Healthy Approach to weIght Management and Food in Eating Disorders (HAPIFED)

Conditions

Binge Eating Disorder, Bulimia Nervosa, Eating Disorder

Keywords

BED, Binge Eating Disorer, BN, Bulimia Nervosa, Obesity

Brief summary

The investigators have developed a new integrated therapy, namely a Healthy Approach to weIght management and Food in Eating Disorders (HAPIFED). HAPIFED is an enhanced behavioral weight loss therapy integrated with CBT for the management of EDs. HAPIFED uses CBT to treat ED behaviors and body image distress, whilst simultaneously emphasize a healthy lifestyle, the role of food and physical activity in mood regulation, and revised but clinically meaningful goals for weight loss. The investigators propose a randomized controlled trial (RCT) that will compare HAPIFED to CBT-E in people with obesity and either BN or BED. The two main aims will be to reduce symptoms of ED and to improve weight management. The RCT will be conducted in Sydney and in São Paulo with a one year follow-up.

Detailed description

In sum, a new approach in management of the increasing numbers of obese people with BN and BED is needed. The investigators propose a RCT that will compare a novel therapy HAPIFED with the current 'gold-standard' trans diagnostic treatment, CBT-E. HAPIFED has been developed by the CIs and is based on recent developments in psychological approaches to obesity in general (as highlighted in Casazza et al.'s (2013) paper on Myths, presumptions and facts about obesity) and in people with co-morbid obesity and BN or BED. Unlike CBT-E, it allows reduced energy intake and education around specific food choices - a necessary element in weight loss.

Hay P, Palavras MA, da Luz FQ, Dos Anjos Garnes S, Sainsbury A, Touyz S, Appolinario JC, Claudino AM.

2022-05-2426 citations

10.1186/s12888-022-04005-y

1544Baseline predictors of attrition in a randomised controlled trial of treatments for people with recurrent binge eating episodes associated to overweight or obesity

Haider Mannan, Phillipa Hay

International Journal of Epidemiology2021-09-01

10.1093/ije/dyab168.414

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

Palavras MA, Hay P, Mannan H, da Luz FQ, Sainsbury A, Touyz S, Claudino AM.

2020-01-2523 citations

10.1007/s40519-020-00846-2

Comparing cognitive behavioural therapy for eating disorders integrated with behavioural weight loss therapy to cognitive behavioural therapy-enhanced alone in overweight or obese people with bulimia nervosa or binge eating disorder: study protocol for a randomised controlled trial.

Palavras MA, Hay P, Touyz S, Sainsbury A, da Luz F, Swinbourne J, Estella NM, Claudino A.

2015-12-1821 citations

10.1186/s13063-015-1079-1

Interventions

BEHAVIORALHAPIFED

HAPIFED is adapted from CBT to promote a positive relationship with food, eating and activity, appetite awareness, and weight loss to be achieved over a longer and more intensive period of therapy, thus recognizing the importance of longer-term therapy in weight loss (Casazza et al., 2013). Notably, HAPIFED is also multidisciplinary. Clinical practice and consensus views are to utilize the special expertise of dietitians and other allied health professionals (Robinson, 2009).

BEHAVIORALCBT-E

CBT-E therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* Diagnosis of threshold or subthreshold for Bulimia Nervosa or Binge Eating Disorder (DSM-5/ICD-11) * BMI between ≥ 27 and \< 40

Exclusion criteria

* Diagnosis of psychosis, bipolar disorder or substance abuse dependence and/or a high level of suicide risk. * Use of weight loss medication or medications that interfere with appetite. * Cushing or Prader-Willi syndromes * History of bariatric surgery * Patients who are already in treatment

Design outcomes

Primary

Measure	Time frame	Description
Sustained change weight (for less) of 5% of previous body weight. This is a level known to improve physical health (metabolic) outcomes.	Baseline, 25-weeks (end) treatment, 6 and12 months follow-up.	Change of 5% of body weight.

Secondary

Measure	Time frame	Description
Severity of loss of control over eating	Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.	Change (for less) in the Global (total) Loss of Control over Eating Scale (LOCES) score
Change in severity of binge eating	Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.	Binge eating severity as measured by a reduced total score on the Binge Eating Scale questionnaire
Change in binge eating frequency	Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.	Change (for less) in binge eating frequency as measured on the Eating Disorder Examintaion Questionnaire
Change in the levels of depression, anxiety and stress.	Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.	Changed level of depression, anxiety and stress as measured on the Depression, Anxiety and Stress Scale 21 item questionnaire - subscale scores of depression, anxiety and stress
Health related quality of life	Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.	Improved physical and mental health related quality of life as measured by increased scores on the Short Form 12-item survey (SF-12) Physical and Mental Health Component scores
Improved metabolic indicators of weight management	Baseline, 25 weeks (end) treatment	Waist and Hip circumference and blood markers (Blood fasting lipid profile, fasting glucose matched with insulin, liver function tests, electrolytes, urea, uric acid and creatinine.

Countries

Brazil

Outcome results

None listed