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Trial registered on ANZCTR


Registration number
ACTRN12611000139976
Ethics application status
Approved
Date submitted
7/02/2011
Date registered
7/02/2011
Date last updated
23/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Staying Fit Adolescent Weight Management Study
Scientific title
In overweight or obese Adolescents is the Staying Fit internet based intervention better than general health information for weight loss, promoting weight maintenance, decreasing weight and shape concerns, healthy eating and increasing physical activity?
Secondary ID [1] 253509 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 261056 0
overweight 261057 0
Condition category
Condition code
Public Health 259204 259204 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet based program will run for 12 weeks. Participants work through a new session each week for a self directed period of time (between 30-60mins recommended). Activities and goals will be set for each week. Goals will be set by the participant from a framework recommended within the program (for example to increase moderate activity from 0 to 30 mins on most days) and reviewed every week, activities will be specific to intervention group but not to each individual. Participants will be recommended to gradually increase their physical activity until they are reaching a minimum of 60 minutes moderate to vigorous activity per day. All participants in the intervention group will receive a pedometer and a walking program to help achieve this goal. Cognitive behaviour aspect of the program will address self monitoring, goal setting, stimulus control, social eating etc. Diet and exercise info will be recorded in weekly online diaries the participant completes. Participants will receive feedback at least weekly. Parents of participants will be sent monthly newsletters for the 3 months of the intervention program with tips on creating a supportive environment. After the 12 week program is finished participants will receive monthly follow up via text or email (whichever preferred) asking them to review their eating and physical activity habits, and provide feedback. They can also review the materials from the program. Breakdown of weekly session themes/content (activities and goals will be based around this): Session One: Introduces key themes and concepts (lifestyle change, red foods/ green foods, good/ not so good reasons to change your lifestyle habits, understanding portion sizes). Session Two: Info on physical activity and why it is important, and difference between moderate and vigorous activity. Session Three: Setting goals and an exercise plan. Session Four: Understanding nutrition labels, how to eat out healthily. Session Five: Binge Eating- what it is, recognise it and how to reduce it. Paying attention to body cues. Mindful eating, a way to relax and eat in a healthy way. Session Six: Body image and self esteem, Triggers: Direct and indirect. Session Seven: Barriers to eating healthy, and how to overcome them Ways to get active, Creating healthy sleep routines. Session Eight: How to keep snacks healthy, the truth about diets and diet pills. Session Nine: What are eating disorders? Body image triggers and tips for avoiding a negative body image, challenging negative thoughts. Session Ten: Creating a good food environment, coping with cravings. Session Eleven: How to not take part in perpetuating stigma about weight, Ways to stay confident, Strategies for helping people deal with teasing. Session Twelve : Long term goal setting, weight maintenance. Tips for staying on top of eating and exercise. What to take away from Staying Fit.
Intervention code [1] 257940 0
Lifestyle
Comparator / control treatment
The control treatment will receive publicly available generic health information about healthy eating and physical activity at the beginning of the 12 week treatment period. This information will be sourced from reliable health information websites (government/ evidence based) and presented in both paper and online format (e.g. participant will receive a pack with flyers about the physical activity requirements for adolescents, general information about healthy eating and planning healthy meals and a sheet with links to websites about the healthy eating, physical activity and mental health- all websites will be age appropriate). There will be no Cognitive behaviour aspect for the control group. It is up to the control participants whether they read the paper information given and/or access the available websites. This group will self direct their use of the control information.
The control group will receive a hard copy of the program sessions once the program and follow up are completed. Again, the length of time spent on these sessions will be self directed.
Control group
Active

Outcomes
Primary outcome [1] 262077 0
reduction in Body Mass Index (BMI) z score
Timepoint [1] 262077 0
measured at baseline, 3 , 6 and 12 months follow up (from baseline/ beginning of program)
Secondary outcome [1] 273106 0
Smaller measured waist circumference. A non-stretch anthropometric tape will be used to measure waist circumference according to the ISAK protocols.
Timepoint [1] 273106 0
measured at baseline, 3 , 6 and 12 months follow up (from baseline/ beginning of program).
Secondary outcome [2] 273107 0
A decrease in percent body fat. Body composition will be assessed using a bioelectric impedance analyser which will provide measures of total body fat and lean mass.
Timepoint [2] 273107 0
measured at baseline, 3 , 6 and 12 months follow up (from baseline/ beginning of program)
Secondary outcome [3] 273108 0
A decrease in blood pressure. Oscillometric automatic blood pressure monitors will be used to measure BP at each appointment.
Timepoint [3] 273108 0
measured at baseline, 3 , 6 and 12 months follow up (from baseline/ beginning of program)
Secondary outcome [4] 273109 0
a decrease in psychological distress as measured by the K-10 (Kessler 10 Psychological Distress Scale)
Timepoint [4] 273109 0
measured at baseline, 3 , 6 and 12 months follow up (from baseline/ beginning of program)
Secondary outcome [5] 273110 0
an increase in quality of life as measure by the Pediatric Quality of Life Inventory (PEDS_QL) 4.0 for ages 13-18 years
Timepoint [5] 273110 0
measured at baseline, 3 , 6 and 12 months follow up (from baseline/ beginning of program)
Secondary outcome [6] 273111 0
no difference in eating disorder psychopathology as measured by the Eating Disorder Examination Questionnaire (EDE-Q) 6.0
Timepoint [6] 273111 0
measured at baseline, 3 , 6 and 12 months follow up (from baseline/ beginning of program)
Secondary outcome [7] 273112 0
This low cost intervention will be acceptable and feasible within Australia. Adherence will be monitored by the participants completion of program (submitting weekly logs), and satisfaction with program content will be measured by simple questions at the end of most of the 12 sessions (e.g. how interesting was this session? scaled from 'not interesting' to 'very interesting'). Also at 3, 6 and 12 month follow up participants will be asked about their satisfaction with the program overall (these questions still under development).
Timepoint [7] 273112 0
measured at 3 , 6 and 12 months (from baseline/ beginning of program) follow up

Eligibility
Key inclusion criteria
(i) age 12 to 17 years; (ii) overweight or obese (>= 85th centile) according to the age and gender specific BMI data from the International Obesity Task Force; (iii) internet access at home or at a location where regular use is possible (i.e school, library). To facilitate complete follow-up assessments by maximising opportunities to collect height and weight data, and to contain study costs, recruitment will be restricted to those living in the Melbourne metropolitan area.
Minimum age
12 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Young people with a known endocrine or chromosomal cause for their obesity; those taking prescription medication resulting in weight changes (eg Prednisolone); those with complications of overweight that contraindicate moderate physical activity (e.g. orthopaedic disorders); those with past or current medical diagnosis of a clinical eating disorder (i.e., anorexia or bulimia nervosa, binge eating disorder) or those who suffer from a significant health disability or condition which prevents their participation will be excluded from the trial.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At the initial meeting (if formal consent has been fully given) baseline measurement will be completed and participant will be randomised to either the treatment or control arm of the study. The research team member will contact the statistician (by phone) who holds the allocation schedule to ascertain whether or not the participant is in the intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to recruitment, a randomisation list will be computer generated using random permuted blocks with varying block sizes (4, 6 and 8 randomly arranged) with a ratio of 1:1 assignment by the trial statistician (Dr Romaniuk) and checked by a reviewing statistician from the Clinical Epidemiology and Biostatistics Unit. Block sizes will not be documented in the protocol to protect allocation concealment and the randomisation list will be stored in a location that is not accessible to the research personnel. After recruitment into the study, web-based randomisation will be used to determine if the participant will be in the intervention or control group according to the next consecutive random allocation on the list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 258443 0
Government body
Name [1] 258443 0
National Health and Medical Research Council
Address [1] 258443 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 258443 0
Australia
Primary sponsor type
Individual
Name
Joanne Williams
Address
Murdoch Childrens Research Institute
The Royal Children's Hospital
Flemington Road Parkville Victoria 3052 Australia
Country
Australia
Secondary sponsor category [1] 257589 0
Individual
Name [1] 257589 0
Dr Angela Celio Doyle
Address [1] 257589 0
University of Chicago
5801 South Ellis Ave., Chicago, IL 60637
Country [1] 257589 0
United States of America
Secondary sponsor category [2] 257590 0
Individual
Name [2] 257590 0
Prof. Susan Sawyer
Address [2] 257590 0
Director, Centre for Adolescent Health
Chair of Adolescent Health, Department of Paediatrics, Royal Children's Hospital
Flemington Road Parkville Victoria 3052 Australia
Country [2] 257590 0
Australia
Secondary sponsor category [3] 257591 0
Individual
Name [3] 257591 0
Prof. C. Barr Taylor
Address [3] 257591 0
401 Quarry Road, Stanford Medical Center, Stanford, Ca 94305-5722
Country [3] 257591 0
United States of America
Other collaborator category [1] 251800 0
Individual
Name [1] 251800 0
Dr Helena Romaniuk
Address [1] 251800 0
The Royal Children's Hospital
Centre for Adolescent Health
Flemington Road
Parkville
Victoria 3052
Country [1] 251800 0
Australia
Other collaborator category [2] 251801 0
Individual
Name [2] 251801 0
Peter Kremer
Address [2] 251801 0
1 Gheringap Street
Geelong Waterfront Campus,
Deakin University, Geelong Victoria 3217
Country [2] 251801 0
Australia
Other collaborator category [3] 251804 0
Individual
Name [3] 251804 0
Prof. George Patton
Address [3] 251804 0
The Royal Children's Hospital
Centre for Adolescent Health
Flemington Road
Parkville
Victoria 3052
Country [3] 251804 0
Australia
Other collaborator category [4] 251805 0
Individual
Name [4] 251805 0
Associate Professor Evie Leslie
Address [4] 251805 0
1 Gheringap Street
Geelong Waterfront Campus,
Deakin University, Geelong Victoria 3217
Country [4] 251805 0
Australia
Other collaborator category [5] 251807 0
Individual
Name [5] 251807 0
Karly Cini
Address [5] 251807 0
The Royal Children's Hospital
Centre for Adolescent Health
Flemington Road
Parkville
Victoria 3052
Country [5] 251807 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260431 0
The Royal Children's Hospital- Melbourne
Ethics committee address [1] 260431 0
The Royal Children's Hospital
Flemington Road Parkville
Victoria
3052
Australia
Ethics committee country [1] 260431 0
Australia
Date submitted for ethics approval [1] 260431 0
31/01/2011
Approval date [1] 260431 0
12/04/2011
Ethics approval number [1] 260431 0
31021A.

Summary
Brief summary
Staying Fit has been designed as an Internet-based adolescent weight management program for overweight or mildly obese Australian young people.

Goals of the program include: targeting weight loss, promoting weight maintenance, decreasing weight and shape concerns, healthy eating and increasing physical activity.

We propose to conduct a project, commencing in July, 2011, in metropolitan Melbourne, involving approximately 570 young people aged 12-17 years. We will be recruiting voluntary participants from the community via advertisements in local media, posters in youth friendly services and through school nurses and general practitioners.
Parent consent will be sought using an active consent process; young people will not be able to participate without a signed consent form from their parent or guardian. Participation for the young person is completely voluntary and they will also be required to provide written consent.
Half of the participants will be randomly assigned to the intervention group, and will participate in the program with access to all modules. The other participants will be randomly assigned to the control group, and will receive a list of health websites and handouts on healthy food choices and physical activity recommendations.
There are 12 sessions in the program and it takes approximately 1-2 hours to work through each session. Sessions are released at the rate of one each week. Online interactive monitoring of key behaviours (e.g., food and physical activity logs) and an online discussion group are used to encourage participation.
Data will be collected at the start of the program, at 3 months, 6 months and 12 months. Data from the project will be collected and analysed by the Centre for Adolescent Health (CAH) at the Royal Children’s Hospital.
Trial website
http://www.rch.org.au/cah/research.cfm?doc_id=14887
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 32150 0
A/Prof Joanne Williams
Address 32150 0
The Royal Children’s Hospital Flemington Road Parkville Victoria 3052 Australia
Country 32150 0
Australia
Phone 32150 0
+61 3 9345 6954
Fax 32150 0
Email 32150 0
jo.williams@mcri.edu.au
Contact person for public queries
Name 15397 0
Mrs Karly Cini
Address 15397 0
The Royal Children’s Hospital
Flemington Road Parkville Victoria 3052 Australia
Country 15397 0
Australia
Phone 15397 0
+61 3 9345 6954
Fax 15397 0
Email 15397 0
karly.cini@mcri.edu.au
Contact person for scientific queries
Name 6325 0
A/Prof Joanne Williams
Address 6325 0
The Royal Children’s Hospital
Flemington Road Parkville Victoria 3052 Australia
Country 6325 0
Australia
Phone 6325 0
+61 3 9345 5088
Fax 6325 0
Email 6325 0
jo.williams@mcri.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary