Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000925842
Ethics application status
Approved
Date submitted
13/05/2021
Date registered
15/07/2021
Date last updated
8/08/2022
Date data sharing statement initially provided
15/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Fussy Eating Rescue: Evaluating the feasibility and acceptability of a mobile-web app for responsive feeding practises among parents of toddlers
Scientific title
A pilot randomised controlled trial (RCT) examining the feasibility and acceptability of a parent-focused, mobile-web app delivered intervention for responsive feeding practises among parents of toddlers with fussy eating
Secondary ID [1] 303722 0
None
Universal Trial Number (UTN)
U1111-1266-2136
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parent feeding practices 321148 0
Fussy eating behaviours 321149 0
Condition category
Condition code
Public Health 318952 318952 0 0
Health promotion/education
Diet and Nutrition 319999 319999 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A mobile web app and push notifications will be used to deliver intervention content. Participants in the intervention group will have access to the app for 6 weeks. The amount of time that they engage with the app will be at the participants' own discretion. Intervention content, developed by a team of experts, offers education and practical advice based on established behaviour change theory and techniques to help parents use evidence-based feeding practises to manage toddler fussy eating. This includes information about toddler growth and development, parent feeding strategies (e.g. repeated offers of vegetables, family meals, offering foods without pressure, avoiding the use of food to reward eating or behaviour), and toddler nutrition requirements. Information will be presented as short articles and interactive activities. The mobile web app also includes a self-monitoring tool to help parents keep track of repeated offers of vegetables (a key parent feeding strategy) and tools to help parents self-regulate emotions and behaviours related to their toddler’s fussy eating (e.g. promoting mindfulness, practical tips for toddler tantrums).

Text messaging (SMS) will be used to promote parent engagement, provide feedback on goal setting and self-monitoring activities, and remind them of key messages. Participants will be able to specify their own personalized SMS notification schedule (e.g. days and times). SMS notifications will be personalised where appropriate. Participants who are inactive after 1 week will receive an SMS notification to invite them to engage with the app. Inactive participants will continue to receive a weekly reminder to engage with the app until the end of the 6 week pilot or until the participant requests that the notifications no longer be sent. Intervention adherence will be monitored by app usage data and push notifications will be used to encourage participants to re-engage after predetermined periods of app inactivity.
Intervention code [1] 320031 0
Behaviour
Intervention code [2] 320032 0
Lifestyle
Intervention code [3] 320845 0
Treatment: Devices
Comparator / control treatment
The control group will be assigned to a 6-week wait list. After that time, they will be given access to the app for 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 327510 0
Participant retention rate, assessed as the percent of recruited participants who complete the 6-weeks post-intervention questionnaire.
Timepoint [1] 327510 0
6 weeks post-intervention commencement
Primary outcome [2] 327511 0
Intervention engagement, assessed by (1) describing app usage metrics (e.g. session interval, session length, time in app, screen flow, retention, push notifications received/read), using app usage metrics to calculate its App Engagement Index (previously developed by members of the research team).
Timepoint [2] 327511 0
6 weeks post-intervention commencement
Primary outcome [3] 328021 0
Usability of the app platform, assessed with the System Usability Scale (SUS)
Timepoint [3] 328021 0
6 weeks post-intervention commencement
Secondary outcome [1] 395460 0
PRIMARY OUTCOME 4:

Perceived ease in using the app platform, assessed with the mHealth App Usability Questionnaire
Timepoint [1] 395460 0
6 weeks post-intervention commencement
Secondary outcome [2] 395461 0
PRIMARY OUTCOME 5:

Perceived usefulness of the app platform, assessed with the mHealth App Usability Questionnaire
Timepoint [2] 395461 0
6 weeks post-intervention commencement
Secondary outcome [3] 395462 0
PRIMARY OUTCOME 6:

User satisfaction with the app platform, assessed with the mHealth App Usability Questionnaire
Timepoint [3] 395462 0
6 weeks post-intervention commencement
Secondary outcome [4] 397253 0
BEGIN SECONDARY OUTCOMES:

Parent modelling of healthy eating, assessed with the “modelling” subscale of the Comprehensive Feeding Practises Questionnaire
Timepoint [4] 397253 0
6 weeks post-intervention commencement
Secondary outcome [5] 397254 0
Parents' trust in children's appetites, assessed with the "distrust in appetite" subscale of the Feeding Practices and Structure Questionnaire
Timepoint [5] 397254 0
6 weeks post-intervention commencement
Secondary outcome [6] 397255 0
Parents' use of reward for eating, assessed with the "reward for eating' subscale of the Feeding Practices and Structure Questionnaire
Timepoint [6] 397255 0
6 weeks post-intervention commencement
Secondary outcome [7] 397256 0
Parents' use of persuasive feeding practices, assessed with the "persuasive feeding" subscale of the Feeding Practices and Structure Questionnaire
Timepoint [7] 397256 0
6 weeks post-intervention commencement
Secondary outcome [8] 397269 0
Structure of meal settings, assessed with the "structured meal setting" subscale of the Feeding Practices and Structure Questionnaire
Timepoint [8] 397269 0
6 weeks post-intervention commencement
Secondary outcome [9] 397270 0
Structured meal timing, assessed with the "structured meal timing" subscale of the Feeding Practices and Structure Questionnaire
Timepoint [9] 397270 0
6 weeks post-intervention commencement
Secondary outcome [10] 397271 0
Family meal setting, assessed with the family meal setting subscale of the Feeding Practices and Structure Questionnaire
Timepoint [10] 397271 0
6 weeks post-intervention commencement
Secondary outcome [11] 397272 0
Parents' use of repeated exposure, assessed with one question previously validated for this purpose" (How many times do you offer a food to your child before deciding whether they like the food?)
Timepoint [11] 397272 0
6 weeks post-intervention commencement
Secondary outcome [12] 397273 0
Parent perception of child's food fussiness, assessed with the "food fussiness" subscale of the Child Eating Behaviour Questionnaire
Timepoint [12] 397273 0
6 weeks post-intervention commencement
Secondary outcome [13] 397274 0
Parent description of child's specific food avoidance behaviours, assessed with the Meal Behaviour Questionnaire
Timepoint [13] 397274 0
6 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they currently live in Australia, are able to read and write in English, have a mobile phone that can access the internet and care for a child that is 12-36 months old and lives with them at least half of the time.
Minimum age
12 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Because the intervention has been developed to address the concerns of parents whose children display developmentally typical eating behaviours and have no co-existing conditions that present additional nutritional risk, participants will also excluded if they indicate that their child has been diagnosed with autism spectrum disorder, learning difficulties, avoidant/restrictive intake disorder, or a condition that requires them to follow special dietary requirements (e.g. type 1 diabetes, cystic fibrosis, celiac disease, or metabolic conditions).

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)
Allocation concealment will be carried out using the randomisation module of RedCap survey software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Data will be analysed using R. Frequencies and proportions will be calculated for categorical data; means and SDs will be calculated for continuous data; medians and IQRs will be calculated for ordinal data. Descriptive statistics derived from app usage data (e.g. session interval, session length, time in app, screen flow, retention, push notifications received/read) will be used to calculate its App Engagement Index. Although this pilot will not be powered to detect intervention effects, the within-group mean differences and 95% CIs will be reported for changes in secondary intervention outcomes between baseline and 6 weeks. Standardised differences will be interpreted as: 0.2 = small effect, 0.5 = moderate effect, 0.8 = large effect, and 1.2 = very large effect.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/08/2021
Actual
14/09/2021
Date of last participant enrolment
Anticipated
11/10/2021
Actual
5/11/2021
Date of last data collection
Anticipated
10/12/2021
Actual
28/02/2022
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308131 0
University
Name [1] 308131 0
Deakin University
Country [1] 308131 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 309903 0
None
Name [1] 309903 0
Address [1] 309903 0
Country [1] 309903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308118 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 308118 0
Ethics committee country [1] 308118 0
Australia
Date submitted for ethics approval [1] 308118 0
14/04/2021
Approval date [1] 308118 0
14/05/2021
Ethics approval number [1] 308118 0
2021-139

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

Contacts
Principal investigator
Name 109598 0
Ms Brittany Markides
Address 109598 0
Deakin University
221 Burwood Hwy, Burwood VIC 3125
Country 109598 0
Australia
Phone 109598 0
+61 3 9244 6613
Fax 109598 0
Email 109598 0
[email protected]
Contact person for public queries
Name 109599 0
Brittany Markides
Address 109599 0
Deakin University
221 Burwood Hwy, Burwood VIC 3125
Country 109599 0
Australia
Phone 109599 0
+61 3 9244 6613
Fax 109599 0
Email 109599 0
[email protected]
Contact person for scientific queries
Name 109600 0
Brittany Markides
Address 109600 0
Deakin University
221 Burwood Hwy, Burwood VIC 3125
Country 109600 0
Australia
Phone 109600 0
+61 3 9244 6613
Fax 109600 0
Email 109600 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12222Study protocol    In preparation



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.