Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000862347
Ethics application status
Approved
Date submitted
8/06/2017
Date registered
13/06/2017
Date last updated
13/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Weight management attempts following a brief consultation for patients with obesity in a tertiary hospital
Scientific title
Efficacy of a brief consultation for adult patients with obesity in a tertiary hospital in improving weight management
Secondary ID [1] 292031 0
None
Universal Trial Number (UTN)
Trial acronym
BIFO (brief intervention for obesity)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 303421 0
weight management 303422 0
Condition category
Condition code
Diet and Nutrition 302833 302833 0 0
Obesity
Public Health 302834 302834 0 0
Health promotion/education
Public Health 302835 302835 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: a brief intervention for obesity.

This 'brief intervention' will involve a 5-10 minute private conversation between the patient and their doctor in hospital which is integrated into their existing interaction during their hospital admission (timing at the discretion of the doctor) or during the pre-admission clinic consultation. :
1) Informing the patient of their weight and diagnosis of obesity.
2) Providing a pamphlet (developed by the Nutrition and Dietetics Department at The Alfred) which contains educational material on the problem of obesity, basic advice on weight loss and links to community resources (LiveLighter.com and The Alfred website to a page also developed by the Nutrition and Dietetics Department).
3) Advising the patient to see their GP for further support
4) Informing the patient's GP of the diagnosis of obesity via discharge summary or letter

Medical staff involved have been instructed that the objective of the conversation is to prompt the patient to take further steps following up with weight management post-discharge.
Intervention code [1] 298159 0
Behaviour
Intervention code [2] 298315 0
Treatment: Other
Comparator / control treatment
Control group will receive standard care during their hospital visit. Patients are routinely weighed by nursing staff so if obesity is identified, they are alerted that this is a risk to their health and advised to seek further support from their GP.
Control group
Active

Outcomes
Primary outcome [1] 302226 0
Proportion of participants who have commenced a weight management attempt.

Assessed by online or phone survey asking:
- if patient has accessed the online information in pamphlet (if provided)
- if patient has newly attempted weight management (yes or no)
- if yes, what strategies they have tried (diet, exercise, referral to allied health such as dietitian/exercise physiologist, pharmacological agents, referral for bariatric surgery, other)
Timepoint [1] 302226 0
3 months post randomisation
Primary outcome [2] 302227 0
Proportion of participants who have discussed weight management with their GPs since discharge from hospital, assessed via online/phone survey
Timepoint [2] 302227 0
3 months post randomisation
Primary outcome [3] 302228 0
Proportion of participants who complete the consultation in hospital, assessed by treating doctors reporting to trial coordinator
Timepoint [3] 302228 0
Upon patient discharge from hospital
Secondary outcome [1] 335233 0
Patient weight assessed by self-report on online/phone survey
Timepoint [1] 335233 0
3 months post randomisation
Secondary outcome [2] 335234 0
Consumer feedback on the intervention, as assessed by online/phone survey of participants asking:
- did you find the programme acceptable
- did you find the programme helpful
- suggestions for improvement
- further comments
Timepoint [2] 335234 0
3 months post randomisation
Secondary outcome [3] 335235 0
Staff satisfaction with the program as assessed by a 5-Point Likert Scale
Timepoint [3] 335235 0
At end of rotations with units involved
Secondary outcome [4] 335236 0
GP satisfaction with intervention as assessed by a 5-point Likert Scale
Timepoint [4] 335236 0
3 months post randomisation

Eligibility
Key inclusion criteria
Body mass index (BMI) > 30 kg/m^2
Admitted to inpatient ward or attendance at a scheduled pre-admission clinic appointment
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with current or past history of bariatric surgery
Major medical illness which contraindicates weight loss
Non-English speaking

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)
Central randomisation with computer software and opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculation:
We estimate that if 5% of patients have a discussion with their GP about their weight following discharge in the control group and we are able to increase this to 20% with the brief intervention this would be clinically significant. To detect a difference of this magnitude with a two-sided a of 0.05 and power of 0.8 we would require 75 patients in each arm. Allowing for a 15% drop out rate, we aim to recruit a total of 174 patients.

Data anaylsis:
Standard statistical tests will be used. For primary endpoints categorical outcomes (yes/no) will be analysed using fisher exact or chi-squared test, adjusting for baseline imbalances and potential covariates . Logistic regressions will be used for continuous outcomes (weight).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/02/2017
Date of last participant enrolment
Anticipated
30/09/2017
Actual
Date of last data collection
Anticipated
31/12/2017
Actual
Sample size
Target
174
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8116 0
The Alfred - Prahran
Recruitment postcode(s) [1] 16173 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 296563 0
University
Name [1] 296563 0
Centre of Obesity Research and Education, Monash University
Country [1] 296563 0
Australia
Funding source category [2] 296700 0
Hospital
Name [2] 296700 0
The Alfred
Country [2] 296700 0
Australia
Primary sponsor type
University
Name
Centre of Obesity Research and Education, Monash University
Address
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 295514 0
Hospital
Name [1] 295514 0
The Alfred
Address [1] 295514 0
55 Commercial Rd, Melbourne VIC 3004

Postal address
The Alfred
PO Box 315
Prahran VIC 3181
Country [1] 295514 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297779 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 297779 0
Ethics committee country [1] 297779 0
Australia
Date submitted for ethics approval [1] 297779 0
24/10/2016
Approval date [1] 297779 0
29/11/2016
Ethics approval number [1] 297779 0
514/16
Ethics committee name [2] 297781 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 297781 0
Ethics committee country [2] 297781 0
Australia
Date submitted for ethics approval [2] 297781 0
09/02/2017
Approval date [2] 297781 0
09/02/2017
Ethics approval number [2] 297781 0
7825

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

Contacts
Principal investigator
Name 75086 0
Prof Wendy Brown
Address 75086 0
Centre for Obesity Research and Education (CORE), Monash University
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne Vic 3004
Country 75086 0
Australia
Phone 75086 0
+61 3 9903 0725
Fax 75086 0
+61 3 9903 0717
Email 75086 0
[email protected]
Contact person for public queries
Name 75087 0
Tiffany Tie
Address 75087 0
Centre for Obesity Research and Education (CORE), Monash University
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne Vic 3004
Country 75087 0
Australia
Phone 75087 0
+61399030369
Fax 75087 0
Email 75087 0
[email protected]
Contact person for scientific queries
Name 75088 0
Tiffany Tie
Address 75088 0
Centre for Obesity Research and Education (CORE), Monash University
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne Vic 3004
Country 75088 0
Australia
Phone 75088 0
+61399030369
Fax 75088 0
Email 75088 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
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