Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000465257
Ethics application status
Approved
Date submitted
21/03/2018
Date registered
29/03/2018
Date last updated
29/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new online program to improve teenage eating and lifestyle behaviours
Scientific title
A feasibility study of Health Online for Teens (HOT) - a new Australian technology-based program to improve healthy lifestyle behaviours, weight status, and cardiovasular disease risk in overweight adolescents
Secondary ID [1] 294414 0
Heart Foundation of Australia 2017 Vanguard Grant Reference Number 101808
VG 2017 101808
Universal Trial Number (UTN)
Trial acronym
HOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight 307146 0
obesity 307147 0
cardiovascular disease 307148 0
Condition category
Condition code
Diet and Nutrition 306267 306267 0 0
Obesity
Cardiovascular 306268 306268 0 0
Coronary heart disease
Diet and Nutrition 306270 306270 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adolescents:
The Health Online for Teens (HOT) program is a 14-week multi-disciplinary healthy lifestyle and wellbeing program delivered via Moodle Mobile. HOT consists of diet, physical activity, and wellbeing educational modules. The aims of the program are to improve adolescent lifestyle through reducing obesity risk factors of poor diet and insufficient activity. There are a series of HOT behaviour targets which are informed by evidence-based National guidelines for diet (the Australian Dietary Guidelines and the Australian Guide to Healthy Eating) and activity (Australia’s Physical Activity & Sedentary Behaviour Guidelines for Young People (13 – 17 years)).

In this study, adolescents will review and reflect their current lifestyle behaviours, and will be encouraged to set goals to improve these. Each week they will assess their progress against these goals and be supported to uphold existing or set additional sustainable behaviour change goals.

Adolescent participants will have access to HOT-BOT, which is an automated online chatbot, designed in the Program ChatFuel and delivered over the Facebook Messenger platform. HOT-BOT will check in weekly with participants to ask whether they have completed the HOT program module on Moodle and activities to try at home that week. HOT-BOT is a personalised motivational tool which is fun and engaging and will deliver goal setting and review content from the HOT program in a different way.

Adolescent use of the program and features will be analysed from in-built metrics collected by Moodle and ChatFuel/Facebook Messenger.

Parents
Parents will receive access to an abridged version of the HOT program, separate to their adolescent children. This decision has been made so that adolescents can say anything in their HOT program forums which will be confidential and private from their parents. Parents may also wish for the same privacy when interacting with other parents in online forums.

The parent version of HOT includes content the children receive that week, as well as information for them on how to be a supportive parent. In addition, dietary guidelines and physical activity guidelines for adults will also be a part of the parent HOT program.

Parent use of the program and features will be analysed from in-built metrics collected by Moodle.
Intervention code [1] 300703 0
Treatment: Other
Intervention code [2] 300704 0
Lifestyle
Intervention code [3] 300705 0
Prevention
Comparator / control treatment
There is no control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305271 0
User engagement (adolescents and parents) with the program, measured by access of 14 program sessions, expressed as a proportion of content covered as measured by Moodle metrics
Timepoint [1] 305271 0
from the start to the end of the program (14 weeks)
Primary outcome [2] 305272 0
adolescent self-reported weight status (measured height and weight and International Obesity Task Force (IOTF) extended weight status)
Timepoint [2] 305272 0
change from pre-program (enrolment) to post-program (after 14-week intervention)
Secondary outcome [1] 344670 0
adolescent diet behaviour (Children's Dietary Questionnaire and Serves of Core Foods)
Timepoint [1] 344670 0
change from pre-program (enrolment) to post-program (after 14-week intervention)
Secondary outcome [2] 344671 0
adolescent physical activity behaviour(7 day accelerometry)
Timepoint [2] 344671 0
change from pre-program to post-program (immediately after 14-week intervention)
Secondary outcome [3] 344672 0
adolescent sedentary behaviour (7 day accelerometry)
Timepoint [3] 344672 0
change from pre-program to post-program (immediately after 14-week intervention)
Secondary outcome [4] 344673 0
adolescent self-perception (Harter questionnaire)
Timepoint [4] 344673 0
change from pre-program (enrolment) to post-program (immediately after 14-week intervention)
Secondary outcome [5] 344674 0
parent and adolescent program satisfaction (purpose-designed questionnaire)
Timepoint [5] 344674 0
post-program (immediately after the 14-week intervention)

Eligibility
Key inclusion criteria
Adolescents:
- girls and boys
- aged 13 – 17 years at enrolment
- above a healthy weight for their age and gender (overweight or obese)
- not pregnant or breastfeeding or planning pregnancy (girls)
- access to stable and reliable Wi-Fi network at home

Parents of adolescent participants
- any age
- parent and/or caregiver of an adolescent participant (generally 1-2 parents/caregivers per adolescent participant but may be more)
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adolescents:
- <13 or >17 years of age
- healthy weight or underweight
- pregnant or breastfeeding girls
- no Wi-Fi or internet at home
- unable to read/write English

Parents:
- not a parent of a participating eligible adolescent child

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/04/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299042 0
Charities/Societies/Foundations
Name [1] 299042 0
Heart Foundation of Australia
Country [1] 299042 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
College of Nursing and Health Sciences
Flinders University
Sturt Road
Bedford Park
SOUTH AUSTRALIA 5042
Australia
Country
Australia
Secondary sponsor category [1] 298276 0
None
Name [1] 298276 0
Address [1] 298276 0
Country [1] 298276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299976 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 299976 0
Ethics committee country [1] 299976 0
Australia
Date submitted for ethics approval [1] 299976 0
15/01/2018
Approval date [1] 299976 0
21/03/2018
Ethics approval number [1] 299976 0
7896

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

Contacts
Principal investigator
Name 82142 0
Prof Michelle Miller
Address 82142 0
College of Nursing and Health Sciences
GPO Box 2100
Flinders University
Adelaide
SOUTH AUSTRALIA 5001
Australia
Country 82142 0
Australia
Phone 82142 0
+61882012421
Fax 82142 0
Email 82142 0
[email protected]
Contact person for public queries
Name 82143 0
Carly Moores
Address 82143 0
College of Nursing and Health Sciences
GPO Box 2100
Flinders University
Adelaide
SOUTH AUSTRALIA 5001
Australia
Country 82143 0
Australia
Phone 82143 0
+61882015913
Fax 82143 0
Email 82143 0
[email protected]
Contact person for scientific queries
Name 82144 0
Carly Moores
Address 82144 0
College of Nursing and Health Sciences
GPO Box 2100
Flinders University
Adelaide
SOUTH AUSTRALIA 5001
Australia
Country 82144 0
Australia
Phone 82144 0
+61882015913
Fax 82144 0
Email 82144 0
[email protected]

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.