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A Healthy APproach to weIght management and Food in Eating Disorders (HAPIFED)

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001209785
Acronym
HAPIFEDPilot
Enrollment
33
Registered
2013-11-04
Start date
2013-08-30
Completion date
2015-03-03
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

At least a third of people with eating disorders bulimia nervosa or binge eating disorder will be overweight. However, therapies for such disorders do not address weight management well. Similarly, treatments for obesity do not address the eating disorder symptoms , and whilst there may be short term reductions in binge eating with weight loss therapy this is not sustained over time. We have developed an approach that integrates standard cognitive behaviour therapy (CBT) for eating disorders with behavioural weight loss management adapted for this group i.e. HAPIFED. The present study is a preliminary controlled trial of HAPIFED versus CBT.

Interventions

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 o

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.

Sponsors

University of Western Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026