Type  C     •  S.A.  70  year-­‐old  W  female   •  Wt.  172.2  pounds   •  Ht.  60”   •  W.C.  42”   •  Fat  %  52   •  BMI  34   •  VLCKD  +  Phentermine  37.5  mg/day   •  Rx  Dura'on:  8  months,  -­‐22.3  lbs.,  -­‐13.5%    
  • 41. 0   -­‐3.4   -­‐5.3   -­‐7.5   -­‐9.6   -­‐9.9   -­‐12.0   -­‐12.3   -­‐13.5   0   -­‐8.0   -­‐12.2   -­‐15.1   -­‐17.2   -­‐18.1   -­‐18.8   -­‐18.8   -­‐18.9   -­‐25   -­‐20   -­‐15   -­‐10   -­‐5   0   0   1   2   3   4   5   6   7   8   %  Weight  loss     Months   S.A.  vs.  Avg.  %  Weight  Loss  through  8  Months     EBQ:    31                                  35                                                      33     -­‐22.3  #   Average  Pa'ent  Wt.  Loss  by  month  from:   Hendricks,  Obesity  2011;  19:2351-­‐2360.  
  • 42. EBQ  Comments   •  Scores  dependent  on  pa'ent’s  observa'ons.   •  Some  pa'ents  poor  at  self-­‐observa'on.   •  Inappropriate  in  our  hands  for  5%  of  pa'ents.   •  Some  untreated  pa'ents  present  with  low   scores.   •  Low  EBQ  score  may  occur  in  untreated  pa'ents   who  have  dieted  previously.   •  Pa'ents  treated  with  diet  alone  some'mes  have   high  Δ1-­‐2  
  • 43. Clinical  usefulness  of  EBQ   •  Useful  as  ancillary  metric  of  treatment   effec'veness.   •  Scores  <  50  suggest  treatment  is  effec've     •  Large  EBQ  Δ1-­‐2  suggests  good  Rx  effect.   •  Scores  >  50  suggest  no  or  ineffec've   treatment   •  Increases  pa'ent  awareness  of  Rx  effects.   •  Could  improve  long-­‐term  Rx  compliance?  
  • 44. EBQ  Summary  &  Conclusions   •  Discriminates  treated  from  untreated  pts.   •  Good  test-­‐retest  reliability.     •  Low  scores  persist  for  years  in  con'nuously   treated  pts.  with  good  response.   •  High  or  increasing  scores  are  one  indica'on   treatment    altera'on  should  be  considered.   •  Tes'ng  and  scoring  can  be  accomplished   usually  in  <  3  minutes.  
  • 45. Comments   •  These  data  suggest  the  EBQ  deserves  further   inves'ga'on.   •  The  EBQ  has  not  yet  been  validated.   •  Prac''oners  are  encouraged  to  use  the  EBQ,   and  to  assist  with  further  inves'ga'ons.   •  The  Ea'ng  Behavior  Ques'onnaire©  is   available  from  the  Obesity  Treatment   Founda'on.  
  • 46. Some  Ques'ons  for  Future  Research     •  Does  high  EBQ  Δ1-­‐2  indicate  a  good  6  month   weight  loss  (i.e.  is  the  pa'ent  a  responder)?   •  What  are  EBQ  Δ1-­‐2  values  for  other  drugs?   •  Why    do  some  pa'ents  have  low  ini'al   scores?   •  Can  the  EBQ  be  used  to  jus'fy  drug  or  dose   changes?   •  Does  high  EBQ  Δ1-­‐2  occur  with  all  treatments?  
  • 47. This  EBQ  study  was  funded  by  the  ASBP.     With  Thanks  to  Study  Collaborators:     Frank  L.  Greenway,  MD   Professor  and  Director  of  Outpa'ent  Clinic   Pennington  Biomedical  Research  Center   Louisiana  State  University   Baton  Rouge,  LA     Stacy  L.  Schmidt,  PhD   Director,  Obesity  Treatment  Founda'on     Yelena  Istra'y   Student,  Pre-­‐medicine     Sierra  College,   Rocklin,  CA     Margaret  (Mia)  J.  Hendricks   Student,  Psychology   Pepperdine  University   Malibu,  CA