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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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Randomized controlled trial to test the efficacy of a brief, communication-based, substance use preventive intervention for parents of adolescents: Protocol for the SUPPER Project (Substance Use Prevention Promoted by Eating family meals Regularly).
Skeer, MR, Sabelli, RA, Rancaño, KM, Lee-Bravatti, M, Ryan, EC, Eliasziw, M, Spirito, A
PloS one. 2022;(2):e0263016
Abstract
BACKGROUND Substance use among adolescents in the U.S. is associated with adverse physical and mental health outcomes in the long-term. Universal youth-focused substance use prevention programs have demonstrated effectiveness but are often not sustainable due to the significant amount of time, effort, and resources required. We describe a trial protocol for a brief, low-participant-burden intervention to improve substance use-specific parent-child communication through the promotion of family meals and increased parental engagement. METHODS This study is a parallel-group randomized controlled trial designed to assess the efficacy of a 13-week intervention. A total of 500 dyads of parents and their 5th-7th grade children are recruited from across Massachusetts. Dyads are randomized to the intervention or attention-control condition using block urn randomization, based on child grade, gender, and school. Parents/guardians in the substance use preventive intervention arm receive a short handbook, attend two meetings with an interventionist, and receive two SMS messages per week. Parents/guardians in the control arm receive the same dose but with content focused on nutrition, physical activity, and weight stigma. Participant dyads submit videos of family meals, audio recordings of prompted conversations, and quantitative surveys over an 18-month period (baseline, 3, 6, 12, 18 months post-intervention). The primary outcomes measure the quantity and quality of parent-child substance use conversations and proximal child indicators (i.e., substance use attitudes and expectancies, affiliation with substance-using peers, and intentions and willingness to use substances). The secondary outcome is child substance use initiation. DISCUSSION This is a novel, brief, communication-focused intervention for parents/guardians that was designed to reduce participant burden. The intervention has the potential to improve parent-child engagement and communication and conversations about substance use specifically and decrease child substance use risk factors and substance use initiation. TRIAL REGISTRATION ClinicalTrials.gov NCT03925220. Registered on 24 April 2019.
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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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Raising Children on a Vegan Diet: Parents' Opinion on Problems in Everyday Life.
Bivi, D, Di Chio, T, Geri, F, Morganti, R, Goggi, S, Baroni, L, Mumolo, MG, de Bortoli, N, Peroni, DG, Marchi, S, et al
Nutrients. 2021;(6)
Abstract
A growing number of Italian families are adopting a vegan diet (VD) for their offspring from infancy for various reasons, with health benefits and ethics being the most common reasons. Barriers to effective communication with primary care pediatricians (PCPs) are perceived by many parents and, depending on the actors involved and the environment, a VD may affect social interactions in everyday life. A national cross-sectional survey was conducted between July and September 2020. Parents of children following a VD completed an online questionnaire. Data from 176 Italian parents were collected. About 72% (71.8%) of the children included in this study had been on a VD since weaning. Parents did not inform their primary care pediatricians (PCP) about the VD in 36.2% of the cases. In 70.8% of the cases, PCPs were perceived as skeptical or against a VD. About 70% (71.2%) of the parents relied on medical dietitians, and 28.2% on nutritionists/dietitians for dietary counseling. Parents administered an individual B12 supplement in 87.2% of the cases. To the best of our knowledge, this survey is the first which explores the relationship between vegan parents and their PCPs, the parental management of their children's diet and problems regarding the implementation of a VD in everyday life.
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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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Communication of children's weight status: what is effective and what are the children's and parents' experiences and preferences? A mixed methods systematic review.
Ames, H, Mosdøl, A, Blaasvær, N, Nøkleby, H, Berg, RC, Langøien, LJ
BMC public health. 2020;(1):574
Abstract
BACKGROUND Early intervention and conversation about a child's weight may offer an important chance of success in reducing weight and implementing a healthier lifestyle. This review explores the most effective ways to notify parents and children about the child's weight as well as their preferences and experiences around weight notification. METHODS We systematically searched nine databases for relevant primary research. Records were independently screened by two authors. We extracted data into a form designed for this review. Effect data was analysed using narrative synthesis and qualitative data using a best-fit framework synthesis. We assessed our confidence in the evidence using GRADE and GRADE-CERQual. RESULTS Studies of effect found that the format of feedback made little or no difference in parents attending further treatment, recognising their child as overweight or obese, reactions to the way the weight notification is given, motivation for lifestyle change, understanding how to reduce the risk of overweight, or taking any action. However, parents receiving feedback with motivational interviewing have somewhat greater satisfaction with the way the healthcare provider supports them. Qualitative studies found that parents had clear preferences for the format, timing, content and amount of information they wanted to receive in relation to both the weighing process and weight notification. They also had clear preferences for how they wanted health care providers to interact and communicate with them and their children. Both parents and children often felt that they were not receiving enough information and worried about how their results would be kept private. Many parents experienced an emotional response when told about their child's weight ranging from positive, disbelief and negative feelings. Those who reacted with disbelief or negatively were less likely to accept their child's weight status and/or act upon the notification letter. No studies reported results for children who were underweight. CONCLUSIONS Based on these qualitative results people working with weight assessment and notification programs should consider parents' preferences when developing feedback formats, considering the mode of feedback they are going to use and provide parents and children with tailored feedback and personalized follow up once a child is identified as overweight or obese.
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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.