ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Loozit

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Diet and Nutrition

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]

Lifestyle

Comparator / control treatment

Control (G): current recommended treatment for adolescent overweight and obesity

Control group

Active

Outcomes

Primary outcome [1]

Body mass index standard deviation score (BMI z score)

Timepoint [1]

At baseline, 2 months, 12 months, and 24 months

Primary outcome [2]

Waist circumference standard deviation score (waist z score)

Timepoint [2]

At baseline, 2 months, 12 months, and 24 months

Secondary outcome [1]

Fasting insulin, glucose total cholesterol, HDL cholesterol, LDL cholesterol

Timepoint [1]

Baseline, 2 months, 12 months, 24 months

Secondary outcome [2]

Blood pressure

Timepoint [2]

Baseline, 2 months, 12 months, 24 months

Secondary outcome [3]

Physical activity

Timepoint [3]

Baseline, 2 months, 12 months, 24 months

Secondary outcome [4]

Food intake and eating patterns

Timepoint [4]

Baseline, 2 months, 12 months, 24 months

Secondary outcome [5]

Psychosocial assessment

Timepoint [5]

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]

University

Name [1]

University of Sydney Research & Development Grant

Address [1]

University of Sydney, NSW 2006

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Macquarie Bank Foundation

Address [2]

GPO Box 4294, Sydney NSW 1164

Country [2]

Australia

Funding source category [3]

Commercial sector/Industry

Name [3]

Estate of the Late RT Hall

Address [3]

Nexia Court & Co., Chartered Accountants, PO Box H195, Australia Square NSW 1215

Country [3]

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]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Ethics Committee of the Children’s Hospital at Westmead

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

2006/004

Ethics committee name [2]

The Sydney West Area Health Service Human Research Ethics Committee

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

30/04/2006

Ethics approval number [2]

2006/2/4.23(2295)

Ethics committee name [3]

The Ethics Committee of the University of Sydney

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

04/05/2006

Ethics approval number [3]

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

Prof Louise Baur

Address

Clinical School, The Children's Hospital at Westmead, Locked Bag 4001, Westmead NSW 2145, AUSTRALIA

Country

Australia

Phone

61-2-9845-0000

Fax

Email

louise.baur@health.nsw.gov.au

Contact person for public queries

Name

Mrs Janice O’Connor

Address

Clinical School
The Children’s Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145

Country

Australia

Phone

+61 2 98451291

Fax

+61 2 98453389

Email

janiceo@chw.edu.au

Contact person for scientific queries

Name

Louise Baur

Address

Discipline of Paediatrics & Child Health
University of Sydney
The Children’s Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145

Country

Australia

Phone

+61 2 98450000

Fax

+61 2 98453389

Email

louiseb3@chw.edu.au

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.