Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000250831
Ethics application status
Approved
Date submitted
24/02/2012
Date registered
29/02/2012
Date last updated
15/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Connecting Health and Technology (CHAT): Effectiveness of a mobile phone intervention to promote dietary change
Scientific title
A randomised control trial using a mobile device to collect food intake data, provide dietary feedback and on-going tailored nutrition messages to promote dietary change in young adults from 18 to 30 years.
Secondary ID [1] 280014 0
Nil
Universal Trial Number (UTN)
Trial acronym
CHAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Improving fruit and vegetable intake in young adults 285923 0
Prevention of overweight and obesity 285924 0
Prevention of some cancers 285925 0
Condition category
Condition code
Public Health 286113 286113 0 0
Health promotion/education
Diet and Nutrition 286152 286152 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 6 month intervention using a mobile device to collect food intake data using an investigator-designed application which users will be provided with on a study iPod touch or downloaded into the user's iPhone. The 4-day mobile device food record will be completed by all participants at baseline and at six months completion. They will take images of all food and drinks consumed over a continuous four day period. Intervention groups 1 and 2 will receive dietary feedback on the number of serves of fruits, vegetables and extra food (junk food) consumed compared with recommended serves by a message sent to their mobile phone. Intervention group 1 will also receive additional ongoing tailored nutrition messages (motivational messages on fruits, vegetables and extra foods or recipes) to promote dietary change via a mobile telephone. Arm 1: Intervention Group 1: 4-day mobile device food record, dietary feedback, weekly Text Messages for six months. Arm 2: Intervention Group 2: 4-day mobile device food record, dietary feedback, no Text Messages over six months.
Intervention code [1] 284335 0
Prevention
Intervention code [2] 284370 0
Lifestyle
Intervention code [3] 284371 0
Behaviour
Comparator / control treatment
Control: Group 3: 4-day mobile food record, no dietary feedback, no text messages over six months.
Control group
Active

Outcomes
Primary outcome [1] 286586 0
An increase in vegetable serves in the intervention Group 1 compared with the Intervention Group 2 and Control Group participants. Data collected by self-report mobile device food record.
Timepoint [1] 286586 0
Baseline and 6 months after intervention commencement
Primary outcome [2] 286587 0
An increase in fruit serves in the intervention Group 1 compared with the Intervention Group 2 and Control Group participants. Data collected by self-report mobile device food record.
Timepoint [2] 286587 0
Baseline and 6 months after intervention commencement
Primary outcome [3] 286588 0
A reduction in junk food serves (high fat, high sugar food) in the intervention Group 1 compared with the Intervention Group 2 and Control Group participants. Data collected by self-report mobile device food record.
Timepoint [3] 286588 0
Baseline and 6 months after intervention commencement
Secondary outcome [1] 296222 0
Physical activity as assessed by self report IPAQ short questionnaire.
Timepoint [1] 296222 0
Baseline and 6 months after intervention commencement

Eligibility
Key inclusion criteria
1. have a mobile telephone
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. pregnant women
2. unlikely to complete the 6 month study
3. undertake extreme forms of exercise or dieting
4. unable to attend the study centre on 4 occasions.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Names and address of current electors in WA will be selected from the electoral roll by the Data Linkage Unit (DLU), Department of Health (WA). These samples will be checked against death registrations to remove any one who has died. The names and addresses will be encrypted and burnt to disc and delivered to Quickmail who will do the recruitment letter mail out. People who wish to take part in the study will contact the research team by email, telephone or via a web form. Participants will undergo a screening questionnaire. If they meet the selection criteria, once being informed of the details of the study and if willing to participate, they will be asked to attend a training session on the use of the mobile device food record (MDFR) at Curtin University. The study objectives and requirements will be explained to the subjects who will complete an informed consent, questionnaires and 4-day MDFR. The following week, participants will return the mobile device and will then be randomized to one of three treatment groups. Six months later they will be asked to repeat the 4-day MDFR and evaluation questionnaires.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be conducted by a biostatistician not involved in the implementation of the trial on site (therefore not in contact with the study participants). Participants will be randomised to one of three treatment groups using a randomisation table created by computer software. A hard copy of the code will be kept in locked filing cabinet. The electronic file will be kept in a secure server.
Masking / blinding
Open (masking not 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
24/03/2012
Actual
31/07/2012
Date of last participant enrolment
Anticipated
Actual
7/12/2012
Date of last data collection
Anticipated
Actual
19/07/2013
Sample size
Target
247
Accrual to date
Final
247
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 284783 0
Government body
Name [1] 284783 0
Healthway Health Promotion Research Project Grant
Country [1] 284783 0
Australia
Primary sponsor type
Government body
Name
Healthway
Address
Healthway,
PO BOX 1284,
WEST PERTH WA 6872
Country
Australia
Secondary sponsor category [1] 283669 0
University
Name [1] 283669 0
Curtin University
Address [1] 283669 0
GPO Box U1987
Perth, WA 6845
Country [1] 283669 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286777 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 286777 0
Ethics committee country [1] 286777 0
Australia
Date submitted for ethics approval [1] 286777 0
Approval date [1] 286777 0
08/02/2012
Ethics approval number [1] 286777 0
HR 181/2011

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

Contacts
Principal investigator
Name 33075 0
A/Prof Deborah Kerr
Address 33075 0
School of Public Health Curtin University GPO Box U1987 Perth WA 6845
Country 33075 0
Australia
Phone 33075 0
+61892664122
Fax 33075 0
+61892662958
Email 33075 0
[email protected]
Contact person for public queries
Name 16322 0
Associate Professor Deborah Kerr
Address 16322 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 16322 0
Australia
Phone 16322 0
+61892664122
Fax 16322 0
+61892662958
Email 16322 0
[email protected]
Contact person for scientific queries
Name 7250 0
Associate Professor Deborah Kerr
Address 7250 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 7250 0
Australia
Phone 7250 0
+61892664122
Fax 7250 0
+61892662958
Email 7250 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
SourceTitleYear of PublicationDOI
EmbaseA novel dietary assessment method to measure a healthy and sustainable diet using the mobile food record: Protocol and methodology.2015https://dx.doi.org/10.3390/nu7075226
EmbaseThe connecting health and technology study: A 6-month randomized controlled trial to improve nutrition behaviours using a mobile food record and text messaging support in young adults.2016https://dx.doi.org/10.1186/s12966-016-0376-8
EmbaseBMI is associated with the willingness to record diet with a mobile food record among adults participating in dietary interventions.2017https://dx.doi.org/10.3390/nu9030244
EmbaseImage-based dietary assessment and tailored feedback using mobile technology: Mediating behavior change in young adults.2019https://dx.doi.org/10.3390/nu11020435
EmbaseHealthy and Sustainable Diet Index: Development, Application and Evaluation Using Image-Based Food Records.2022https://dx.doi.org/10.3390/nu14183838
N.B. These documents automatically identified may not have been verified by the study sponsor.