Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000325202
Ethics application status
Approved
Date submitted
17/02/2018
Date registered
5/03/2018
Date last updated
5/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Advice, Ideas and Motivation for My Eating (AIM4ME) study: technology-delivered personalised dietary feedback for young Australia adults
Scientific title
Efficacy and cost effectiveness of varying level of technology-delivered personalised feedback on dietary patterns in motivating young Australian adults (18-24 years) to improve diet quality and eating habits: The Advice, Ideas and Motivation for My Eating (AIM 4 ME) study.
Secondary ID [1] 293800 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AIM4ME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 306215 0
Condition category
Condition code
Diet and Nutrition 305315 305315 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
AIM4ME is a 12 month intervention. There are three groups : Intervention group 1 (AIM4ME website) , Intervention group 2 (AIM4ME Website plus brief video consultation) and control group ( Healthy Eating Quiz)

AIM4ME Website: Participants assigned to intervention groups 1 and 2 will BOTH receive access to the AIM4ME website for 12 months
The features of the website include:
• Personalised dietary feedback: Participants will complete the Australian Eating Survey (AES), a feedback report will then be generated which compares their usual dietary intake to Australian dietary recommendations and nutrient reference values. The report highlights % contribution of specific food groups to average daily energy intake and how much comes from healthy food groups compared to amount from discretionary foods.
• Healthy eating resource materials: An online resource library (self-seleted) will include tools, apps, articles, fact sheets, and information related to healthy eating targeting motivators and barriers expressed by young males and females..These resources are readily available and come from a range of government organisations and associations in Australia.

• Goal setting and goal tracking: Support and instructions on how to set SMART goals based on the feedback they have received from the AES. They will be prompted to set goals (baseline, 3 and 6 months) and reminded to self monitor and reflect on goals monthly.

Brief video consultation
For those participants assigned to intervention group 2 they will have a one-on-one 30 minute video consultation with an Accredited Practising Dietitian during the first 7-10 days of enrolling into the study. This structured consultation session will include reviewing participant goals they have created goals based on the personalised feedback report they received after completing the AES and assistance to set personalised strategies to overcome self-identified barriers to healthy eating.




Engagement and use of the intervention for group 1 and 2 will be measured using usage statistics captured by the website. Outcomes measures include website log ins, healthy eating resource page visits, viewed personalised dietary feedback, viewed and completed goal setting and self monitoring of goals. For group 2 only engagement will be measured by attendance at the brief video consultation

Retention will be measured by the completion of 3, 6 and 12 month data collection including assessment questionnaires and AES. This will be tracked by the website,

Reach will be measured by tracking of recruitment materials used, screening and socio-demographic characteristics in the baseline questionnaire.
Intervention code [1] 300055 0
Lifestyle
Intervention code [2] 300056 0
Behaviour
Comparator / control treatment
Participants in the control group will compete the Healthy Eating Quiz (HEQ) There will be a link on their dashboard which will direct them to the quiz outside of the website. The HEQ is a five-minute online assessment quiz assessment tool that provides general feedback on current eating patterns and a total score on diet quality. This feedback is automatically generated by the system after completing the quiz. Participants in this group will be able to access the HEQ throughout the duration of the study.

Control group
Active

Outcomes
Primary outcome [1] 304472 0
Diet Quality assessed by the Australian Recommended Food Score
Timepoint [1] 304472 0
Baseline, 3, 6 and 12 months (primary endpoint) after baseline
Secondary outcome [1] 342061 0
Dietary intake measured using Australian Eating Survey (FFQ)
Timepoint [1] 342061 0
Baseline, 3, 6 and 12 months after baseline
Secondary outcome [2] 342181 0
Self reported Weight (kg)
Timepoint [2] 342181 0
Baseline, 3, 6 and 12 months after baseline
Secondary outcome [3] 342182 0
Quality of Life measured using the AQoL-6D
Timepoint [3] 342182 0
Baseline, 3, 6 and 12 months after baseline
Secondary outcome [4] 342183 0
Alcohol intake measured by AUDIT-C
Timepoint [4] 342183 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [5] 342184 0
Smoking measured by 2 validated questions items from the Australian Institute Health and Welfare Health data dictionary
Timepoint [5] 342184 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [6] 342185 0
Sitting time measured by Marshal Sitting time questionnaire
Timepoint [6] 342185 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [7] 342186 0
Daytime sleepiness measured by The Epworth Sleepiness Scale
Timepoint [7] 342186 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [8] 342187 0
Mental well being measured by DASS 21
Timepoint [8] 342187 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [9] 342188 0
Regulation of eating measured by REBS scale
Timepoint [9] 342188 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [10] 342189 0
Habit formation using the Self Report Behavioral Automaticity Index (SRBAI)
Timepoint [10] 342189 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [11] 342190 0
Competence in maintaining or changing healthy eating measured by Perceived Competence Scale (PCS)
Timepoint [11] 342190 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [12] 342191 0
Social support measured by Multidimensional Scale of Perceived Social Support (PSSS)
Timepoint [12] 342191 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [13] 342192 0
Cost effectiveness measured by Client Service Receipt inventory (CSRI)
Timepoint [13] 342192 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [14] 342193 0
Self reported satisfaction on intervention components aim4me website (groups 1 and 2) and brief video consultation (group 2) and also on overall intervention. Will be measured by process evaluation survey which has been designed specifically for this study.
Timepoint [14] 342193 0
3, 6 , 12 months after baseline
Secondary outcome [15] 342971 0
Engagement and use of the intervention for group 1 and 2 will be measured using usage statistics captured by the website. Outcomes measures include website log ins, healthy eating resource page visits, viewed personalised dietary feedback, viewed and completed goal setting and self monitoring of goals. For group 2 only engagement will be measured by attendance at the brief video consultation
Timepoint [15] 342971 0
Duration of intervention (12 months)
Secondary outcome [16] 342972 0
Reach: the number of young adults screen for eligibility, consenting , enrolled and randomised and completing the intervention will be recorded,. Their socio-demographic characteristics captured in the baseline survey.
Timepoint [16] 342972 0
Duration of intervention (12 months)
Secondary outcome [17] 342973 0
Retention: Proportion of participants who complete data collection at 3, 6 and 12 months will be tracked.
Timepoint [17] 342973 0
Duration of intervention (12 months)
Secondary outcome [18] 343548 0
BMI using self reported weight [kg] and height [m]
Timepoint [18] 343548 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [19] 343753 0
Self-reported .7 day abstinence at follow up: participants will be asked : “Have you smoked at least part of a cigarette in the last 7 days?” recommended by expert group. Reference Hughes J, Keely J, Niaura R, et al
Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res 2003;5:13–26
Timepoint [19] 343753 0
Baseline, 3,6 and 12 months after baseline
Secondary outcome [20] 343779 0
Social desirability as measured by Marlow -Crowe Social Desirability scale
Timepoint [20] 343779 0
Baseline, 3, 6 and 12 months after baseline
Secondary outcome [21] 343780 0
Social approval as measured by Martin Larsen Approval motivation scale
Timepoint [21] 343780 0
Baseline, 3, 6 and 12 months after baseline

Eligibility
Key inclusion criteria
• live in Australia
• Have access to a computer, and/or a tablet (e.g. iPAD) and a smartphone (e.g. Android, iPhone) with email and internet connection for 12 months.
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• BMI < 18.5kg/m2
• Currently pregnant or planning to be pregnant in the next year
• A major medical condition (for e.g. type 1 diabetes, heart failure, chronic respiratory disease, pancreatitis, liver disease, renal disease ) or similar conditions that may be exacerbated by diet
• Diagnosed or treated for an eating disorder.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There will be a computer generated randomisation system that will be accessed online. The randomisation will be stratified by postcode location (using Monash Modified model) sex (males and females) and BMI (less than 25 versus greater than or equal to 25 kg/m2).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be performed using SAS version 9.4 (or later) All variables will be checked for plausibility and missing values. Data will be presented as means (sd) for continuous variable and counts (%) for categorical variables .

The outcome effects will be evaluated using repeated measures ( using Baseline ARFS) to assess within groups’ change in ARFS diet quality score and modelling between group changes over time using a generalised linear mixed model. The model will be fitted with ARFS at all follow-up points as the outcome variable, with fixed effects for group, time and time by group interaction.

Statistical significance of primary efficacy analysis will be based on Hochberg’s multiple testing procedures with family wise error rate for each time point held at 2.5%. The main analysis will follow the intention-to-treat principle; sensitivity analyses will be done for completers only, using last observation carried forward, and also using multiple imputations for missing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/03/2018
Actual
Date of last participant enrolment
Anticipated
5/09/2018
Actual
Date of last data collection
Anticipated
5/09/2019
Actual
Sample size
Target
2570
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 298417 0
Government body
Name [1] 298417 0
National Healthy and Medical Research Council
Country [1] 298417 0
Australia
Primary sponsor type
Individual
Name
Professor Clare Collins
Address
University of Newcastle
ATC310
Advance Technology Centre
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 297554 0
None
Name [1] 297554 0
Address [1] 297554 0
Country [1] 297554 0
Other collaborator category [1] 279898 0
Individual
Name [1] 279898 0
Professor Helen Truby
Address [1] 279898 0
Monash University
Level 1, 264 Ferntree Gully Road
Notting Hill Vic 3168
Country [1] 279898 0
Australia
Other collaborator category [2] 279899 0
Individual
Name [2] 279899 0
Professor John Attia
Address [2] 279899 0
Level 3 The Pod
Hunter Medical Research Institute
1 Kookaburra Close
New Lambton Heights
NSW 2305
Country [2] 279899 0
Australia
Other collaborator category [3] 279900 0
Individual
Name [3] 279900 0
Dr Melinda Hutchesson
Address [3] 279900 0
Hunter Building
University Drive
University of Newcastle
Callaghan NSW 2308
Country [3] 279900 0
Australia
Other collaborator category [4] 279901 0
Individual
Name [4] 279901 0
Asscociate Professor Tracy Burrows
Address [4] 279901 0
Hunter Building
University Drive
University of Newcastle
Callaghan NSW 2308
Country [4] 279901 0
Australia
Other collaborator category [5] 279902 0
Individual
Name [5] 279902 0
Professor Robin Callister
Address [5] 279902 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University Of Newcastle
Callaghan, NSW 2308
Country [5] 279902 0
Australia
Other collaborator category [6] 279903 0
Individual
Name [6] 279903 0
Professor Billie Bonevski
Address [6] 279903 0
University of Newcastle

Level 5, McAuley Centre,
Calvary Mater
Waratah NSW 2298
Country [6] 279903 0
Australia
Other collaborator category [7] 279904 0
Individual
Name [7] 279904 0
Professor Leanne Hides
Address [7] 279904 0
The University of Queensland
School of Psychology
Faculty of Health and Behavioural Sciences
Brisbane, St Lucia 4072 QLD
Country [7] 279904 0
Australia
Other collaborator category [8] 279905 0
Individual
Name [8] 279905 0
Professor Chris Doran
Address [8] 279905 0
Central Queensland University
160 Ann Street
Brisbane 4000 QLD
Country [8] 279905 0
Australia
Other collaborator category [9] 279906 0
Individual
Name [9] 279906 0
Associate Professor Deb Kerr
Address [9] 279906 0
Curtin University (Bentley Campus)
Kent Street, Bentley, Perth
Western Australia, 6102
Country [9] 279906 0
Australia
Other collaborator category [10] 279907 0
Individual
Name [10] 279907 0
Professor David Lubans
Address [10] 279907 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University Of Newcastle
Callaghan, NSW 2308
Country [10] 279907 0
Australia
Other collaborator category [11] 279954 0
Individual
Name [11] 279954 0
Associate Professor Sharon Kirkpatrick
Address [11] 279954 0
University of Waterloo
School of Public Health and Health Systems
Office: LHN 1713
200 University Ave West
N2L 3G1 Waterloo, Ontario
Country [11] 279954 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299413 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 299413 0
Ethics committee country [1] 299413 0
Australia
Date submitted for ethics approval [1] 299413 0
31/03/2017
Approval date [1] 299413 0
11/08/2017
Ethics approval number [1] 299413 0
H-2017-0087

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

Contacts
Principal investigator
Name 80318 0
Prof Clare Collins
Address 80318 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University of Newcastle
Callaghan
NSW 2308
Country 80318 0
Australia
Phone 80318 0
+61 2 4921 4656
Fax 80318 0
Email 80318 0
[email protected]
Contact person for public queries
Name 80319 0
Clare Collins
Address 80319 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University of Newcastle
Callaghan
NSW 2308
Country 80319 0
Australia
Phone 80319 0
61 2 4921 5646
Fax 80319 0
Email 80319 0
[email protected]
Contact person for scientific queries
Name 80320 0
Clare Collins
Address 80320 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University of Newcastle
Callaghan
NSW 2308
Country 80320 0
Australia
Phone 80320 0
+61 2 4921 5646
Fax 80320 0
Email 80320 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

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