Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001209785
Ethics application status
Approved
Date submitted
31/10/2013
Date registered
4/11/2013
Date last updated
7/08/2019
Date data sharing statement initially provided
7/08/2019
Date results provided
7/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Healthy APproach to weIght management and Food in Eating Disorders (HAPIFED)
Scientific title
A randomised controlled trial of a new integrated approach to management of eating and weight disorders, namely a Healthy APproach to weIght management and Food in Eating Disorders (HAPIFED) compared to cognitive behaviour therapy – enhanced (CBT-E): A Pilot study
Secondary ID [1] 283495 0
None
Universal Trial Number (UTN)
U1111-1149-7766
Trial acronym
HAPIFEDPilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Binge eating 290412 0
Obesity 290413 0
Condition category
Condition code
Mental Health 290804 290804 0 0
Eating disorders
Diet and Nutrition 290805 290805 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychotherapy - HAPIFED
HAPIFED has been developed to be multidisciplinary and integrate CBT-E with behavioural weight loss approaches. HAPIFED comprises (i) One one hour individual initial clinical assessment session with a psychologist followed by 19 90-minute twice weekly group office-based sessions with a registered psychologist over 2.5 months that include (i) one psychoeducation session conducted conjointly with a specialist (A/Prof Salis) in the psychobiology of obesity and weight loss of 90 minutes at session 2, (ii) one conjoint session of 90 minutes at session 3 with a dieticain and (iii)one session conducted conjointly at session 13 with an activity therapist of 90 minutes. As recommended by Bulik et al. (2012) HAPIFED introduces approaches that address healthy lifestyle changes and appetite awareness with the aim to reduce eating as a means of emotion regulation. Approaches are also informed by an understanding of effects of starvation (e.g. Sainsbury-Salis, 2007).
HAPIFED is delivered in office-based sessions over four stages which are in temporal sequence but once commenced in stage 2 behavioural experiments and monitoring of food intake and activity continues throughout therapy.

In stage one and two (sessions 1-6) there is psycho-education to include information on why ‘diets’ fail, non-hungry and hungry eating, and the ‘false hope syndrome’ and reviewing the individual’s history. Family, weight and medical history are also relevant in determining both the likelihood of gaining or losing weight with treatment and obesity-related health risks. The patient is provided with information about eating disorders (EDs) and an introduction to a cogntive behaviuoral therapy (CBT) formulation of the development of the ED. In addition to the central disordered eating (bingeing alternating with attempted or actual fasting) and compensatory behaviours (e.g. vomiting, compulsive exercise) it incorporates weight history, life events and mood intolerance and (where relevant) interpersonal deficits, low self-esteem and clinical perfectionism. In session two, in session weighing, regular eating and monitoring of key behaviours commence. In this stage a hunger regulation session and rationale for the approach as outlined in the book ‘The Don’t Go Hungry Diet’ will be lead by A/Prof Salis (Sainsbury-Salis, 2007). Specific steps will be outlined to help people to lose weight by listening to their appetite, including hunger and satiety scores that are used to monitor appetite awareness. This is an alternate to a conventional weight loss program which is based on external measures of control (e.g. counting calories or portion sizes and portion numbers) and explicit messages about restriction (e.g. reduce fat, reduce sweets, etc). Most people who seek treatment for binge eating are already familiar with information about calories, portion sizes and restriction and we consider an approach that deliberately avoids restrictive messages would be better for a program aimed at reducing bingeing. There will also be a motivating talk from an exercise physiologist during Stage 1, and pedometers will be provided to promote physical activity.

Stage 2 (sessions 5-6) is a brief ‘reformulation’ time and personalisation of the formulation.

In Stage three (sessions 7-14) monitoring of key eating and related behaviours (including binge eating, exercise and urge to exercise, other compensations such as vomiting, and body checking) continues with concomitant ratings of mood and appetite, with an additional emphasis on behavioural activation and activity monitoring while also addressing the key behaviours associated with binge eating disorders. Approaches include appetite focused CBT techniques. Monitoring is based on appetite cues and not solely food monitoring. This is so as to direct attention away from an excessive focus on type of food (Dicker & Craighead, 2004). Behavioural experiments are introduced to prevent ED behaviours, establish regular meal patterns and promote self-control. In phase two, nutritional education and counselling and exercise are addressed. The participants will work to make changes to lifestyle which establish healthy eating patterns, physical activity patterns and food choices which are less than sufficient to meet energy needs in order to bring about modest weight loss (DAA 2011; NHMRC 2012, 2013). Exercise is addressed using behavioural activation strategies and exercises from the LEAPOut manual (Hay et al., 2011) with the goal to incorporate “healthy” exercise in the program. In stage four (sessions 15-17) Socratic questioning and challenging of beliefs and attitudes which reinforce ED behaviours, such as valuing oneself according to one’s weight and shape and “all or nothing” dichotomous thinking is employed. Problem-solving is also incorporated here. Mood intolerance is addressed with training in specific emotion regulation skills. Behavioural experiments and the reduced energy nutrition plan from phase two continue in this phase.
As in CBT, the final stage (sessions 18-20) of HAPIFED involves relapse prevention strategies.
Intervention code [1] 288202 0
Treatment: Other
Comparator / control treatment
Psychotherapy - CBT Enhanced
The control therapy is group office based CBT-E-focused (Fairburn, 2008) and includes the additional mandatory mood intolerance skills module. The standard delivery is ‘19 plus one’ individual sessions over 4 months for BN and BED. This will be modified to ‘19 group plus 1 individual’ session in this RCT. Sessions will be each for 90 minutes.
Control group
Active

Outcomes
Primary outcome [1] 290799 0
Reduced binge eating
This will be measured by the Eating Disorder Examination Questionnaire (EDEQ) (Beglin & Fairburn, 1992; Mond et al., 2004)
Beglin SJ, Fairburn CG. Evaluation of a new instrument for the detection of eating disorders in community samples. Psychiatry Res 1992; 44: 191-201.
Mond JM et al. (2004) Validity of the Eating Disorders Examination Questionnaire (EDE-Q) in screening for eating disorders in community samples. Behav Res Ther 42,551-567.
Timepoint [1] 290799 0
End of treatment - within the week following session 20
Primary outcome [2] 290800 0
Reduced body weight - measured by the research assistant using height & weight (calibrated scale) measuring equipment.
Timepoint [2] 290800 0
End-of-treatment, within the week following session 20
Secondary outcome [1] 305319 0
Reduced global eating disorder symptoms as reported on the Eating Disorder Examination Questionnaire (EDEQ) (Beglin & Fairburn, 1992; Mond et al., 2004) which includes a global score of overall symptom severity and four subscale scores of weight concern, shape concern, dietary restraint and eating concern, as well as frequency of behaviours vomiting, laxative misuse, and hard exercise for weight control.
Timepoint [1] 305319 0
End of treatment - within the week following session 20
Secondary outcome [2] 305320 0
Reduced depression
Depression will be assessed with the 21-item Depression Anxiety and Stress Scales (DASS) (Lovibond & Lovibond, 1995; Henry & Crawford, 2005). The DASS is a well-known Australian inventory, measures depression, anxiety and stress. The DASS possesses adequate convergent and discriminant validity in samples drawn from the normal population (Crawford & Henry, 2003; Lovibond & Lovibond, 1995). Reliability, assessed using Cronbach’s alpha, has also been shown to be acceptable for all three scales in both clinical and non-clinical samples (Crawford & Henry, 2003; Lovibond & Lovibond, 1995).
Crawford, J.R., & Henry, J.D. (2003). The Depression Anxiety Stress Scales (DASS): normative data and latent structure in a large non-clinical sample. British Journal of Clinical Psychology, 42, 111-131.
Henry JD, Crawford JR. (2005) The short-form version of the Depression Anxiety Stress Scales (DASS-21) Br J Clin Psychol. 44:227-39.
Lovibond, S.H., & Lovibond, P.F. (1995). Manual for the depression anxiety stress scales (2nd ed.). Sydney, NSW.
Timepoint [2] 305320 0
End of treatment - within the week following session 20
Secondary outcome [3] 305321 0
Reduced anxiety
Anxiety will be assessed with the 21-item Depression Anxiety and Stress Scales (DASS) (Lovibond & Lovibond, 1995; Henry & Crawford, 2005). The DASS is a well-known Australian inventory, measures depression, anxiety and stress. The DASS possesses adequate convergent and discriminant validity in samples drawn from the normal population (Crawford & Henry, 2003; Lovibond & Lovibond, 1995). Reliability, assessed using Cronbach’s alpha, has also been shown to be acceptable for all three scales in both clinical and non-clinical samples (Crawford & Henry, 2003; Lovibond & Lovibond, 1995).
Crawford, J.R., & Henry, J.D. (2003). The Depression Anxiety Stress Scales (DASS): normative data and latent structure in a large non-clinical sample. British Journal of Clinical Psychology, 42, 111-131.
Henry JD, Crawford JR. (2005) The short-form version of the Depression Anxiety Stress Scales (DASS-21) Br J Clin Psychol. 44:227-39.
Lovibond, S.H., & Lovibond, P.F. (1995). Manual for the depression anxiety stress scales (2nd ed.). Sydney, NSW.
Timepoint [3] 305321 0
End of treatment - within the week following session 20
Secondary outcome [4] 305322 0
Improved quality of life
Adaptive Function and Health related Quality of life will be assessed with the ‘days out of role’ items from the Australian National Survey of Health and Well-being (http://www.abs.gov.au) and the Short Form-12 Health Status Questionnaire (SF-12, Ware et al., 1996) respectively.
Ware JE et al. (1996) A 12-item short-form health survey. Medical Care 1996; 34: 220-233
Timepoint [4] 305322 0
End of treatment- within the week following session 20

Eligibility
Key inclusion criteria
BMI (kg/m2) 27-35
Age greater than or equal to 18 years
Primary diagnosis of bulimia nervosa or binge eating disorder according to DSM-5 criteria (APA, 2013)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of psychosis or bipolar disorder.
A high level of suicide risk.
Taking weight loss medication.
History of bariatric surgery.
Medical conditions that interfere with appetite control (e.g. Prader-Willi syndrome, Cushing’s syndrome).
Taking medications that interfere with appetite control (e.g. insulin, hydrocortisone).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be screened for eligibility but the study research assistant. Screening will identify those patients at least 18 years and likely to meet eligibility criteria. Those deemed eligible will be scheduled for further assessment including obtaining informed consent. Assessment procedures will include BMI and semi-structured evaluation interview (MINI SCID (Spitzer et al., 2002)) to determine diagnosis/co-morbid diagnoses and suicide risk.
A medical history and a physical examination will be conducted through the standard clinic procedures. Physical state reviews will accord with international guidelines for weight loss management.
Those who meet eligibility criteria will provide informed consent, and will then be randomised by an external investigator (i.e. investigator at another site not involved in assessment or therapy) using an internet program (sealedenvelope.com). Allocation until the final participant completes follow-up will be known only to PH.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised using computer programme held by Sealed Envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants are treated in groups but are randomised as individuals prior and then allocated to the group appropriate to their randomisation outcome.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Research persons will be responsible for data entry that is blind to study group and preparing this for data merging at the point of analysis post completion of the final follow-up assessment. Data that does not identify active or control group will be analysed by PH. Baseline univariate between group tests will be done to compare groups on outcome variables, clinical and demographic data. Data will be analysed following “intention-to-treat” principles. Generalised estimating equations (Zeger & Liang, 1986) with a logit response function will be used for dichotomous outcomes, such as achieving a 5% reduction in body weight. Linear mixed effects modeling (Hedeker & Gibbons, 2006) will be used to test for between group differences in the continuous outcome measures, namely levels of ED symptom change, adaptive function, quality of life, depression and anxiety levels and BMI.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2013
Actual
30/08/2013
Date of last participant enrolment
Anticipated
1/06/2014
Actual
3/03/2015
Date of last data collection
Anticipated
Actual
10/08/2016
Sample size
Target
32
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288195 0
Self funded/Unfunded
Name [1] 288195 0
Professor Phillipa Hay
Country [1] 288195 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 286922 0
University
Name [1] 286922 0
Boden Insitute
Address [1] 286922 0
The University of Sydney
NSW 2006
Country [1] 286922 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290108 0
HREC University of Sydney
Ethics committee address [1] 290108 0
Ethics committee country [1] 290108 0
Australia
Date submitted for ethics approval [1] 290108 0
Approval date [1] 290108 0
12/09/2013
Ethics approval number [1] 290108 0
2013/755

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44006 0
Prof Phillipa Hay
Address 44006 0
School of Medicine and Center for Health Research
University of Western Sydney
Locked Bag 1797 NSW Penrith 2751
Country 44006 0
Australia
Phone 44006 0
+61 412330428
Fax 44006 0
Email 44006 0
[email protected]
Contact person for public queries
Name 44007 0
Phillipa Hay
Address 44007 0
School of Medicine and Center for Health Research
University of Western Sydney
Locked Bag 1797 NSW Penrith 2751
Country 44007 0
Australia
Phone 44007 0
+61 412330428
Fax 44007 0
Email 44007 0
[email protected]
Contact person for scientific queries
Name 44008 0
Phillipa Hay
Address 44008 0
School of Medicine and Center for Health Research
University of Western Sydney
Locked Bag 1797 NSW Penrith 2751
Country 44008 0
Australia
Phone 44008 0
+61412330428
Fax 44008 0
Email 44008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Subject to ethics restrictions


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.