Trial from ANZCTR


Trial ID ACTRN12606000175572
Trial Status: Registered
Date Submitted: 12/05/2006
Date Registered: 15/05/2006
Prospectively registered

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Public title Community-based weight management of overweight and obese adolescents: a randomised controlled trial
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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
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UTN
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Trial acronym Loozit
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Health condition(s) or problem(s) studied:
Obesity 1148 0
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Condition category: Condition code:
Diet and nutrition Obesity
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1228 1228 0 0

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Descriptions 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
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Intervention Code:
Lifestyle 1035 0
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Comparator / control treatment Control (G): current recommended treatment for adolescent overweight and obesity
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Control group Active
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Primary Outcome: Body mass index standard deviation score (BMI z score) 1666 0
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Timepoint: At baseline, 2 months, 12 months, and 24 months 1666 0
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Primary Outcome: Waist circumference standard deviation score (waist z score) 1667 0
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Timepoint: At baseline, 2 months, 12 months, and 24 months 1667 0
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Secondary Outcome: Fasting insulin, glucose total cholesterol, HDL cholesterol, LDL cholesterol 2981 0
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Timepoint: Baseline, 2 months, 12 months, 24 months 2981 0
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Secondary Outcome: Blood pressure 2982 0
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Timepoint: Baseline, 2 months, 12 months, 24 months 2982 0
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Secondary Outcome: Physical activity 2983 0
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Timepoint: Baseline, 2 months, 12 months, 24 months 2983 0
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Secondary Outcome: Food intake and eating patterns 2984 0
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Timepoint: Baseline, 2 months, 12 months, 24 months 2984 0
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Secondary Outcome: Psychosocial assessment 2985 0
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Timepoint: Baseline, 2 months, 12 months, 24 months 2985 0
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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.
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Minimum age 13 Years
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Maximum age 17 Years
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase
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Anticipated date of first participant enrolment 20/06/2006
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 168
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Recruitment status Recruiting
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: University 1340 0
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Name: University of Sydney Research & Development Grant 1340 0
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Address: University of Sydney, NSW 2006 1340 0
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Country: Australia 1340 0
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Funding Source: Charities/Societies/Foundations 1341 0
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Name: Macquarie Bank Foundation 1341 0
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Address: GPO Box 4294, Sydney NSW 1164 1341 0
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Country: Australia 1341 0
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Funding Source: Commercial sector/Industry 1342 0
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Name: Estate of the Late RT Hall 1342 0
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Address: Nexia Court & Co., Chartered Accountants, PO Box H195, Australia Square NSW 1215 1342 0
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Country: Australia 1342 0
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Primary Sponsor Hospital
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Name: The Children's Hospital at Westmead
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Address: Locked Bag 4001
Westmead NSW 2145
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Country: Australia
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Secondary Sponsor: None 1183 0
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Name: Nil 1183 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: The Ethics Committee of the Children’s Hospital at Westmead 2693 0
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Country: Australia 2693 0
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Approval Date: 2693 0
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Submitted Date: 2693 0
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HREC: 2006/004 2693 0
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Ethics Committee name: The Sydney West Area Health Service Human Research Ethics Committee 2694 0
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Address: 2694 0
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Country: Australia 2694 0
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Approval Date: 30/04/2006 2694 0
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Submitted Date: 2694 0
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HREC: 2006/2/4.23(2295) 2694 0
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Ethics Committee name: The Ethics Committee of the University of Sydney 2695 0
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Country: Australia 2695 0
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Approval Date: 04/05/2006 2695 0
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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
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Mrs Janice O’Connor
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Address: Clinical School The Children’s Hospital at Westmead Locked Bag 4001 Westmead NSW 2145
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Country: Australia
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Tel: +61 2 98451291
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Fax: +61 2 98453389
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Email: janiceo@chw.edu.au
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Contact person for scientific queries
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Name: Louise Baur
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Address: Discipline of Paediatrics & Child Health University of Sydney The Children’s Hospital at Westmead Locked Bag 4001 Westmead NSW 2145
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Country: Australia
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Tel: +61 2 98450000
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Fax: +61 2 98453389
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Email: louiseb3@chw.edu.au
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Addition Cancer fields
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