Integrated weight loss and cognitive behavioural therapy (CBT) for the treatment of recurrent binge eating and high body mass index: a randomized controlled trial

Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
https://doi.org/10.1007/s40519-020-00846-2
ORIGINAL ARTICLE
Integrated weight loss and cognitive behavioural therapy (CBT)
for the treatment of recurrent binge eating and high body mass index:
a randomized controlled trial
Marly Amorim Palavras1,2 · Phillipa Hay2 · Haider Mannan2
Stephen Touyz3,5 · Angélica M. Claudino1
· Felipe Q. da Luz3,4
· Amanda Sainsbury3
·
Received: 29 October 2019 / Accepted: 8 January 2020
© Springer Nature Switzerland AG 2020
Abstract
Purpose The association between binge eating and obesity is increasing. Treatments for disorders of recurrent binge eating comorbid with obesity reduce eating disorder (ED) symptoms, but not weight. This study investigated the efficacy and
safety of introducing a weight loss intervention to the treatment of people with disorders of recurrent binge eating and a
high body mass index (BMI).
Methods A single-blind randomized controlled trial selected adults with binge eating disorder or bulimia nervosa and
BMI ≥ 27 to < 40 kg/m2. The primary outcome was sustained weight loss at 12-month follow-up. Secondary outcomes
included ED symptoms. Mixed effects models analyses were conducted using multiple imputed datasets in the presence of
missing data.
Results Ninety-eight participants were randomized to the Health Approach to Weight Management and Food in Eating
Disorders (HAPIFED) or to the Cognitive Behavioural Therapy-Enhanced (CBT-E). No between-group differences were
found for percentage of participants achieving weight loss or secondary outcomes, except for reduction of purging behaviour,
which was greater with HAPIFED (p = 0.016). Binge remission rates specifically at 12-month follow-up favoured HAPIFED
(34.0% vs 16.7%; p = 0.049). Overall, significant improvements in the reduction of ED symptoms were seen in both groups
and these were sustained at the 12-month follow-up.
Conclusion HAPIFED was not superior to CBT-E in promoting clinically significant weight loss and was not significantly
different in reducing most ED symptoms. No harm was observed with HAPIFED, in that no worsening of ED symptoms
was observed. Further studies should test approaches that target both the management of ED symptoms and the high BMI.
Level of evidence Level I, randomized controlled trial
Trial registration US National Institutes of Health clinical trial registration number NCT02464345, date of registration 1
June 2015.
Keywords Binge-eating disorder · Bulimia nervosa · Therapy · Weight loss
* Marly Amorim Palavras
[email protected]
1
Eating Disorders Program (PROATA), Department
of Psychiatry, Universidade Federal de São Paulo
(UNIFESP), Rua Major Maragliano 241, São Paulo,
SP 04017‑030, Brazil
2
School of Medicine, Translational Health Research Institute,
Western Sydney University, 1797 Locked Bag Avenue,
Sydney 2751, Australia
3
Boden Collaboration for Obesity, Nutrition, Exercise
and Eating Disorders, Faculty of Medicine and Health,
Charles Perkins Centre, The University of Sydney,
Sydney 2006, Australia
4
Eating Disorders Program (AMBULIM), Faculty
of Medicine, Universidade de São Paulo (USP), Rua
Dr. Ovidio Pires de Campos, 785, São Paulo, SP 05403‑010,
Brazil
5
School of Psychology, Faculty of Science, The University
of Sydney, Sydney 2006, Australia
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Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
Introduction
Around 40% of people in the community with eating disorders (EDs) characterized by recurrent binge eating, specifically bulimia nervosa (BN) or binge eating disorder (BED),
have a high body mass index (BMI; kg/m2) [1].This comorbidity is increasing faster than either problem alone. Darby
et al. [2] have reported that, from 1995 to 2005 in Australia,
the increase in prevalence of people with ED behaviours
comorbid with obesity is significantly higher (4.5 times)
than either the increase in prevalence of people with obesity
alone (1.6 times), or with ED behaviours without obesity
(3.1 times). The combination of an ED with obesity shows
greater mental health impact as demonstrated in an observational study in a clinical sample of women that compared
four groups—obese + BN, obese + BED, obese without ED
and normal weight controls. The authors reported more
severity for binge eating frequency, depressive and anxiety
traits, drive for thinness, body dissatisfaction, harm avoidance and self-directedness for the obese + BN group, followed by the obese + BED group, when compared with the
other two groups [3].
In a study comparing group-based cognitive behavioural
therapy (CBT) to CBT delivered online, Bulik et al. (2012)
identified that 30% of participants with BN were overweight.
Because of an observed trend of high BMI in this sample,
these authors highlighted the need to include weight management in new approaches for this disorder [4]. In a systematic review of randomized controlled trials (RCTs) reporting
psychological treatment for people with BN or BED comorbid to overweight/obesity, no study including people with
BN associated with high BMI was found [5]. Systematic and
qualitative reviews reinforce that psychological approaches
do not promote weight loss in people with BED [6–8]. Treatment for individuals with BN or BED comorbid with a high
BMI is, however, problematic because the approaches used
for weight loss generally do not focus on the presence of
binge eating and its related psychological symptoms [9, 10],
and, on the other hand, psychological treatments for EDs
are ineffective in promoting weight loss [5–8]. The efficacy
of psychological therapies treating the association between
weight loss and binge eating in adults with EDs comorbid
with high BMI was evaluated through a systematic review of
RCTs, and CBT was the most consistently tested intervention [5]. CBT reduced binge eating frequency, but not BMI
when compared with the wait list. For the same variables
(weight loss and binge eating reduction), CBT was not superior compared with active interventions, e.g., interpersonal
psychotherapy [11]. The meta-analyses showed superiority
for CBT versus behavioural weight loss therapy (BWLT)
related to binge eating reduction at the end of treatment, but
not at 12-month follow-up [5].
13
A manualized therapy named a Healthy Approach to
Weight Management and Food in Eating Disorders (HAPIFED) has been since developed [12]. Originally, a pilot
study tested this new intervention in a 20-session group
format with 11 participants receiving the therapy. At the
end of treatment, six participants had reduction of body
weight (range − 1.1 to − 6.0%) and decreased EDs symptoms (measured by the Eating Disorder Examination-Questionnaire) [12]. HAPIFED combines the main features of
CBT-Enhanced (CBT-E) [13] with BWLT that are effective
for binge eating reduction and weight loss in BED [14]. Its
aim is a modest weight loss goal of 5% of body weight that
may yet improve physical and metabolic health status [15].
In addition, self-awareness of hunger, internal appetite regulation and satiety cues are highlighted when treating these
conditions and have greater emphasis compared to external
regulation of food intake, an approach suggested by Bulik
et al. [4] and Sainsbury-Salis [16]. Compared with CBTE, HAPIFED provides more psychoeducation about a high
BMI including its risks, nutritional counselling, self-monitoring of appetite regulation, promotion of physical exercise
and the management of behavioural activation of daily routine activities that increase energy expenditure. HAPIFED
also requires the participation of a multidisciplinary team.
An important feature of HAPIFED is the longer number
of sessions (30) and treatment period (over 6 months), i.e.
one-third more sessions and 2 months longer duration than
CBT-E [13]. It may allow more time for patients to make the
necessary behavioural changes to reduce disordered eating
and weight.
The aim of this study was to examine the efficacy and
safety of introducing weight loss management in the treatment of people with disorders of recurrent binge eating and
a high BMI. The primary hypothesis of this RCT was that,
at the end of treatment, 6-month and 12-month follow-ups,
the participants receiving HAPIFED would have lost more
body weight than those receiving CBT-E. In addition, it was
hypothesized that individuals who achieved binge eating
remission would have a greater degree of weight loss than
those with continuing binge eating, regardless of intervention type. Safety was investigated in regards to concerns that
BWLT may worsen ED symptoms and comparing outcomes
of both groups on levels of EDs symptoms, i.e. binge eating,
purging behaviours or any compensatory method, restraint
and eating, weight and shape concerns.
Methods
This paper reports weight loss as the primary outcome and
ED psychopathology as the secondary outcome. Other secondary outcomes stated in clinicaltrials.gov (registration
Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
number NCT02464345) will be provided in a subsequent
publication.
Design
This was a single blind, two-arm RCT conducted at the
Eating Disorders Program (PROATA) of the Department
of Psychiatry of the Universidade Federal de São Paulo
(UNIFESP), Brazil.
Participants
Participants were recruited from July 2015 to November 2017 through the Eating Disorders Program waiting list, advertisements in radio and printed media and
printed notices. Participants were included if they were
aged ≥ 18 years, fulfilled the primary threshold or subthreshold criteria for diagnosis of BED or BN according to DSM-5
[17] and/or the proposed ICD-11 criteria [18] and had a
BMI ≥ 27 kg/m2 and < 40 kg/m2. The main exclusion criteria
were the presence of severe mental disorders, current use of
weight loss medication, history of bariatric surgery, clinical
conditions that interfere with appetite regulation, or current
psychological treatment for an ED (For details see Palavras
et al. [19]).
Sample size
The sample size calculation was based on the estimate of
a moderate effect size (i.e. 0.6) between groups for the primary outcome (weight loss). To achieve this with a power
of 0.8 and alpha = 0.05 (one-tailed test), a minimum of 36
participants per group were required according to Cohen´s
tables. Allowing for attrition, the sample size was defined
as 50 per treatment arm.
Interventions
Both treatments comprised an initial individual session followed by a 29 × 90-min group sessions twice weekly for
4 weeks, then weekly thereafter, with a total duration of
6 months. The individual session assessed the participant’s
personal history (mainly related to the ED symptoms) and
created a personalized formulation of the process that might
be contributing to sustained eating problems, in accordance
with the CBT-E model [13]. The treatment program, and
any concerns the participant might have about it, was also
clarified.
HAPIFED (experimental intervention)
HAPIFED is a multidisciplinary manualized program and
its manual has been published [12]. Four conjoint sessions
were included, involving dietician and/or an occupational
therapist plus the psychological therapists, occurring in the
first stage of therapy. Moreover, the treatment included two
home visits by the occupational therapist with the purpose
of assessing weight-maintaining habits and the domestic
environment, proposing changes in the daily routine to
favour a better management of food preparation and consumption, and stimulating physical activities. Stage one
(sessions 2–11): information about dieting, EDs diagnoses
and their main symptoms, high BMI-related health risks,
the relevance and role of life events and mood intolerance
and other aspects of the CBT-E formulation were presented.
The use of real-time self-monitoring of eating and associated behaviours, thoughts, feelings and events was a central
component introduced early in the treatment and checked in
each session. Regular times for eating, appetite awareness
according to internal versus external cues and increased fruit
and vegetable intake and exercise in the daily routine were
promoted. Stage two (session 12): the CBT-E formulation
was revised and discussed. An attempt to identify barriers to
change was also checked (fear of change, monitoring, treatment priority, etc.). Stage three (sessions 13–19): promotion
of increased activity was continued along with behavioural
experiments aimed to reduce EDs behaviours (e.g., binge
eating, excessive exercise, compensatory mechanisms) and
to establish regular meal patterns and a sense of self-control. Participants were counselled in lifestyle changes that
enhance better food choices and increase physical activity
patterns. Stage four (sessions 20–27): problem-solving and
Socratic questioning were introduced. This stage involved
the challenging of unhealthy beliefs and attitudes, which
reinforce ED behaviours. Examples are valuing oneself
according to one’s weight and shape, and the “all or nothing” type of binary thinking often experienced by people
with EDs. Specific emotion regulation skills were taught
to address mood intolerance. Stage five (sessions 28–30):
similar to the final stage of CBT, this was a preparation for
relapse prevention and review of successful cognitive and
behavioural strategies. At the end of therapy, the goal was
achieving a regular pattern of eating a varied and appetizing
diet with mild to modest energy restriction. EDs behaviours,
especially binge eating and self-induced vomiting, should be
markedly reduced or absent, and food, eating and weight no
longer dominate the person’s self-regard.
CBT‑E (control intervention)
The control intervention was CBT-E [13], which is based
on CBT, the standard leading evidence-based therapy for
BN and BED [20–22], here administered in a group format. The CBT-E [13] focus version and its broad version
comprise four stages along 20 sessions (when applied to
individuals above BMI 17.5 kg/m2). In this study, the broad
13
Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
version was used, which included additional topics (clinical
perfectionism, low self-esteem and interpersonal problems).
It has been extended to 30 sessions offered over 6 months, to
match HAPIFED in duration and number of sessions. Stage
one (sessions 2–7): aimed to engage the participant in treatment, to create the formulation, to provide psychoeducation
and to introduce real-time self-monitoring (as mentioned
above in HAPIFED), in-session weighting and regular eating. Stage two (sessions 8–9): progress was reviewed, the
formulation was revised and ongoing barriers to change
were addressed. Stage three (sessions 10–17): therapy was
provided for maintaining mechanisms, such as mood intolerance. Stage four (sessions 18–20): the participant was prepared for therapy end and continued progress beyond the
active treatment phase.
In the present study, four group follow-up sessions over
the subsequent 6 months were provided for both interventions. The same psychologists who led the group sessions
also conducted these subsequent sessions of 6-month and
12-month follow-ups. The purpose was to address relapses/
lapses, review ongoing progress and facilitate continued
improvement. (For more details on both interventions, see
Palavras et al. [19]).
1.1 Socio-demographic and clinical self-report questionnaire.
1.2 Objective measure of height and weight.
2. For psychiatric diagnoses evaluation:
2.1 Mini International Neuropsychiatric Interview–
MINI [23].
3. For ED diagnoses and symptomatology:
3.1 The Eating Disorder Examination (EDE) interview—Edition 17.0D [24]. Cronbach’s α for the global
score in this sample was 0.77 (22 items). Evaluation
of binge eating frequency and the presence of compensatory methods were based on the EDE specific
questions.
3.2 The Loss of Control over Eating Scale (LOCES)
[25]. Cronbach’s α for the current sample was 0.92
(24 items).
Treatment integrity: evaluation of blindness integrity in
the trial was checked at the end of treatment and it was conducted by asking participants to guess which group, experimental or control, they thought they were in.
Assessment
Outcomes
After a brief screening by telephone or email to check eligibility (n = 589), 191 participants were invited for in-person
interview. First, the study was further explained, eligibility criteria was double checked and informed consent was
obtained. Then a medical history was undertaken and height
and weight were obtained. Additionally, a semi-structured
interview to access psychiatric disorders’ diagnosis (including EDs) and self-report questionnaires were applied to
evaluate the presence and severity of the prospective participant’s ED. All measurements were collected after the
informed consent was signed. In a second visit, a semi-structured interview was conducted to confirm the EDs diagnosis
and to obtain detailed information on ED psychopathology
and behaviours.
Assessments occurred at baseline, mid and end therapy,
and 6- and 12-month follow-ups and were conducted on all
participants who agreed to complete evaluations, including
those who withdrew before the end of treatment. All instruments used in this study have satisfactory psychometric
properties as detailed in the previously published protocol
[19]. The final assessment occurred in March 2019 when the
length of 12-month follow-up was achieved.
The instruments used to collect the measures of this study
were:
The primary outcome of this intervention was a reduced
body weight sustained to 12 months after completion of the
intervention, considering the percentage of total body weight
loss and the percentage of participants presenting a weight
loss ≥ 5% of baseline measure. ED symptoms were secondary outcomes.
1. For socio-demographic and clinical measures:
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Randomization, masking and protection
against bias
Randomization was conducted in blocks of 20, with participants randomized in a 1:1 ratio to either a HAPIFED
or CBT-E group with up to ten participants per group. An
investigator external to the site (PH) administered the allocation using a computer-generated sequence facilitated by the
sealed envelope website (www.seale​denve​lope.com). The
therapists and therapy supervisors had access to the allocation of participants, but the individuals randomized were
blind to the treatment group. The allocation of participants
occurred after the first individual session, which was similar
for both interventions. To maintain blinding, no handouts or
written material given to participants during the intervention identified the name of the treatment (e.g. by referring
to the original therapy manual). Assessors collecting outcome data were blind to participant’s treatment arm, with
the exception of one assessor (the dietitian) who performed
Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
anthropometric measurements. A statistician blind to treatment arms conducted the outcome analyses only after the
final, 12-month follow-up.
Treatment fidelity
Therapies were guided in accordance with their treatment
manuals. Four therapists trained in both therapies conducted the treatments. Each group of two therapists provided
CBT-E and HAPIFED in turn to control for non-specific
therapists’ effect. In preparation for this RCT, therapists
experienced with CBT-E and HAPIFED (PH, Jessica Swinbourne) trained all therapists (psychologists, occupational
therapist and dietitian) and conducted monthly telephone
supervision sessions during two pilot therapy groups, one
for HAPIFED and one for CBT-E (August 2014 to February 2015). PH provided regular supervision throughout the
trial, with additional specialist supervision by AS, who has
expertise in appetite regulation and other specific approaches
to weight management. Moreover, PH visited Brazil twice
a year for 3 years for face-to-face supervision of the Brazilian team. In addition, an onsite Brazilian therapist, CM,
had undergone the Oxford CBT-E online training. During
the RCT, another author (FQdL) conducted regular qualitative appraisals of a random sample of de-identified digitally
recorded audiotaped sessions to assess for and promote fidelity to the manual.
Statistical analyses
Baseline univariate between-group tests were done to compare groups on outcome variables, as well as clinical and
demographic data. For univariate analysis, the Chi-squared
test or Fisher´s exact test was used to assess the association
between the categorical dependent variable and treatment
versus control groups. Two independent sample t tests were
performed to compare the means for between the treatment
and control groups when the outcomes followed a normal
distribution.
Linear mixed effects modelling, Poisson mixed and
logistic mixed models [26] were used to test between-group
differences for continuous, counting and binary outcome
measures, respectively. The overall effects of group, time and
time by group interactions were tested by likelihood ratio
Chi-squared tests. Whenever statistically significant time or
time by group interactions were found, multiple comparisons
using Bonferroni correction were conducted to identify distinct groups of means or proportions. Mixed effects linear
model assumed a normal distribution. This assumption was
verified using Kolmogorov–Smirnov normality test.
Effect sizes between the treatment and control groups for
a continuous or a count outcome variable were estimated
using Cohen’s d, with small, moderate and large effect
sizes being defined as 0.20–0.49, 0.50–0.79 and 0.80–1.00,
respectively [27]. For categorical outcome variables, odds
ratios were calculated, with small, moderate and large effect
sizes being defined as 1.52, 2.74 and 4.72, respectively [28].
The confidence intervals for Cohen’s d were estimated using
non-central t distributions when the outcome variables for
the two groups were normally distributed. All 95% confidence intervals were corrected for multiplicity using the
Bonferroni method.
Data were analysed following “intention-to-treat” principles. To perform all statistical analysis in the presence of
missing data, multiple imputed datasets were used based
on multivariate normal (numerical variables) or (dichotomous variables) imputation with Markov chain Monte Carlo
(MCMC) algorithm [29]. For this trial, 15 imputations were
performed. Finally, the results were pooled using Rubin’s
rules [30]. Statistical analyses were performed using STATA
15 [31], with a small number of analyses (i.e. for baseline
socio-demographic and clinical features) being performed
using SPSS version 20 for Windows [32].
Results
Participants
Ninety-eight participants were randomized to enter the trial.
Fifty participants were allocated in the experimental intervention group (HAPIFED) and 48 in the control intervention
group (CBT-E). Dropout rates along the study time points
for the total sample (N = 98) were: 31.6%, 48.0% and 36.7%
for end of treatment, 6-month follow-up and 12-month follow-up, respectively. Attrition did not differ between groups
along the stages of the trial. Figure 1 outlines the participant’s flowchart diagram.
This sample consisted mainly of women (96%) who were
white (75%) and employed (60%). Almost half of the participants were married (45%) and had completed a tertiary
degree (43%). The mean age was 41 (SD 11.7) years, and the
mean BMI was 33.68 (SD 3.31) kg/m2. The most prevalent
psychiatric comorbidities among participants were major
depressive episodes (32%) and generalized anxiety disorder
(47%). Thirty-four percent of the participants were taking
medication for diabetes mellitus and 12% were on psychotropic/antidepressant medication.
Sixty-six (67.3%) participants met the DSM-5 diagnostic
criteria for BED and 13 (13.3%) for BN. Of the remaining 19 participants, 5 (5.1%) had other specified feeding or
eating disorder (OSFED) BED-type, 7 (7.1%) had OSFEDBN type and 7 (7.1%) unspecified feeding or eating disorder
(UFED). Of those receiving UFED diagnosis, all reported
regular recurrent binge eating, but five did not fulfil Criterion B or C for BED, one with recurrent binge eating and
13
Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
Assessed for eligibility
(n = 589)
Randomized
(n = 98)
Allocated to HAPIFED group (n = 50)
Received allocated intervention (n = 46)
Did not receive allocated intervention
(n = 4)
Got sick (n = 2)
Got a job (n = 2)
Excluded (n = 491)
Declined (n = 266)
Not meeting selection criteria
(n =190)
Other reasons (n = 35)
Allocated to CBT-E group (n = 48)
Received allocated intervention (n = 44)
Did not receive allocated intervention
(n = 4)
No interest (n = 2)
Got a job (n = 2)
Middle of treatment
Assessed (n = 42)
Discontinued intervention (n = 4)
Lost to follow-up (n = 4)
Middle of treatment
Assessed (n = 35)
Discontinued intervention (n = 5)
Lost to follow-up (n = 8)
End of treatment
Assessed (n = 37)
Discontinued intervention (n = 8)
Lost to follow-up (n = 5)
End of treatment
Assessed (n = 30)
Discontinued intervention (n = 10)
Lost to follow-up (n = 8)
Follow-up 6 months
Assessed (n = 28)
Discontinued intervention (n = 10)
Lost to follow-up (n = 12)
Follow-up 6 months
Assessed (n = 23)
Discontinued intervention (n = 12)
Lost to follow-up (n = 13)
Follow-up 12 months
Assessed (n = 31)
Discontinued intervention (n = 7)
Lost to follow-up (n = 12)
Follow-up 12 months
Assessed (n = 31)
Discontinued intervention (n = 6)
Lost to follow-up (n = 11)
Analysed (n = 50)
Analysed (n = 48)
Excluded from analysis (n = 0)
Excluded from analysis (n = 0)
Fig. 1 Participant flowchart
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Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
self-induced vomiting episodes did not meet Criterion D
for BN, and one met all criteria for BN, but only reported
subjective binge eating.
As shown in Table 1, treatment groups did not differ at
baseline in any socio-demographic or clinical features, with
the exception of the EDE restraint subscale (p = 0.042), for
which the HAPIFED group showed a higher level of eating
restraint behaviours.
Outcomes
The outcome findings are summarized in Table 2 and all participants (n = 98) were analysed by original assigned groups
in all outcome measures.
Primary outcome: weight loss
No differences were found for between-group comparisons
in weight loss measures, in the percentage of total body
weight loss (χ2(3) = 0.19, p = 0.979) or in the percentage
of participants presenting a weight loss ≥ 5% of baseline
weight (χ2(3) = 0.22, p = 0.974). A time effect was found
for ≥ 5% body weight loss measures from baseline to end
of treatment (using Bonferroni-adjusted correction for multiple comparisons), which was sustained across the 6- and
12-month follow-up (χ2(3) = 9.06, p = 0.029). At 12-month
follow-up, 20.5% of participants in the HAPIFED group and
21.9% in the CBT-E group achieved ≥ 5% of body weight
loss (Table 2).
Secondary outcomes
Binge eating
Although no differences were found for between-group
comparisons for the frequency of objective binge eating
(OBE) and subjective binge eating (SBE), a time effect was
observed for both types of binge eating (p < 0.001). The
mean OBE frequency decreased from baseline to end of
treatment and was sustained in subsequent time points in
both groups. For SBE, the mean frequency also decreased
from baseline to end of treatment and did not change until
the 6-month follow-up, but increased in the 12-month follow-up, as shown in Table 2.
Complete abstinence from any type of binge eating was
considered for the definition of the variable binge eating
remission. No difference in between-group comparisons was
found in the group x time interaction analysis. However, a
post hoc analysis revealed that, specifically at the 12-month
follow-up, a greater percentage of individuals (34.0% versus 16.7%) achieved binge eating remission in the HAPIFED group (χ 2(1) = 3.97, p = 0.049). In addition, binge
eating remission was not associated with greater reduction
of weight at any time point of the study in the whole sample
(end of treatment: p = 0.654; 6-month follow-up: p = 0.528;
12-month follow-up: p = 0.589).
ED behaviours and psychopathology
As EDE restraint differed between groups at baseline (group
x time interaction: χ2(3) = 7.90, p = 0.048), an adjusted analysis of this outcome using the EDE restraint subscale as a
covariable in the model was conducted, but results did not
alter previous findings (χ2(1) = 2.47, p = 0.116).
No differences were observed for the presence of “any”
type of compensatory behaviour between groups at any time
point, but a greater reduction of any “purging” behaviour
(group x time interaction: χ 2(3) = 10.35, p = 0.016) was
found favouring HAPIFED. The percentage of any purging
behaviour between groups was higher (18.8%) in CBT-E
than in HAPIFED (6.0%) at the 6-month follow-up (Wald
χ 2(1) = 9.321, p = 0.002), but not different at other time
points (Wald χ2(2) = 3.21, p = 0.201).
Group x time interaction analyses did not find betweengroup differences for any measure of ED psychopathology as measured with the EDE subscales and LOCES,
although a trend favouring HAPIFED was observed for EDE
global score (p = 0.051) and EDE weight concern subscale
(p = 0.054). Bonferroni-adjusted comparisons for time effect
showed significant differences for restraint, as well as for
concerns about eating, shape and weight, which decreased
in severity from baseline to end of treatment, stabilizing over
the follow-up period (p < 0.001). Loss of control over eating
(LOCES scores) significantly decreased from baseline until
the 12-month follow-up (p < 0.001).
A further outcome was achieving a global EDE
score ≤ one standard deviation of the community mean
(EDE global score cutoff = 1.737) [13]. A time effect was
observed for the reduction in the percentage of individuals remaining above one standard deviation of EDE global
mean. At the end of treatment, 61.5% (HAPIFED group)
and 58.6% (CBT-E group) achieved a global EDE global
score ≤ 1.737, and for 12-month follow-up, the values were
67.7% and 52.5%, respectively.
Protocol integrity and blinding
Protocol violations (antidepressant prescription) occurred in
seven participants due to worsening of depressive symptoms
(3.3% CBT-E versus 16.2% HAPIFED; p = 0.120).
Participant blinding was examined at the end of treatment
questionnaires, and of the 65 who replied to this question,
55.4% (36/65) chose the correct treatment allocation. This
was equally distributed between groups (p = 0.140).
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Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
Table 1 Baseline sociodemographic and clinical
features of treatment groups
(n = 98)
Gender, female
Ethnicity
White/Caucasian
Black/African/Asian*
Marital status
Married
Single
Divorced/widowed
Educational level
Completed middle school
Completed high school
Completed undergraduation
Completed postgraduation
Current occupation
Employed
Not employed
Student
Housewife
Presence of current major depressive episodes
Presence of any current anxiety disorder
Use of psychotropic medication
Use of diabetes medication
DSM-5 diagnoses
Binge eating disorder
Bulimia nervosa
OSFED
UFED
Presence of any purging behaviour
Presence of any compensatory behaviour
Age, years
Weight, kg
Body mass index (kg/m2)
Eating disorder illness duration
EDE global score
EDE restraint subscale
EDE eating concern subscale
EDE shape concern subscale
EDE weight concern subscale
Loss of Control over Eating Scale
Current (3-month) frequency of objective binge eating
HAPIFED
(n = 50)
CBT-E
(n = 48)
p
N (%)
48 (96.0)
46 (96.0)
38 (77.6)
11 (22.4)
35 (74.5)
12 (25.5)
1.000a
0.904c
22 (44.0)
22 (44.0)
6 (12.0)
22 (45.8)
19 (39.6)
7 (14.6)
2 (4.0)
17 (34.0)
24 (48.0)
7 (14.0)
0 (0.0)
21 (43.8)
18 (37.5)
9 (18.8)
30 (60.0)
14 (28.0)
3 (6.0)
3 (6.0)
15 (30.0)
27 (54.0)
7 (14.0)
18 (36.0)
29 (60.4)
14 (29.2)
1 (2.1)
4 (8.3)
16 (33.3)
22 (45.8)
5 (10.4)
15 (31.3)
30 (60.0)
8 (16.0)
8 (16.0)
4 (8.0)
9 (18.0)
16 (32.0)
Mean (SD)
40.90 (11.47)
88.96 (11.93)
33.62 (3.19)
15.18 (10.09)
2.72 (0.82)
2.05 (1.24)
1.56 (1.14)
3.78 (1.05)
3.49 (1.02)
3.28 (0.57)
40.10 (30.39)
36 (75.0)
5 (10.4)
4 (8.4)
3 (6.3)
9 (18.8)
9 (18.8)
40.19 (12.05)
89.59 (13.34)
33.74 (3.47)
14.74 (11.56)
2.40 (0.79)
1.58 (0.98)
1.44 (1.19)
3.53 (1.24)
3.08 (1.17)
3.13 (0.66)
38.67 (29.19)
0.940c
0.375c
0.841c
0.723b
0.419b
0.589b
0.619b
0.597c
0.924b
0.132b
0.765b
0.805a
0.854a
0.849a
0.057a
0.042a
0.619a
0.285a
0.068a
0.257a
0.812a
CBT-E Cognitive behavioural therapy-enhanced, DSM Diagnostic and statistical manual of mental disorders, EDE Eating disorder examination, HAPIFED Health approach to weight management and food in
eating disorders, OSFED other specified feeding or eating disorder, UFED unspecified feeding or eating
disorder
*There was only one Asian participant
a
13
T test;bx2test;cFisher’s test
HAPIFED
CBT-E
HAPIFED
CBT-E
HAPIFED
CBT-E
HAPIFED
CBT-E
HAPIFED
CBT-E
HAPIFED
CBT-E
HAPIFED
EDE weight
concern
EDE shape
concern
EDE restraint
EDE eating
concern
Current
frequency
of OBE last
3 months
Current
frequency
of SBE last
3 months
LOCES
CBT-E
HAPIFED
CBT-E
EDE global
% reduction in HAPbody weight/ IFED
kg
CBT-E
Group
3.13
(0.10)
2.72
(0.12)
2.40
(0.11)
3.49
(0.15)
3.08
(0.17)
3.78
(0.15)
3.53
(0.18)
2.05
(0.18)
1.58
(0.14)
1.56
(0.16)
1.44
(0.17)
40.10
(4.30)
38.67
(4.21)
10.30
(3.48)
10.17
(2.91)
3.28
(0.08)
n.a
n.a
Mean
(SE)
Baseline
Cohen’s d Mean
(95% CI) (SE)
1.92
(0.13)
28.55, 3
(< 0.001)
42.79, 3
(< 0.001)
145.25, 3 5.82, 3
(< 0.001) (0.121)
105.07, 3 7.10, 3
(< 0.001) (0.069)
1.14, 1
0.00
( − 0.40 to (0.286)
0.39)
0.51, 1
0.11
( − 0.28 to (0.477)
0.51)
0.06, 1
0.23
( − 0.17 to (0.811)
0.63)
0.00, 1
− 0.04
( − 0.43 to (0.976)
0.36)
(0.13)
32.63, 3
(< 0.001)
1.28, 1
0.22
( − 0.18 to (0.257)
0.61)
(0.15)
34.76, 3
(< 0.001)
3.37, 1
0.26
( − 0.14 to (0.067)
0.66)
1.23, 1
0.05
( − 0.35 to (0.268)
0.44)
51.91, 3
(< 0.001)
3.68, 1
0.19
( − 0.21 to (0.055)
0.58)
305.23, 4 4.29, 4
(< 0.001) (0.368)
3.50, 3
(0.320)
3.75, 3
(0.290)
5.32, 3
(0.150)
7.63, 3
(0.054)
7.76, 3
(0.051)
0.19, 3
(0.979)
1.19, 3
(0.756)
0.02, 1
0.02
( − 0.38 to (0.896)
0.41)
Group ×
time
Chi sq, df
(p value)
− 0.01
− 0.02
( − 0.41 to (1.11)
0.38)
0.14
(1.41)
1.42
0.03
( − 0.36 to (0.16)
0.43)
1.63
(0.16)
1.87
− 0.02
( − 0.42 to (0.22)
0.38)
2.29
(0.24)
2.42
0.04
( − 0.36 to (0.21)
0.44)
2.75
(0.22)
0.84
0.00
( − 0.40 to (0.50)
0.40)
0.82
(0.53)
0.55
0.12
( − 0.27 to (0.13)
0.52)
0.66
(0.15)
3.98
− 0.04
( − 0.44 to (2.58)
0.35)
8.32
(2.75)
8.37
0.03
( − 0.37 to (3.74)
0.42)
7.45
(3.50)
1.69
0.10
( − 0.29 to (0.11)
0.50)
1.73
Time
0.42
0.03
( − 0.37 to (1.09)
0.42)
0.28
(1.21)
1.42
− 0.13
( − 0.53 to (0.14)
0.26)
1.45
(0.16)
1.93
− 0.05
( − 0.45 to (0.22)
0.34)
1.91
(0.22)
2.60
− 0.02
( − 0.41 to (0.21)
0.38)
2.66
(0.23)
0.61
− 0.11
( − 0.50 to (0.50)
0.29)
0.61
(0.57)
0.54
− 0.18
( − 0.57 to (0.12)
0.22)
0.64
(0.12)
5.07
0.05
( − 0.34 to (2.18)
0.45)
4.42
(2.10)
0.77
− 0.22
( − 0.61 to (0.53)
0.18)
0.86
(0.37)
1.89
0.01
( − 0.38 to (0.15)
0.41)
2.00
Group
Cohen’s d Chi sq, df Chi sq, df
(95% CI) (p value) (p value)
12-month follow-up
Cohen’s d Mean
(95% CI) (SE)
6-month follow-up
Cohen’s d Mean
(95% CI) (SE)
End of treatment
− 0.22
0.03
( − 0.37 to (0.78)
0.43)
− 0.31 (0.71)
− 0.06
(0.88)
n.a
n.a
1.67
(0.17)
n.a
1.52
(0.15)
n.a
n.a
2.22
(0.19)
n.a
2.15
(0.19)
n.a
n.a
2.71
(0.19)
n.a
2.68
(0.20)
n.a
n.a
0.96
(0.42)
n.a
0.65
(0.43)
n.a
n.a
0.84
(0.18)
n.a
0.63
(0.16)
n.a
n.a
4.85
(2.01)
n.a
5.63
(2.35)
n.a
n.a
5.35
(3.03)
n.a
1.34
(2.11)
2.33
0.00
1.91
(0.12)
( − 0.39 to 0.40)
(0.13)
− 0.45 (0.67)
− 0.23
( − 0.63 to
0.17)
2.34
(0.13)
− 0.01
( − 0.40 to
0.39)
− 0.05
( − 0.44 to
0.35)
− 0.10
( − 0.50 to
0.30)
− 0.42
( − 0.82 to
0.02)
− 0.22
( − 0.61 to
0.18)
− 0.37
( − 0.77 to
0.03)
− 0.39
( − 0.79 to
0.01)
n.a
Cohen’s d Mean (SE)
(95% CI)
Middle of treatment
Table 2 Outcomes of each group for the total sample using imputation (n = 98 in all analyses, being n = 50 in HAPIFED and n = 48 in CBT-E) and mixed effect models
Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
13
13
HAPIFED
CBT-E
Above 1
standard
deviation
EDE global
score
n.a
18.0
(5.4)
18.8
(5.6)
32.0
(6.6)
18.8
(5.6)
90.0
(4.2)
81.3
(5.6)
n.a
% (SE)
Mean
(SE)
Baseline
2.08
(0.64 to
6.72)
2.04
(0.8 to
5.21)
0.95
(0.34 to
2.64)
Odds
Ratio
(95%
CI)
n.a
n.a
n.a
n.a
n.a
n.a
5.7 (4.6)
n.a
5.9 (3.8)
% (SE)
Cohen’s d Mean (SE)
(95% CI)
n.a
n.a
n.a
1.15
(0.1 to 12.97)
38.5 (7.5) 0.89
(0.36 to
2.18)
41.4 (7.8)
26.0 (6.2) 2.06
(0.74 to
5.71)
14.6 (5.1)
Odds
Ratio
(95%
CI)
12.3 (5.6) 0.79
(0.19 to
3.30)
15.0 (6.3)
12.0 (4.6) 0.80
(0.25 to
2.57)
14.6 (5.1)
% (SE)
Time
1.57, 1
(0.210)
32.3 (7.6) 0.52
(0.2 to
1.38)
47.5 (8.4)
24.31, 3
(< 0.001)
3.55, 3
(0.314)
2.25, 1
(0.134)
24.0 (6.0) 1.20
(0.46 to
3.11)
20.8 (5.9)
33.2 (8.1) 0.98
(0.37 to
2.63)
33.5 (7.7)
3.25, 3
(0.355)
0.00, 1
(0.961)
22.0 (5.9) 1.22
(0.46 to
3.28)
18.8 (5.6)
9.06, 3
(0.029)
0.05, 1
(0.825)
Odds
Ratio
(95%
CI)
20.5 (6.6) 0.92
(0.32 to
2.65)
21.9 (7.2)
8.0 (3.8) 0.43
(0.12 to
1.55)
16.7 (5.4)
% (SE)
Odds
Ratio
(95%
CI)
17.2 (7.5) 0.73
(0.19 to
2.84)
21.7 (7.0)
6.0 (3.4) 0.28
(0.07 to
1.09)
18.8 (5.6)
% (SE)
Group
Cohen’s d Chi sq, df Chi sq, df
(95% CI) (p value) (p value)
12-month follow-up
Cohen’s d Mean
(95% CI) (SE)
6-month follow-up
Cohen’s d Mean
(95% CI) (SE)
End of treatment
Cohen’s d Mean
(95% CI) (SE)
Odds Ratio (95% CI)
Middle of treatment
4.39, 3
(0.222)
6.83, 3
(0.078)
10.35, 3
(0.016)
0.22, 3
(0.974)
Group ×
time
Chi sq, df
(p value)
Presence of any purging behaviour: HAPIFED BL > EoT = 6 M FU = 12 M FU, CBT-E BL = EoT = 6 M FU = 12 M FU, group comparison 6 M FU: A > B, for another time of evaluation there
were no differences between groups
Bonferroni-adjusted correction for multiple comparisons interaction group × time
CBT-E cognitive behavioural therapy – enhanced, EDE Eating Disorder Examination interview, HAPIFED Health Approach to Weight Management and Food in Eating Disorders, LOCES Loss
of Control over Eating Scale, OBE objective binge eating episode, SBE subjective binge eating episode
HAPIFED
CBT-E
Presence of
any compensatory
behaviour
Achieved ≥ 5% HAPIFED
reduction in
body weIght CBT-E
HAPPresence of
IFED
any purging
behaviour
CBT-E
Group
Table 2 (continued)
Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
Discussion
To our knowledge, this is the first RCT that has tested a new
intervention (HAPIFED) examining the efficacy and safety
of integrating CBT with weight loss management in the
treatment of people with disorders of recurrent binge eating
and a high BMI. In this RCT, HAPIFED was not different
from CBT-E for measures of weight loss (primary outcome).
A greater reduction of purging behaviours was observed in
individuals receiving HAPIFED, but only a limited number
of participants included in the trial presented this behaviour.
Overall, significant reductions were observed in both groups
for most primary and secondary outcomes with end of treatment measures, and up to 12-month follow-up (i.e. loss of
control over eating). Binge remission was not associated
with greater weight loss in this trial.
A modest weight loss (≥ 5% of body weight) has been
found to show improvements in the medical status of individuals with a high BMI [15]. However, and in line with
findings in the literature relative to psychological approaches
to BED associated with high BMI [5–8], HAPIFED did not
significantly improve weight loss over CBT-E in this trial,
with only about 12% of individuals achieving ≥ 5% of baseline weight at the end of treatment, and around 21% at the
12-month follow-up. It is unclear why HAPIFED did not
promote weight change at least in the range observed for lifestyle interventions. It is possible that the "dose" of therapy
dedicated to weight management in HAPIFED was insufficient to achieve weight loss. In addition, a higher level of
impairment due to the combination of EDs with recurrent
binge eating and high BMI may have influenced the lack of
expected weight loss.
Nevertheless, a relevant improvement of the ED psychopathology (EDE and binge eating measures) was achieved
from baseline to the end of the active interventions (time
effect). The reduction in measures of ED psychopathology is
reflected in the finding of reduction in the percentage of participants that presented EDE global scores remaining above
one standard deviation of the mean EDE global score (based
in community norms) [13] in the course of the study. In
other words, many individuals reduced their ED symptoms
to levels commonly encountered in the general population,
in line with findings of other studies [20, 33, 34].
Systematic reviews support the effectiveness of CBT in
promoting binge eating abstinence in people with BED,
with rates varying from 22.5% (at the end of treatment and
4-month follow-up) [35], 61% (end of treatment), 58% (12month follow-up) [36] and 52% (4-year follow-up) [37]. For
BN, binge abstinence rates tend to be lower in trials testing
CBT (and other therapies), being in the range of 12%–50% at
the end of treatment and 15% at 1-year follow-up [38]. This
study identified apparently lower abstinence rates of binge
eating (around 30% at the end of treatment and 34% at the
12-month follow-up for HAPIFED) compared to the literature. However, our measure was based on the frequency of
binge eating in the last 3 months, while studies usually report
on 15–28 days’ abstinence of binge eating. It is of note that,
although both objective and subjective binge eating showed
significant reductions in frequency over the course of the
study, objective binge eating showed significant reduction
during the treatment phase and stabilized during the followups (up to 12 months). Subjective binge eating reduction
was maintained only up to 6 months and increased after that.
This result may seem contradictory with the finding of continuous improvement and reduction of loss of control over
eating (LOCES) score, but this scale reflects loss of control
in both types of binges, and all but one individual included
in this trial reported objective binge eating.
In this RCT, a significantly greater decrease of any purging behaviour favouring HAPIFED was found. Our positive
finding was an isolated result that must be considered with
caution due to the small number of participants with BN
included. However, when taken together with the similar
effects obtained with CBT on reduction of ED measures and
binge eating reduction, it reinforces the safety of HAPIFED
in relation to the introduction of weight management for
people with BN and high BMI. In other words, introduction
of approaches to healthy eating and weight management did
not worsen ED symptoms.
The mean dropout rates in this trial were higher at the
end of treatment (31.6%) compared to a mean around 24%
reported in a recent meta-analysis of RCTs testing CBT
for ED [39]. Nonetheless, the authors highlighted the large
range of dropout definition in studies. A novelty in this trial
is the greater number of sessions (30) offered, aiming to
propose a reasonable time for changes in ED behaviours
and weight loss. This higher number is supported by Ariel
et al. [40], who reported that a higher duration of sessions
(from 16 to 24 sessions) in behavioural treatment could promote better results for binge eating severity compared to a
smaller duration (8 sessions). However, the authors reported
that no additional improvements were observed comparing a
high dose (24 sessions) versus a moderate dose (16 sessions)
of treatment. Thus, an optimum dose for HAPIFED needs
to be reconsidered, as it is possible that the long duration
of the treatment influenced the attrition rates. Participants
described struggling to meet competing demands of therapy and employment and having paid employment has been
reported to increase the risk of attrition [41].
It is known that findings of small effect sizes in the
psychology field are common (around 30% of findings
are below a Cohen´s d of 0.2) and effects in the 0.05–0.2
range are frequently reported in medical research; however, even small effect sizes may have clinical impact [42].
Our results were mostly of small effect sizes favouring the
13
Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
HAPIFED approach; thus, replication in larger samples is
needed to clarify the benefits of this new approach.
In the future, research approaches to the conjoint conditions of this trial require innovative techniques that can
handle the complexity of this combination. New integrative strategies with the goal of targeting both binge remission and weight loss are being developed. Cooper et al.
[43] proposed a new model to be tested combining CBT-E
and CBT for high BMI for individuals with BED comorbid
to high BMI. Pattinson et al. [44] have designed a new
prospective study to test the real-world effectiveness of
HAPIFED, including people with BED and BN comorbid
to high BMI.
The strengths of this study are the novelty of introducing an integrative approach that targets ED psychopathology and weight management for people with disorders of
recurrent binge eating and a high BMI, which resulted in
the improvement (not worsening) of ED symptoms. The
participants were blind to group, and an intention-to-treat
approach was applied to analyses, reducing risk of bias.
Limitations include moderate attrition, a small number of
participants with BN, as well as the low number of men,
limiting generalizability and precluding subgroup analyses. The lack of a greater effect of HAPIFED on weight
loss compared to CBT-E and the moderate attrition support the need of restructuring interventions to better tackle
these goals. Finally, this study suggests that this new multidisciplinary psychological approach (HAPIFED) may be
used when participants clearly look for help for addressing
both ED symptoms and weight problem, or where individuals with BN or BED present in the context of weight
loss treatment (e.g. in multidisciplinary metabolic clinics
where the primary goal is weight loss management). As
a standalone therapy, HAPIFED may need to be extended
to enhance its weight loss management strategies, such as
firmer emphasis and monitoring of portion sizes. HAPIFED, in the modified form, may also be appropriate for
people at risk of recurrent binge eating relapse, where the
goal is weight loss maintenance following a weight loss
treatment.
What is already known on this subject?
Over half of the people with BN and/or BED are of a high
BMI. To our knowledge, however, no study has tested as yet
a psychological approach that integrates the management of
weight and recurrent binge eating in individuals with these
EDs and a high BMI, especially for people with bulimia
nervosa.
13
What does this study add?
This study suggests that this new approach (HAPIFED)
integrating the expertise of an interconnected and multidisciplinary team of professionals can safely treat weight
and EDs behaviours (e.g. recurrent binge eating) in a
group format, joining individuals with BN and BED (a
transdiagnostic approach) and high BMI. The reduction of
binge eating and improvement of other related ED symptoms were comparable to those observed with CBT, the
intervention with greater evidence of efficacy in the field.
The progress of research focused on the improvement of
techniques that can safely and effectively manage this
specific combination (BN or BED and high BMI) may
help reduce the burden of the growing number of people
affected by both conditions.
Conclusion
HAPIFED presented good results for the improvement of
ED symptomatology in people with disorders of recurrent
binge eating associated with high BMI, but did not achieve
greater weight loss than CBT-E. Further studies should
test approaches that effectively target the management of
ED symptoms and high BMI.
Acknowledgements The authors acknowledge Jessica Swinbourne
who contributed to the HAPIFED manual development, Nara Mendes
who contributed to the translation of LOCES and protocol development, Mireille Coelho and Mitti Koyama for the support with different
aspects of the trial and the entire team of professionals from PROATA
who collaborated with the study execution.
Author contributions All authors contributed to the study conception
and design. Material preparation and data collection were performed by
Marly A. Palavras, and analysis was performed by Marly A. Palavras,
Haider Mannan, Phillipa Hay and Angélica M. Claudino. The first draft
of the manuscript was written by Marly A. Palavras, Phillipa Hay and
Angélica M. Claudino. All authors commented on previous versions
of the manuscript. All authors read and approved the final manuscript.
Funding This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior–Brasil (CAPES)–Finance
Code 001. PH was part supported by the School of Medicine WSU
for travel to Sao Paulo including sabbatical leave in 2012. AS was
supported by the National Health and Medical Research Council
(NHMRC) of Australia via Senior Research Fellowships (1042555
and 1135897) and via a Sydney Outstanding Academic Researcher
(SOAR) Fellowship–the University of Sydney. FQdL was supported
by The São Paulo Research Foundation (FAPESP) via a Young Investigator Fellowship.
Data availability The datasets generated during and/or analysed during the current study are available from the corresponding author on
reasonable request.
Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
Compliance with ethical standards
Conflicts of interest Marly A. Palavras participated in a 2016 meeting
of an advisory board for the treatment of binge eating disorder at Shire
Pharmaceuticals, Brazil. Phillipa Hay receives/has received sessional
fees and lecture fees from the Australian Medical Council, Therapeutic
Guidelines publication and New South Wales Institute of Psychiatry;
royalties/honoraria from Hogrefe and Huber, McGraw Hill Education,
Blackwell Scientific Publications, Biomed Central and PlosMedicine;
and has received research grants from the NHMRC and ARC. She is
Chair of the National Eating Disorders Collaboration Steering Committee in Australia (2019–) and a Member of the ICD-11 Working
Group for Eating Disorders (2012–2018) and was Chair of the Clinical Practice Guidelines Project Working Group (Eating Disorders) of
RANZCP (2012–2015). She has received honoraria from Shire Pharmaceuticals for educational seminars for psychiatrists and prepared a
commissioned report. Angélica M. Claudino is a member of the World
Health Organization Working Group on Feeding and Eating Disorders
for the Revision of ICD-10 Mental and Behavioral Disorders. Amanda
Sainsbury is the author of The Don’t Go Hungry Diet (Bantam, Australia and New Zealand, 2007) and Don’t Go Hungry for Life (Bantam,
Australia and New Zealand, 2011). She has also received payment
from Eli Lilly, the Pharmacy Guild of Australia, Novo Nordisk, the Dietitians Association of Australia, Shoalhaven Family Medical Centres,
the Pharmaceutical Society of Australia, and Metagenics for presentation at conferences, and served on the Nestlé Health Science Optifast® VLCDTM Advisory Board from 2016 to 2018. Stephen Touyz
receives royalties from Hogrefe and Huber, Routledge and McGrawHill Publishers. He has also been the recipient of honoraria and travel
and research grants from Shire Pharmaceuticals. He has chaired their
Australian Binge-Eating Disorder Advisory Board and has been the
author of commissioned reports. All views expressed in these reports
have been his own. He is a mental health advisor to the Australian
Commonwealth Department of Veterans Affairs and a consultant to
Weight Watchers (WW). Haider Mannan and Felipe Quinto da Luz
have no conflicts of interest to report.
Ethical approval All procedures performed in studies involving human
participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki
Declaration and its later amendments or comparable ethical standards.
The study was approved by the Human Research Ethics Committee of
UNIFESP (CAAE 43874315.4.0000.5505).
Informed consent Informed consent was obtained from all participants
included in the study.
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