Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001828213
Ethics application status
Approved
Date submitted
22/10/2018
Date registered
9/11/2018
Date last updated
18/06/2021
Date data sharing statement initially provided
9/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact on patient outcomes of a five session, tailored nutrition and dietetic intervention for outpatients receiving psychological treatment for an eating disorder: a proof of principle study
Scientific title
The impact on patient outcomes of a five session, tailored nutrition and dietetic intervention for outpatients receiving psychological treatment for an eating disorder: a proof of principle study
Secondary ID [1] 296521 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating disorder 310137 0
Anorexia nervosa 310138 0
Bulimia nervosa 310139 0
Binge eating disorder 310140 0
Condition category
Condition code
Diet and Nutrition 308883 308883 0 0
Other diet and nutrition disorders
Mental Health 308884 308884 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention will comprise of ten 50 minute sessions of individual face to face “treatment as usual” psychological intervention with a clinical psychologist at Basten & Associates clinical psychology practice + five 50 minutes sessions of individual face to face nutrition and dietetic intervention.

Psychological "treatment as usual":
Psychological intervention will be delivered weekly. All clinical psychologists at Basten & Associates are trained in the use of cognitive behaviour therapy-enhanced (CBT-E), motivational enhancement, schema therapy, family-based therapy and dialectical behaviour therapy, all of which are known to have effectiveness with eating disorders. Treatment needs for each patient are adapted based on several factors:
• The motivational status and readiness for change of the client;
• Their diagnosis e.g. binge eating disorder is treated differently from binge-purge subtype anorexia nervosa; and
• The patient’s weight e.g. for instance a low BMI requires an early focus on weight restoration above all else.

Therefore, TAU within the practice where patients will be recruited is a broad set of options that can be summarised as universal (done with all clients) and optional (likely to be used, depending on the type of presentation).

Universal interventions include:
• A thorough assessment process
• Forming a therapeutic alliance
• Developing a formulation
• Identifying maintaining factors including adaptive functions for the individual
• Psychoeducation about dieting issues
• Commencing some form of self-monitoring (e.g. of eating and its antecedents or just emotions)
• Weighing and discussing weight trajectory over time
• Selecting goals collaboratively with the patient.

Optional interventions are more numerous and include the following:
• Recommendations for normalising eating (differs for anorexia nervosa, bulimia nervosa and binge eating disorder)
• Addressing fear of weight gain through cognitive therapy informed by motivational interviewing
• Identifying fears of change (other than fear of weight gain) and addressing each concern thoroughly
• Behavioural experiments
• Teaching cognitive therapy skills (targeting fear of weight gain, importance placed on weight and shape, core self-worth)
• Exploring personal idiosyncratic cognitive errors (such as dichotomous thinking)
• Teaching emotional regulation skills other than cognitive therapy
• Teaching interpersonal skills (e.g. assertiveness, expressing needs, decision-making, developing closeness, building sensitivity to criticism)
• Targeting perfectionism with cognitive therapy
• Targeting core self-worth with cognitive therapy and schema-focused therapy
• Targeting body-image distress with approaches such as psychoeducation, limit avoidance, limit checking, thought challenging, attentional retraining, behavioural experiments and mirror exposure

Nutrition and dietetic intervention:
An individual, face to face nutrition and dietetic assessment will be conducted by investigator and dietitian Caitlin McMaster with all participants at two time points:
1) Once participants have consented to be involved in the study, and
2) Once participants have completed 10 sessions of psychological intervention (TAU) and 5 sessions of nutrition and dietetic treatment.

Both nutrition and dietetic assessments will have two components:
1) Thorough nutritional assessment conducted by specialist dietitian Caitlin McMaster as per the Position of the American Dietetic Association: nutrition intervention in the treatment of eating disorders recommendations.
2) 24 hour dietary recall conducted using the National Cancer Institute’s online Automated Self Administered 24 Hour Recall (ASA-24) program with guidance from Caitlin McMaster.

Participants will receive five 50 minute sessions of individual, face to face nutrition and dietetic intervention in addition to the 10 sessions of psychological TAU as described in the "comparator/control treatment" section. The nutrition and dietetic treatment will take place at the same practice location where the participant is receiving psychological treatment for their eating disorder.

The five sessions of nutrition and dietetic intervention will be delivered on a weekly to fortnightly basis. As intake into the study will occur after session 3 of psychological treatment, the nutrition and dietetic sessions will occur between session 4 and session 10 of the participant's psychological treatment. The nutrition and dietetic treatment will comprise of:
• Review of patient progress and feedback
• Nutrition education (i.e. Macronutrients, micronutrients, core food groups, fluid intake, importance of calcium, fun foods, social eating and diet foods, consequences of starvation/malnutrition and eating disorder behaviours, Importance and benefits of regular eating, importance of targeting feared foods, disordered behaviours involved in food choice and preparation, minimizing vs maximising meal plan, making choices at the supermarket and in social situations, tackling barriers to meal plan compliance)
• Education on food and eating skills (i.e. Structure of meal plan, “Thirds rule” for main meals, mechanical eating, increasing regularity of eating, food monitoring, eating with support, meal planning, behavioural experiment framework for feared foods, managing barriers to meal plan adherence, skills to decrease use of disordered behaviours when choosing and preparing food, practical assistance with measuring portions, managing supermarket shopping, targeting common “minimizing” of meal plan, helpful and unhelpful strategies to maintain and build on improvements, treatment planning)
• Homework tasks (i.e. construct food hierarchy, practice mechanical and regular eating,eat with others where possible, behavioural experiments targeting feared foods, practice strategies to ensure adequate portion sizes, shop for groceries utilising strategies discussed, practice skills discussed to target meal plan minimizing)

Nutrition education, education related to food and eating skills and homework tasks will include the use of informational resources (written resources and worksheets developed by the Centre for Clinical Interventions - https://www.cci.health.wa.gov.au/Resources/For-Clinicians/Eating-Disorders).
Intervention code [1] 312723 0
Behaviour
Comparator / control treatment
No comparator/control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307856 0
Primary outcome is participant's weight which will be measured as both weight in kilograms and body mass index (BMI)

Outcome will be assessed using stadiometer and digital scales
Timepoint [1] 307856 0
1. Baseline
2. At session 6 of psychological therapy
3. At session 10 of psychological therapy
Primary outcome [2] 307857 0
Eating disorder psychopathology and behaviours as assessed using the Eating Disorder Examination Questionnaire
Timepoint [2] 307857 0
1. Baseline
2. At session 6 of psychological therapy
3. At session 10 of psychological therapy
Primary outcome [3] 307858 0
Nutritional intake and eating behaviours and attitudes as assessed by nutrition and dietetic assessment, 24 hour dietary recall and Eating Attitudes Test-26
Timepoint [3] 307858 0
1. Baseline
2. During nutrition and dietetic assessment (after 3 sessions of psychological therapy)
3. At session 6 of psychological therapy
4. At session 10 of psychological therapy
Secondary outcome [1] 353163 0
Patient satisfaction and acceptability of nutrition and dietetic intervention

Assessed by semi structured phone interviews with participants conducted by investigator not involved in participants' treatment.
Timepoint [1] 353163 0
Immediately post trial
Secondary outcome [2] 353164 0
Clinical psychologists' satisfaction and acceptability of nutrition and dietetic intervention

Assessed by semi structured phone interviews with clinical psychologists conducted by investigator not involved in participants' treatment or in contact with clinical psychologist outside of this study.
Timepoint [2] 353164 0
Immediately post trial

Eligibility
Key inclusion criteria
a. Attending Basten & Associates clinical psychology practice.
b. Diagnosis of anorexia nervosa (AN), bulimia nervosa (BN), binge eating disorder (BED) or other specified feeding and eating disorder (OSFED) as determined by Basten & Associates clinical psychologist according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) V. Patients with atypical or subclinical eating disorder presentations will also be eligible if they are judged by a clinical psychologist to benefit from participation in the clinical trial.
c. Aged 16 years and older. If a patient is aged < 18 they must have been recommended to undertake individual psychological treatment by their clinical psychologist, not family based therapy, and will require parental consent to participate in this research.
d. Engaged in regular medical monitoring with a general practitioner and deemed to be medically stable (i.e. not requiring inpatient admission).
e. Stable accommodation.
f. Able to commit to regular psychological and dietetic appointments i.e. 10 x 50 minute sessions and 5 x 50 minute sessions respectively.
g. Not currently seeing dietitian as part of treatment for an eating disorder and agree not to seek treatment from other dietitian until after post treatment evaluation measures completed.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Medical instability (i.e. not engaged in regular medical monitoring with general practitioner or has been recommended more intensive treatment than outpatient care due to medical instability).
b. Severe and current co-morbid drug and alcohol issues.
c. Suicidality/cannot guarantee safety including recurrent self-harm.
d. No safe and stable accommodation.
e. Active psychosis or acute psychiatric crises.
f. High risk of requiring hospitalization for eating disorder or other mental illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study is a 4 (time) x 1 (group) design, where participants will be assessed at entry to psychological treatment, at the commencement of the nutrition and dietetic intervention and then at the end of session 6 and session 10 of psychological TAU.

Missing data will be examined in order to confirm missing at random. Treatment outcome data will be primarily analysed using an intention-to-treat approach using multi-level modelling (MLM) with linear mixed effects modelling for continuous variables, and chi-square analysis for dichotomous variables.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
25/03/2019
Actual
27/05/2019
Date of last participant enrolment
Anticipated
31/03/2020
Actual
31/03/2020
Date of last data collection
Anticipated
30/06/2020
Actual
31/03/2020
Sample size
Target
26
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 24413 0
2145 - Westmead
Recruitment postcode(s) [2] 24414 0
2067 - Chatswood
Recruitment postcode(s) [3] 24415 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 300994 0
University
Name [1] 300994 0
University of Sydney
Country [1] 300994 0
Australia
Primary sponsor type
University
Name
Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, University of Sydney
Address
Level 2 Charles Perkins Centre D17
Johns Hopkins Drive (off Missenden Road)
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 300583 0
None
Name [1] 300583 0
Address [1] 300583 0
Country [1] 300583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301754 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 301754 0
Ethics committee country [1] 301754 0
Australia
Date submitted for ethics approval [1] 301754 0
04/10/2018
Approval date [1] 301754 0
30/11/2018
Ethics approval number [1] 301754 0

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

Contacts
Principal investigator
Name 87986 0
Dr Susan Hart
Address 87986 0
Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
Level 2 Charles Perkins Centre D17
Johns Hopkins Drive (off Missenden Road)
The University of Sydney
Camperdown NSW 2006
Country 87986 0
Australia
Phone 87986 0
+61 2 8627 1933
Fax 87986 0
+ 61 2 8627 0141
Email 87986 0
[email protected]
Contact person for public queries
Name 87987 0
Caitlin McMaster
Address 87987 0
Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
Level 2 Charles Perkins Centre D17
Johns Hopkins Drive (off Missenden Road)
The University of Sydney
Camperdown NSW 2006
Country 87987 0
Australia
Phone 87987 0
+61 2 8627 1933
Fax 87987 0
+ 61 2 8627 0141
Email 87987 0
[email protected]
Contact person for scientific queries
Name 87988 0
Caitlin McMaster
Address 87988 0
Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
Level 2 Charles Perkins Centre D17
Johns Hopkins Drive (off Missenden Road)
The University of Sydney
Camperdown NSW 2006
Country 87988 0
Australia
Phone 87988 0
+61 2 8627 1933
Fax 87988 0
+ 61 2 8627 0141
Email 87988 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
The confidentiality of participants and privacy of their data be protected in the dissemination of overall research results.


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
SourceTitleYear of PublicationDOI
EmbaseRationale and development of a manualised dietetic intervention for adults undergoing psychological treatment for an eating disorder.2021https://dx.doi.org/10.1007/s40519-020-00955-y
N.B. These documents automatically identified may not have been verified by the study sponsor.