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Health promotion intervention to prevent risk factors of chronic diseases: Protocol for a cluster randomized controlled trial among adolescents in school settings of Chandigarh (India).
Kaur, S, Kaur, M, Kumar, R
PloS one. 2022;(2):e0263584
Abstract
BACKGROUND Chronic diseases like diabetes, cardiovascular diseases and cancers are on the rise. Most of the risk factors of these diseases commence in Adolescence. Therefore, a cluster randomised controlled trial is designed to evaluate the effect of school-based health promotion intervention on the risk factors of chronic diseases. METHODOLOGY Considering school as a cluster, twelve schools will be randomly selected from the public schools of Chandigarh, a city in India. After baseline assessment, six schools will be randomly allocated to intervention and six to the control arm. Study participants will be students of 8th grade (age 10-16 years), their parents and teachers. A sample of 360 students (12 clusters x 30 students) has been estimated to provide statistically valid inference. The PRECEDE PROCEED Model will be used to develop health promotion interventions to prevent the use of an unbalanced diet, physical inactivity, alcohol, and tobacco. Interventions will be implemented for six-months in the school setting. For students, the intervention will comprise interactive learning sessions of 30 minutes duration per week and physical activity sessions of 30 minutes duration four times every week. Educational sessions will be conducted for parents and teachers for 30 minutes, four times during the intervention period. Primary outcomes will be changes in the prevalence of behavioural risk factors from pre- to post-intervention. Changes in anthropometric, physiological, and biochemical measures will be the secondary outcomes. The difference-in-difference (DID) method will be used to measure the net change in the outcomes. DISCUSSION It is essential to understand whether health promotion interventions implemented in the school setting simultaneously targeting adolescents, teachers, and parents are effective. Using the PRECEDE-PROCEED model for planning, implementing, and evaluating the intervention as part of a cluster Randomized Controlled Trial design with DID analysis, could objectively assess the impact.
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The impact of pictorial health warnings on purchases of sugary drinks for children: A randomized controlled trial.
Hall, MG, Grummon, AH, Higgins, ICA, Lazard, AJ, Prestemon, CE, Avendaño-Galdamez, MI, Taillie, LS
PLoS medicine. 2022;(2):e1003885
Abstract
BACKGROUND Pictorial warnings on tobacco products are promising for motivating behavior change, but few studies have examined pictorial warnings for sugary drinks, especially in naturalistic environments. This study aimed to examine the impact of pictorial warnings on parents' purchases of sugary drinks for their children in a naturalistic store laboratory. METHODS AND FINDINGS Parents of children ages 2 to 12 (n = 325, 25% identifying as Black, 20% Hispanic) completed a shopping task in a naturalistic store laboratory in North Carolina. Participants were randomly assigned to a pictorial warnings arm (sugary drinks displayed pictorial health warnings about type 2 diabetes and heart damage) or a control arm (sugary drinks displayed a barcode label). Parents selected 1 beverage and 1 snack for their child, as well as 1 household good; one of these items was selected for them to purchase and take home. The primary outcome was whether parents purchased a sugary drink for their child. Secondary outcomes included reactions to the trial labels, attitudes toward sugary drinks, and intentions to serve their child sugary drinks. Pictorial warnings led to a 17-percentage point reduction in purchases of sugary drinks (95% CI for reduction: 7% to 27%), with 45% of parents in the control arm buying a sugary drink for their child compared to 28% in the pictorial warning arm (p = 0.002). The impact of pictorial warnings on purchases did not differ by any of the 13 participant characteristics examined (e.g., race/ethnicity, income, education, and age of child). Pictorial warnings also led to lower calories (kcal), purchased from sugary drinks (82 kcal in the control arm versus 52 kcal in the pictorial warnings arm, p = 0.003). Moreover, pictorial warnings led to lower intentions to serve sugary drinks to their child, feeling more in control of healthy eating decisions, greater thinking about the harms of sugary drinks, stronger negative emotional reactions, greater anticipated social interactions, lower perceived healthfulness of sugary drinks for their child, and greater injunctive norms to limit sugary drinks for their child (all p < 0.05). There was no evidence of difference between trial arms on noticing of the labels, appeal of sugary drinks, perceived amount of added sugar in sugary drinks, risk perceptions, or perceived tastiness of sugary drinks (all p > 0.05). CONCLUSIONS Pictorial warnings reduced parents' purchases of sugary drinks for their children in this naturalistic trial. Warnings on sugary drinks are a promising policy approach to reduce sugary drink purchasing in the US. TRIAL REGISTRATION The trial design, measures, power calculation, and analytic plan were registered before data collection at www.clinicaltrials.gov NCT04223687.
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A Health-Literacy Intervention for Early Childhood Obesity Prevention: A Cluster-Randomized Controlled Trial.
Sanders, LM, Perrin, EM, Yin, HS, Delamater, AM, Flower, KB, Bian, A, Schildcrout, JS, Rothman, RL, ,
Pediatrics. 2021;(5)
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Abstract
BACKGROUND AND OBJECTIVES Children who become overweight by age 2 have greater risk of long-term obesity and health problems. The study aim was to assess the effectiveness of a primary care-based intervention on the prevalence of overweight at age 24 months. METHODS In a cluster-randomized trial, sites were randomly assigned to the Greenlight intervention or an attention-control arm. Across 4 pediatric residency clinics, we enrolled infant-caregiver dyads at the 2-month well-child visit. Inclusion criteria included parent English- or Spanish-speaking and birth weight ≥1500 g. Designed with health-literacy principles, the intervention included a parent toolkit at each well-child visit, augmented by provider training in clear-health communication. The primary outcome was proportion of children overweight (BMI ≥85th percentile) at age 24 months. Secondary outcomes included weight status (BMI z score). RESULTS A total of 459 intervention and 406 control dyads were enrolled. In total, 49% of all children were overweight at 24 months. Adjusted odds for overweight at 24 months (treatment versus control) was 1.02 (95% confidence interval [CI]: 0.63 to 1.64). Adjusted mean BMI z score differences (treatment minus control) were -0.04 (95% CI: -0.07 to -0.01), -0.09 (95% CI: -0.14 to -0.03), -0.19 (-0.33 to -0.05), -0.20 (-0.36 to -0.03), -0.16 (95% CI: -0.34 to 0.01), and 0.00 (95% CI -0.21 to 0.21) at 4, 6, 12, 15, 18, and 24 months, respectively. CONCLUSIONS The intervention resulted in less weight gain through age 18 months, which was not sustained through 24 months. Clinic-based interventions may be beneficial for early weight gain, but greater intervention intensity may be needed to maintain positive effects.
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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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Confident Body, Confident Child: Outcomes for Children of Parents Receiving a Universal Parenting Program to Promote Healthful Eating Patterns and Positive Body Image in Their Pre-Schoolers-An Exploratory RCT Extension.
Hill, KE, Hart, LM, Paxton, SJ
International journal of environmental research and public health. 2020;(3)
Abstract
Objective: A four-arm randomized controlled trial (RCT) conducted in Victoria, Australia, previously evaluated parent-report outcomes following Confident Body, Confident Child: a program for parents to promote healthful eating patterns and positive body image in pre-schoolers. This exploratory study evaluated data from children of parents in the trial at 18 months follow-up. Method: Participants were 89 children (58 girls, 31 boys) of parents across all RCT arms (group A: Confident Body, Confident Child (CBCC) resource + workshop, n = 27; group B: CBCC resource only, n = 26; group C: nutrition booklet, n = 18; group D: wait-list control, n = 18). Children's eating patterns, body image and weight bias were assessed via play-based interview. Results: Children of CBCC parents reported higher body esteem. Children of nutrition booklet parents reported stronger weight bias. Children of CBCC workshop parents reported lower External Eating. Discussion: This exploratory study suggests that CBCC may promote healthy eating patterns and child body image 18 months after parents receive the intervention.
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Health-related quality of life of children and their parents 2 years after critical illness: pre-planned follow-up of the PEPaNIC international, randomized, controlled trial.
Hordijk, J, Verbruggen, S, Vanhorebeek, I, Güiza, F, Wouters, P, Van den Berghe, G, Joosten, K, Dulfer, K
Critical care (London, England). 2020;(1):347
Abstract
BACKGROUND Pediatric intensive care unit (PICU) survivors are at risk for prolonged morbidities interfering with daily life. The current study examined parent-reported health-related quality of life (HRQoL) in former critically ill children and parents themselves and aimed to determine whether withholding parenteral nutrition (PN) in the first week of critical illness affected children's and parents' HRQoL 2 years later. METHODS Children who participated in the pediatric early versus late parenteral nutrition in critical illness (PEPaNIC) trial and who were testable 2 years later (n = 1158) were included. Their HRQoL outcomes were compared with 405 matched healthy controls. At PICU admission, children had been randomly assigned to early-PN or late-PN. In the early-PN group, PN was initiated within 24 h after PICU admission. In the late-PN group, PN was withheld for up to 1 week in the PICU. Parents completed the Infant Toddler Quality of Life Questionnaire (ITQOL; age 2-3 years) or the Child Health Questionnaire-Parent Form 50 (CHQ-PF50; age 4-18 years). Besides, they completed the Health Utility Index (HUI) and the Short Form Health Survey (SF-12) regarding their child's and their own HRQoL, respectively. RESULTS For the total age group of 786 post-PICU survivors, parents reported lower scores for almost all HRQoL scales compared to healthy children. Age-specifically, younger critically ill children (2.5 to 3 years old) scored worse for growth and development and older children (4-18 years old) scored worse for role functioning and mental health. Parents' own mental and physical HRQoL was comparable to that of healthy control parents. No HRQoL differences were found between children in the late-PN and those in the early-PN group. CONCLUSIONS Parent-reported HRQoL of children 2 years after critical illness was impaired compared with healthy controls. In relation to their child's HRQoL, parents reported impairments in emotions, personal time, and family activities; however, their own HRQoL was not impaired. Withholding PN in the first week during critical illness had no impact on longer-term HRQoL of the child. TRIAL REGISTRATION Clinical trials, NCT01536275. Registered 22 February 2012.
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Effects of Discontinuing Methylphenidate on Strengths and Difficulties, Quality of Life and Parenting Stress.
Matthijssen, AM, Dietrich, A, Bierens, M, Kleine Deters, R, van de Loo-Neus, GHH, van den Hoofdakker, BJ, Buitelaar, JK, Hoekstra, PJ
Journal of child and adolescent psychopharmacology. 2020;(3):159-165
Abstract
Objectives: To study the effects of discontinuation of long-term methylphenidate use on secondary outcome measures of strengths and difficulties, quality of life (QoL), and parenting stress. Methods: Ninety-four children and adolescents aged 8 to 18 years who had used methylphenidate for over 2 years were randomly assigned to double-blind continuation of treatment for 7 weeks (36 or 54 mg extended release methylphenidate) or to gradual withdrawal over 3 to 4 weeks placebo. We used mixed models for repeated measures to investigate effects on parent, teacher, and child ratings of hyperactivity/inattention and comorbid symptoms with the Strengths and Difficulties Questionnaire (SDQ), investigator- and teacher-rated oppositional symptoms (Conners Teacher Rating Scale-Revised: short form [CTRS-R:S]), and parent-rated aggression with the Retrospective Modified Overt Aggression Scale. QoL was assessed with the Revised Questionnaire for Children and Adolescents to record health-related quality of life and parenting stress with the Nijmegen Parental Stress Index. Results: Hyperactivity/inattention scores from the parent- and teacher-rated SDQ (difference in mean change over time of respectively: -1.1 [95% confidence interval, CI, -2.0 to -0.3]; p = 0.01; -2.9 [95% CI -2.9 to -0.7; p = 0.01]) and oppositional scores of the teacher-rated CTRS-R:S (difference in mean change -1.9 95% CI [-3.1 to -0.6; p < 0.01]) deteriorated to a significantly larger extent in the discontinuation group than in the continuation group. We did not find effects on other symptom domains, aggression, QoL, and parenting stress after discontinuation of methylphenidate. Conclusion: Our study suggests beneficial effects of long-term methylphenidate use beyond 2 years for oppositional behaviors in the school environment. Similarly, beneficial effects were found on hyperactivity-inattention symptoms as rated by parent and teacher scales, confirming our primary study on investigator ratings of attention-deficit/hyperactivity disorder. However, discontinuation of methylphenidate did not appear to have impact on other comorbid problems or aspects of the child's or parental functioning.
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Can counter-advertising diminish persuasive effects of conventional and pseudo-healthy unhealthy food product advertising on parents?: an experimental study.
Dixon, H, Scully, M, Gascoyne, C, Wakefield, M
BMC public health. 2020;(1):1781
Abstract
BACKGROUND To help address rising rates of obesity in children, evidence is needed concerning impacts of common forms of marketing for unhealthy child-oriented food products and the efficacy of educational interventions in counteracting any detrimental impacts of such marketing. This study aims to explore parents' responses to advertising for unhealthy children's food products that employ different types of persuasive appeals and test whether a counter-advertising intervention exposing industry motives and marketing strategies can bolster parents' resistance to influence by unhealthy product advertising. METHODS N = 1613 Australian parents were randomly assigned to view online either a: (A) non-food ad (control); (B) conventional confectionery ad (highlighting sensory benefits of the product); (C) pseudo-healthy confectionery ad (promoting sensory benefits and health attributes of the product); (D) conventional confectionery ad + counter-ad (employing inoculation-style messaging and narrative communication elements); (E) pseudo-healthy confectionery ad + counter-ad. Parents then viewed various snacks, including those promoted in the food ads and counter-ad. Parents nominated their preferred product, then rated the products. RESULTS Exposure to the conventional confectionery ad increased parents' preference for the advertised product, enhanced perceptions of the product's healthiness and reduced sugar content and boosted brand attitude. Exposure to the pseudo-healthy confectionery ad increased parents' preference for the advertised product, and enhanced perceptions of healthiness, fibre content and lower sugar content. The counter-ad diminished, but did not eliminate, product ad effects on parents' purchasing preference, product perceptions and brand attitudes. The counter-ad also prompted parents to perceive processed foods as less healthy, higher in sugar and lower in fibre and may have increased support for advertising regulation. CONCLUSIONS Exposure to unhealthy product advertising promoted favourable perceptions of products and increased preferences for advertised products among parents. Counter-advertising interventions may bolster parents' resistance to persuasion by unhealthy product advertising and empower parents to more accurately evaluate advertised food products.
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An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability.
Marker, AM, Monzon, AD, Nelson, EL, Clements, MA, Patton, SR
Diabetes technology & therapeutics. 2020;(1):25-33
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Background: Fear of hypoglycemia (FH) is common in parents of young children with type 1 diabetes (T1D) and problematically linked to maladaptive behaviors to avoid low blood glucose, parenting stress, and burnout. This study examined the feasibility and acceptability of a novel group-based telemedicine intervention to reduce FH in parents of young children with T1D. Materials and Methods: Forty-three families of a young child with T1D (1-6 years of age; diagnosed with T1D for at least 6 months) enrolled in the study and 36 completed the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention. We assessed intervention feasibility with rates of attrition, intervention attendance, and fidelity to the treatment manual. We assessed acceptability with treatment satisfaction surveys and qualitative interviews (from a subset of completers; n = 10) about intervention acceptability, facilitators, and challenges. Results: Study attrition was 21%, including long-term follow-up (16% before or during the treatment phase). On average, parents attended 94% of intervention sessions and fidelity to the treatment manual was 89%. Intervention completers reported high satisfaction with the treatment groups (89% average satisfaction rating). Parent-reported positive influencers of the REDCHiP intervention were increased knowledge, fear awareness, coping strategies, confidence, behavioral parenting strategies, and support, whereas intervention challenges included feeling fearful or overwhelmed, family stress, lack of trust, and difficulty connecting with other group members. Conclusions: The REDCHiP intervention demonstrated initial feasibility and acceptability. Next steps include determining the intervention's impact on objective parent and child outcomes (e.g., glycemic control, parental FH, and parental stress/distress) as well as large-scale efficacy testing.