Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000816459
Ethics application status
Approved
Date submitted
16/06/2016
Date registered
21/06/2016
Date last updated
22/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Weighing Practices in the early stages of inpatient treatment for Anorexia and Bulimia Nervosa
Scientific title
Anxiety levels, weight gain and weight preoccupation following open vs blind weighing in the early stages of inpatient treatment for Anorexia Nervosa and Bulimia Nervosa
Secondary ID [1] 289332 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 298939 0
Bulimia Nervosa 306293 0
Condition category
Condition code
Mental Health 299017 299017 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"Open weighing”: Patients are individually weighed in their underwear by a nurse twice weekly for four weeks. Weighing takes place in the morning in front of the nurses station before patients have breakfast. The outcome is communicated clearly to the patient in form of an actual weight (not simply "up", "down", or "OK"). The patient's weight is then overtly discussed between the patient and treating team (e.g., dieticians, psychologists, psychiatrists) and this information is used as a part of treatment. For example, dieticians may make changes to the patient's meal plan depending on weight gain/loss and psychologist may discuss weight in the context of cognitive behavioural therapy sessions. Patients are asked to complete outcome measure questionnaires directly before and after being weighed.
Intervention code [1] 294892 0
Treatment: Other
Comparator / control treatment
“Blind weighing”: Patients are individually weighed in their underwear by a nurse twice weekly for four weeks. Weighing takes place in the morning in front of the nurses station before patients have breakfast. The patient's weight information is shared with the treating team (e.g., dieticians, psychologists, psychiatrists) but not with the patient. Specific weight information (i.e., the exact number on the scale) is not used as a part of treatment. To justify treatment decisions (e.g., changes in meal plan) the treating team may communicate to the patient whether the weight has gone up or down but will not discuss actual numbers. Patients are asked to complete outcome measure questionnaires directly before and after being weighed.
Control group
Active

Outcomes
Primary outcome [1] 298615 0
Mean anxiety reactions to being weighed as assessed by 100mm Visual Analogue Scales (4 questions; e.g., How anxious are you about being weighed right now?)
Timepoint [1] 298615 0
At baseline session immediately before and after being weighed; and then twice weekly on weighing days for 4 weeks. .
Secondary outcome [1] 324765 0
Rate of weight gain. Participants are weighed by registered nurses using calibrated digital scales
Timepoint [1] 324765 0
Baseline and then twice weekly for 4 weeks
Secondary outcome [2] 324766 0
Mean body and weight preoccupations as assessed by the Eating Disorder-15
Timepoint [2] 324766 0
Baseline and then weekly for 4 weeks
Secondary outcome [3] 324767 0
Mean tolerance of uncertainty scores as assessed by the Intolerance of Uncertainty scale
Timepoint [3] 324767 0
At baseline and at completion of the intervention (at 4 weeks)
Secondary outcome [4] 324768 0
Meal completion. Patients who refuse or cannot complete a meal or snack are required to drink a liquid meal supplement (e.g., Ensure) of equal caloric content. The quantity of liquid meal supplement required (this is always equivalent to the amount of food left on the plate) is recorded by nurses and will be used to assess meal non compliance.
Timepoint [4] 324768 0
Meal completion (or non compliance) is recorded in the patient's chart after each meal/snack. This data will be used to track meal completion across 4 weeks from intervention commencement.
Secondary outcome [5] 324769 0
Treatment motivation as assessed by 100mm Visual Analogue Scales (3 questions; e.g., How motivated do you feel right now to engage with your treatment?)
Timepoint [5] 324769 0
At baseline and then on a weekly basis.

Eligibility
Key inclusion criteria
Females, 16 years and over. Newly admitted patients to Wesley Hospital Ashfield, diagnosed with Anorexia Nervosa and/or Bulimia Nervosa.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age (<16), gender (male)

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation. Each new block will be randomised through a blind random binary list created by an external statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will be randomised to either open weighing or blind weighing. To prevent potential problems of drop-out that may result if participants from different groups are treated alongside one another in hospital and become dissatisfied with their allocation, we will divide the sample into blocks and randomly assign these blocks to one of the two conditions. Once all participants from a block have discharged, recruitment for the next block will start.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For a between group difference in mean scores on the visual analogue ratings of anxiety, a medium to large (clinically relevant) effect size of 0.6 would at power of 80%, thus beta of 0.20, and significance (p) of 5% (0.05) for 1-sided test a group size of n=36 would be required and thus allowing for some attrition (6/42 per group or approximately 15%) a total sample size of n=84 is needed.
The data of this study will be analysed using mixed-effects models (MEM). We hope to determine which approach is more beneficial for patients in the early stages of therapy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/08/2016
Actual
29/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5969 0
Wesley Hospital Ashfield - Ashfield
Recruitment hospital [2] 9842 0
Northside West Clinic - Wentworthville
Recruitment postcode(s) [1] 13391 0
2131 - Ashfield
Recruitment postcode(s) [2] 18622 0
2145 - Wentworthville
Recruitment outside Australia
Country [1] 7953 0
United Kingdom
State/province [1] 7953 0
West Midlands

Funding & Sponsors
Funding source category [1] 293842 0
University
Name [1] 293842 0
UNSW Australia
Country [1] 293842 0
Australia
Primary sponsor type
University
Name
UNSW Australia
Address
UNSW Australia
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 292679 0
Hospital
Name [1] 292679 0
Wesley Hospital Ashfield
Address [1] 292679 0
91 Milton Street Ashfield NSW 2131
Country [1] 292679 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295240 0
UNSW Human Research Ethics
Ethics committee address [1] 295240 0
Ethics committee country [1] 295240 0
Australia
Date submitted for ethics approval [1] 295240 0
30/06/2016
Approval date [1] 295240 0
10/08/2016
Ethics approval number [1] 295240 0
HC 16539

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

Contacts
Principal investigator
Name 66282 0
Ms Franzisca Froreich
Address 66282 0
UNSW Australia, Sydney NSW 2052
Country 66282 0
Australia
Phone 66282 0
+61 449 559 470
Fax 66282 0
Email 66282 0
[email protected]
Contact person for public queries
Name 66283 0
Franzisca Froreich
Address 66283 0
UNSW Australia, Sydney NSW 2052
Country 66283 0
Australia
Phone 66283 0
+61 449 559 470
Fax 66283 0
Email 66283 0
[email protected]
Contact person for scientific queries
Name 66284 0
Franzisca Froreich
Address 66284 0
UNSW Australia, Sydney NSW 2052
Country 66284 0
Australia
Phone 66284 0
+61 449 559 470
Fax 66284 0
Email 66284 0
[email protected]

No information has been provided regarding IPD availability


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.