- Open Access
Parent engagement in co-design of clinical trials: the PARENT trial
Trials volume 22, Article number: 347 (2021)
Evidence generated from partnering with parents to design and conduct research together may be used to refine, adjust, and modify future research approaches. This study aimed to describe the initial approaches to parent engagement in the design of the PARENT trial as well as understand parent perspectives on the acceptability and relevance of the PARENT trial and potential barriers and facilitators to participation.
Parents participating in the TARGet Kids! cohort were invited to participate in a focus group, called the PARENT panel, to co-design the PARENT trial. This focus group was conducted to capture diverse individual and collective parents’ experiences. Overall methodological approaches for the PARENT panel were informed by the CIHR Strategy for Patient Oriented Research (SPOR) guiding principles (mutual respect, co-building, inclusiveness, and support) for patient engagement in research, and facilitated through the Knowledge Translation Program in the Li Ka Shing Knowledge Institute at Unity Health Toronto. Using a Nominal Group Technique, the PARENT panel provided feedback on the feasibility, relevance, and acceptability of the proposed intervention. Findings from this work will be used to further refine, adjust, and modify the next iteration of the PARENT trial, which will also serve as an opportunity to discuss the efforts made by researchers to incorporate parent suggestions and what additional steps are required for improved patient engagement.
Patient-oriented research focuses on engaging patients in the research process. This type of engagement helps to ensure that research answers questions relevant to patients and uses collaboratively developed methods, and interpretation of results, with the goal of improved patient outcomes . Though efforts to conduct patient-oriented clinical trials have increased , the degree of engagement in patient-oriented research is paradoxically poor  or may appear tokenistic. Patient engagement is intended to align research goals between researchers and patients, ensure research design and methods are feasible and accessible, and facilitate effective dissemination of study findings to those who contributed data as well as other stakeholders and the public. Patient engagement research has the potential to be especially impactful in trials focusing on young children, where parents can develop ongoing and genuine interactions with study teams, including clinicians and researchers, and provide meaningful input such as steering study design and dissemination of results. There is limited literature on engaging parents and young children as partners in research involving young children [4,5,6,7].
The Applied Research Group for Kids (TARGet Kids!; www.targetkids.ca) is an ongoing cohort study with embedded randomized controlled trials (RCTs), which involves parents and young children from primary care practices in three cities in Canada (Toronto, Montreal, and Kingston). TARGet kids! is a collaboration between parents, their children, child health researchers, and primary care practitioners, which aims to link early life exposures to health problems including obesity, micronutrient deficiencies, and developmental problems . TARGet Kids! presents a unique opportunity to engage parents and inform research priorities, improve study recruitment and generalizability, and co-develop embedded clinical trials. One embedded randomized controlled clinical trial in TARGet Kids! is called PARENT (Parenting Addressing Early Years Intervention with Home Visits in Toronto: A Pragmatic Randomized Controlled Trial; NCT03219697), a pragmatic, parallel-group, one-to-one, superiority RCT. The aim of the PARENT trial is to determine if participation (experimental group) with a public health nurse via group parenting sessions (i.e. coaching calls addressing goal setting), and home virtual visits (i.e. addressing behaviours in the home setting) focused on nutrition, physical activity, and sleep among young children at risk of obesity can improve health outcomes such as reduced risk for overweight or obesity, and better mental health and nutrition. The control group comprised of children and parents who received usual care. In Canada, this consists of individual well-child health supervision visits, guided by the Rourke Baby Record (as endorsed by the Canadian Pediatric Society and the College of Family Physicians of Canada) . Ethical approval for the PARENT trial and supporting material was received from the Hospital of Sick Children’s and the Toronto Public Health (Toronto, CANADA; REB1000054998). Informed consent was obtained from the parents of children who participated in this study.
In accordance with the International Association of Public Engagement (IAP2) , researchers in TARGet Kids! aim to inform, consult, involve, collaborate, and empower parents as co-creators. Thus, the PARENT trial was designed with the support of and in collaboration with parents of young children. Models of co-designing clinical trials are increasingly being seen as a way of addressing power imbalances by designing and delivering research in more democratic, equal, and reciprocal relationships between healthcare professionals, researchers, participants, and end-users . While there have been speculations on the “best” or “correct” way of engaging in co-production and co-development and assessment of clinical trials , some key principles that help underpin this practice include developing peer support and engaging a range of stakeholder networks inside and outside health care; removing tightly defined boundaries among researchers, practitioners, and recipients such as parents; enabling shared control, responsibility, and mutuality; and supporting reciprocal relationships with mutual responsibilities and expectations . It has been well documented that the priorities of researchers may not align well with the priorities of patients and clinicians [13,14,15,16]. Patient involvement in setting research priorities may lead to research that is more relevant to patients [17, 18]. Although patients and clinicians are increasingly recognized as important research partners, a review of priority setting studies found that only 49 of 258 (19%) studies involved both patients and clinicians in the process . Nevertheless, evidence generated from partnering with parents to design and conduct research together may be used to refine, adjust, and modify future research approaches, and provide an opportunity to evaluate the process taken to engage patient partners and determine areas of strength, weakness, and need for growth.
The primary objective of this study was to describe the initial approaches to parent engagement in the design of the PARENT trial in TARGet Kids!. The secondary objectives were to understand parent perspectives on the acceptability and relevance of the PARENT trial and potential barriers and facilitators to participation, though a parent focus group.
Approach to patient engagement in co-design of the PARENT trial
A priority setting process was conducted to identify parent and clinician research priorities in prevention research. Using the James Lind Alliance  framework, this exercise revealed that the prevention of obesity and mental illness in young children were two high priority areas worthy of further investigation . This was consistent with priorities of the WHO , Public Health Agency of Canada , Public Health Ontario , and the Canadian Task Force on Preventive Health Care , as rates of overweight and obesity in children under 5 years of age in Canada are currently 15% and 6%, respectively [26, 27].
Pilot work was initiated to develop an RCT to promote health behaviours and prevent obesity in young children with increased risk factors for future obesity. Existing literature was reviewed and identified using home visits was effective in trials that addressed parenting strategies for obesity prevention [28,29,30,31,32,33]. Funding for the PARENT trial was obtained through the Ontario Child Health SUPPORT Unit (OCHSU) Strategy for Patient-Oriented Research (SPOR) research network, which encouraged partnerships with patients and other patient-oriented research groups (clinicians and researchers with expertise in public health, primary care, nutrition, physical activity, mental health, early child development, obesity treatment, and epidemiology).
PARENT panel in the TARGet Kids! cohort
Parents participating in the TARGet Kids! cohort were invited to participate in a focus group, called the PARENT panel, to co-design the PARENT trial. This focus group intended to capture diverse individual and collective parents’ experiences. Overall methodological approaches for the PARENT panel were informed by the CIHR Strategy for Patient Oriented Research (SPOR) guiding principles (mutual respect, co-building, inclusiveness, and support)  for patient engagement in research, and facilitated through the Knowledge Translation Program in the Li Ka Shing Knowledge Institute at Unity Health Toronto . Along with the PARENT panel, the research team designed an engagement plan inspired by the IAP2 framework to help direct this work . Using a Nominal Group Technique , the PARENT panel helped provide feedback on the feasibility, relevance, and acceptability of the proposed intervention. The PARENT panel prioritized research outcomes in the PARENT trial and contributed to the list of potential child and family barriers and facilitators to participating in the intervention. Through informing how to tailor both TARGet Kids! and the PARENT trial to increase participation, parents had the opportunity to co-build the PARENT trial research to meet their interests and needs.
Participant recruitment for the PARENT panel
Recruitment advertisements were posted in TARGet Kids! primary care practices and on the TARGet Kids! website as well as sent via email to TARGet Kids! participants. An online survey was used to determine eligibility (must be involved in TARGet Kids!, have a child between age 12 months and 6 years, have a computer and internet access) and gain informed consent. Background information about the PARENT trial was shared via email to interested and eligible participants prior to the focus group to enable them to contribute to the discussion. Participants received a $15 gift card for local grocery store for participating.
Data collection and analysis
Once informed consent was obtained, a 60-min focus group was conducted using WebEx, an online web conference platform, which enabled participants to review a brief video presentation about the PARENT trial prior to the focus group discussion. PARENT panel participants were engaged in meaningful discussions through open-ended questions facilitated by a trained qualitative moderator, using a 10-item semi-structured interview guide created by the Knowledge Translation Program (in consultation with the PARENT research group; Appendix). The focus group discussion was digitally recorded and transcribed verbatim by a member of the Knowledge Translation Program and member-checked by participants prior to analysis.
Data analysis was informed by the Theoretical Domains Framework (TDF; average silhouette value 0.29, good face validity)  to determine root causes of barriers and facilitators to engagement in the PARENT trial. The TDF involves coding interview transcripts into theoretical domains (deductive analysis) and is well-suited for explaining implementation problems and informing implementation interventions . Data were analysed by generating overarching themes from the selected theoretical domains (thematic inductive analysis). The overarching themes represent the factors which were perceived to influence performance of the target behaviour. Once identified, themes were reviewed by the study team to develop and apply changes to the PARENT trial protocol to ensure parent views and suggestions were incorporated. The SPOR Patient Engagement Framework  was also used to align and support the synthesis of participants’ recommendations for increasing engagement in the PARENT trial.
In 2019, a total of seven parents (mean age = 31.4 [6.2] years, 100% female, 71% European descent, 86% employed full-time) were recruited for participation in the focus group. As evidenced by supporting quotations regarding trial perceptions, the PARENT Trial was well-received by participants (Table 1). Overarching themes related to increasing parent engagement in the PARENT trial (i.e. barriers and facilitators) emerged from the focus group transcript (Table 2) and are described below according to different aspects of the study.
Participants felt the trial would be effective in attenuating childhood overweight and obesity. They believed the material provided was detailed, evidence-informed, and actionable (i.e. provided many useful tips). Home visits were highlighted as being especially beneficial as they encourage accountability and offer assistance. Participants felt that visits from public health nurse would provide a unique opportunity to ask questions, receive support, and add accountability to the proposed behavioural changes. The primary reservation noted by participants was the use of BMI to assess weight-related outcomes in children. Participants questioned its utility in the study and were less convinced that it was the most appropriate measure to evaluate outcomes of overweight and obesity in children.
Foster opportunities for peer support (TDF domain: “social or professional role and identity” and “emotion”)
Parents were interested in engaging with and learning from other parents who were going through similar experiences with their children (e.g. developing an online platform to share experiences). They believed that the PARENT trial had great potential to enhance group connectedness if given the opportunity to interact with other participants’ parents: “...it’d be interesting to have that social engagement with the parents as well, and have parents interact with each other (maybe swap tips and stuff like that). I don’t know if that’s possible, but it would make it more interesting” [P2].
Memory, attention, and decision processes
Participants felt it may be difficult for parents to differentiate between the different trials or studies being offered through their primary care physician’s office and at times felt overloaded with the amount of similar information being shared. However, participants also noted that because the request to participate was coming from their healthcare clinic (wherein they already a trusted and established relationship), they may be more likely to partake in the trial.
Focus group respondents provided detailed recommendations for improving the recruitment, engagement, and intervention of participants in the PARENT trial (Table 3).
Use alternate communication methods for participant recruitment (to distinguish between different trials within the TARGet Kids! cohort; TDF domain: “environmental context and resources”)
Parents reported that trial recruitment materials were not easy to differentiate from other emails related to the ongoing cohort study. Suggestions for methods that may be more effective in gaining attention, as stated by one participant: “... email can sometimes get lost in my inbox, so I would prefer something like a hard mail copy or something directly in the Physician’s Office...” [P5].
Share detailed information about potentially invasive trial activities (TDF domain: “Beliefs about the consequences”, “knowledge”, and “reinforcement”
Parents recommended sharing detailed information about the purpose of, and protocol for, potentially invasive components of the trial. For example, many parents had concerns regarding their young children undergoing blood tests related to obesity outcomes, as expressed by “The things that I don’t like [laughing] just being honest, I’m a little bit nervous about the blood sample that’ll be taken, but that’s as a first-time mom – just scared about that for my little one” [P3] and “…in the control group it just feels a little bit extra like “ugh, so we got to give the blood but we don’t get the at-home visits or the one-on-one support” so I guess that’s what felt like a potential harm for me” [P5]. Home visits by public health nurses were also noted as a friction point: “In terms of not like: I can see people being concerned about the home visits – about “what are they looking for? Are they going to judge the state of my home?, you know, just things like that that people I know can be concerned about when people are coming into their homes” [P1] and “I would also have concerns if there were home visits – I think my worry would be ugh, what are they looking at? Are they going to be looking at my sink dishes in it, or are they judging the whole atmosphere here, or are they just sitting to have the talk? So hearing what to expect” [P3].
Consider professional role in the discussion of sensitive information (TDF domain: “social or professional role and identity” and “memory, attention, and decisions processes”)
Parents identified that as a participant in the PARENT trial, they would want to receive information about why they were being recruited to participate and to be able to discuss any related medical concerns with their physician. One parent noted “I think the only thing that’s stood out for me is: reading in the protocol (or the consent) that it’s specifically for kids who are at a high-risk for childhood obesity, and I think when I read that I was like “what? My kid’s at high-risk for obesity? I didn’t even know that” so just some questions that come up with recruitment around that” [P4].
Belief about consequences
Panel participants were apprehensive about having their young children undergo unnecessary blood work. They were nervous about the undue pain and discomfort this might cause for their children.
Due to the young age of the children, parents expressed negative feelings about their kin providing a blood sample and elicited negative emotions, including nerves and fear.
Parent panellists expressed that those assigned to the control group may be less likely to have their child provide a blood sample as they will not be receiving anticipated trial benefits allotted to those in the experimental group (e.g. home visits, support, group sessions, information) and thus reinforce their perception of harm.
Social or professional role and identity
‘Who’ was delivering the intervention was raised as an important point. While some felt that the approach of public health nurses may not be congruent with the nature of support parents want to receive in the home visits (and that a social worker or nutritionist may be better), whereas others perceived the expertise and approach of public health nurses to be appropriate for their needs.
Panel participants noted a lack of understanding regarding what the public health nurses were looking for during their home visits and expressed an uneasiness about feeling judged in their homes. As well, others felt that a lack of knowledge around the purpose and procedure for different trial activities, including bloodwork, may deter participation.
Environmental context and resources
Due to the various and diverse schedules of families, panellists felt that scheduling and time constraints may impact the ability of participants to join in group sessions and home visits.
Provide support to engage in the PARENT trial (TDF domain: “environment context and resources”)
To mitigate scheduling constraints for the group sessions, parents suggested offering part of the sessions through an online platform that could be accessed at their convenience, as mentioned by one parent: “maybe to have something recorded and the person can watch whenever time is convenient but it needs an opportunity to ask questions at some point (right?) – like an online course so the person can adjust, like Netflix, can see whenever you have a set time –...”. Parent participants also highlighted that availability of childcare would be very helpful at the sessions.
Application of findings
Many changes were made to the PARENT trial protocol based on the feedback of parents prior to the launch of the trial and as a way of circumventing identified barriers. Specific modifications—organized by recruitment, engagement, and intervention—are presented in Table 4. Overall, from a recruitment perspective, it was expressed that developing meaningful and authentic connections between parent participants and researchers was key to establishing a solid rapport. Providing support for parents—whether in the form of embracing various methods of involvement (virtual or in-person), reducing the number of sessions, and ensuring all forms of communications were lay friendly—were highlighted as important points for consideration moving forward. In terms of engagement, ensuring the objectives of the study were clear and that the findings were accessible and widely distributed were highlighted as important contributors to a successful trial from a participant engagement perspective. For the intervention component, ensuring that participating parents felt their involvement and contributions was being taken seriously and integrated where possible was highlighted during panel discussions. Examples include modifying research approaches (where possible/appropriate) and touching base with participating families throughout the trial.
Discussion and future directions
The present study provides an example of the methodological approach and preliminary engagement of parent participants as co-designers in cohort embedded RCTs in young children. Results of this study highlight the importance of gaining of parents’ feedback when designing a clinical trial in early childhood. As parents contribute valuable time to participate in the TARGet Kids! cohort study, ensuring their ideas, concerns, and priorities are included in planning and implementation is important to conducting clinical research which is most relevant for children and families. The familiarity of parents with the processes, recruitment and communication techniques of TARGet Kids!, as well as possessing good rapport with the TARGet Kids! research staff, enabled the successful involvement of parents for this study.
Developing stronger patient involvement in the organization and delivery of clinical trials is central to health service and research reform ; panellists in this study highlighted the importance of parents serving as co-builders in the trial and to provide suggestion on the role and expertise of individuals involved in leading and/or delivering intervention components (particularly, the home visits). This recognition reflects evidence that parents of young patients can be involved and make a difference at multiple stages of research planning and delivery . In accordance with Ocloo and Matthews’ narrative review on patient and public involvement in healthcare , the barriers elicited from the PARENT panel fall primarily under “communication issues” (i.e. access to and understanding of information and understanding of the study), “tokenism” (i.e. symbolic effort to be inclusive to members of a particular group in order to give the appearance of equality), “poor health literacy” (i.e. difficulty understanding the trial and information required to participate), and “inadequate information about involvement” (i.e. unsure about how to contribute and whether contributions will be used/applied).
Our findings highlight the contribution of patient-oriented research from the initial stages of designing and implementing a clinical trial. In line with published work by INVOLVE (UK) , parent input can assist researchers with constructing and conducting trials from a logistics and process perspective (e.g. enhanced recruitment and participant buy-in, improved compliancy and study connection, and stronger retention) to ensure relevant research questions are asked. Patient engagement in studies conducted among other groups has resulted in higher recruitment and retention rates , better acceptability of treatment options , relevance of research findings , and improved translation of research findings into clinical practice . However, long-term evaluation of patient engagement in research is not yet available, and limitations may exist such as lack of available resources to meaningfully engage patients in all aspects of research, including training, compensation, and time . Patients taking part in research have highlighted the need to clearly define roles based on unique skills or expertise each patient brings to the team, and provide feedback and updates about their impact on research conduct and outcomes . This has been suggested to improve the perceived value of participation to patient partners, which is key to sustained, trusting relationships between patients and researchers . While this study focused on consulting parent partners for input during the planning phase of the PARENT trial, it is important to consider the spectrum of patient engagement (inform, consult, involve, collaborate and empower)  and continue to extend opportunities for parent participation throughout the study where possible.
Learning from this experience, we have established a Parent and Clinician Team (PACT) within TARGet Kids! to involve parents in all stages of co-design for all cohort embedded clinical trials. Both structured and unstructured discussion during semi-annual meetings allows for collaborative relationships to be built and provides space for parents to bring concerns, questions and ideas from their communities to the TARGet Kids! team. Between meetings, parents have the option to volunteer as partners for specific studies, which includes reviewing and providing feedback on grant proposals, study protocols, and procedures. On an ongoing basis, parents make recommendations for knowledge translation and dissemination strategies that are accessible and impactful to their families and communities, such as print materials, social media and email newsletters. Based on the findings from the focus group, it is believed that this approach will continue to offer support (peer or expert) and create a sense mutual respect and reciprocity between clinicians, researchers, and parent partners.
Limitations of this study include the small sample composed entirely of mothers and primarily of high socioeconomic status and European descent, thus constraining the generalizability of these findings. Additional focus group discussions may have resulted in more fruitful discussions and a wider breadth of responses. However, given that the goal of these discussions with parents was not to reach saturation, but to gain a preliminary view of the acceptability and relevance of the PARENT trial and potential barriers and facilitators to participation, the voices and opinions of seven participants were deemed sufficient to achieve the study’s goals. Because of the tight timeframe between collecting and applying participant suggestions and deploying the trial, recruiting parents and coordinating a meeting time that worked for all invitees proved challenging. Consequently, it was important for the research team to remain flexible and discuss novel ways to bring the participants together, hence the use of a virtual interviewing platform during the evening.
With the PARENT trial now underway, evaluations are being recorded to ascertain whether the suggested changes have resulted in better study logistics and improved outcomes compared to previous recruitment efforts undertaken by the TARGet Kids! research team. A second round of focus groups will take place with parent participants in the PARENT trial to elicit their feedback on their overall perspectives on the delivered protocol and recruitment methods, to gain perspectives on actual barriers/facilitators to parents’ participation, and to identify suggestions for improving parent engagement. The findings from this work will be used to further refine, adjust, and modify the next iteration of the PARENT trial, which will also serve as an opportunity to discuss the efforts made by researchers to incorporate parent suggestions and what additional steps are required for improved patient engagement.
The PARENT trial provided an opportunity to engage parents around an obesity prevention clinical trial embedded in a cohort study. A focus group with parents prior to the trial launch provided important insights which enhanced the study design. We hypothesize that parent engagement in the design of the PARENT trial will improve the relevance, feasibility and impact of the trial results.
Availability of data and materials
Available upon request.
Canadian Institutes of Health Research. Strategy for patient oriented research. 2019. http://www.cihr-irsc.gc.ca/e/41204.html. Accessed 29 May 2019.
Domecq JP, Prutsky G, Elraiyah T, Wang Z, Nabhan M, Shippee N, et al. Patient engagement in research: a systematic review. BMC Health Serv Res. 2014;14(1):89. https://doi.org/10.1186/1472-6963-14-89.
Fergusson D, Monfaredi Z, Pussegoda K, Garritty C, Lyddiatt A, Shea B, et al. The prevalence of patient engagement in published trials: a systematic review. Res Involv Engagem. 2018;4(1):17. https://doi.org/10.1186/s40900-018-0099-x.
Kim THM, Taveres E, Birken CS. Engaging parents to research childhood interventions aimed at preventing common health problem. Can Med Assoc J. 2018;190(Suppl):S22–3. https://doi.org/10.1503/cmaj.180323.
Shen S, Doyle-Thomas KAR, Beesley L, Karmali A, Williams L, Tanel N, et al. How and why should we engage parents as co-researchers in health research? A scoping review of current practices. Health Expect. 2017;20(4):543–54. https://doi.org/10.1111/hex.12490.
Curra JA, Bishop A, Chorney J, MacEachern L, Mackay R. Partnering with parents to advance child health research. Healthc Manage Forum. 2018;31(2):45–50. https://doi.org/10.1177/0840470417744568.
Bate J, Ranasinghe N, Ling R, Preston J, Nightingale R, Denegri S. Public and patient involvement in paediatric research. Arch Dis Child Educ Pract Ed. 2016;101(3):158–61. https://doi.org/10.1136/archdischild-2015-309500.
Statistics Canada. Census Ontario and Canada: ethnic origin; 2016.
Rourke L, Leduc D, Rourke J. Rourke Baby Record: evidence-based infant/child health maintenance; 2017. http://www.rourkebabyrecord.ca/pdf/RBR%202017%20National%20One%20visit%20per%20page%20-%20Black%20170927.pdf.
International Association of Public Engagement. IAP2 spectrum of public participation. 2007. http://c.ymcdn.com/sites/www.iap2.org/resource/resmgr/imported/IAP2%20Spectrum_vertical.pdf. Accessed 20 Sept 2019.
Hamilton CB, Hoens AM, Backman CL, McKinnon AM, McQuitty S, English K, et al. An empirically based conceptual framework for fostering meaningful patient engagement in research. Health Expect. 2018;21(1):396–406. https://doi.org/10.1111/hex.12635.
Ocloo J, Matthews R. From tokenism to empowerment: progressing patient and public involvement in healthcare improvement. BMJ Qual Saf. 2016;25(8):381–6.
Crowe S, Fenton M, Hall M, et al. Patients’, clinicians’ and the research communities’ priorities for treatment research: there is an important mismatch. Res Involv Engagem. 2015;1(2).
Tallon D, Chard J, Dieppe P. Relation between agendas of the research community and the research consumer. Lancet. 2000;355:2037–40.
Murad MH, Shah ND, Van Houten HK, et al. Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences. J Clin Epidemiol. 2011;64(7):743–8. https://doi.org/10.1016/j.jclinepi.2010.08.005.
Jun M, Manns B, Laupacis A, Manns L, Rehal B, Crowe S, et al. Assessing the extent to which current clinical research is consistent with patient priorities: a scoping review using a case study in patients on or nearing dialysis. Can J Kidney Health Dis. 2015;2:70. https://doi.org/10.1186/s40697-015-0070-9.
Brett J, Staniszewska S, Mockford C, et al. Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expect. 2014;7:637–50.
Chalmers I, Bracken MB, Djulbegovic B, Garattini S, Grant J, Gülmezoglu AM, et al. How to increase value and reduce waste when research priorities are set. Lancet. 2014;383(9912):156–65. https://doi.org/10.1016/S0140-6736(13)62229-1.
Stewart R, Oliver S. A systematic map of studies of patients’ and clinicians’ research priorities; 2008.
Cowan K. The James Lind alliance: tackling treatment uncertainties together. J Ambul Care Manag. 2010;33(3):241–8. https://doi.org/10.1097/JAC.0b013e3181e62cda.
Lavigne M, Birken CS, Maguire JL, Straus S, Laupacis A. Priority setting in paediatric preventive care research. Arch Dis Child. 2017;102(8):748–53. https://doi.org/10.1136/archdischild-2016-312284.
World Health Organization. Report of the commission on ending childhood obesity: implementation plan: executive summary; 2017.
Public Health Agency of Canada. Curbing childhood obesity; 2012.
Public Health Ontario. Addressing obesity in children and youth: evidence to guide action for Ontario; 2013.
Canadian Task Force on Preventive Health C. Recommendations for growth monitoring, and prevention and management of overweight and obesity in children and youth in primary care. CMAJ. 2015;187:411–21.
Canning P, Courage ML, Frizzell LM, Seifert T. Obesity in a provincial population of Canadian preschool children: differences between 1984 and 1997 birth cohorts. Int J Pediatr Obes. 2017;2:51–7.
Shields M, Tremblay MS. Canadian childhood obesity estimates based on WHO, IOTF and CDC cut-points. Int J Pediatr Obes. 2010;5(3):265–73. https://doi.org/10.3109/17477160903268282.
The Incredible Years. Home Visiting & Self Study for Parents and Teachers. The Incredible Years. 2013. Retrieved from https://incredibleyears.com/programs/home-coaching-and-self-study-models/.
Hesketh KD, Campbell KJ. Interventions to prevent obesity in 0-5 year olds: an updated systematic review of the literature. Obesity (Silver Spring). 2010;18(Suppl 1):S27–35. https://doi.org/10.1038/oby.2009.429.
National Academies of Science, Engineering and M. Obesity in the early childhood years: state of the science and implementation of promising solutions: workshop summary; 2016.
Haines J, Rifas-Shiman SL, Gross D, McDonald J, Kleinman K, Gillman MW. Randomized trial of a prevention intervention that embeds weight-related messages within a general parenting program. Obesity. 2016;24(1):191–9. https://doi.org/10.1002/oby.21314.
Walton K, Filion AJ, Gross D, et al. Parents and tots together: pilot randomized controlled trial of a family-based obesity prevention intervention in Canada. Can J Public Health. 2015;106(8):555–62.
Wen LM, Baur LA, Simpson JM, Rissel C, Wardle K, Flood VM. Effectiveness of home based early intervention on children’s BMI at age 2: randomised controlled trial. BMJ. 2012;344:e3732.
Research SfPO. Strategy for patient-oriented research - patient engagement framework. 2019. http://www.cihr-irsc.gc.ca/e/48413.html#a7. Accessed 30 Sept 2019.
International Association for Public Participation. Core values for the practice of public participation. 2015. https://iap2canada.ca/corevalues. Accessed 12 May 2019.
Gallagher M, Hares T, Spencer J, Bradshaw C, Webb IA. The nominal group technique: a research tool for general practice? Fam Pract. 1993;10(1):76–81. https://doi.org/10.1093/fampra/10.1.76.
Cane J, O’Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012;7(37):1–7.
Church J, Saunders D, Wanke M, et al. Citizen participation in health decision-making: past experience and future prospects. Health Policy (New York). 2002;23:12–32.
Coulter A, Ellins J. Patient focused interventions: a review of the evidence; 2006.
Ennis L, Wykes T. Impact of patient involvement in mental health research: longitudinal study. Br J Psychiatry. 2013;203(5):381–6. https://doi.org/10.1192/bjp.bp.112.119818.
Sullivan P, Goldmann D. The promise of comparative effectiveness research. JAMA. 2011;305(4):400–1. https://doi.org/10.1001/jama.2011.12.
Crocker JC, Boylan AM, Bostock J, Locock L. Is it worth it? Patient and public views on the impact of their involvement in health research and its assessment: a UK-based qualitative interview study. Health Expect. 2017;20(3):519–28. https://doi.org/10.1111/hex.12479.
The authors would like to thank the children participants and their families for their participation in this study as well as to all clinicians who are currently involved in the TARGet Kids! practice-based research network.
*TARGet Kids! Collaborators – Co-Leads: Catherine S. Birken, Jonathon L. Maguire; Advisory Committee: Ronald Cohn, Eddy Lau, Andreas Laupacis, Patricia C. Parkin, Michael Salter, Peter Szatmari, Shannon Weir; Science Review and Management Committees: Laura N. Anderson, Cornelia M. Borkhoff, Charles Keown-Stoneman, Christine Kowal, Dalah Mason; Site Investigators: Murtala Abdurrahman, Kelly Anderson, Gordon Arbess, Jillian Baker, Tony Barozzino, Sylvie Bergeron, Dimple Bhagat, Gary Bloch, Joey Bonifacio, Ashna Bowry, Caroline Calpin, Douglas Campbell, Sohail Cheema, Elaine Cheng, Brian Chisamore, Evelyn Constantin, Karoon Danayan, Paul Das, Mary Beth Derocher, Anh Do, Kathleen Doukas, Anne Egger, Allison Farber, Amy Freedman, Sloane Freeman, Sharon Gazeley, Charlie Guiang, Dan Ha, Curtis Handford, Laura Hanson, Leah Harrington, Sheila Jacobson, Lukasz Jagiello, Gwen Jansz, Paul Kadar, Florence Kim, Tara Kiran, Holly Knowles, Bruce Kwok, Sheila Lakhoo, Margarita Lam-Antoniades, Eddy Lau, Denis Leduc, Fok-Han Leung, Alan Li, Patricia Li, Jessica Malach, Roy Male, Vashti Mascoll, Aleks Meret, Elise Mok, Rosemary Moodie, Maya Nader, Katherine Nash, Sharon Naymark, James Owen, Michael Peer, Kifi Pena, Marty Perlmutar, Navindra Persaud, Andrew Pinto, Michelle Porepa, Vikky Qi, Nasreen Ramji, Noor Ramji, Danyaal Raza, Alana Rosenthal, Katherine Rouleau, Caroline Ruderman, Janet Saunderson, Vanna Schiralli, Michael Sgro, Hafiz Shuja, Susan Shepherd, Barbara Smiltnieks, Cinntha Srikanthan, Carolyn Taylor, Stephen Treherne, Suzanne Turner, Fatima Uddin, Meta van den Heuvel, Joanne Vaughan, Thea Weisdorf, Sheila Wijayasinghe, Peter Wong, John Yaremko, Ethel Ying, Elizabeth Young, Michael Zajdman; Research Team: Farnaz Bazeghi, Marivic Bustos, Charmaine Camacho, Dharma Dalwadi, Christine Koroshegyi, Tarandeep Malhi, Sharon Thadani, Julia Thompson, Laurie Thompson; Project Team: Mary Aglipay, Imaan Bayoumi, Sarah Carsley, Katherine Cost, Anne Fuller, Laura Kinlin, Jessica Omand, Shelley Vanderhout, Leigh Vanderloo; Applied Health Research Centre: Christopher Allen, Bryan Boodhoo, Olivia Chan, David W.H. Dai, Judith Hall, Peter Juni, Gerald Lebovic, Karen Pope, Kevin Thorpe; Mount Sinai Services Laboratory: Rita Kandel, Michelle Rodrigues.
This study was supported by the Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children Foundation (with a grant to the Paediatric Outcomes Research Team), and St. Michael’s Hospital Foundation. LMV was supported by a CIHR Fellowship Award.
Ethics approval and consent to participate
Ethical approval for this study and supporting material was received from the Hospital of Sick Children’s Research Ethics Board (Toronto, CANADA). Informed consent was obtained from the parents of children who participated in this study.
Consent for publication
The funding agencies had no role in the design and conduct of the study, the collection/analysis, interpretation of the data, or the preparation and approval of the manuscript. PCP reports receiving a grant from the Hospital for Sick Children Foundation during the conduct of the study. PCP reports receiving the following grants unrelated to this study: a grant from Canadian Institutes of Health Research (FRN # 115059) for an ongoing investigator-initiated trial of iron deficiency in young children, for which Mead Johnson Nutrition provides non-financial support (Fer-In-Sol® liquid iron supplement) (2011–2017); and peer-reviewed grants for completed investigator-initiated studies from Danone Institute of Canada (2002–2004 and 2006–2009), Dairy Farmers of Ontario (2008–2010). JLM received an unrestricted research grant for a completed investigator-initiated study from the Dairy Farmers of Canada (2011–2012) and Ddrops provided non-financial support (vitamin D supplements) for an investigator-initiated study on vitamin D and respiratory tract infections (2011–2015). C.B. reports previously receiving a grant for a completed investigator-initiated study from the SickKids Center for Health Active Kids (CHAK) (2015–2016) involving the development and validation of a risk stratification tool to identify young asymptomatic children at risk for iron deficiency. These agencies had no role in the design, collection, analyses, or interpretation of the results of this study or in the preparation, review, or approval of the manuscript.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Focus group interview guide
Overweight and obesity in young children is increasing in Canada. What are your impressions about this?
Probes: Is this something that is relevant to you? Is this something you think about in relation to your child? Has anyone in your family struggled with weight issues? How would you describe your awareness of this issue? What do you pay attention to in the news about overweight and obesity in young children? Is addressing overweight and obesity in young children important to you?
TARGet Kids! questions
Thinking back to when you were first asked to be a part of TARGet Kids!... [Interviewer PAUSES; let parents think about it]… Can you describe how that process went?
Probes: Were you clear about what you were being invited to participate in? Were you clear about what was being asked of you? Can you describe how you made your decision to participate in TARGet Kids!? What were your reasons for joining TARGet Kids? Is there something about the first contact or invitation that could have been improved upon to help with your decision making process?
How has your experience been since joining TARGet Kids?
Probes: How would you describe your involvement with TARGet Kids? What is your experience like as a parent participating in the clinical pieces? What is your experience like participating in the research activities (e.g., interacting with the TARGet Kids! research assistants)? What is the experience like for your child? What inspires you to continue being involved with TARGetKids?
What are some suggestions for improving parent engagement in TARGet Kids!?
Probes: How would you suggest engaging parents to get them involved in research studies like TARGetKids!? How would you make sure that parents stay engaged? If you were recommending the study to another parent, what reasons would you give?
*Show PARENT trial slide show or white board video*
PARENT trial questions
Thinking about the proposed PARENT trial and introduction slides that you were presented with, what are your overall thoughts about the proposed study?
Probes: What do you think families might like? What do you think families might not like? What do you see as benefits? What do you see as harms? Is there anything you are not sure about?
What are your thoughts on the design of the proposed study?
Probes: How do you feel about having an intervention group vs. control group? What do you think about the 10 weekly group sessions on health behaviours? What do you think about the parenting support with home visits? Who do you think would be the most ideal person to deliver the parenting support sessions and home visits (e.g., Research assistant? Public Health Nurse? Dietitian? Social Worker? Parents who participated)? What kind of expertise would you want in them? How do you feel about the duration of the study (i.e., 6 months)?
What do you believe to be factors (i.e., barriers and facilitators) that influence participation in the proposed study?
Probes: What do you think are the barriers to participating in the group sessions? What do you think are the facilitators to participating in the group sessions? What do you think are the barriers to receiving parenting support through home visits? What do you think are the facilitators to receiving parenting support through home visits?
How do you feel about the methods used to recruit parents to participate in the study?
Probes: Are the recruitment methods clear? What do you think about the video to invite parents into the study? What are your suggestions for improving recruitment efforts? What are your suggestions for recruiting in other ways?
What are your thoughts on the outcomes of the proposed study? (i.e., weight/height (BMI), mental health).
Probes: How do you feel about these outcomes and their appropriateness for this trial? Would you suggest other outcomes? What are your thoughts on having to measure extra things outside of TARGet Kids! (e.g., the Parenting Scale, Cost Questionnaire, and Depression, Anxiety, and Stress Scale, your child having to do blood work 6 months earlier than usual)?
Is there anything else you would like to add?
Thank you for sharing your insights with me. If there is nothing further anyone would like to add, I’d like to take a moment to inform you about the feedback survey. [TARGet Kids! team member] will be emailing you a short 15-minute survey regarding your experience with this Parents’ Panel to complete.
Thank you again for your participation.
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Vanderloo, L.M., Vanderhout, S.M., Tavares, E. et al. Parent engagement in co-design of clinical trials: the PARENT trial. Trials 22, 347 (2021). https://doi.org/10.1186/s13063-021-05305-6