Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000175572
Ethics application status
Approved
Date submitted
12/05/2006
Date registered
15/05/2006
Date last updated
9/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Community-based weight management of overweight and obese adolescents: a randomised controlled trial
Scientific title
Community-based weight management of overweight and obese adolescents: a randomised controlled trial of extended therapeutic contact vs recommended care with primary outcomes body mass index standard deviation score and waist circumference standard deviation score
Secondary ID [1] 287838 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Loozit
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 1148 0
Condition category
Condition code
Diet and Nutrition 1228 1228 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention (G+E): current recommended treatment for adolescent overweight & obesity + extended therapeutic contact.
Extended therapeutic contact will include a combination of telephone coaching, emails and short messaging service (SMS) text messaging
Current recommended treatment: group program weekly initially for 8 weeks followed by one booster group session each term for the next 7 terms.
Group program focuses on modification of behaviour, diet and physical activity, and building self-esteem
Total time period of the intervention is 2 years
Intervention code [1] 1035 0
Lifestyle
Comparator / control treatment
Control (G): current recommended treatment for adolescent overweight and obesity
Control group
Active

Outcomes
Primary outcome [1] 1666 0
Body mass index standard deviation score (BMI z score)
Timepoint [1] 1666 0
At baseline, 2 months, 12 months, and 24 months
Primary outcome [2] 1667 0
Waist circumference standard deviation score (waist z score)
Timepoint [2] 1667 0
At baseline, 2 months, 12 months, and 24 months
Secondary outcome [1] 2981 0
Fasting insulin, glucose total cholesterol, HDL cholesterol, LDL cholesterol
Timepoint [1] 2981 0
Baseline, 2 months, 12 months, 24 months
Secondary outcome [2] 2982 0
Blood pressure
Timepoint [2] 2982 0
Baseline, 2 months, 12 months, 24 months
Secondary outcome [3] 2983 0
Physical activity
Timepoint [3] 2983 0
Baseline, 2 months, 12 months, 24 months
Secondary outcome [4] 2984 0
Food intake and eating patterns
Timepoint [4] 2984 0
Baseline, 2 months, 12 months, 24 months
Secondary outcome [5] 2985 0
Psychosocial assessment
Timepoint [5] 2985 0
Baseline, 2 months, 12 months, 24 months

Eligibility
Key inclusion criteria
Overweight or obese by body mass index (ie BMI z score range 1.0 – 3.5); access to a landline telephone and either the internet or a mobile phone, or both; facility with English.
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severely obese adolescents (BMI z score > 3.5 ), adolescents with secondary causes for overweight/obesity, intellectual disability, significant medical illness, psychiatric disturbance, lack of facility with spoken English, extreme dietary restriction, inability to take part in physical activity sessions, on medications that affect weight.

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)
Concealed allocation to groups will be the responsibility of the trial manager. The subject ID will be written on the outside of a sealed opaque envelope which contains the group allocation. The trial manager will give the envelopes to the group facilitator. Facilitators will not know how the randomisation sequence was generated. Facilitators will explain the study and obtain consent from the adolescent and his/her parent. Only after consent is obtained will the next numbered envelope be opened and the group allocation logged with subject ID. A separate file will list subject ID and the group allocation and will be accessed only by the group facilitator, who is also responsible for contact with the subjects and intervention delivery. All data files will contain subject ID only. Measurements of subjects at each time point will be performed by a person who is blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to groups will be undertaken using minimization to balance age and gender between the two study groups. A computer generated randomisation schedule will be used to initially allocate participants to either the control (G) or the intervention (G+E) and then minimization will be used to resolve group imbalances if they occur. The strata that will be used in the minimization process will be as follows: boys aged 13-14 years, girls aged 13-14 years, boys aged 15-16 years and girls aged 15-16 years.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/06/2006
Actual
20/06/2006
Date of last participant enrolment
Anticipated
Actual
28/10/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
168
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1340 0
University
Name [1] 1340 0
University of Sydney Research & Development Grant
Country [1] 1340 0
Australia
Funding source category [2] 1341 0
Charities/Societies/Foundations
Name [2] 1341 0
Macquarie Bank Foundation
Country [2] 1341 0
Australia
Funding source category [3] 1342 0
Commercial sector/Industry
Name [3] 1342 0
Estate of the Late RT Hall
Country [3] 1342 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 1183 0
None
Name [1] 1183 0
Nil
Address [1] 1183 0
Country [1] 1183 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2693 0
The Ethics Committee of the Children’s Hospital at Westmead
Ethics committee address [1] 2693 0
Ethics committee country [1] 2693 0
Australia
Date submitted for ethics approval [1] 2693 0
Approval date [1] 2693 0
Ethics approval number [1] 2693 0
2006/004
Ethics committee name [2] 2694 0
The Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [2] 2694 0
Ethics committee country [2] 2694 0
Australia
Date submitted for ethics approval [2] 2694 0
Approval date [2] 2694 0
30/04/2006
Ethics approval number [2] 2694 0
2006/2/4.23(2295)
Ethics committee name [3] 2695 0
The Ethics Committee of the University of Sydney
Ethics committee address [3] 2695 0
Ethics committee country [3] 2695 0
Australia
Date submitted for ethics approval [3] 2695 0
Approval date [3] 2695 0
04/05/2006
Ethics approval number [3] 2695 0
2006/004

Summary
Brief summary
The aim of this study is to determine the effect of extended therapeutic contact over a 2 year period on a community-based weight management group program in overweight and obese young people aged 13-16 years. The additional therapeutic contact, via phone coaching, e-mail and SMS messages, is designed to give each young person the extra support and guidance to empower them to make and maintain healthy lifestyle changes. 168 young people will be randomised into either the group program, or the group program plus extended therapeutic contact. They will be followed up for 2 years to assess the effect of the program on a variety of health outcomes including weight, self-esteem and metabolic health.

Adolescents’ height, weight and waist circumference will be measured at baseline, 12 months and 24 months by contract staff who are blinded to treatment allocation. In addition, adolescents will be asked not to reveal their treatment allocation to staff who perform the measurements. Of course, it will not be possible for the adolescents to be blinded to treatment allocation.

If effective, we expect the following outcomes:

1) A reduction in levels of overweight and obesity in young people aged 13-16 years

2) The adoption and maintenance of healthy lifestyle behaviours in that segment of the population which has most to gain over a lifetime - overweight and obese young people

3) A novel, replicable, feasible, cost-effective community-based approach to overweight and obesity in young people tailored to the Australian health care system
Trial website
Trial related presentations / publications
1. Shrewsbury VA, O’Connor J, Steinbeck KS, Stevenson K, Lee A, Hill AJ, Kohn MR, Shah S, Torvaldsen S, Baur LA. A randomised controlled trial of a community-based healthy lifestyle program for overweight and obese adolescents: the Loozit? study protocol. BMC Public Health 2009, 9:119 (http://www.biomedcentral.com/1471-2458/9/119).
2. Kornman KP, Shrewsbury VA, Chou AC, Nguyen B, Lee A, O’Connor J, Steinbeck KS, Hill AJ, Kohn MR, Shah S, Baur LA. Electronic therapeutic contact for adolescent weight management: The Loozit® Study. Telemedicine and e-Health 2010; 16:678-685.
3. Shrewsbury VA, Nguyen B, O’Connor J, Steinbeck KS, Lee A, Hill AJ, Shah S, Kohn M, Torvaldsen S, Baur LA. Short-term outcomes of community-based adolescent weight management: The Loozit Study. BMC Pediatrics 2011; 11:13. Available at: http://www.biomedcentral.com/1471-2431/11/13
4. Twelve month outcomes of the Loozit randomized controlled trial: a community-based healthy lifestyle program for overweight and obese adolescents. Arch Pediatr Adolesc Med 2012; 166:170-177.
5. Nguyen B, McGregor K, O’Connor J, Shrewsbury VA, Lee A, Steinbeck KS, Hill AJ, Shah S, Kohn MR, Baur LA. Recruitment challenges and recommendations for adolescent obesity trials. J Paediatr Ch Health 2012; 48:38-43.
6. Nguyen T, Shrewsbury VA, O’Connor J, Steinbeck KS, Hill AJ, Shah S, Kohn MR, Baur LA. Two-year outcomes of an adjunctive telephone coaching and electronic contact intervention for adolescent weight-loss maintenance: the Loozit randomized controlled trial. Int J Obesity 2013; 37:468-72.
7. Nguyen B, Shrewsbury VA, O’Connor J, Lau C, Steinbeck KS, Hill AJ, Baur LA. Process evaluation of an adolescent weight management intervention. Health Prom Int 2015; 30:201-212.
Public notes

Contacts
Principal investigator
Name 35270 0
Prof Louise Baur
Address 35270 0
Clinical School, The Children's Hospital at Westmead, Locked Bag 4001, Westmead NSW 2145, AUSTRALIA
Country 35270 0
Australia
Phone 35270 0
61-2-9845-0000
Fax 35270 0
Email 35270 0
[email protected]
Contact person for public queries
Name 10224 0
Mrs Janice O’Connor
Address 10224 0
Clinical School
The Children’s Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 10224 0
Australia
Phone 10224 0
+61 2 98451291
Fax 10224 0
+61 2 98453389
Email 10224 0
[email protected]
Contact person for scientific queries
Name 1152 0
Louise Baur
Address 1152 0
Discipline of Paediatrics & Child Health
University of Sydney
The Children’s Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 1152 0
Australia
Phone 1152 0
+61 2 98450000
Fax 1152 0
+61 2 98453389
Email 1152 0
[email protected]

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