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Childhood obesity is a challenging public health issue, with 30% of children aged 2 to 4 years classified as being overweight or obese in New Zealand. This is concerning, given that up to 90% of obese 3-year-old children are overweight or obese by the time they reach adolescence. Interventions that target this age range often fail to demonstrate long-term effectiveness and primarily focus on traditional weight-related behaviors, including diet and physical activity. However, research suggests that targeting nontraditional weight-related behaviors, such as sleep, screen time, and family meals, may be a more effective approach in this age group, given the immense challenges in changing traditional weight-related behaviors in the long term.
The aim of the proposed study was to develop and pilot the 3 Pillars Study (3PS), a 6-week program for parents of New Zealand toddlers and preschoolers aged 2 to 4 years to promote positive parent-child interactions during 3 family routines, specifically adequate sleep, regular family meals, and restricted screen time.
Screen time at the end of the 6-week program is the primary endpoint. The effects of the program on screen time, frequency of family meals, parent feeding practices, diet quality, and sleep duration will be piloted using a randomized controlled trial, with outcomes compared between the active intervention group and a wait-list control group at 6 weeks (at the end of the program) and 12 weeks (at final follow-up). We aim to recruit 50 participants (25 per arm). Eligibility criteria include parents of children aged 2 to 4 years who are currently exceeding screen use recommendations (ie, greater than 1 hour of screen time per day). The 3PS program involves a half-day workshop, run by a community worker trained to deliver the program content, and 6-week access to a study website that contains in-depth information about the program. All participants will also receive a study pack, which includes resources to encourage engagement in the 3 family routines promoted by the program. Study data will be collected in REDCap. All statistical analyses will be performed using SAS version 9.4 and have been specified a priori in a statistical analysis plan prepared by the study statistician.
Trial recruitment opened in July 2018. Final follow-up was completed in December 2018, with trial findings expected to be available in early 2019.
Findings from this pilot study will provide relevant data to inform the design of a larger effectiveness study of the 3PS program.
Australian New Zealand Clinical Trials Register ACTRN12618000823279; https://www.anzctr.org. au/Trial/Registration/TrialReview.aspx?id=375004 (Archived by WebCite at http://www.webcitation.org/773CALeTK)
DERR1-10.2196/12792
Childhood obesity remains one of the most pervasive and challenging public health issues, with 30% of children aged 2 to 4 years classified as being overweight or obese in New Zealand [
Although a number of interventions targeting obesity prevention in toddlers and preschoolers have been undertaken, results have been mixed [
For example, the Prevention of Overweight in Infancy study found that children randomized to receive additional support for more traditional weight-related behaviors, including breastfeeding, healthy eating, and physical activity during the first 2 years of life, had significantly higher body mass index (BMI) z scores compared with controls at age 5 years (adjusted difference: 0.25; 95% CI 0.04 to 0.47) [
There are now a growing number of experts calling for a shift to identify and focus on these nontraditional weight-related behaviors, including adequate night-time sleep, regular participation in family meals, and limiting screen time [
It is likely that family routines actually represent the broader constructs of family functioning and family organization [
Second, it makes sense pragmatically that organized families will simply be better placed to arrange their time and resources in such a way that it facilitates both structuring of routines in the first instance and then ongoing participation in them. For example, children from disorganized families are significantly more likely to demonstrate sleep problems, and it is proposed that the disorganization these families experience interferes with their ability to engage in a regular bedtime routine, which is known to support healthy sleep in children [
The approach of targeting family routines, such as sleep and family meals, rather than traditional weight-management behaviors, such as diet and physical activity, may have a number of benefits. First, parents do not need to perceive their child to be at risk of being overweight or feel criticized for their parenting behaviors [
Third, although family routines are directly modifiable by parents, more traditional weight-management behaviors, such as what and how much a child eats, are also affected by a child’s individual characteristics, such as temperament [
It may also be valuable to consider the importance of promoting positive parent-child interactions during family routines associated with obesity prevention. It is possible that families eating together at mealtimes may only protect against childhood obesity because of positive parent-child interactions [
The parent-child relationship appears important with respect to obesity prevention, with poorer quality of interactions during playtime interactions, lower maternal sensitivity, and insecure attachment, all associated with obesity risk [
The aim of the proposed study was to develop and pilot the 3 Pillars Study (3PS), a 6-week program for parents of New Zealand toddlers and preschoolers aged 2 to 4 years to promote positive bidirectional interactions between the parent and child during 3 family routines shown to protect against childhood obesity. Specifically, the program targets adequate night-time sleep, engaging in regular family meals, and restricting screen time. These 3 routines represent the
A 2-arm, 6-week pilot RCT, with final follow-up at 12 weeks (ie, 6 weeks after the end of the 6-week program), will be conducted to assess 3PS. Intervention participants will attend 1 half-day workshop and have access to a study website with supplementary information for a period of 6 weeks. Both the intervention group and wait-list control group will undergo study measures at baseline, 6 weeks, and 12 weeks. After the final data collection at 12 weeks, the control group will be offered the intervention. The study has been approved by the University Auckland Human Participants Ethics Committee (UAHPEC; reference 021311) and is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12618000823279).
A total of 50 participants, 25 in the intervention group and 25 in the wait-list control group, will be recruited to the free 3PS program through social media (ie, targeted Facebook advertising), playgroups, and word of mouth. Participants will be eligible for inclusion if they are the parent or primary caregiver of a child aged 2 to 4 years, if they are aged at least 18 years, and if their child exceeds recommendations for screen use, that is >1 hour per day for this age group, as reported by the parent. Participants will be required to live in Auckland, have internet access, be available to attend 1 half-day workshop, and be able to provide electronic informed consent and speak and read English. Due to the exploratory nature of the intervention, parents of children with serious physical or mental illness or known developmental problems will not be eligible to participate.
This study will be conducted in Auckland, New Zealand. The 3PS workshop will take place at the University of Auckland, and participants will be able to access the study website wherever they have access to the internet.
Flowchart illustrating the enrollment and randomization process. 3PS: 3 Pillars Study.
After the baseline questionnaire is complete, the research assistant will randomize the participant to either the intervention group or the wait-list control and inform them of their randomization group. Completion of the baseline questionnaire and randomization will take place during the 2 weeks before the first workshop.
The research assistant will use sequentially numbered, opaque, sealed envelopes to randomize participants. Participants will be allocated to 1 of the 2 groups in a 1:1 ratio using block randomization with varying block sizes of 2 and 4. The randomization sequence will be generated by the study statistician, who will also prepare and seal the envelopes.
The 3PS program is designed to promote mutually responsive, positive parent-child interactions and help primary caregivers, herein referred to as parents, of children aged 2 to 4 years to engage in 3 family routines shown to be protective against childhood obesity: adequate night-time sleep, restricted screen time, and regular participation in family meals. The content development process took place over an 18-month period and involved 2 sets of community focus groups, face-to-face parent interviews, and a series of end-user panels with parents. Recruitment criteria used for the formative work was the same as that described above for the pilot study.
Community focus groups (5 focus groups; n=26) and one-on-one interviews (n=8) with parents of 2- to 4-year olds were conducted to establish perceived barriers to engaging in healthy weight-related behavior recommendations in the context of a young family, in addition to establishing the preferred delivery method for a parent intervention. Feedback from the focus groups revealed that one of the biggest barriers to engaging in health-promoting activities was being too busy, either due to family commitments; rushing between activities and chores; or having 2 parents who worked outside the home. In particular, parents said they wanted help with managing the
When asked how they deal with busyness, parents frequently reported using screens to distract their children while they got things done; yet, at the same time described harboring feelings of guilt about the amount of time their child spent on screens. These conflicting feelings around child screen use were further highlighted when parents conveyed negative responses to messages promoting the importance of reducing screen time. As a result of these discussions, the decision was made to reframe the family routine of
Responses from the focus groups regarding the delivery format of the program were mixed, with some parents preferring the potential for more tailored information during face-to-face workshops and others preferring the convenience and lower level of commitment required of a Web-based resource. Furthermore, focus group participants revealed that parents would like the workshop delivered by members of the community who were parents themselves and who could report back on their personal experience using the program content. On the basis of this feedback, the decision was made to deliver the program via a workshop and a study website, with the workshop facilitated by a member of the community, rather than a researcher or health professional. Furthermore, given that parents frequently cited lack of time as a barrier to attending workshops, the decision was made to deliver the workshop as an intensive half-day course, rather than requiring parents to commit to several sessions over a number of weeks.
Findings from the initial set of focus groups and parent interviews were then integrated with scientific literature focusing on family routines and rituals [
Trainings took place at the University and were divided into 4 units. The first unit focused on general skills facilitating groups. During the second unit, the intent, philosophy, and theory behind the 3PS program were delivered. Unit 3 focused primarily on how to deliver the content of the workshop, and unit 4 involved practicing delivery of the content in front of an audience and dealing with any questions or concerns that might arise. The facilitator was also provided with a detailed training manual and access to readings to provide further knowledge and understanding of the program content.
Participants randomized to the intervention group will participate in a half-day, face-to-face workshop and have access to the study website for a period of 6 weeks. The first part of the workshop is theory based and provides parents with insight into their children’s behavior and development [
A 5-step process for implementing the CARE framework is then introduced to guide parents in finding practical solutions within their own family around getting adequate night-time sleep, participating in family meals, and reducing screen time and promoting free play. In brief, parents identify things they do that might interfere with positive parent-child interactions (step 1). For example, at family meals, a parent using their mobile phone at the dinner table may interfere with positive parent-child interactions. These things are referred to as
The second part of the workshop is more practical and divided into 3 sections that correspond with the 3 study pillars—supporting sleep, screen-free play, and family meals. Each of the pillars is introduced using a similar format; there is a background reading, which provides a brief overview as to why the activity is important to health and child development, and then the workshop facilitator walks the parents through the 5-step process outlined above as it relates to each specific pillar. For each of the 3 pillars, a number of group activities are used to encourage parent engagement and highlight the study messages and learnings. At the end of the workshop, parents will be given a study pack [
Due to the intensive nature of the workshop, parents will also be given access to a study website. This website will allow parents to return to the material covered during the 3PS workshop and review it at their own pace. In addition to providing all the content delivered during the workshop, the website will also include links to related readings, selected references (as a number of parents said they wanted to know the
Participants log-in to the 3PS website on the study landing page and then are taken to a homepage, which has links to 4 additional pages: (1) the CARE Framework page, which discusses the framework used in detail; (2) the 3 Pillars page, which links to 3 subpages that reflect each of the pillars; (3) an Info page, which provides study-related information; and (4) a Contact Us page, which provides the contact information for the study team. For each of the 3 Pillars subpages, background is provided about how the specific pillar is related to child health and well-being, and a step-by-step approach to using the CARE Framework to address the pillar. For example, with respect to sleep, there is information about what children find disconnecting at bedtime, what a simple bedtime routine might look like, a list of ideas for how parents might be able to infuse connection into the bedtime routine, and then ideas for reducing household chaos to create a peaceful sleep environment. Their access to the study website will be active for a period of 6 weeks.
Participants will be given the choice of attending 1 of the 3 half-day workshops. The day before the workshop, participants will be contacted via email with a reminder of the workshop and also detailed instructions of where to find the room and parking. If a participant does not turn up to the workshop, they will be contacted via phone or email to reschedule the workshop they attend, in an attempt to improve study adherence. The workshop will be catered and dietary requirements provided for.
Parents allocated to the wait-list control group will not receive the intervention until final follow-up is complete, that is, at the end of the 12-week study period. At this stage, participants will be offered the 3PS program, including the opportunity to participate in the workshop and access to the study website.
Participants in the intervention group will be asked to complete their 6- and 12-week questionnaires 6 and 12 weeks after the date of the workshop they attend, respectively. Furthermore, 3 workshop dates will be offered on 3 consecutive Saturdays. Participants in the wait-list control group will complete their 6- and 12-week questionnaires 6 and 12 weeks from the date of the first workshop, respectively.
Schedule of assessments.
Outcomes | Baseline | 6 weeks | 12 weeks | |
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Total screen timea (minutes) | xb | x | x |
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Percentage of children meeting screen recommendationsc | x | x | x |
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Brief Screening Questionnaire for Infant Sleep Problems-Extended [ |
x | x | x |
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Frequency of family meals [ |
x | x | x |
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Fruit servings per daya | x | x | x |
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Vegetables servings per daya | x | x | x |
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Frequency of sugar-sweetened beverages in the previous weeka | x | x | x |
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Frequency of fast foods in the previous weeka | x | x | x |
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Feeding Practices and Structure Questionnaire [ |
x | x | x |
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|
Child Routine Inventoryd [ |
x | x | x |
|
Chaos, Hubbub, and Order Scale [ |
x | x | x |
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Exit questionnaire | —f | — | x |
|
Exit interview | — | — | x |
aNew Zealand Health Survey Questions.
bx: measure taken.
cLess than 1 hour per day.
dDaily Living Routines subscale only.
eIntervention group only.
fNot applicable.
The primary outcome is screen time at 6 weeks, which is one of the program’s targeted routines and the primary endpoint used in a previous study [
Screen time will be assessed using 4 questions from the New Zealand Health Survey [
Family meals, diet, and parent feeding practices: A single item investigating the frequency of family meals, taken from the validated Family Routines Inventory questionnaire [
Sleep: Sleep will be assessed using the Brief Screening Questionnaire for Infant Sleep Problems-Extended [
Routines and Home Environment: The
Exit Questionnaire: The exit questionnaire, completed at 6 weeks by intervention participants only, will assess acceptability and feedback of the 3PS program using 5 open-ended questions about what the participants liked and disliked about the program and what they would keep the same or change.
Exit Interviews: A subgroup of 6 to 10 intervention participants will take part in an exit interview at the 6-week follow-up. The exit interview will be conducted by a trained research assistant on the telephone or face-to-face at a community venue and will take approximately 20 min. Participants will be asked to provide informed consent before participating in the interview. Participants will be prompted to explore in more depth their responses to the exit questionnaire, in particular, whether they used the study website and if they found it helpful. Furthermore, given that the formative work revealed that many parents had concerns about parenting interventions making them feel guilty and judged, we will explore their perceptions of the language and tone used in the program and explore ways in which we could avoid any negative experiences in the future.
We will aim to recruit 50 people (25 in each group). As this is a pilot trial, it is not powered to detect significant differences between the 2 groups but will provide sufficient data to ascertain recruitment and the direction and likely effect size for the screen-time outcomes.
Study data will be collected in REDCap. All statistical analyses will be performed using SAS version 9.4 and will be specified a priori in a statistical analysis plan prepared by the study statistician. All baseline variables will be summarized by group and descriptive summary statistics provided. Analyses will be carried out on an intention-to-treat basis. Chi-square tests, incidence rates, relative risks, and 95% CI will be calculated for all binary variables followed by multiple logistic regression analysis adjusting for other variables if needed. Continuous data will be analyzed using multiple linear regression modeling or nonparametric analysis. Sensitivity analyses will be undertaken to determine the impact of missing data. Repeated measures models will be used to analyze data collected repeatedly over time. A trained research assistant will conduct interviews. Interviews will be recorded (with permission) and transcribed verbatim. A general inductive thematic approach will be followed that allows research findings to emerge from multiple readings of the raw data. NVivo9 software will be used to manage the transcripts and facilitate the analysis process and to identify themes and categories.
Trial recruitment started in July 2018. Final follow-up was completed in December 2018, with trial findings expected to be available in early 2019.
This paper presents the design of an RCT to pilot the effectiveness of the 3PS program. Findings from the pilot study will be used to inform the design of a larger effectiveness study of the 3PS program. Family meals, restricting screen time, and adequate night-time sleep have been shown to promote obesity resilience in young children [
This pilot study intervention with short-term follow-up is not able to assess the effect of the 3PS program on child body size. Although the ultimate goal of this approach is to prevent obesity, the decision not to measure children’s body weight was pragmatic, due to limited resources and the short duration of the study. Indeed, although promoting family routines, creating a supportive home environment, and facilitating positive parent-child interactions have the potential to prevent overweight and obesity in later childhood and adulthood, we would not expect to see changes in body weight during the 12-week study period. Finally, although preventing obesity is the long-term aim of this approach, the short-term aims are to improve engagement in the 3 routines shown to protect against obesity, increase engagement in positive parental feeding practices at mealtimes, and reduce household chaos. As such, the study measures have been chosen to reflect these aims.
3 Pillars Study
body mass index
Connecting Activities, Routines, and Environments
randomized controlled trial
socioeconomic status
The authors would like to thank everyone involved in the design, development, and implementation of the study. This study is funded by a Health Research Council Explorer Grant and a Lottery Health Research Postdoctoral Fellowship.
SM primary investigator, conceptualization, funding acquisition, investigation, methodology, project administration, content development, and writing; SG content development (family meals), review and editing; RT methodology, intervention content development (sleep), review and editing; BG methodology, intervention content development (sleep), review and editing; VP formal analysis and methodology; RM conceptualization, funding acquisition, methodology, review and editing.
None declared.