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Understanding risk and causal mechanisms for developing obesity in infants and young children: A National Institutes of Health workshop.
Aagaard, KM, Barkin, SL, Burant, CF, Carnell, S, Demerath, E, Donovan, SM, Eneli, I, Francis, LA, Gilbert-Diamond, D, Hivert, MF, et al
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2024;(4):e13690
Abstract
Obesity in children remains a major public health problem, with the current prevalence in youth ages 2-19 years estimated to be 19.7%. Despite progress in identifying risk factors, current models do not accurately predict development of obesity in early childhood. There is also substantial individual variability in response to a given intervention that is not well understood. On April 29-30, 2021, the National Institutes of Health convened a virtual workshop on "Understanding Risk and Causal Mechanisms for Developing Obesity in Infants and Young Children." The workshop brought together scientists from diverse disciplines to discuss (1) what is known regarding epidemiology and underlying biological and behavioral mechanisms for rapid weight gain and development of obesity and (2) what new approaches can improve risk prediction and gain novel insights into causes of obesity in early life. Participants identified gaps and opportunities for future research to advance understanding of risk and underlying mechanisms for development of obesity in early life. It was emphasized that future studies will require multi-disciplinary efforts across basic, behavioral, and clinical sciences. An exposome framework is needed to elucidate how behavioral, biological, and environmental risk factors interact. Use of novel statistical methods may provide greater insights into causal mechanisms.
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Effectiveness of a participatory approach to develop school health interventions in four low resource cities: study protocol of the 'empowering adolescents to lead change using health data' cluster randomised controlled trial.
Guthold, R, Kann, L, Bhatti, L, Abduvahobov, P, Ansong, J, Atkinson, U, Baltag, V, Caffe, S, Caixeta, R, Diallo, CB, et al
BMJ open. 2023;(7):e071353
Abstract
INTRODUCTION Comprehensive local data on adolescent health are often lacking, particularly in lower resource settings. Furthermore, there are knowledge gaps around which interventions are effective to support healthy behaviours. This study generates health information for students from cities in four middle-income countries to plan, implement and subsequently evaluate a package of interventions to improve health outcomes. METHODS AND ANALYSIS We will conduct a cluster randomised controlled trial in schools in Fez, Morocco; Jaipur, India; Saint Catherine Parish, Jamaica; and Sekondi-Takoradi, Ghana. In each city, approximately 30 schools will be randomly selected and assigned to the control or intervention arm. Baseline data collection includes three components. First, a Global School Health Policies and Practices Survey (G-SHPPS) to be completed by principals of all selected schools. Second, a Global School-based Student Health Survey (GSHS) to be administered to a target sample of n=3153 13-17 years old students of randomly selected classes of these schools, including questions on alcohol, tobacco and drug use, diet, hygiene, mental health, physical activity, protective factors, sexual behaviours, violence and injury. Third, a study validating the GSHS physical activity questions against wrist-worn accelerometry in one randomly selected class in each control school (n approximately 300 students per city). Intervention schools will develop a suite of interventions using a participatory approach driven by students and involving parents/guardians, teachers and community stakeholders. Interventions will aim to change existing structures and policies at schools to positively influence students' behaviour, using the collected data and guided by the framework for Making Every School a Health Promoting School. Outcomes will be assessed for differential change after a 2-year follow-up. ETHICS AND DISSEMINATION The study was approved by WHO's Research Ethics Review Committee; by the Jodhpur School of Public Health's Institutional Review Board for Jaipur, India; by the Noguchi Memorial Institute for Medical Research Institutional Review Board for Sekondi-Takoradi, Ghana; by the Ministry of Health and Wellness' Advisory Panel on Ethics and Medico-Legal Affairs for St Catherine Parish, Jamaica, and by the Comité d'éthique pour la recherche biomédicale of the Université Mohammed V of Rabat for Fez, Morocco. Findings will be shared through open access publications and conferences. TRIAL REGISTRATION NUMBER NCT04963426.
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Impact of risk of generalizability biases in adult obesity interventions: A meta-epidemiological review and meta-analysis.
Beets, MW, von Klinggraeff, L, Burkart, S, Jones, A, Ioannidis, JPA, Weaver, RG, Okely, AD, Lubans, D, van Sluijs, E, Jago, R, et al
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2022;(2):e13369
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Abstract
Biases introduced in early-stage studies can lead to inflated early discoveries. The risk of generalizability biases (RGBs) identifies key features of feasibility studies that, when present, lead to reduced impact in a larger trial. This meta-study examined the influence of RGBs in adult obesity interventions. Behavioral interventions with a published feasibility study and a larger scale trial of the same intervention (e.g., pairs) were identified. Each pair was coded for the presence of RGBs. Quantitative outcomes were extracted. Multilevel meta-regression models were used to examine the impact of RGBs on the difference in the effect size (ES, standardized mean difference) from pilot to larger scale trial. A total of 114 pairs, representing 230 studies, were identified. Overall, 75% of the pairs had at least one RGB present. The four most prevalent RGBs were duration (33%), delivery agent (30%), implementation support (23%), and target audience (22%) bias. The largest reductions in the ES were observed in pairs where an RGB was present in the pilot and removed in the larger scale trial (average reduction ES -0.41, range -1.06 to 0.01), compared with pairs without an RGB (average reduction ES -0.15, range -0.18 to -0.14). Eliminating RGBs during early-stage testing may result in improved evidence.
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Physical activity, screen time and the COVID-19 school closures in Europe - An observational study in 10 countries.
Kovacs, VA, Starc, G, Brandes, M, Kaj, M, Blagus, R, Leskošek, B, Suesse, T, Dinya, E, Guinhouya, BC, Zito, V, et al
European journal of sport science. 2022;(7):1094-1103
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Abstract
To date, few data on how the COVID-19 pandemic and restrictions affected children's physical activity in Europe have been published. This study examined the prevalence and correlates of physical activity and screen time from a large sample of European children during the COVID-19 pandemic to inform strategies and provide adequate mitigation measures. An online survey was conducted using convenience sampling from 15 May to 22 June, 2020. Parents were eligible if they resided in one of the survey countries and their children aged 6-18 years. 8395 children were included (median age [IQR], 13 [10-15] years; 47% boys; 57.6% urban residents; 15.5% in self-isolation). Approximately two-thirds followed structured routines (66.4% [95%CI, 65.4-67.4]), and more than half were active during online P.E. (56.6% [95%CI, 55.5-57.6]). 19.0% (95%CI, 18.2-19.9) met the WHO Global physical activity recommendation. Total screen time in excess of 2 h/day was highly prevalent (weekdays: 69.5% [95%CI, 68.5-70.5]; weekend: 63.8% [95%CI, 62.7-64.8]). Playing outdoors more than 2 h/day, following a daily routine and being active in online P.E. increased the odds of healthy levels of physical activity and screen time, particularly in mildly affected countries. In severely affected countries, online P.E. contributed most to meet screen time recommendation, whereas outdoor play was most important for adequate physical activity. Promoting safe and responsible outdoor activities, safeguarding P.E. lessons during distance learning and setting pre-planned, consistent daily routines are important in helping children maintain healthy active lifestyle in pandemic situation. These factors should be prioritised by policymakers, schools and parents. HighlightsTo our knowledge, our data provide the first multi-national estimates on physical activity and total screen time in European children roughly two months after COVID-19 was declared a global pandemic.Only 1 in 5 children met the WHO Global physical activity recommendations.Under pandemic conditions, parents should set pre-planned, consistent daily routines and integrate at least 2-hours outdoor activities into the daily schedule, preferable on each day. Schools should make P.E. lessons a priority. Decision makers should mandate online P.E. be delivered by schools during distance learning. Closing outdoor facilities for PA should be considered only as the last resort during lockdowns.
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Early-stage studies to larger-scale trials: investigators' perspectives on scaling-up childhood obesity interventions.
von Klinggraeff, L, Dugger, R, Okely, AD, Lubans, D, Jago, R, Burkart, S, Weaver, RG, Armstrong, B, Pfledderer, CD, Beets, MW
Pilot and feasibility studies. 2022;(1):31
Abstract
BACKGROUND Pilot/feasibility studies play an important role in the development and refinement of behavioral interventions by providing information about feasibility, acceptability, and potential efficacy. Despite their importance and wide-spread use, the approaches taken by behavioral scientists to scale-up early-stage studies to larger-scale trials has received little attention. The aim of our study was to understand the role that pilot studies play in the development and execution of larger-scale trials. METHODS We conducted interviews with childhood obesity researchers who had published pilot behavioral interventions and larger-scale trials of the same or similar interventions. Questions were asked about the role of pilot studies in developing larger-scale trials and the challenges encountered when scaling-up an intervention based upon pilot findings. Data were coded and analyzed using an inductive analytic approach to identify themes. RESULTS Twenty-four interventionists (54% women, 37-70 years old, mean 20 years since terminal degree) completed a total of 148 pilot studies across their careers (mean 6.4, range 1-20), of which 59% were scaled-up. Scaling was described as resource intensive and pilot work was considered essential to successfully competing for funding by 63% of the sample (n = 15). When asked to define a high-quality pilot study, interventionists described studies that allowed them to evaluate two independent factors: components of their intervention (e.g., acceptability, feasibility) and study parameters (e.g., sample size, measures). Interventionists expressed that more process implementation measures, different study designs, and additional iterations could improve decisions to scale-up. Most agreed that pilot studies were likely to produce inflated estimates of potential efficacy though only nine interventionists provided potential solutions for decreasing inflated measures of efficacy. Suggested major causes of inflated effects included high levels of oversight in pilot studies (e.g., researcher support), reliance on subjective measures, and utilizing convenience or highly motivated samples. Potential solutions included designing pilots for real-world implementation, only conducting randomized controlled pilot studies, and pre-registering pilot studies. CONCLUSIONS Pilot studies purposes are multifaceted and deemed essential to obtaining funding for larger-scale trials. Clarifying the form and function of preliminary, early-stage research may enhance the productive utilization of early-stage studies and reduced drops in efficacy when transitioning to larger scale studies.
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Translation of Two Healthy Eating and Active Living Support Programs for Parents of 2-6-Year-Old Children: Outcomes of the 'Time for Healthy Habits' Parallel Partially Randomised Preference Trial.
Hammersley, ML, Wyse, RJ, Jones, RA, Stacey, F, Okely, AD, Wolfenden, L, Batterham, MJ, Yoong, S, Eckermann, S, Green, A, et al
Nutrients. 2021;(10)
Abstract
This translation study assessed the effectiveness of two remotely delivered healthy eating and active living interventions for parents of 2- to 6-year-old children in improving child fruit and vegetable intake, non-core food intake, body mass index (BMI), physical activity, screen time, and sleep. Parents (n = 458) were recruited to a partially randomised preference trial comprising three intervention groups. Healthy Habits Plus comprised six telephone calls, Time2bHealthy comprised six online modules, and the active control comprised ten information sheets and a summary booklet. Data were collected from parents via a telephone questionnaire at baseline and nine months post-baseline. Data were analysed for randomised participants alone (n = 240), preference participants alone (n = 218), and all participants combined (n = 458). There was no significant improvement in fruit and vegetable intake (primary outcome) when comparing the telephone and online interventions to the control. In both the randomised only and all participants combined analyses, there was a significant improvement in non-core food intake for the telephone intervention compared to the control (p < 0.001). Differences between interventions for other outcomes were small. In conclusion, the telephone and online interventions did not improve child fruit and vegetable intake relative to written materials, but the telephone intervention did improve non-core food intake.
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Global effect of COVID-19 pandemic on physical activity, sedentary behaviour and sleep among 3- to 5-year-old children: a longitudinal study of 14 countries.
Okely, AD, Kariippanon, KE, Guan, H, Taylor, EK, Suesse, T, Cross, PL, Chong, KH, Suherman, A, Turab, A, Staiano, AE, et al
BMC public health. 2021;21(1):940
Abstract
BACKGROUND The restrictions associated with the 2020 COVID-19 pandemic has resulted in changes to young children's daily routines and habits. The impact on their participation in movement behaviours (physical activity, sedentary screen time and sleep) is unknown. This international longitudinal study compared young children's movement behaviours before and during the COVID-19 pandemic. METHODS Parents of children aged 3-5 years, from 14 countries (8 low- and middle-income countries, LMICs) completed surveys to assess changes in movement behaviours and how these changes were associated with the COVID-19 pandemic. Surveys were completed in the 12 months up to March 2020 and again between May and June 2020 (at the height of restrictions). Physical activity (PA), sedentary screen time (SST) and sleep were assessed via parent survey. At Time 2, COVID-19 factors including level of restriction, environmental conditions, and parental stress were measured. Compliance with the World Health Organizations (WHO) Global guidelines for PA (180 min/day [≥60 min moderate- vigorous PA]), SST (≤1 h/day) and sleep (10-13 h/day) for children under 5 years of age, was determined. RESULTS Nine hundred- forty-eight parents completed the survey at both time points. Children from LMICs were more likely to meet the PA (Adjusted Odds Ratio [AdjOR] = 2.0, 95%Confidence Interval [CI] 1.0,3.8) and SST (AdjOR = 2.2, 95%CI 1.2,3.9) guidelines than their high-income country (HIC) counterparts. Children who could go outside during COVID-19 were more likely to meet all WHO Global guidelines (AdjOR = 3.3, 95%CI 1.1,9.8) than those who were not. Children of parents with higher compared to lower stress were less likely to meet all three guidelines (AdjOR = 0.5, 95%CI 0.3,0.9). CONCLUSION PA and SST levels of children from LMICs have been less impacted by COVID-19 than in HICs. Ensuring children can access an outdoor space, and supporting parents' mental health are important prerequisites for enabling pre-schoolers to practice healthy movement behaviours and meet the Global guidelines.
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Effect of Omega-3 Supplementation on Self-Regulation in Typically Developing Preschool-Aged Children: Results of the Omega Kid Pilot Study-A Randomised, Double-Blind, Placebo-Controlled Trial.
Roach, LA, Byrne, MK, Howard, SJ, Johnstone, SJ, Batterham, M, Wright, IMR, Okely, AD, de Groot, RHM, van der Wurff, ISM, Jones, AL, et al
Nutrients. 2021;(10)
Abstract
Supplementation of omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) may enhance self-regulation (SR) and executive functioning (EF) in children of preschool age. The aim of the Omega Kid Study was to investigate the effect of n-3 LCPUFA supplementation on SR and EF in typically developing preschool-aged children. A double-blind placebo-controlled pilot trial was undertaken, the intervention was 12 weeks and consisted of 1.6 g of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day compared to placebo. The HS-Omega-3 Index® was assessed by capillary blood samples at baseline and post-intervention. Seventy-eight children were enrolled and randomised to either the n-3 LCPUFA treatment (n = 39) or placebo (n = 39) group. Post intervention, there was a significant three-fold increase in the HS-Omega-3 Index® in the n-3 LCPUFA group (p < 0.001). There were no improvements in SR or EF outcome variables for the n-3 LCPUFA group post intervention compared to the placebo group determined by linear mixed models. At baseline, there were significant modest positive Spearman correlations found between the HS-Omega-3 index® and both behavioural self-regulation and cognitive self-regulation (r = 0.287, p = 0.015 and r = 0.242, p = 0.015 respectively). Although no treatment effects were found in typically developing children, further research is required to target children with sub-optimal self-regulation who may benefit most from n-3 LCPUFA supplementation.
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'Jump start' childcare-based intervention to promote physical activity in pre-schoolers: six-month findings from a cluster randomised trial.
Okely, AD, Stanley, RM, Jones, RA, Cliff, DP, Trost, SG, Berthelsen, D, Salmon, J, Batterham, M, Eckermann, S, Reilly, JJ, et al
The international journal of behavioral nutrition and physical activity. 2020;17(1):6
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Plain language summary
Australian national guidelines recommend children have at least 180 minutes of physical activity per day. But many do not reach this, especially those in low socio-economic areas. There is a lack of evidence on effective interventions to increase movement in children. This 6-month randomised control trial aimed to assess the promotion of physical activity in 658 children from disadvantaged areas. The results showed that daily physical activity was not increased in children who participated in a structured exercise programme. When further analysis was performed it was shown that overweight and obese children did marginally increase their daily physical activity whilst on a structured exercise programme. It was concluded that six-month intervention of a structured exercise programme did not increase a child’s overall daily physical activity.; six months may not be an adequate amount of time to embed this type of regime. Healthcare professionals could use this study to understand that although a structured exercise programme may not be the answer for children with low activity levels, participating in movement and exercise is important from a young age.
Abstract
BACKGROUND Participation in adequate levels of physical activity during the early years is important for health and development. We report the 6-month effects of an 18-month multicomponent intervention on physical activity in early childhood education and care (ECEC) settings in low-income communities. METHODS A cluster randomised controlled trial was conducted in 43 ECEC settings in disadvantaged areas of New South Wales, Australia. Three-year-old children were recruited and assessed in the first half of 2015 with follow-up 6 months later. The intervention was guided by Social Cognitive Theory and included five components. The primary outcome was minutes per hour in total physical activity during ECEC hours measured using Actigraph accelerometers. Intention-to-treat analysis of the primary outcome was conducted using a generalized linear mixed model. RESULTS A total of 658 children were assessed at baseline. Of these, 558 (85%) had valid accelerometer data (mean age 3.38y, 52% boys) and 508 (77%) had valid accelerometry data at 6-month follow-up. Implementation of the intervention components ranged from 38 to 72%. There were no significant intervention effects on mins/hr. spent in physical activity (adjusted difference = - 0.17 mins/hr., 95% CI (- 1.30 to 0.97), p = 0.78). A priori sub-group analyses showed a greater effect among overweight/obese children in the control group compared with the intervention group for mins/hr. of physical activity (2.35mins/hr., [0.28 to 4.43], p = 0.036). CONCLUSIONS After six-months the Jump Start intervention had no effect on physical activity levels during ECEC. This was largely due to low levels of implementation. Increasing fidelity may result in higher levels of physical activity when outcomes are assessed at 18-months. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12614000597695.
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Identification and evaluation of risk of generalizability biases in pilot versus efficacy/effectiveness trials: a systematic review and meta-analysis.
Beets, MW, Weaver, RG, Ioannidis, JPA, Geraci, M, Brazendale, K, Decker, L, Okely, AD, Lubans, D, van Sluijs, E, Jago, R, et al
The international journal of behavioral nutrition and physical activity. 2020;(1):19
Abstract
BACKGROUND Preliminary evaluations of behavioral interventions, referred to as pilot studies, predate the conduct of many large-scale efficacy/effectiveness trial. The ability of a pilot study to inform an efficacy/effectiveness trial relies on careful considerations in the design, delivery, and interpretation of the pilot results to avoid exaggerated early discoveries that may lead to subsequent failed efficacy/effectiveness trials. "Risk of generalizability biases (RGB)" in pilot studies may reduce the probability of replicating results in a larger efficacy/effectiveness trial. We aimed to generate an operational list of potential RGBs and to evaluate their impact in pairs of published pilot studies and larger, more well-powered trial on the topic of childhood obesity. METHODS We conducted a systematic literature review to identify published pilot studies that had a published larger-scale trial of the same or similar intervention. Searches were updated and completed through December 31st, 2018. Eligible studies were behavioral interventions involving youth (≤18 yrs) on a topic related to childhood obesity (e.g., prevention/treatment, weight reduction, physical activity, diet, sleep, screen time/sedentary behavior). Extracted information included study characteristics and all outcomes. A list of 9 RGBs were defined and coded: intervention intensity bias, implementation support bias, delivery agent bias, target audience bias, duration bias, setting bias, measurement bias, directional conclusion bias, and outcome bias. Three reviewers independently coded for the presence of RGBs. Multi-level random effects meta-analyses were performed to investigate the association of the biases to study outcomes. RESULTS A total of 39 pilot and larger trial pairs were identified. The frequency of the biases varied: delivery agent bias (19/39 pairs), duration bias (15/39), implementation support bias (13/39), outcome bias (6/39), measurement bias (4/39), directional conclusion bias (3/39), target audience bias (3/39), intervention intensity bias (1/39), and setting bias (0/39). In meta-analyses, delivery agent, implementation support, duration, and measurement bias were associated with an attenuation of the effect size of - 0.325 (95CI - 0.556 to - 0.094), - 0.346 (- 0.640 to - 0.052), - 0.342 (- 0.498 to - 0.187), and - 0.360 (- 0.631 to - 0.089), respectively. CONCLUSIONS Pre-emptive avoidance of RGBs during the initial testing of an intervention may diminish the voltage drop between pilot and larger efficacy/effectiveness trials and enhance the odds of successful translation.