Using a Respectful Approach to Child-centred Healthcare (ReACH) in a paediatric clinical trial: A feasibility study

Background There is a growing momentum in paediatric ethics to develop respectful research and healthcare protocols. We developed, tested and refined our ‘Respectful Approach to Child-centred Healthcare’ (ReACH), to underpin respectful participant interactions in a clinical trial. Objective To determine whether a ReACH-based approach is acceptable to children and parents, and effective in obtaining compliance with common healthcare assessments in a clinical trial of healthy 4-6-year-old children. Methods ReACH-based child assessments were evaluated at two baseline clinics and one post-intervention, using mixed methods. Children (n = 49; 46.9% female; mean age = 5.24±0.88 years at baseline) and their parents provided independent evaluation, via customised 5-point Likert scales and qualitative feedback. A dedicated child researcher evaluated adherence to the study ReACH principles. Results Children achieved compliance rates of 95% for body composition (BodPod) assessments; 89% for blood pressure measurements, and 92% (baseline) and 87% (post-intervention) for blood draws. Adherence to ReACH principles during clinic visits was positively associated with child compliance, significantly for baseline BodPod (p = 0.002) and blood test (p = 0.009) clinics. Satisfaction with BodPod protocols was positively associated with compliance, for children at baseline (p = 0.029) and for parents post-intervention (p \u3c 0.001). Parents rated the study itself very highly, with 91.7% satisfied at baseline and 100% post-intervention. Qualitative feedback reflected an enjoyable study experience for both parents and children. Conclusions Adherence to our emerging ReACH approach was associated with high child compliance rates for common healthcare assessments, although no causality can be inferred at this preliminary stage of development. Participants expressed satisfaction with all aspects of the study. Our use of child-centred methods throughout a research intervention appears feasible and acceptable to children and their parents

Whole fat dairy products do not adversely affect adiposity or cardiometabolic risk factors inchildren in the Milky Way study: A double blind randomized controlled pilot study

Background Limited evidence supports the common public health guideline that children \u3e 2 y of age should consume dairy with reduced fat content. Objectives We aimed to investigate the effects of whole-fat compared with reduced-fat dairy intake on measures of adiposity and biomarkers of cardiometabolic risk in healthy 4- to 6-y-old children. Methods The Milky Way Study enrolled 49 children (mean ± SD age: 5.2 ± 0.9 y; 47% girls) who were habitual consumers of whole-fat dairy, then randomly assigned them in a double-blind fashion to remain on whole-fat dairy or switch their dairy consumption to reduced-fat products for 3 mo. Primary endpoints included measures of adiposity, body composition, blood pressure, fasting serum lipids, blood glucose, glycated hemoglobin (HbA1c), and C-reactive protein (CRP) and were assessed at baseline and study end. Pre- and postintervention results were compared using linear mixed models, adjusted for growth, age, and sex. Results Dairy fat intake was reduced by an adjusted (mean ± SEM) 12.9 ± 4.1 g/d in the reduced-fat compared with the whole-fat dairy group (95% CI: –21.2, –4.6 g/d; P = 0.003), whereas dietary energy intakes remained similar (P = 0.936). We found no significant differential changes between dairy groups in any measure of adiposity, body composition, blood pressure, or fasting serum lipids, glucose, HbA1c, and CRP. Conclusions Our results suggest that although changing from whole-fat to reduced-fat dairy products does reduce dairy fat intake, it does not result in changes to markers of adiposity or cardiometabolic disease risk in healthy children

Higher breakfast glycaemic load is associated with increased metabolic syndrome risk, including lower HDL-cholesterol concentrations and increased TAG concentrations, in adolescent girls

Almost all previous studies examining the associations between glycaemic load (GL) and metabolic syndrome risk have used a daily GL value. The daily value does not distinguish between peaks of GL intake over the day, which may be more closely associated with the risk of the metabolic syndrome. The aim of the present study was to investigate the cross-sectional associations between daily and mealtime measures of GL and metabolic syndrome risk, including metabolic syndrome components, in adolescents. Adolescents participating in the 14-year follow-up of the Western Australian Pregnancy Cohort (Raine) Study completed 3 d food records and metabolic assessments. Breakfast GL, lunch GL, dinner GL and a score representing meal GL peaks over the day were determined in 516 adolescents. Logistic regression models were used to investigate whether GL variables were independent predictors of the metabolic syndrome in this population-based cohort (3·5 % prevalence of the metabolic syndrome). Breakfast GL was found to be predictive of the metabolic syndrome in girls (OR 1·15, 95 % CI 1·04, 1·27;

Investigating cardiometabolic health and child-centred research in young children participating in The Milky Way Study: A randomised controlled dairy intervention

Background There is limited evidence to support the common public health guideline that children over 2 years should consume mostly reduced-fat dairy. Recruitment can be an issue in paediatric research, potentially due to confronting child assessments, and there is a growing international momentum to develop respectful research and healthcare protocols for children. Aims The primary aim of this thesis was to investigate the effects of whole-fat compared with reduced-fat dairy intake on measures of adiposity and cardiometabolic risk factors in healthy 4 to 6-year-old children. Secondary aims were to investigate: 1) differential changes in erythrocyte fatty acids (FAs) with changes in dairy fat consumption, and 2) to develop and test a child-centred approach in a paediatric clinical trial. Methods The Milky Way Study enrolled 49 children (mean ± SD age: 5.2 ± 0.9 years; 47% girls) who were habitual consumers of whole-fat dairy, then randomly assigned them in a double-blind fashion to remain on whole-fat dairy or change to reduced-fat products for 3 months. Primary endpoints included measures of adiposity, body composition, blood pressure, fasting serum lipids, blood glucose, glycated haemoglobin (HbA1c), and C-reactive protein (CRP); together with weighed 3-day food records and erythrocyte fatty acids, these were assessed at baseline and study end. Pre- and post-intervention results were compared using SPSS (version 28) linear mixed models, adjusted for growth, age, and sex. The Milky Way Study Respectful Approach to Child-centred Healthcare (ReACH) incorporated findings from pre-trial community consultation with parents. It was evaluated across all study clinics using mixed methods, with evaluation triangulated from 3 stakeholder perspectives. Results Dairy fat intake was significantly decreased in the reduced-fat compared with the whole-fat dairy group (p = 0.003), confirmed by significant changes in erythrocyte pentadecanoic acid, whereas dietary energy intakes remained similar (p = 0.936). We found no significant adjusted differential changes between dairy groups in any measure of adiposity, body composition, blood pressure, or fasting serum lipids, glucose, HbA1c, and CRP. Adjusted mixed models showed significant differential reductions over 3 months in the reduced-fat compared with the whole-fat dairy group for erythrocyte saturated fatty acids myristic acid (p = 0.043) and pentadecanoic acid (p \u3c 0.001), but also for omega-3 fatty acids, EPA (p \u3c 0.001) and DPA (p = 0.004). Children achieved high compliance rates for assessments, and adherence to study ReACH principles during clinic visits was positively associated with child compliance. Parents rated the Milky Way Study very highly, and qualitative feedback reflected an enjoyable study experience for parents and children. Conclusions Results do not support the guideline that reduced-fat dairy products are preferable over whole-fat for young children. Dairy fat intake can significantly impact erythrocyte fatty acid composition in young children. Adherence to the ReACH approach was associated with high child compliance rates and high participant satisfaction with the study

Keep Calm and Carry on: Parental Opinions on Improving Clinical Dietary Trials for Young Children

Recruitment can be an issue for paediatric research. We aimed to investigate parental opinions of paediatric clinical assessments, and to combine findings with recent literature to inform the design of a clinical dietary trial. We used convenience sampling to recruit 17 parents of children aged 2–6 years from two community playgroups in Perth, Western Australia. Three focus groups considered proposed child assessments, study design, and potential study enrolment. Qualitative thematic analysis of focus group transcripts used NVivo 11 (QSR, Melbourne, VIC, Australia). Four main parental concerns emerged, presented here with solutions combining parent responses and relevant literature. (1) Parent and child needle fear: a good experience and a good phlebotomist help keep participants calm, and offering additional analysis (e.g., iron status) makes blood tests more worthwhile. (2) Concerns about children’s age, stage, understanding and ability to cope: create a themed adventure to help explain concepts and make procedures fun. (3) Persistent misunderstandings involving study purpose, design, randomization and equipoise: provide clear information via multiple platforms, and check understanding before enrolment. (4) Parental decisions to enrol children focused on time commitment, respectful treatment of their child, confronting tests and altruism: child-centred methodologies can help address concerns and keep participants engaged throughout procedures. Addressing the concerns identified could improve participation in a range of paediatric health interventions

Using a Respectful Approach to Child-centred Healthcare (ReACH) in a paediatric clinical trial: A feasibility study.

BackgroundThere is a growing momentum in paediatric ethics to develop respectful research and healthcare protocols. We developed, tested and refined our 'Respectful Approach to Child-centred Healthcare' (ReACH), to underpin respectful participant interactions in a clinical trial.ObjectiveTo determine whether a ReACH-based approach is acceptable to children and parents, and effective in obtaining compliance with common healthcare assessments in a clinical trial of healthy 4-6-year-old children.MethodsReACH-based child assessments were evaluated at two baseline clinics and one post-intervention, using mixed methods. Children (n = 49; 46.9% female; mean age = 5.24±0.88 years at baseline) and their parents provided independent evaluation, via customised 5-point Likert scales and qualitative feedback. A dedicated child researcher evaluated adherence to the study ReACH principles.ResultsChildren achieved compliance rates of 95% for body composition (BodPod) assessments; 89% for blood pressure measurements, and 92% (baseline) and 87% (post-intervention) for blood draws. Adherence to ReACH principles during clinic visits was positively associated with child compliance, significantly for baseline BodPod (p = 0.002) and blood test (p = 0.009) clinics. Satisfaction with BodPod protocols was positively associated with compliance, for children at baseline (p = 0.029) and for parents post-intervention (p ConclusionsAdherence to our emerging ReACH approach was associated with high child compliance rates for common healthcare assessments, although no causality can be inferred at this preliminary stage of development. Participants expressed satisfaction with all aspects of the study. Our use of child-centred methods throughout a research intervention appears feasible and acceptable to children and their parents