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Trial registered on ANZCTR


Registration number
ACTRN12609001004257
Ethics application status
Approved
Date submitted
18/11/2009
Date registered
19/11/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of the Bioenterics Intragastric Balloon (BIB) Versus Lifestyle Intervention Alone on Weight Loss and Reversal of Weight Related Diseases in Obese Adolescents.
Scientific title
Obese adolescents in randomized control trial of the intragastric balloon and lifestyle intervention combination versus lifestyle intervention alone in reducing weight and associated health risks.
Universal Trial Number (UTN)
Trial acronym
BIB Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity in adolescents, and obesity-related comorbidities 252238 0
Condition category
Condition code
Metabolic and Endocrine 252424 252424 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the lifestyle intervention plus BIB will receive a Bioenterics Intragastric Balloon (BIB) for a duration of six months. The BIB is a smooth silicone, saline filled temporary device placed in the stomach. Participants will be admitted under the gastroenterology team at Princess Margaret Hospital (PMH) for 3 days duration for insertion. Both insertion and removal procedures involve a short general anaesthetic followed by inspection of the stomach and duodenum using an endoscope. The balloon device is inserted into the stomach; the balloon is inflated with saline and methylene blue and then disconnected. The insertion equipment is withdrawn.
A detailed post operative dietary plan has been developed to slowly wean participants from liquid diet back to solids. A liquid vitamin and mineral supplement will be taken for the first week until the participant is back on a nutritionally balanced diet. Participants will have an individualized nutrition plan drawn up based on Australian dietary guidelines for children and adolescents.
Removal of the balloon will occur after 6 months duration.
Intervention code [1] 241571 0
Treatment: Devices
Comparator / control treatment
No balloon.
All participants will be enrolled into the Changes in Lifestyle Are Successful in Partnership (CLASP) program. The program is part of standard clinical care for children with obesity or impaired glucose tolerance (IGT) and is run through the Department of Endocrinology and Diabetes at Princess Margaret Hospital. The program is run by a multidisciplinary team consisting of a dietician, psychologist, social worker, nurse, exercise physiologist, physiotherapist and physician. Achieving a healthy diet, learning how to self-monitor, behavioural changes and improving physical activities are taught in detail to both the participant and parent/guardian through a series of individual and group sessions. This program comprises of two and a half hour sessions held once a week for 10 weeks.
Control group
Active

Outcomes
Primary outcome [1] 253299 0
Adiposity: Body mass index (BMI) raw score and Z score will be used as indicators of total adiposity.
Timepoint [1] 253299 0
Assessed at baseline, 6 and 18 months.
Secondary outcome [1] 262331 0
Anthropometry: Height, weight, waist circumference, hip circumference and bi-acromial distance, percentage of body fat will be measured using standard measures.
Timepoint [1] 262331 0
Assessed at baseline, 6 and 18 months.
Secondary outcome [2] 262332 0
Biochemical tests: Changes in biochemical markers.
Timepoint [2] 262332 0
Assessed at baseline, 6 and 18 months.
Secondary outcome [3] 262333 0
Clinical symptoms and signs of obesity complications, assessed through clinic visits and biochemical markers.
Timepoint [3] 262333 0
Assessed at baseline, 6 and 18 months.
Secondary outcome [4] 262334 0
Fitness, physical activity and sedentary behaviour, using validated questionnaires. Fitness will be assessed by the 6-minute walk test, step test and balance test.
Timepoint [4] 262334 0
Assessed at baseline, 6 and 18 months.
Secondary outcome [5] 262335 0
Dietary habits and intake changes, using a three-day food diary and an eating habits questionnaire.
Timepoint [5] 262335 0
Assessed at baseline, 6 and 18 months.
Secondary outcome [6] 262336 0
Psychological scores on validated questionnaires
Timepoint [6] 262336 0
Assessed at baseline, 6 and 18 months.
Secondary outcome [7] 262337 0
Tolerance and adverse events, including nausea, vomiting and abdominal pain. This will be measured by assessing the postoperative requirement for antiemetics and documentation of symptoms.
Timepoint [7] 262337 0
Assessed at 1 week, 2 weeks, 4 weeks, 10 weeks, 6 months.
Secondary outcome [8] 262338 0
Blood pressure, measured using a handheld aneroid sphygmomanometer .
Timepoint [8] 262338 0
Assessed at baseline, 6 and 18 months.

Eligibility
Key inclusion criteria
Participants must fulfil the following criteria:
1. Living in metropolitan Perth and willing to attend outpatient appointments.
2. No significant weight loss despite = 3 months attempted lifestyle improvements.

Participants must have a BMI Z-score >+3 OR a BMI Z-score>+2 AND 2 or more of the following co-morbidities.
1. Hyperlipidaemia
2. Impaired glucose tolerance/hyperinsulinaemia
3. Hepatitis steatosis
4. Hypertension,
5. Polycystic ovarian syndrome
6. Obstructive sleep apnoea
7. Benign intracranial hypertension
8. Degenerative joint disease.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous gastrointestinal resections
2. Structural abnormalities of the gastrointestinal tract.
3. Psychiatric/eating disorder
4. Rural dwelling,
5. Active oesophagitis (Grade1) / active gastric ulcer or its previous complications/hiatus hernia (>5cm)
6. Pregnancy
7. Type 2 diabetes
8. Patient on anticoagulants or non-steroidal anti-inflammatory drugs gastric irritants, unwilling to make lifestyles changes or attend regular clinic appointments.
9. Unwilling to accept the probability of nausea and vomiting in the postoperative period.
10. Physical inability to maintain regular follow-up
11. Obstructive sleep apnoea requiring a continuous positive airway pressure (CPAP) machine

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)
All doctors seeing adolescents for their obesity and/or obesity related complications will follow a step-by-step guide on assessing patients for possible entry into the study. The subject’s doctor will refer any eligible and interested patients to Investigators, who will contact the family via telephone within 2 weeks of referral. In the event of the treating Dr being the investigator a different member of the research team will discuss the study with the adolescent and their family.
Informed consent from the participant’s guardian will be obtained prior to the baseline assessment. Participants will be contacted by a member of the research team for consent as an adult when they reach 18 years of age.
A detailed assessment will be conducted to ensure that the participant meets the inclusion criteria/exclusion criteria and to collect data at baseline. Eligible consented participants will be randomised to the control group lifestyle/CLASP or the intervention (BIB) group plus lifestyle/ CLASP. Randomisation will occur in blocks of 6 in a one-to-one ratio and will be performed using a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence was generated by a computer-based random number-producing algorithm in block lengths of six to ensure an equal chance of allocation to each group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In the event of a significant difference between the groups being observed before completion of the study, the study will be ceased.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244050 0
Government body
Name [1] 244050 0
National Health and Medical Research Council
Country [1] 244050 0
Australia
Primary sponsor type
Individual
Name
Dr Elizabeth Davis
Address
Princess Margaret Hospital for Children
Department of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country
Australia
Secondary sponsor category [1] 251397 0
Individual
Name [1] 251397 0
Dr Jacqueline Curran
Address [1] 251397 0
Princess Margaret Hospital for Children
Department of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country [1] 251397 0
Australia
Other collaborator category [1] 963 0
Individual
Name [1] 963 0
Colin Sherrington
Address [1] 963 0
Princess Margaret Hospital for Children
Department of Gastroenterology
Roberts Road
Subiaco, WA 6008
Country [1] 963 0
Australia
Other collaborator category [2] 964 0
Individual
Name [2] 964 0
Dr Timothy Jones
Address [2] 964 0
Princess Margaret Hospital for Children
Department of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country [2] 964 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258144 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 258144 0
Ethics committee country [1] 258144 0
Australia
Date submitted for ethics approval [1] 258144 0
Approval date [1] 258144 0
16/10/2009
Ethics approval number [1] 258144 0
1489EP

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

Contacts
Principal investigator
Name 30527 0
Address 30527 0
Country 30527 0
Phone 30527 0
Fax 30527 0
Email 30527 0
Contact person for public queries
Name 13774 0
Rachelle Kalic
Address 13774 0
Princess Margaret Hospital for Children
Roberts Road, Subiaco
WA, 6008
Country 13774 0
Australia
Phone 13774 0
+61 8 9340 7857
Fax 13774 0
Email 13774 0
[email protected]
Contact person for scientific queries
Name 4702 0
Dr Jacqueline Curran
Address 4702 0
Princess Margaret Hospital for Children
Roberts Road, Subiaco
WA, 6008
Country 4702 0
Australia
Phone 4702 0
+61 8 9340 8090
Fax 4702 0
Email 4702 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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