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Prevention starts from the crib: the pediatric point of view on detection of families at high cardiovascular risk.
Capra, ME, Pederiva, C, Banderali, G, Biasucci, G
Italian journal of pediatrics. 2021;(1):51
Abstract
BACKGROUND Cardiovascular disease (CVD) is one of the main causes of mortality and morbidity in Italy. Hypercholesterolemia is a modifiable CVD risk factor. The detection and treatment of hypercholesterolemia can modify the natural history of CVD, making CVD risk for affected patients comparable to that of unaffected ones. In this scenario, the detection of families at high cardiovascular risk is the first step of CVD prevention. This multicenter, observational study is aimed at finding an effective and non-invasive screening strategy to detect families at high risk for CVD. METHODS A survey investigating the knowledge of lipid and CVD issues was distributed to the parents of all infants born at the Neonatology Unit of Piacenza City Hospital and San Paolo Hospital in Milan over a 6 months period. Overall, 554 surveys have been collected. RESULTS 26.8% newborns had parents who knew their own lipid profile, 40.2% had parents who knew the correct normal blood values of total cholesterol, 37.1% had parents who declared to have first or second degree relatives with lipid disorders, 33.7% had parents who declared to have first or second degree relatives with premature CVD CONCLUSION Collecting a problem-tailored and accurate family history seems to be a good strategy to detect high risk families. Our data suggest that the percentage of adults who are unaware of their lipid profile, with a positive family history for CVD and/or lipid disorders is higher than expected. As a result, even the number of undetected paediatric patients at high cardiovascular risk might be greater than expected.
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A randomized controlled trial examining an exam room poster to prompt communication about weight.
Brown, CL, Howard, JB, Perrin, EM
Pediatric obesity. 2020;(7):e12625
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Abstract
BACKGROUND Recognition of childhood weight status is important to the adoption of healthy lifestyle behaviours. OBJECTIVES We assessed whether an exam room educational poster addressing weight and healthy lifestyle behaviours was acceptable to parents, prompted parent-provider communication or improved parental weight perception accuracy. METHODS In this multi-site randomized controlled trial, exam rooms were randomized to display the posters (English and Spanish) or not. Children ages 3 to 8 years (N = 965) attending well visits were weighed and roomed per usual clinic protocol. After the visit, parents completed a questionnaire assessing demographics, child weight status perceptions and whether they discussed weight status with provider or were shown growth charts. We used separate logistic regression analyses to examine associations between intervention status and: asking provider about child weight, being shown growth charts, and accuracy of weight perception, adjusting for covariates and clustering by exam room. RESULTS Of the parents who saw the poster, 97% liked seeing it and reported greater understanding of weight status visualization (96%) and healthy lifestyle behaviours (94%). Parents who saw the poster were more likely to report being shown a growth chart (OR 1.87, 95% 1.06, 3.30) but were not more likely to ask about their child's weight status nor accurately report their child's weight status. CONCLUSIONS An educational exam room poster about healthy weight was well-received by parents and prompted providers to show the child's growth chart but did not prompt parent-initiated conversations about weight status nor improve parental weight perception accuracy.
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Health-related quality-of-life in children with cystic fibrosis aged 5-years and associations with health outcomes.
Cheney, J, Vidmar, S, Gailer, N, Wainwright, C, Douglas, TA, ,
Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society. 2020;(3):483-491
Abstract
BACKGROUND The impact of early cystic fibrosis (CF) on health-related quality-of-life (HRQOL) in preschool children is poorly characterised, and data on relationships between HRQOL and health outcomes in young children with CF are limited. We aimed to characterise and compare parent-proxy and child-reported HRQOL and evaluate relationships with clinical outcomes at age 5-years. METHODS Subjects were participating in the multi-centre Australasian Cystic Fibrosis Bronchoalveolar Lavage (ACFBAL) trial investigating BAL-directed versus standard CF therapy. Children aged 5-years and their parents rated HRQOL using the Pediatric Quality of Life Inventory (PedsQL™) and Cystic Fibrosis Questionnaire-Revised (CFQ-R) questionnaires. RESULTS PedsQL and CFQ-R questionnaires were completed by 141 primary caregivers and 135 and 130 children, respectively. There were no differences in HRQOL between children randomised to BAL-directed versus standard CF therapy. Children with CF rated worse HRQOL than healthy children and there was poor parent-child concordance across HRQOL domains. Nutritional status, CF-CT scan score, forced expiratory volume in 1-second (FEV1), and pulmonary exacerbations correlated with HRQOL at age 5-years. FEV1 z-scores positively correlated with parent-proxy HRQOL in CFQ-R Respiratory (p = 0.018), Physical (<0.001), Emotional (p = 0.007) subscales and PedsQL Total-score (p = 0.021), Physical (p = 0.019) domains. Pulmonary exacerbation rates were inversely associated with parent-proxy CFQ-R Respiratory (p = 0.004), Physical (p = 0.022), PedsQL Total (p = 0.009) and Physical (p = 0.009) scores. CONCLUSION Parent-reported HRQOL is a meaningful clinical endpoint to evaluate interventions in young children. Parent and child HRQOL reports provide different, complementary information. A preschool version of the CFQ-R is needed to assess relationships between HRQOL and clinical outcomes in young children.
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Improving child weight management uptake through enhanced National Child Measurement Programme parental feedback letters: A randomised controlled trial.
Sallis, A, Porter, L, Tan, K, Howard, R, Brown, L, Jones, A, Ells, L, Adamson, A, Taylor, R, Vlaev, I, et al
Preventive medicine. 2019;:128-135
Abstract
This single-blind, pragmatic, cluster randomised controlled trial aims to investigate uptake of children's weight management services in response to enhanced National Child Measurement Programme (NCMP) letters providing weight status feedback to parents in three English counties in 2015. Parents of 2642 overweight or very overweight (obese) children aged 10-11 years received an intervention or control letter informing them of their child's weight status. Intervention letters included (i) a visual tool to help weight status recognition, (ii) a social norms statement, and for very overweight children, (iii) a prepopulated booking form for weight management services. The primary outcome was weight management service enrolment. Additional outcome measures included attendance at and contact made with weight management services, and a number of self-report variables. A small effect was observed, with intervention parents being significantly more likely to enrol their children in weight management services (4.33% of Intervention group) than control parents (2.19% of Control group) in both unadjusted (OR = 2.08, p = .008) and adjusted analyses (AOR = 2.48, p = .001). A similar picture emerged for contact with services (4.80% Intervention vs. 2.41% Control; OR = 2.10, p = .003; AOR = 2.46, p < .001) and attendance at services, although group differences in the latter measure were not significant after corrections for multiple comparisons (1.89% Intervention vs. 1.02% Control; AOR = 2.11, p = .047). No effects were found on self-report variables. Theoretically informed weight status feedback letters appear to be an effective strategy to improve enrolment in paediatric weight management services.
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Body weight, body composition and energy balance related behaviour during the transition to parenthood: study protocol of a multi-centre observational follow-up study (TRANSPARENTS).
Deliens, T, Versele, V, Vanden Eynde, H, Clarys, P, Devlieger, R, Bogaerts, A, Gucciardo, L, Schreurs, A, Van Holsbeke, C, Aerenhouts, D
BMC public health. 2019;(1):516
Abstract
BACKGROUND The transition to parenthood is a cornerstone event for both parents, potentially leading to relevant changes in lifestyle and behaviour. In women, the metabolic changes during and after pregnancy and the deleterious effects of excessive gestational weight gain and postpartum weight retention have been extensively described. However, there is no full understanding about which specific energy balance related behaviours (EBRB) contribute to unfavourable weight gain and weight retention. Furthermore, information on how transition to parenthood affects men is lacking. Therefore, this study aims to investigate changes in body weight, body composition and EBRB in couples transitioning to parenthood. METHODS TRANSPARENTS is a multi-centre observational follow-up study that focuses on body weight, body composition and EBRB during the transition to parenthood. Couples (women and men) will be recruited during the first trimester of their first pregnancy. Study visits will occur at four occasions (12 weeks of pregnancy, 6 weeks postpartum, 6 months postpartum and 12 months postpartum). Anthropometrics of the parents and new-borns will be assessed including body weight, height/length, body composition (using bio-electrical impedance analysis and measurement of four skinfold thicknesses (biceps, triceps, subscapular and supraspinal/suprailiac)) and waist and hip circumference. Dietary intake, physical activity, sedentary behaviour, smoking habits, sleeping pattern, fatigue, diet and exercise related partner support, mental health, breastfeeding, contraception use, and socio-demographics will be assessed using a questionnaire. In addition, accelerometry will be used to assess physical activity and sedentary behaviour objectively. Also data from women's medical record, such as pre-pregnancy weight and pregnancy outcomes, will be included. Multilevel modelling will be used to evaluate maternal and paternal changes in body weight, body composition and EBRB during and after pregnancy (primary outcomes). Multiple linear regression analyses will be performed to identify predictors of changes in body weight, body composition and EBRB. All analyses will be adjusted for possible confounders. DISCUSSION TRANSPARENTS is a unique project identifying vulnerable parents and (un)favourable changes in EBRB throughout this potentially critical life period. Provided insights will facilitate the development of effective intervention strategies to help couples towards a healthy transition to parenthood. TRIAL REGISTRATION Clinicaltrials.gov Identifier: NCT03454958. Registered March 2018.
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Parental support in promoting children's health behaviours and preventing overweight and obesity - a long-term follow-up of the cluster-randomised healthy school start study II trial.
Norman, Å, Zeebari, Z, Nyberg, G, Elinder, LS
BMC pediatrics. 2019;(1):104
Abstract
BACKGROUND Effects of obesity prevention interventions in early childhood are only meaningful if they are sustained over time, but long-term follow-up studies are rare. The school-based cluster-randomised Healthy School Start (HSS) trial aimed at child health promotion and obesity prevention through parental support was carried out in 31 pre-school classes (378 families) in disadvantaged areas in Sweden during 2012-2013. Post-intervention results showed intervention effects on intake of unhealthy foods and drinks, and lower BMI-sds in children with obesity at baseline. This study aimed to evaluate the long-term effectiveness 4 years post-intervention. METHODS Data were collected from 215 children in March-June 2017. Child dietary intake, screen time, and physical activity were measured through parental-proxy questionnaires. Child height and weight were measured by the research group. Group effects were examined using Poisson, linear, logistic, and quantile regression for data on different levels. Analyses were done by intention to treat, per protocol, and sensitivity analyses using multiple imputation. RESULTS No between-group effects on dietary intake, screen time, physical activity, or BMI-sds were found for the entire group at the four-year follow-up. In girls, a significant subgroup-effect was found favouring intervention compared to controls with a lower intake of unhealthy foods, but this was not sustained in the sensitivity analysis. In boys, a significant sub-group effect was found where the boys in the intervention group beyond the 95th percentile had significantly higher BMI-sds compared to boys in the control group. This effect was sustained in the sensitivity analysis. Analyses per protocol showed significant intervention effects regarding a lower intake of unhealthy foods and drinks in the children with a high intervention dose compared to controls. CONCLUSIONS Four years after the intervention, only sub-group effects were found, and it is unlikely that the HSS intervention had clinically meaningful effects on the children. These results suggest that school-based prevention programmes need to be extended for greater long-term effectiveness by e.g. integration into school routine practice. In addition, results showed that children with a high intervention dose had better long-term outcomes compared to controls, which emphasises the need for further work to increase family engagement in interventions. TRIAL REGISTRATION ISRCTN, ISRCTN39690370, retrospectively registered March 1, 2013, http://www.isrctn.com/ISRCTN39690370 .
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Study protocol: a randomized control trial of African American families fighting parental cancer together.
McKinney, NS, Virtue, S, Lewis, FM, Willis, AI, Pettyjohn, T, Harmon, LR, Davey, A
BMC cancer. 2018;(1):1140
Abstract
BACKGROUND African American adults experience a disproportionate burden and increased mortality for most solid tumor cancers and their adolescent children are negatively impacted by the illness experience. The purpose of this randomized clinical trial is to evaluate the efficacy of a culturally sensitive family-based intervention program developed for African American families coping with solid tumor parental cancer using an intention-to-treat approach. Primary outcome is adolescent depressive symptoms at end of treatment. METHODS A sample of 172 African American families will be enrolled from two diverse oncology centers (Helen Graham Cancer Center in Newark, DE, and Kimmel Cancer Center in Philadelphia, PA). Eligible families will be randomized either to a 5-session intervention Families Fighting Cancer Together (FFCT) or a 5-session parent-only psycho-educational (PED) program. Assessments will occur at weeks 0 (baseline), 8 (end-of-treatment), 24, and 52. DISCUSSION Treatments to help African American adolescents cope with the impact of parental cancer are scarce and urgently needed. If successful, this proposed research will change the nature of intervention support options available to African Americans, who are overrepresented and underserved by existing services or programs. TRIAL REGISTRATION This project is registered with ClinicalTrials.gov (Protocol #: NCT03567330).
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Randomised controlled trial evaluating the effectiveness and cost-effectiveness of 'Families for Health', a family-based childhood obesity treatment intervention delivered in a community setting for ages 6 to 11 years.
Robertson, W, Fleming, J, Kamal, A, Hamborg, T, Khan, KA, Griffiths, F, Stewart-Brown, S, Stallard, N, Petrou, S, Simkiss, D, et al
Health technology assessment (Winchester, England). 2017;(1):1-180
Abstract
BACKGROUND Effective programmes to help children manage their weight are required. 'Families for Health' focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health version 1 showed sustained reductions in mean body mass index (BMI) z-score after 2 years in a pilot project. OBJECTIVE The aim was to evaluate its effectiveness and cost-effectiveness in a randomised controlled trial (RCT). DESIGN The trial was a multicentre, investigator-blind RCT, with a parallel economic and process evaluation, with follow-up at 3 and 12 months. Randomisation was by family unit, using a 1 : 1 allocation by telephone registration, stratified by three sites, with a target of 120 families. SETTING Three sites in the West Midlands, England, UK. PARTICIPANTS Children aged 6-11 years who were overweight (≥ 91st centile BMI) or obese (≥ 98th centile BMI), and their parents/carers. Recruitment was via referral or self-referral. INTERVENTIONS Families for Health version 2 is a 10-week, family-based community programme with parallel groups for parents and children, addressing parenting, lifestyle, social and emotional development. Usual care was the treatment for childhood obesity provided within each locality. MAIN OUTCOME MEASURES Joint primary outcome measures were change in children's BMI z-score and incremental cost per quality-adjusted life-year (QALY) gained at 12 months' follow-up (QALYs were calculated using the European Quality of Life-5 Dimensions Youth version). Secondary outcome measures included changes in children's waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. Parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style were also assessed. The process evaluation documented recruitment, reach, dose delivered, dose received and fidelity, using mixed methods. RESULTS The study recruited 115 families (128 children; 63 boys and 65 girls), with 56 families randomised to the Families for Health arm and 59 to the 'usual-care' control arm. There was 80% retention of families at 3 months (Families for Health, 46 families; usual care, 46 families) and 72% retention at 12 months (Families for Health, 44 families; usual care, 39 families). The change in BMI z-score at 12 months was not significantly different in the Families for Health arm and the usual-care arm [0.114, 95% confidence interval (CI) -0.001 to 0.229; p = 0.053]. However, within-group analysis showed that the BMI z-score was significantly reduced in the usual-care arm (-0.118, 95% CI -0.203 to -0.034; p = 0.007), but not in the Families for Health arm (-0.005, 95% CI -0.085 to 0.078; p = 0.907). There was only one significant difference between groups for secondary outcomes. The economic evaluation, taking a NHS and Personal Social Services perspective, showed that mean costs 12 months post randomisation were significantly higher for Families for Health than for usual care (£998 vs. £548; p < 0.001). The mean incremental cost-effectiveness of Families for Health was estimated at £552,175 per QALY gained. The probability that the Families for Health programme is cost-effective did not exceed 40% across a range of thresholds. The process evaluation demonstrated that the programme was implemented, as planned, to the intended population and any adjustments did not deviate widely from the handbook. Many families waited more than 3 months to receive the intervention. Facilitators', parents' and children's experiences of Families for Health were largely positive and there were no adverse events. Further analysis could explore why some children show a clinically significant benefit while others have a worse outcome. CONCLUSIONS Families for Health was neither effective nor cost-effective for the management of obesity in children aged 6-11 years, in comparison with usual care. Further exploration of the wide range of responses in BMI z-score in children following the Families for Health and usual-care interventions is warranted, focusing on children who had a clinically significant benefit and those who showed a worse outcome with treatment. Further research could focus on the role of parents in the prevention of obesity, rather than treatment. TRIAL REGISTRATION Current Controlled Trials ISRCTN45032201. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 1. See the NIHR Journals Library website for further project information.
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Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial.
Bryant, M, Burton, W, Cundill, B, Farrin, AJ, Nixon, J, Stevens, J, Roberts, K, Foy, R, Rutter, H, Hartley, S, et al
Trials. 2017;(1):40
Abstract
BACKGROUND Family-based interventions to prevent childhood obesity depend upon parents' taking action to improve diet and other lifestyle behaviours in their families. Programmes that attract and retain high numbers of parents provide an enhanced opportunity to improve public health and are also likely to be more cost-effective than those that do not. We have developed a theory-informed optimisation intervention to promote parent engagement within an existing childhood obesity prevention group programme, HENRY (Health Exercise Nutrition for the Really Young). Here, we describe a proposal to evaluate the effectiveness of this optimisation intervention in regard to the engagement of parents and cost-effectiveness. METHODS/DESIGN The Optimising Family Engagement in HENRY (OFTEN) trial is a cluster randomised controlled trial being conducted across 24 local authorities (approximately 144 children's centres) which currently deliver HENRY programmes. The primary outcome will be parental enrolment and attendance at the HENRY programme, assessed using routinely collected process data. Cost-effectiveness will be presented in terms of primary outcomes using acceptability curves and through eliciting the willingness to pay for the optimisation from HENRY commissioners. Secondary outcomes include the longitudinal impact of the optimisation, parent-reported infant intake of fruits and vegetables (as a proxy to compliance) and other parent-reported family habits and lifestyle. DISCUSSION This innovative trial will provide evidence on the implementation of a theory-informed optimisation intervention to promote parent engagement in HENRY, a community-based childhood obesity prevention programme. The findings will be generalisable to other interventions delivered to parents in other community-based environments. This research meets the expressed needs of commissioners, children's centres and parents to optimise the potential impact that HENRY has on obesity prevention. A subsequent cluster randomised controlled pilot trial is planned to determine the practicality of undertaking a definitive trial to robustly evaluate the effectiveness and cost-effectiveness of the optimised intervention on childhood obesity prevention. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02675699 . Registered on 4 February 2016.
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Design and rationale for NOURISH-T: a randomized control trial targeting parents of overweight children off cancer treatment.
Stern, M, Ewing, L, Davila, E, Thompson, AL, Hale, G, Mazzeo, S
Contemporary clinical trials. 2015;:227-37
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Approximately 40% of off-treatment pediatric cancer survivors (PCS) are overweight or obese, which increases their risk for negative long-term physical health complications. Consistent with the Institute of Medicine's (IOM) emphasis on patients transitioning from treatment to cancer survivorship and increasing long-term healthy behaviors in these survivors, we plan to conduct a pilot RCT to address the increasing overweight/obesity rates among PCS by targeting their caregivers as agents for PCS behavior change. We plan to focus on parents' behaviors, attitudes and roles in promoting healthier eating and physical activity (PA) in PCS and adapt an evidence-informed, manualized parent intervention - NOURISH - found to be effective for parents of overweight and obese children and adolescents in reducing child and adolescent BMI. We plan to adapt NOURISH for caregivers of 5-12 year old PCS (6 months-4 years off active cancer treatment). Our pilot feasibility RCT - NOURISH-T (Nourishing Our Understanding of Role modeling to Improve Support for Healthy Transitions) evaluates: 1) the preliminary efficacy of NOURISH-T for PCS, compared with an Enhanced Usual Care (EUC) control condition, and 2) factors to consider to improve future adaptations of the intervention. The project will enroll caregivers of PCS at two pediatric oncology clinics into the 6-week intervention (or EUC) with assessments occurring pre- and post-6 weeks of intervention, and at a 4-month follow-up.