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OBES SURG

DOI 10.1007/s11695-016-2337-3

ORIGINAL CONTRIBUTIONS

Project HELP: a Remotely Delivered Behavioral


Intervention for Weight Regain after Bariatric Surgery
Lauren E. Bradley 1 & Evan M. Forman 2 & Stephanie G. Kerrigan 2 &
Stephanie P. Goldstein 2 & Meghan L. Butryn 2 & J. Graham Thomas 3 &
James D. Herbert 2 & David B. Sarwer 4

# Springer Science+Business Media New York 2016

Abstract ceive the 10-week intervention. Participants were assessed at


Background Weight regain following bariatric surgery is baseline, mid-treatment, post-treatment, and at 3-month fol-
common and potentially compromises the health benefits ini- low-up.
tially attained after surgery. Poor compliance to dietary and Results Support for the intervention’s feasibility and accept-
physical activity prescriptions is believed to be largely respon- ability was achieved, with 70 % retention among those who
sible for weight regain. Patients may benefit from developing started the program and a high mean rating (4.7 out of 5.0) of
specialized psychological skills necessary to engage in posi- program satisfaction among study completers. On average,
tive health behaviors over the long term. Unfortunately, pa- weight regain was reversed with a mean weight loss of
tients often face challenges to physically returning to the bar- 5.1 ± 5.5 % throughout the intervention. This weight loss
iatric surgery program for support in developing and maintain- was maintained at 3-month follow-up. Significant improve-
ing these behaviors. Remotely delivered interventions, in con- ments in eating-related and acceptance-based variables also
trast, can be conveniently delivered to the patient and have were observed.
been found efficacious for a number of health problems, in- Conclusions This pilot study provides initial support for the
cluding obesity. To date, they have received little attention feasibility, acceptability, and preliminary efficacy of a remote-
with bariatric surgery patients. The study aimed to evaluate a ly delivered acceptance-based behavioral intervention for
newly developed, remote acceptance-based behavioral inter- postoperative weight regain.
vention for postoperative weight regain.
Methods Patients at least 1.5 years out from surgery who ex- Keywords Postoperative weight regain . Behavioral
perienced postoperative weight regain were recruited to re- intervention . eHealth . The research described in this paper

* Lauren E. Bradley James D. Herbert


lauren_e_bradley@rush.edu jh49@drexel.edu
David B. Sarwer
Evan M. Forman
dsarwer@temple.edu
evan.forman@drexel.edu
Stephanie G. Kerrigan 1
Department of Behavioral Sciences, Rush University Medical
sgk36@drexel.edu Center, 1645 W. Jackson Blvd. Suite 400, Chicago, IL 60625, USA
Stephanie P. Goldstein 2
Department of Psychology, Drexel University, Philadelphia, PA,
spg38@drexel.edu USA
Meghan L. Butryn 3
Weight Control and Diabetes Research Center, Warren Alpert
mlb34@drexel.edu Medical School of Brown University, Providence, RI, USA
4
J. Graham Thomas Center for Obesity Research and Education, Temple University,
John_G_Thomas@brown.edu Philadelphia, PA, USA
OBES SURG

was supported in part by grants to the first author from the one’s willingness to experience a range of internal experiences
American Psychological Association and the Society for a (e.g., thoughts, emotions, urges) in order to behave in ways
Science of Clinical Psychology. consistent with what is most important to them [18–20]. These
interventions are largely based on Acceptance and
Commitment Therapy (ACT) [21]. ABTs for weight control
Introduction/Purpose specifically target the challenges faced by postoperative pa-
tients by helping individuals enact goal-directed behaviors
Although bariatric surgery is the most successful weight loss (e.g., healthy eating, physical activity) that are in line with
treatment, 20–30 % of patients fail to reach targeted weight one’s values in spite of aversive (or non-preferred) internal
loss (i.e., 25 to 35 % of total body weight) or begin to regain experiences, such as those that lead to dietary inadherence
large amounts of weight beginning 6 to 24 months postoper- [22, 23]. These skills (i.e., distress tolerance, present-
atively [1–4]. Longer-term data suggest that 30 to 70 % of moment awareness of internal states, clarity of one’s personal
patients fail to maintain a 20 % weight loss 10 years after values and linking values to in-the-moment decision-making,
surgery, depending on type of surgery received [1]. These psychological distancing, or Bdefusion^ (as described in [20]))
suboptimal weight outcomes have critical implications, as are synthesized with behavioral elements known to be crucial
they have been linked with poorer postoperative health out- for weight control. It is hypothesized that ABTs will improve
comes [2, 3, 5, 6]. Poor long-term weight outcomes are largely post-surgery patients’ adherence to demanding dietary guide-
attributed to behavioral factors, including non-adherence to lines which will, in turn, enable weight loss maintenance in
the recommended postoperative diet and the development or the years following bariatric surgery.
re-emergence of maladaptive eating behaviors (e.g., grazing, Previous research supports the use of ABTs for weight loss
loss of control eating, emotional eating) [7–10]. in nonsurgical populations [23–25], and several studies have
Immediately after surgery, compliance to postoperative di- applied acceptance-based strategies to bariatric surgery pa-
etary recommendations is facilitated by the physical and met- tients; however, data are limited [26–28]. Weineland et al.
abolic effects of surgery. Specifically, the volume of food that [26] reported improvements in disordered eating, body dissat-
can be consumed is limited by the restrictive nature of surgery isfaction, and quality of life following an ABT compared to
and changes in gut hormones are believed to mediate changes treatment as usual; however, changes in weight were not mea-
in hunger and food preferences [11, 12]. However, it is possi- sured. Two mindfulness-based interventions have shown to
ble that over time, some effects deteriorate, making adherence enhance postoperative weight outcomes; however, sample
increasingly difficult for patients. Specifically, following the sizes were small (i.e., n = 1 and n = 7 [27, 28]). Our previous
initial weight loss phase, patients report increased hunger, research also provides support for ABT for this population.
food cravings, and ability to physically consume greater We conducted an open trial of a newly developed, 10-week,
amounts of food [13–16]. Long-term changes in eating behav- ABT in-person group intervention for bariatric surgery pa-
ior are therefore necessary for sustained success post-surgery. tients who displayed a 10 % weight regain since their lowest
Given the need to enhance compliance with recommended weight after surgery (n = 11; [29]). The intervention was
postoperative eating behaviors in order to improve weight loss shown to be feasible and acceptable, with 72 % retention
and related health outcomes, a number of studies have evalu- (100 % retention in those who attended more than 1 session)
ated the efficacy of postoperative behavioral weight control and high mean rating (4.25 out of 5.00) of program satisfac-
interventions. A meta-analysis of controlled trials of these tion. In addition, a mean weight loss of 3.6 ± 3.0 % throughout
interventions found minimal differences in percent excess the 10-week intervention was observed. There were also sig-
weight loss between treatment and control conditions (i.e., nificant improvements in eating-related variables, including
1.6 %) 6–12 months following the beginning of the interven- decreased responsivity to internal cues.
tion [17], suggesting that the provision of behavioral skills Even with these encouraging results, delivering the inter-
alone has modest effects on weight. Standard interventions vention postoperatively remains a significant challenge.
such as these provide participants with behavioral strategies Patients struggle to return to their bariatric programs for reg-
(e.g., self-monitoring, stimulus control) to target weight re- ular follow-up, limiting the effective delivery of treatment.
gain. However, given the challenges reported by patients Over two thirds of patients (72 %) miss appointments during
who are regaining weight (e.g., return of food cravings, in- the first two postoperative years [30], and only 40 % of pa-
creased hunger, ability to consume greater amounts of food), tients return for their first four annual follow-up visits [31].
there is a need for interventions that also provide Studies evaluating behavioral postoperative interventions sim-
psychological skills to help patients appropriately engage in ilarly report high attrition. For example, in one study, only
weight control behaviors. 20 % of participants who expressed interest in a postoperative
Acceptance-based treatments (ABTs) are a type of behav- intervention enrolled in the study and approximately 40 % of
ioral intervention that provides patients with skills to enhance consented participants withdrew from the study prior to group
OBES SURG

assignment [32]. In another study, 60 % of patients attended to provide consent or to implement behavior changes), or
half or less than half of the intervention sessions [33]. Several reported acute suicidality. Medications known to affect body
studies have found a correlation between travel distance and weight (gain or loss), such as chronic systemic steroids or
postoperative follow-up [34–36], indicating that in-person ap- psychiatric medications including lithium, tricyclic antide-
pointments may be difficult for many patients to attend. pressants, and anti-psychotic agents [49], were required to
Remote interventions (e.g., delivered via phone and/or be stable for at least 3 months.
Internet) appear to be well-suited to address the challenges
of engaging bariatric surgery patients postoperatively. Intervention
Internet-based interventions targeting weight loss are particu-
larly desirable, due to cost-effectiveness, increased access, and The intervention (Project HELP: Healthy Eating and Lifestyle
reduced patient burden [37]. Internet-based interventions have Post-surgery) was delivered via online modules. Specifically,
been shown to result in meaningful weight losses in non- 10 weekly sessions were developed using an e-learning soft-
surgical populations [38, 39]. Previous research has also sup- ware suite (i.e., Articulate) and hosted on Coursesites (a popular
ported the application of remotely delivered ABTs, including e-learning platform). Module content was developed by trans-
those for type 2 diabetes [40], chronic pain [41], smoking lating material from the treatment protocol used for the in-
cessation [42], anxiety disorders [43–45], depression [46], person group program version of the intervention previously
and tinnitus [47]. In addition, Weineland and colleagues’ described [29]. These modules included the presentation of
(2012) ABT intervention for bariatric surgery patients (de- material using images, text, audio, and video to convey session
scribed above [26]) combined face-to-face sessions with content comprehensively. Other components included interac-
Internet modules; 12 of 16 participants were retained from tive exercises, examples of other Bpatients^ utilizing ABT skills
study enrollment to follow-up [48]. in the moment, quizzes that aimed to support participants’ un-
The current study builds on this prior work and was de- derstanding of the material, and directed assignments to be
signed to investigate the feasibility, acceptability, and prelim- completed throughout the week (i.e., BSkill Builders^).
inary efficacy of a novel remotely delivered ABT intervention Participants were assigned to view each module over the course
for postoperative weight regain. Based on our preliminary of the week (at any time they chose, with the ability to control
data [29], we hypothesized that at post-treatment, patients the flow of material, including replaying and rewinding module
would demonstrate significant weight loss and improvements materials). They were also asked to record their food intake
in self-reported eating behavior, as well as change in the pos- daily using MyFitnessPal and to record their weights and aver-
tulated mechanisms of action (i.e., acceptance of internal ex- age daily calories in an online spreadsheet each week that self-
periences, defusion, or psychological distancing). populated a graph to visually represent progress.
This intervention focused on ABT strategies with an empha-
sis on willingness to experience less pleasurable (e.g., choosing
Materials and Methods low-calorie foods vs. more pleasurable calorically dense foods)
and aversive internal experiences (e.g., hunger, food cravings,
Participants negative emotions). Strategies to increase willingness were
taught, including defusion (i.e., gaining distance from internal
Participants were recruited by contacting respondents to a sur- experiences such that one gains the ability to act independently
vey [13] of attitudes of patients on postoperative interventions of them). Mindful decision-making, as it relates to eating and
from the University of Pennsylvania Bariatric Surgery exercise, was also emphasized. Clarification of, and commit-
Program and by posting advertisements through community ment to, core values was another key component, as living life
flyers and Craigslist. Inclusion criteria were 18–70 years old, in accordance with one’s values (e.g., health) makes willingness
weight loss surgery (i.e., RYGB, gastric sleeve, gastric to engage in difficult weight control behaviors worthwhile.
banding) at least 1.5 years out from surgery, ≥10 % weight Standard behavioral techniques for weight loss (i.e., self-mon-
regain of maximum weight loss or 5 % of their minimum itoring, stimulus control, portion control, psychoeducation)
weight post-surgery, and weight regain lasting for at least were also included in each module. These skills were framed
3 months prior to enrollment. Potential participants were ex- as the core behaviors necessary for weight control, while the
cluded if they were enrolled in a structured weight loss pro- acceptance-based skills were presented as essential tools to en-
gram, were pregnant/planned to become pregnant within able the patients to continue to engage in these behaviors over
6 months of enrollment, had a medical condition that had the long term despite the difficulties in doing so (see [50] for
the potential to affect weight (e.g., Cushing’s disease) or more details on the application of these skills).
would limit one’s ability to make dietary or physical activity Following the introduction of each ABT skill, a behavioral
changes, exhibited psychiatric symptoms that would interfere application section was included. In this section, participants
with the ability to benefit from the intervention (i.e., inability received specific examples of utilizing the ABT skill to engage
OBES SURG

in particular weight control behaviors. Specifically, in most was to discuss and clarify the content of the session, discuss
modules, participants were given a list of common challenges how the participant utilized skills demonstrated in the mod-
relating to the topic covered and they were able to choose ules, problem-solve difficulties in utilizing the skills, and re-
which challenge was most relevant to them. They would sub- view homework. Feedback regarding weight losses and food
sequently see a specific example of a character utilizing ABT records was also provided. This component is particularly
skills in response to that behavioral challenge. Participants important, as prior research conducted on Internet-based
were then prompted to plan for how they would personally weight loss treatments has shown that such feedback results
use these ABT skills in a similar situation (see Fig. 1 for an in significantly greater weight loss compared to when it is not
example). provided [51]. A discussion board feature was also available
In order to ensure that participants were understanding and to participants in the program. Topics were posted on the
applying the skills delivered, a brief (i.e., 20 min) telephone discussion board by research staff designed to facilitate social
call with a member of the study team (i.e., program coach) support among participants (which has been shown to be par-
was conducted every 2 weeks. Program coaches were ad- ticularly important for bariatric surgery patients [52]).
vanced graduate students with at least 1 year of experience As the primary aim of this study was to develop a feasible
delivering ABTs for weight control. The goal of these calls and acceptable treatment, we implemented a structured plan to

Fig. 1 Screenshots from modules


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collect feedback from participants. After completing each Treatment Acceptability and Feasibility
module, participants rated its helpfulness, ease of use, and
level of engagement on a 3-point scale (1 = BNot at all,^ Treatment acceptability was measured using a questionnaire,
2 = BSomewhat,^ 3 = BVery^). Participants were also adapted by the investigators from previous measures used for
prompted to report technological challenges and provide this purpose, using a 5-point Likert scale (1 = BNot at all,^
free-form feedback at the end of each module. In addition, 3 = BSomewhat,^ 5 = BVery^) to evaluate how helpful partic-
all participants completed a treatment acceptability question- ipants found the treatment, their satisfaction with it, and how
naire following the completion of the intervention to gather likely they would be to recommend it to a friend. Feasibility of
additional feedback. the modules was assessed via a brief questionnaire following
the viewing of each module, as described above.

Procedures Eating-Related and Physical Activity Variables

Interested participants underwent a phone screen by study Caloric intake was measured with an online system for dietary
personnel in order to determine eligibility. Eligible partici- self-monitoring (i.e., MyFitnessPal). Participants were
pants were invited to complete the 10 weekly online modules instructed to complete daily food records starting at baseline
(as well as phone check-ins with a program coach). Prior to through the end of the intervention. Calorie data from records
beginning the program, participants were required to complete at baseline and post-treatment (calculated via MyFitnessPal)
a brief tutorial, during which their assigned program coach were analyzed to calculate average daily caloric consumption
would walk them through the technical components of the during the first and last week of the program. Use of electronic
online program. Assessments time points included: (1) base- tools has been shown to improve compliance with self-
line (within 2 weeks prior to starting the intervention), (2) monitoring compared to using paper records [54]. In addition
mid-treatment (after completing the fifth online module), (3) to serving as an outcome variable, this system also served as
post-treatment (at the completion of the final module), and (4) the self-monitoring component of the intervention. A self-
follow-up (3 months following completion of the final mod- monitoring record was considered complete for 1 day if a
ule). Participants were compensated $15 for completing the participant entered at least three separate meals or if he/she
mid-treatment assessment and $25 for the post-treatment and recorded at least 50 % of his/her daily calorie goal (as used by
3-month follow-up assessments. All assessments were con- [55]).
ducted remotely via online questionnaires. Loss of control eating was examined using the Eating
Disorder Examination Questionnaire (EDE-Q; [56]).
Because many bariatric surgery patients cannot physically
Measures consume an objectively large amount of food in one sitting,
both subjective and objective binge episodes as assessed by
Anthropometric Data the EDE-Q were considered loss of control episodes [57].
Good concurrent validity with the EDE interview has been
Weight was self-measured by participants using a digital established for the EDE-Q [58].
scale that they were required to purchase (if they did not Disinhibition, restraint, and reactivity to internal and ex-
already own). Prior to weighing, a scale check was then ternal cues were measured with The Eating Inventory [59],
performed to assess the reliability of participants’ scales which has been shown to be reliable and valid [60].
and participants were given written instructions to enhance Disinhibition scores have been shown to decrease with weight
the accuracy of self-measured weights (e.g., removing shoes loss treatment as well as after bariatric surgery [7, 61], while
or extra layers of clothing, placing the scale on a hard, level cognitive restraint has been shown to increase post-surgery
surface, weighing first thing in the morning). Participants [7].
weighed themselves three times during each assessment The Emotional Eating Scale (EES) was used to assess emo-
and the average of these weights was recorded. If recorded tional eating, which is a self-report measure that assesses the
weights differed by >1 lb., participants were contacted to relationship between overeating and negative emotions [62].
check accuracy of recording. Self-reported weights in bariat- The EES is classified into three subscales (anger/frustration,
ric surgery patients have been shown to be reasonably accu- anxiety, depression). This measure has good construct validity
rate, i.e., on average within 1 kg [53]. Within our sample, and adequate test-retest reliability [62] and has been previous-
self-recorded weights were very reliable (i.e., SD of mean ly used with post-bariatric surgery patients [27].
recorded weights within each subject was 0.1 lbs). Grazing behavior over the past 2 weeks was assessed by
Participants also self-reported their height, which was used self-report based on the definition provided by Colles et al.
to calculate BMI. [9], i.e., Bthe consumption of smaller amounts of food
OBES SURG

continuously over an extended period of time, eating more Results


than the subjects considers best for them,^ (p. 616). A ques-
tionnaire was created by the researchers due to the lack of Participants
validated measures for this eating behavior [63]. In addition
to confirming these criteria in the form of yes or no questions, A total of 114 potential participants who indicated interest in the
participants were asked to what extent they grazed over the study (via a recruitment survey, Craigslist ads, flyers, and refer-
past 2 weeks (from BNever^ to BAlways^). rals from other research studies) were contacted. Of those 114,
The Food Cravings Questionnaire-Trait (FCQ-T; [64]) was 60 were reached by phone or email and provided with further
used to assess food cravings, which has been shown to have information about the study. Of those reached, 8 did not meet
excellent internal consistency (including in a bariatric surgery- eligibility criteria, 20 were lost to contact, and 9 were no longer
seeking population, [65]) and good test-retest reliability [64]. interested in treatment. The remaining 23 potential participants
The Paffenbarger Physical Activity Recall [66], a 15-item, met eligibility criteria and agreed to join the program. Twenty
interview-based measure for assessing physical activity, was of those who met criteria were enrolled in the program (i.e.,
used. By converting these activities into metabolic equivalents completed the baseline assessment and tutorial), and 16 of those
based on body mass, total expenditure from physical activity 20 interacted with the first module (i.e., treatment Butilizers^)
was calculated. and were included in analyses. Eleven of these participants
completed the intervention and post-treatment assessment
(i.e., treatment Bcompleters^). See the CONSORT diagram
Acceptance-Based Process Variables (Fig. 2) for details on screening and enrollment.
Participant demographics are listed in Table 1. Of note, the
The Acceptance subscale of the Philadelphia Mindfulness sample was predominantly White and female. Self-reported
Scale (PHLMS) was used to assess acceptance of internal surgery data (Table 1) indicated that the majority of partici-
experiences [67]. Internal consistency and concurrent validity pants received gastric bypass surgery (75 %), and mean time
with established measures has been demonstrated [67]. since surgery was 5.1 ± 1.0 years.
Acceptance of food-related internal experiences was mea-
sured with the Food-Related Acceptance and Action Treatment Feasibility and Acceptability
Questionnaire (FAAQ), which has demonstrated good reli-
ability and validity [68]. Program retention was defined as completing at least 8 of 10
Defusion was measured with the Drexel Defusion Scale modules. Out of the 20 participants who enrolled in the study
(DDS), a self-report measure assessing the extent of the ability (i.e., completed the tutorial and baseline assessment), 12 par-
to defuse from different internal experiences, which has been ticipants completed 8 modules (60.0 %). However, of the 16
shown to have good internal consistency [69]. participants who utilized the modules, 75 % met retention
Acceptance of physical activity-related internal criteria defined above. The average time to program comple-
experiences was evaluated with the Physical Activity tion was 12.2 ± 4.0 weeks. Although the intervention was
Acceptance Questionnaire (PAAQ). This 10-item measure as- designed to be completed within 10 weeks, participants were
sesses self-reported acceptance of psychological and physical unable to move onto the subsequent weekly module until they
discomfort associated with engaging in physical activity. completed the previous week’s module. The first two com-
Good internal reliability and concurrent validity has been pleters took an average of 20.2 ± 0.1 weeks to complete the
demonstrated [70]. program (i.e., twice the intended amount of time). Following
All measures were completed at each assessment point, this observation, personalized schedules, checklists, and struc-
except that height was reported at baseline only and treatment tured reminders were implemented and the remaining partic-
acceptability at post-treatment only. ipants took an average of 10.4 ± 0.6 weeks to complete the
intervention. The average time spent interacting with each
module was 26.2 ± 10.2 min, and average time of each phone
Data Analysis coach call was 16.5 ± 3.6 min. On average, participants an-
swered quiz questions correctly 85.5 % of the time, indicating
All variables are reported as mean ± standard deviation or adequate understanding and retention of material.
frequency and percentages. T tests were used to assess chang- Program completers completed all five bi-weekly phone
es in weight and secondary variables (eating behaviors and sessions. For program utilizers, 77.5 % of phone coach calls
acceptance-related constructs) pre- to post-treatment. were completed. During the majority of the program, the dis-
Completer analyses and intent-to-treat analyses (using last cussion board was unused. Qualitative feedback indicated that
weight carried forward for participants who provided a base- the discussion board was not user-friendly, which we were
line assessment weight) were conducted for weight data. unable to modify given the use of an already-developed
OBES SURG

Fig. 2 Consort diagram

platform. Additional instructions were provided to assist par- strategies. The helpfulness of the phone coach calls were not
ticipants and targeted posts were implemented; however, these formally assessed; however, discussions with participants in-
steps resulted in only one participant using this feature. dicated high acceptability and usefulness.
Among completers (those who completed the acceptability Participants were able to view modules 75.2 % of the time
questionnaire, n = 11) acceptability ratings were high, includ- without reporting technological issues. The most commonly
ing for overall helpfulness of ABT strategies (4.5/5 ± 0.8), cited issue was user activity not being automatically recorded
overall satisfaction with the program (4.7 ± 0.6), and confi- by the program, requiring participants to re-enter quiz re-
dence in recommending the program to others (4.7 ± 0.6). The sponses and feedback (i.e., 21.6 %).
average ratings of individual modules also indicate high ac- When modules were viewed, skill builders were completed
ceptability, with participants rating them as Bvery^ helpful 79.8 % of the time, weekly self-monitored weights 93.8 % of
71.1 % of the time, Bvery^ easy to use 90.6 % of the time, the time, and weekly self-monitored average calories 85.3 %
and Bvery^ engaging 78.7 % of the time. The highest rated of the time. Participants only entered complete food records
acceptance-based strategies (rated at least 4.5 out of 5) were 67.4 % of days in the program. However, treatment com-
acceptance, willingness, and mindful decision-making pleters recorded their food intake 74.8 % of the time.

Table 1 Participant
demographics and surgery Total sample Completers Utilized only Enrolled only
information (n = 20) (n = 11) (n = 5) (n = 4)

Age (year; M ± SD) 54.3 ± 12.1 50.7 ± 13.7 59.2 ± 5.3 58.0 ± 12.9
Women (%) 85.0 % 72.7 % 100 % 100 %
White (%) 80.0 % 81.8 % 80.0 % 75.0 %
African American (%) 20.0 % 18.2 % 20.0 % 25.0 %
Married or living with partner (%) 55.0 % 54.5 % 80.0 % 25.0 %
Employed full-time (%) 60.0 % 54.5 % 60.0 % 75.0 %
Gastric bypass (%) 75.0 % 72.7 % 80.0 % 75.0 %
Gastric sleeve (%) 15.0 % 27.3 % 0% 0%
Gastric banding (%) 10.0 % 0% 20.0 % 25.0 %
Time since surgery (year; M ± SD) 5.1 ± 1.0 5.1 ± 1.1 5.5 ± 0.7 4.6 ± 1.1

Completers participants who completed all modules and assessments; Utilized only interacted with at least the first
module, but did not complete the program; Enrolled only completed baseline assessment and tutorial only
OBES SURG

Weight Outcomes

Among treatment completers, 10 out of 11 (i.e., 90.9 %) par-


ticipants demonstrated weight stabilization (within 0.2 kg) or
weight loss. Including treatment utilizers who provided at
least one additional weight after beginning treatment, 13 out
of 14 (i.e., 92.9 %) participants demonstrated weight stabili-
zation or weight loss. Treatment completers demonstrated sig-
nificant weight loss from pre- to post-treatment (5.1 ± 5.5 %;
5.9 ± 6.5 kg, t(10) = 3.02, p = .01). Intent-to-treat analyses also
revealed significant weight loss pre- to post-intervention
Fig. 4 Mean weight change since surgery from 2 years pre-treatment to
(3.9 ± 5.0 %; 4.4 ± 5.8 kg, t(15) = 3.05, p = .01). Percent post-treatment. Black square self-reported weights (via a screen), black
weight losses for each treatment completer are displayed in triangle self-measured weights
Fig. 3, and weight trajectories since 2 years prior to starting the
intervention are shown in Fig. 4.
All treatment completers were assessed at 3-month follow- Based on food record data, treatment completers who pro-
up. Weight losses were maintained, with an average additional vided calorie data from pre- and post-treatment (n = 8) re-
weight loss of 0.6 ± 2.7 % from post-treatment to follow-up. duced their average daily calorie intake from 1364.5 ± 342.7
Total average weight loss from pre-treatment to 3-month fol- to 1227.1 ± 69.6 (Mchange = 137.4, SD = 245.9, t(7) = 1.58,
low-up was 5.7 ± 6.1 %. p = .16); however, this difference did not reach statistical
significance. Self-reported caloric expenditure (based on the
Paffenbarger physical activity questionnaire) did not improve;
Process Variable Outcomes
in fact, average calories expended per week evidenced a small
and statistically insignificant decrease from 4048.1 to
Changes in acceptance-based process variables from pre-to
3834.8 kcal/week (M c h a n g e = 213.3, SD = 2513.9,
post-treatment were generally large, in the expected direction
t(9) = 0.27, p = .80).
and supported hypotheses (Table 2). However, acceptance of
Due to our small sample size, we were not able to conduct
general internal experiences did not evidence improvement.
formal mediation analyses. However, exploratory analyses
Significant and generally medium to large improvements in
were conducted to identify potential mediators. Correlations
eating-related variables were also observed (Table 2).
between residualized changes in process measures from pre-
In addition to the changes in scores on these validated
to mid-treatment and residualized change in weight from pre-
measures, changes were also observed on items from our graz-
to post-treatment were conducted. Pre- to post-treatment
ing questionnaire. In particular, the percentage of participants
weights were used for these analyses rather than mid- to
who endorsed problematic grazing decreased from 36.4 to
post-treatments because the majority of weight loss seen in
9.1 % from pre- to post-treatment. In addition, items from
weight control interventions often occurs towards the begin-
the EDE-Q revealed that average frequency of loss of control
ning of the intervention. Residualized changes in several of
eating episodes decreased from 4.3 times to 0.9 times within
our hypothesized mediators were strongly correlated with
the previous 4 weeks (M = 3.36, SD = 6.04, t(10) = 1.85,
residualized changes in weight including defusion
p = .09). In addition, the percentage of participants who en-
(r = −0.58, p = 0.06), disinhibition (r = 0.55, p = 0.08), reac-
dorsed loss of control eating episodes decreased from 63.6 to
tivity to internal cues (r = 0.71, p = 0.02), eating in response to
27.3 % pre- to post-treatment.
depression (r = 0.63, p = 0.04), food cravings (r = 0.54,
p = 0.09), and food-related acceptance (r = −0.50, p = 0.12).

Discussion

The current study provides preliminary support for the use of a


remotely delivered acceptance-based behavioral intervention
for weight regain after bariatric surgery. Specifically, our pilot
study supported the feasibility, acceptability, and preliminary
efficacy of this novel 10-module online program.
Overall, the program proved to be feasible and acceptable,
Fig. 3 Percent weight change from pre- to post-treatment by participant with the vast majority of participants rating the program as
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Table 2 Pairwise comparisons of


process measures from pre- to Baseline Post-treatment Paired t test (df = 10)
post-treatment
M SD M SD t p d
EI disinhibition 8.3 4.2 5.6 2.8 2.9 0.02* 0.75
EI cognitive restraint 12.4 3.2 17.6 2.3 −4.08 <0.01** 1.84
EI internal 4.4 2.6 2.3 1.7 3.0 0.01* 0.95
EI external 2.3 1.8 1.7 1.3 1.60 0.14 0.35
EES anger 22.9 9.4 20.6 7.1 1.24 0.25 0.27
EES depression 14.2 7.0 11.0 4.8 1.93 0.08 0.53
EES anxiety 23.3 8.3 18.9 5.1 2.92 0.02* 0.64
FCQ-T 121.5 36.7 100.9 30.7 1.66 0.13 0.61
PHLMSacceptance 31.5 6.8 31.6 7.7 −0.11 0.92 0.03
DDS 27.5 11.8 35.7 6.7 −2.91 0.02* 0.86
FAAQ 38.9 7.7 52.6 10.6 −3.90 <0.01** 1.47
PAAQ 45.6 13.6 54.3 11.7 −2.22 0.05 0.69

EI Eating Inventory, EES Emotional Eating Scale, FCQ-T Food Cravings Questionnaire-Trait, PHLMS
Philadelphia Mindfulness Scale, DDS Drexel Defusion Scale, FAAQ Food-Related Acceptance and Action
Questionnaire, PAAQ Physical Activity Acceptance Questionnaire
*
p < 0.05 ; ** p < 0.01

very helpful, easy to use, and engaging. It is noteworthy that In addition to proving to be acceptable and feasible, this
despite the reported technological difficulties, acceptability program proved effective: weight regain was halted or re-
ratings remained high. This result parallels data from other versed in all but one case. Moreover, average weight change
recently completed trials of remote treatments, which also (i.e., −5.9 kg) was almost double the amount (−3.3 kg) expe-
suggest that technological problems using these formats tend rienced by participants in a 6-month post-surgery standard
not to qualitatively disrupt the user’s experience [45, 71]. behavioral intervention [32]. Importantly, weight losses were
We predicted that delivering this program remotely would maintained at 3-month follow-up. Notably, mean weight
mitigate the poor enrollment and retention seen in this popu- losses reached 5 %, a clinically significant weight loss shown
lation. Program initiation and retention, however, was not op- to improve obesity-related comorbidities in non-surgery sam-
timal. Only 18 % of individuals who indicated initial interest ples [72]. This degree of weight loss may have similar effects
in a postoperative intervention (via survey and recruitment in bariatric surgery patients who have regained weight; how-
postings) enrolled in the program. Of the 20 participants that ever, more research is necessary to confirm this hypothesis.
did enroll, 11 completed the treatment in its entirety. These The weight loss demonstrated in the current sample is also
results indicate that there are likely more barriers than logisti- notable, given that patients at this point post-surgery are on a
cal ones to engaging patients in postoperative treatment and weight regain trajectory [1]; in fact, these particular partici-
that the use of technology to deliver interventions is only part pants’ postoperative weight losses decreased from 26 to 20 %
of the solution. More work is therefore needed to increase in the 2 years leading up to the start of the intervention. In
engagement in postoperative behavioral programs such as this addition to significant weight losses, this intervention was
one. Recruiting those who are actively regaining weight may successful in producing medium to large improvements in
be especially difficult, as they may be experiencing decreased eating-related variables that have been implicated in post-
motivation due to the challenges they have experienced. It surgical weight regain. These changes mirrored improvements
may be useful to emphasize the amount of time patients would seen in the in-person version of this program [29], including
be required to directly interact with the intervention (which is decreased grazing, loss of control eating, food cravings, and
less than standard in-person treatments) as well as the poten- particularly large effects for decreased disinhibition and inter-
tial effectiveness in halting and/or reversing weight regain. nal responsivity to food cues. The current study results, com-
However, it should be noted that of those participants who bined with the favorable results from the in-person group ver-
actually began the program (i.e., interacted with the first mod- sion of this program [29], highlight the potential benefit of
ule), nearly 70 % completed the intervention and all treatment incorporating acceptance-based skills when treating post-
completers were retained at 3-month follow-up. This relative- surgery weight gain.
ly high retention rate combined with the high ratings of the The goal of this acceptance-based treatment was to empha-
program further indicates that the program was acceptable and size engaging in goal-directed behaviors that are in line with
feasible. one’s values in spite of non-preferred internal experiences,
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such as those that lead to dietary inadherence. The interven- interactive ABT intervention, means that observed outcomes
tion provided participants with acceptance skills that aimed to cannot be definitely attributed to any particular aspect of our
increase the capacity to experience less desirable internal intervention. As discussed earlier, the intervention contained a
states (e.g., hunger, wanting of food, food cravings) and there- number of nonspecific and behavioral components (e.g., self-
fore better allow participants to engage in valued behaviors. monitoring) that may have effects independent of the psycho-
There were, in fact, significant changes in self-reported utili- logical strategies delivered. It may be that standard cognitive-
zation of acceptance-based variables, including increased use behavioral strategies would work just as well as ABT strate-
of defusion and increased food-related and physical activity- gies in this population. The effects of the phone coach calls are
related acceptance. Although exploratory analyses indicated also unknown (i.e., they may have accounted for much of the
strong associations between changes in proposed process effects, or they may not have been necessary). The relatively
measures and weight change, with the small sample size and short follow-up period (i.e., 3 months) represents another lim-
without formal mediation analyses, it is impossible to con- itation; a greater follow-up time is needed to determine the
clude that the integration of specialized psychological strate- longer-term effects of this intervention. Also, weights were
gies were responsible (or necessary) for the observed weight self-measured using home scales, rather than by trained asses-
outcomes. sors using a medical-grade, laboratory scale. However, as not-
Results of this pilot study also highlight the potential effec- ed previously, self-reported weights in bariatric surgery pa-
tiveness of remotely delivered interventions in the post- tients have been shown to be accurate [53]. It should also be
bariatric surgery population. The effectiveness of this program noted that because treatment acceptability was assessed at
is particularly robust when considering the amount of time post-treatment, acceptability ratings might be confounded
participants were actively engaged with the intervention. with treatment response. In addition, the generalizability of
Participants spent an average of 26 min on weekly modules our results may suffer due to our small sample size and the
and 17 min every other week with a program coach, which is fact that we recruited individuals mostly living in close prox-
significantly less time than required by traditional in-person imity to the Philadelphia area (and many who received surgery
groups or individual sessions (i.e., 60–120 min weekly). from the same hospital).
These data support the efficiency and potential cost- As discussed above, future research is necessary to provide
effectiveness of this program. Bariatric programs may there- additional support for the acceptability and efficacy of this
fore be able to reach a wide number of patients (regardless of intervention, including trials with more participants who are
location) using minimal resources by using a program such as drawn from a variety of surgery centers. In addition, future
this. In addition, highlighting the minimal amount of time research is needed to better understand which aspects of the
necessary to engage with the program may increase the enroll- remote intervention are necessary. For example, it may be that
ment and retention of future patients (as most of our lost par- having an online platform for self-monitoring is sufficient to
ticipants dropped out prior to engaging with the intervention). produce weight loss, or that receiving psychological skills and
This intervention specifically targeted those who have ex- interactions with phone coaches enhance outcomes. It may
perienced weight regain after the initial weight loss phase. also be useful to compare remote interventions that provide
Several participants recommended that this program be of- opportunities for interaction within modules (as was present in
fered at the start of the bariatric surgery process (possibly prior this study) compared to those that do not allow of interaction
to undergoing surgery), in order to build skills at the outset (e.g., viewing presentations delivered online with text and
that would prevent weight regain from occurring in the first voiceover).
place. However, one participant noted that it was helpful for
him to struggle on his own in order for him to realize that he
needed the additional help and to be diligent with adherence to Conclusions
weight control behaviors. In fact, previous research with this
population indicates that patients are less likely to utilize a This study is a meaningful addition to this area of research,
behavioral intervention if it is offered pre-surgery compared indicating feasibility and acceptability of a remotely delivered
to post-surgery [73]. Other research has shown minimal ef- acceptance-based behavioral intervention targeting weight re-
fects of a behavioral intervention implemented during the first gain in postoperative patients. Preliminary effectiveness was
4 months after surgery [33], with no differences in weight at also supported, with clinically significant weight losses ob-
follow-up between 12 and 24 months post-surgery. The espe- served. Continuing to improve and refine interventions
cially strong physiological effects of surgery during the initial targeting weight regain in bariatric surgery patients is imper-
weight loss phase may be one of the reasons for this lack of ative, given the significant health consequences of weight re-
significant effect of behavioral treatment. gain. It will be especially important to continue to refine re-
This study has several limitations. The open trial design, cruitment and retention techniques as attrition continues to
while appropriate to evaluating the first remotely delivered, remain a significant barrier in the bariatric surgery population.
OBES SURG

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Conflict of Interest D. B. Sarwer is a consultant for BAROnova, 547–59.
Covidien, and Ethicon and received consulting fees from these organiza- 13. Bradley LE, Sarwer DB, Forman EM, et al. A survey of bariatric
tions during the time of the study. J. G. Thomas received research grants surgery patients’ interest in postoperative interventions. Obes Surg.
from Weight Watchers International, Inc. and is a consultant for Applied 2015.
VR, KetoThrive Corp, and Medtronic and received consulting fees from 14. Stewart K, Olbrisch M, Bean M. Back on track: confronting post-
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Ethical Approval All procedures performed in studies involving hu- between laparoscopic gastric banding and laparoscopic isolated
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institutional and/or national research committee and with the 1964 2006;16(11):1450–6.
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University of Pennsylvania and Drexel University. ized controlled trials. Obes Rev. 2013;14(4):292–302.
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