ANZCTR - Registration

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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 information initially provided

9/07/2021

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]

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

Condition category

Condition code

Diet and Nutrition

Obesity

Public Health

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

Baseline, 6-month and 26-month (approx). post-intervention follow-up.

Secondary outcome [1]

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]

Baseline and 6-month post-intervention follow-up

Secondary outcome [2]

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]

Baseline and 6-month post-intervention follow-up

Secondary outcome [3]

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]

Baseline and 6-month post-intervention follow-up

Secondary outcome [4]

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]

Baseline and 6-month post-intervention follow-up

Secondary outcome [5]

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]

6-month post-intervention follow-up

Secondary outcome [6]

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]

Baseline, 6-month and 26-month (approx.) post-intervention follow-up

Secondary outcome [7]

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]

Baseline and 6-month post-intervention follow-up

Secondary outcome [8]

Mediation effect of fruit and vegetable availability (i.e. available within home environment) (from items in Healthy Home Survey (HHS).

Timepoint [8]

Baseline and 6-month post-intervention follow-up

Secondary outcome [9]

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]

Baseline and 6-month post-intervention follow-up

Secondary outcome [10]

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]

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]

Government body

Name [1]

NSW Ministry of Health (Translational Research Grant Scheme)

Address [1]

73 Miller St
North Sydney NSW 2060

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

NSW Office of Preventive Health (in-kind)

Address [2]

Level 1, Don Everett Building
West End, Liverpool Hospital
Elizabeth Street
Liverpool, NSW 2170

Country [2]

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]

University

Name [1]

University of Wollongong

Address [1]

Northfields Ave
Wollongong NSW 2522

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

University of Newcastle

Address [2]

University Dr
Callaghan NSW 2308

Country [2]

Australia

Secondary sponsor category [3]

Government body

Name [3]

NSW Office of Preventive Health

Address [3]

Locked Bag 7103
Liverpool BC, NSW 1871

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Level 2, UNSW Clinical School
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets
Liverpool NSW 2170

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/11/2018

Approval date [1]

18/04/2019

Ethics approval number [1]

HREC/18/LPOOL/472

Summary

Brief summary

In NSW, one in five children are overweight or obese (Hardy et al 2016). Poor diet, inadequate physical activity, excessive screen time and inadequate sleep are the key behavioural risk factors for unhealthy weight gain in childhood (Bauman et al 2016).
As key role models and decision makers and decision makers regarding their child’s food intake, physical activity, screen time and sleep patterns, parents have a critical role to play in childhood obesity prevention. Despite the important role parents have, there are recognised barriers to parental participation in child obesity prevention or weight management programs such as scheduling of sessions (Young et al 2007), finding childcare for other siblings (Kelleher et al 2017), travel (Warren et al 2007). Also, existing services that provide information for parents with young children are often not evidence based, and lack a population-wide infrastructure, thereby making it difficult for some parents to access and benefit from them.
Online and telephone-based obesity prevention programs offer advantages in convenience and accessibility compared with conventional face-to-face programs currently available in NSW and have the potential to be delivered population wide at relatively low cost (Eakin et al 2010).
This study aims to evaluate the effectiveness and cost-effectiveness of two health promotion programs (‘Healthy Habits’ – telephone based program and ‘Time2bHealthy – online program) designed to support parents of 2-6 year old children to promote healthy eating, physical activity and adequate sleep in children. It also aims to determine the most optimal approaches to maximising recruitment to and retention of parents in such programs.
The study will employ a three-arm parallel-group randomised preference trial design. Participants may choose to participate in a telephone-based program (Healthy Habits), an online program (Time2bHealthy) or receive written educational materials which will serve as the comparison group. Participants who do not have a particular preference will be randomly allocated to one of the three arms.
It is expected that this research will identify one or more programs for parents of children aged 2-6 years that are effective in improving their child’s behaviours (nutrition, physical activity, sedentary time and sleep). The programs will be implemented in New South Wales, Australia and contribute to the Premier’s Priority target of reducing childhood overweight and obesity.

Trial website

www.timeforhealthyhabitsnsw.com

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Tracey Oakman

Address

Murrumbidgee Local Health District
Suite 1B, 620 Macauley St, PO Box 3095, Albury NSW 2640

Country

Australia

Phone

+61 2 6053 4869

Fax

Tracey.Oakman@health.nsw.gov.au

Contact person for public queries

Name

Dr Megan Hammersley

Address

Early Start – Building 21
University of Wollongong
Northfields Ave,
Wollongong NSW 2522

Country

Australia

Phone

+61 2 4221 5670

Fax

mhammers@uow.edu.au

Contact person for scientific queries

Name

Prof Chris Rissel

Address

NSW Office of Preventive Health
Liverpool Hospital
Locked Bag 7103,
Liverpool BC, NSW 1871

Country

Australia

Phone

+61 2 8738 6545

Fax

chris.rissel@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
7143	Informed consent form		http://www.timeforhealthyhabits.com
7144	Other		https://timeforhealthyhabitsnsw.com		Trial website and consent form to be provided when... [More Details]

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Hammersley ML, Wyse RJ, Jones, RA, Stacey F, Okely... [More Details]
Study results article	Yes		Wyse RJ, Jackson, JK, Hammersley ML, Stacey F, Jon... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Translation 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).	2020	https://dx.doi.org/10.1186/s12889-020-08526-7
Embase	Parent Fruit and Vegetable Consumption Outcomes from the Translational 'Time for Healthy Habits' Trial: Secondary Outcomes from a Partially Randomized Preference Trial.	2022	https://dx.doi.org/10.3390/ijerph19106165
Embase	Translation 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.	2021	https://dx.doi.org/10.3390/nu13103348

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically