Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000396123
Ethics application status
Approved
Date submitted
4/03/2019
Date registered
12/03/2019
Date last updated
7/07/2022
Date data sharing statement initially provided
12/03/2019
Date results provided
7/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Time for Healthy Habits: Evaluating Two Healthy Eating and Active Living Support Programs for Parents of 2-6 Year Old Children
Scientific title
Evaluating two healthy eating and active living support programs for parents of 2-6 year old children (Time for Healthy Habits): a parallel randomised preference trial
Secondary ID [1] 297583 0
None
Universal Trial Number (UTN)
U1111-1228-9748
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Childhood Obesity 311839 0
Condition category
Condition code
Diet and Nutrition 310438 310438 0 0
Obesity
Public Health 310439 310439 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Healthy Habits telephone-based intervention
Healthy Habits is a telephone-based intervention consisting of 6 x fortnightly 20-30 minute telephone calls delivered over 3 months by trained telephone interviewers / coaches who have experience in conducting health-related telephone interviews and surveys, but do not have formal qualifications in a health profession. The program was developed by a team of trained health promotion practitioners, dietitians, psychologists and parenting experts, and is based on the family-based model of intervention proposed by Golan, (which draws on socio-ecological theory), focusing on making positive changes in the home environment, parental role-modelling and improving parents’ knowledge and skills in establishing healthy behaviours in their children. The program seeks to improve healthy eating, physical activity and sleep hygiene and reduce sedentary screen time through modifying: i) the availability and accessibility of foods and beverages, (i.e. ensuring fruit and vegetables are present and stored in a ready-to-eat form), physical activity and sedentary behaviour equipment and opportunities in the home; ii) introducing supportive family routines (i.e. eating meals without the television, having a set bedtime) and iii) increasing parental role-modelling of health behaviours. Such factors are associated with obesity-related behaviours in young children. To support behaviour change, the telephone counselling intervention utilises a number of specific behaviour change techniques including barrier identification, goal-setting, self-monitoring, and using prompts or cues. Parents receive print materials (specifically designed for this study), which are used during the telephone contacts and also to facilitate action between calls.

Arm 2: Time2bHealthy online intervention
Time2bHealthy is an online intervention that consists of 6 modules, each taking approximately 30 minutes for parents to complete and will be delivered over 3 months (i.e. one module every two weeks). The intervention was developed by a multi-disciplinary team of health behaviour and parenting experts and practitioners and is guided by Bandura’s Social Cognitive Theory. Like the Healthy Habits telephone-based intervention, the Time2bHealthy online program seeks to improve child healthy eating as well as physical activity and sleep hygiene and reduce child sedentary screen time through targeting characteristics of the home environment, developing supportive routines, and encouraging parental modelling of health behaviours. A backwards intervention mapping process was used to ensure alignment of specific Time2bHealthy intervention activities to the theory, evidence and target behaviours and the selection of appropriate behavioural change strategies to promote parental behaviour change. The intervention incorporates a closed (secret) Facebook group (moderated by a dietitian) which will allow participants the opportunity to communicate with other members of the intervention cohort. While participants are encouraged to use the Facebook group throughout the program, there are no specific requirements about the frequency of access, and participants can access the group as often (or as seldom) as they like. Participants will also receive fortnightly emails providing a summary of the content from the online program and directing participants to visit the online program to review the material and their progress with goals set.
Intervention code [1] 313816 0
Prevention
Intervention code [2] 313817 0
Lifestyle
Intervention code [3] 313818 0
Behaviour
Comparator / control treatment
The comparison group will receive written educational materials that have been developed by the NSW Office of Preventive Health specifically for this study on healthy eating, physical activity, sedentary behaviour and sleep. These materials will be supplied to parents at fortnightly intervals over a 3-month period via email or post (based on preference). Participants will also be referred to the NSW Healthy Kids and Raising Children’s Network websites for further information.
Control group
Active

Outcomes
Primary outcome [1] 319308 0
Update
Child dietary intake Measured by the Children’s Dietary Questionnaire, which assesses intake patterns over the past week or 24 hours for foods and beverages which are recommended or discouraged for a healthy weight. This tool has demonstrated acceptable reliability and validity for assessing child dietary patterns among preschool children at a population level, and for use in assessing the efficacy to improve children’s eating habits (Margarey et al 2009).
As the CDQ does not assess number of servings, crude servings-based measures of child fruit and vegetable intake will also be used. These questions were taken from the New South Wales Child Health Survey and ask parents “How many serves of fruit does [child name] usually eat each day?” and “How many serves of vegetables does [child name] usually eat each day? (Centre for Epidemiology and Evidence 2012).
Timepoint [1] 319308 0
Baseline, 6-month and 26-month (approx). post-intervention follow-up.
Secondary outcome [1] 367675 0
Child weight status
Child BMI percentile based on height (m) and weight (kg) will be assessed via parent self-report using standard items from the NSW Population Health Survey (NSW Department of Health 2012).
Timepoint [1] 367675 0
Baseline and 6-month post-intervention follow-up
Secondary outcome [2] 367676 0
Child physical activity
Child physical activity will be assessed using a parent-reported questionnaire. Parents will be asked about their child’s physical activity during the day before the interview and about their activity over the past 7 days. These questions were modified from the National Nutrition and Physical Activity Survey (Australian Bureau of Statistics 2011). Compared with accelerometer measures, correlations between parent-reported measures of the percentage of time in sedentary, moderate, vigorous and moderate- to vigorous-intensity activity ranged from r=0.35 to 0.49 (Baccardi-Gascon et al 2012).
Timepoint [2] 367676 0
Baseline and 6-month post-intervention follow-up
Secondary outcome [3] 367677 0
Child sleep
The modified Children’s Sleep Habits Questionnaire will be used to assess child sleep duration, efficiency (% time in bed that a child is awake), night waking, awake time and sleep latency (minutes to fall asleep). The questionnaire has been validated against accelerometry in samples that included preschool-aged children (Bonuck et al 2017).
Timepoint [3] 367677 0
Baseline and 6-month post-intervention follow-up
Secondary outcome [4] 367806 0
Child sedentary screen-time
Parents will be asked about their child’s use of electronic media devices while sitting or lying down, both during the day before the interview and over the last 7 days. These questions were modified from the National Nutrition and Physical Activity Survey (Australian Bureau of Statistics 2011).
Timepoint [4] 367806 0
Baseline and 6-month post-intervention follow-up
Secondary outcome [5] 367808 0
Cost effectiveness
Information about resource use and costs will be collected from both intervention and comparison arms in order to conduct health economic analyses of within study and modelled beyond study incremental cost, effects and cost effectiveness.
Timepoint [5] 367808 0
6-month post-intervention follow-up
Secondary outcome [6] 368054 0
Parental food intake
Parents will be asked about their own usual intake of food (serves of vegetables per day, serves of fruit per day, cups of water per day) from National Nutrition and Physical Activity Survey (Australian Bureau of Statistics 2011).
Timepoint [6] 368054 0
Baseline, 6-month and 26-month (approx.) post-intervention follow-up
Secondary outcome [7] 368060 0
Parent physical activity
Parents will be asked about their own physical activity - from National Nutrition and Physical Activity Survey (Australian Bureau of Statistics 2011).
Timepoint [7] 368060 0
Baseline and 6-month post-intervention follow-up
Secondary outcome [8] 368061 0
Mediation effect of fruit and vegetable availability (i.e. available within home environment) (from items in Healthy Home Survey (HHS).
Timepoint [8] 368061 0
Baseline and 6-month post-intervention follow-up
Secondary outcome [9] 368062 0
Mediation effect of fruit and vegetable accessibility (i.e. able to be accessed by children in home environment; fruit and vegetables are within their reach and in ready to eat form) (from items in Healthy Home Survey (HHS).
Timepoint [9] 368062 0
Baseline and 6-month post-intervention follow-up
Secondary outcome [10] 368063 0
Mediation effect of family mealtime practices (from items in Healthy Home Survey (HHS)- family eating dinner at dining table together, not watching TV while eating a meal).
Timepoint [10] 368063 0
Baseline and 6-month post-intervention follow-up

Eligibility
Key inclusion criteria
- Child 2-6 years of age
- Lives in New South Wales, Australia
- Child resides with parent participating in study at least 4 days per week
- Parent speaks and understands English
- Parent has access to phone and internet
Minimum age
2 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous participation in the Healthy Habits or Time2bHealthy randomised controlled trials

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)
Participants will be recruited from a number of community settings throughout New South Wales. Eligibility will be confirmed and consent obtained by NSW Health Local Health District staff or the Project Coordinator. Written or online consent will be obtained. Baseline measures will then be collected over the telephone. Participants will then be asked if they have a strong preference in regard to the group to which they are assigned to. Participants who do not have a strong preference will be randomly allocated to a study arm. Participants who have a strong preference will be allowed to select the study arm of their choice. Randomisation will be conducted by an independent statistician using computer-generated random number function. The statistician is not directly involved in the recruitment or analysis phases of the study.
Stopping rules for the non-randomised preference arm will be applied to ensure enough participants are randomised to power the primary analysis of relative treatment effects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised participants will be randomly assigned to one of the three arms of the study after collection of baseline measures by block randomisation using a random number function in SAS statistical software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Randomised preference trial design

Parents of 2-6 year old children will elect to either be randomised or select a study arm (if they have a strong preference regarding the way in which they would like to receive information)
Stopping rules for the non-randomised preference arm will be applied to ensure enough participants are randomised to power the primary analysis of relative treatment effects.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations are based on detecting differences in the Children’s Dietary Questionnaire scores (Margarey et al 2009), which is the primary outcome. Accounting for 20% attrition, 212 participants will be recruited at baseline per group, resulting in a sample size of 169 per group at the 6-month follow-up. With 80% power at the 0.05 significance level, this will allow a 15% detectable difference between intervention and comparison groups in adherence to dietary guideline recommendations assessed using the Children’s Dietary Questionnaire (or CDQ subscales) assuming conservatively a follow-up prevalence of 50% in the comparison group.

A stopping rule will be implemented, whereby participants will no longer be able to select their study arm if the prevalence of participants with strong treatment group preference precludes estimates of reasonable precision of intervention effects. Specifically, allocation will be ceased based on treatment preference and participants randomly assigned to each of the three experimental arms in the ratio (1:1:1) when, and if 285 (45%) of the anticipated 636 participants opt to select their study arm. This threshold will ensure that there are approximately 117 randomised participants per group.

For the primary analysis, sample size calculations for the randomised population are based on detecting between group differences in the proportion of randomised children with fruit and vegetable intake patterns consistent with dietary guidelines, as determined by a score of 14 or more on the fruit and vegetable subscale of the CDQ (54), the primary outcome alone. Accounting for 20% attrition, 117 randomised participants per arm (351 in total) are needed to complete baseline data collection with adequate power, resulting in a sample size of 93 participants per group at the 9-month post- baseline follow-up. For 80% power at a 0.05 significance level, this will allow a higher 20% detectable difference (based on the randomised design) between intervention and comparison groups in adherence to dietary guideline recommendations assessed using the CDQ fruit and vegetable subscale.

All analyses will be conducted using intention-to-treat principles. Generalised Estimating Equations logistic regression models or mixed models will be used to assess the impact of the intervention on the primary trial outcome of dietary habits consistent with guidelines. Intervention effects will be compared, firstly by including only participants who were randomly allocated and secondly by including all participants adjusting for group (preference) and for other covariates. All significance tests will be 2-tailed with an alpha of 0.05

Post hoc analysis will be conducted to examine interactions by measures of socio economic status.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/03/2019
Actual
30/04/2019
Date of last participant enrolment
Anticipated
9/04/2020
Actual
8/04/2020
Date of last data collection
Anticipated
5/09/2022
Actual
Sample size
Target
636
Accrual to date
Final
458
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302133 0
Government body
Name [1] 302133 0
NSW Ministry of Health (Translational Research Grant Scheme)
Country [1] 302133 0
Australia
Funding source category [2] 302135 0
Government body
Name [2] 302135 0
NSW Office of Preventive Health (in-kind)
Country [2] 302135 0
Australia
Primary sponsor type
Government body
Name
Murrumbidgee Local Health District
Address
Murrumbidgee Local Health District Office
Locked Bag 10
Wagga Wagga NSW 2650
Country
Australia
Secondary sponsor category [1] 301968 0
University
Name [1] 301968 0
University of Wollongong
Address [1] 301968 0
Northfields Ave
Wollongong NSW 2522
Country [1] 301968 0
Australia
Secondary sponsor category [2] 301970 0
University
Name [2] 301970 0
University of Newcastle
Address [2] 301970 0
University Dr
Callaghan NSW 2308
Country [2] 301970 0
Australia
Secondary sponsor category [3] 301971 0
Government body
Name [3] 301971 0
NSW Office of Preventive Health
Address [3] 301971 0
Locked Bag 7103
Liverpool BC, NSW 1871
Country [3] 301971 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302813 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 302813 0
Ethics committee country [1] 302813 0
Australia
Date submitted for ethics approval [1] 302813 0
06/11/2018
Approval date [1] 302813 0
18/04/2019
Ethics approval number [1] 302813 0
HREC/18/LPOOL/472

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

Contacts
Principal investigator
Name 91482 0
Ms Tracey Oakman
Address 91482 0
Murrumbidgee Local Health District
Suite 1B, 620 Macauley St, PO Box 3095, Albury NSW 2640
Country 91482 0
Australia
Phone 91482 0
+61 2 6053 4869
Fax 91482 0
Email 91482 0
[email protected]
Contact person for public queries
Name 91483 0
Megan Hammersley
Address 91483 0
Early Start – Building 21
University of Wollongong
Northfields Ave,
Wollongong NSW 2522
Country 91483 0
Australia
Phone 91483 0
+61 2 4221 5670
Fax 91483 0
Email 91483 0
[email protected]
Contact person for scientific queries
Name 91484 0
Chris Rissel
Address 91484 0
NSW Office of Preventive Health
Liverpool Hospital
Locked Bag 7103,
Liverpool BC, NSW 1871
Country 91484 0
Australia
Phone 91484 0
+61 2 8738 6545
Fax 91484 0
Email 91484 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
IPD sharing was not sought in our ethics application. Therefore ethics approval has been obtained for data to be used for this study only.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7143Informed consent form http://www.timeforhealthyhabits.com 
7144Other https://timeforhealthyhabitsnsw.com  Trial website and consent form to be provided when... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTranslation of two healthy eating and active living support programs for parents of 2-6year old children: a parallel partially randomised preference trial protocol (the 'time for healthy habits' trial).2020https://dx.doi.org/10.1186/s12889-020-08526-7
EmbaseTranslation of two healthy eating and active living support programs for parents of 2-6-year-old children: Outcomes of the 'time for healthy habits' parallel partially randomised preference trial.2021https://dx.doi.org/10.3390/nu13103348
EmbaseParent Fruit and Vegetable Consumption Outcomes from the Translational 'Time for Healthy Habits' Trial: Secondary Outcomes from a Partially Randomized Preference Trial.2022https://dx.doi.org/10.3390/ijerph19106165
N.B. These documents automatically identified may not have been verified by the study sponsor.