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The EBQ is a novel behavioral psychometric scale for clinical evaluation of treatment effectiveness in treating overweight and obese patients with diet, lifestyle modification and pharmacotherapy.
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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
Percen
t 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
Num
ber o
f PaB
ents
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
% W
eight 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
% W
eight 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
Num
ber o
f PaB
ents
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
% W
eight 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
% W
eight 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
% W
eight 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
