Comparison of different mobile health applications for intervention in children and adolescent with overweight: a protocol for systematic review with meta-analysis and trial sequential analysis.

INTRODUCTION: Overweight in children is increasing worldwide. Innovative smartphone health applications (mHealth apps) have either sought to deliver single or multi-component interventions for the management of overweight in children. However, the clinical effects of these apps are poorly explored. The objective of the review will be to compare the benefits and harms of different categories of mHealth apps for intervention of overweight in children. METHODS AND ANALYSIS: We will include randomised clinical trials irrespective of publication type, year, status or language. Children and adolescents between 0 to 18 years will be referred to as children in the remaining part of the paper. Children with all degrees of overweight included obesity and morbidly obese in the remaining part of the paper will be referred to as overweight. We plan to classify different apps according to type of intervention, measurement device, coaching and reward system. The following databases will be used: Cochrane Library, Excerpta Medica database (Embase), PsycINFO, PubMed, IEEE Explore and Web of Science, CINAHL and LILACS. Primary outcomes will be body mass index z-score, quality of life and serious adverse event. Secondary outcomes will be body weight, self-efficacy, anxiety, depression and adverse event not considered serious. Study inclusion, data extraction and bias risk assessment will be conducted independently by at least two authors. We will assess the risk of bias through eight domains and control risks of random errors with Trial Sequential Analysis. The quality of the evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation Tool (GRADE). ETHICS AND DISSEMINATION: As the protocol is for a systematic reviews, we have not included any patient data and we do not require ethical approval. This review will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42019120266.

Psychotherapy versus treatment as usual and other control interventions in children and adolescents with overweight and obesity: a protocol for systematic review with meta-analysis and Trial Sequential Analysis.

INTRODUCTION: The prevalence of children with overweight and obesity is increasing worldwide. Multicomponent interventions incorporating diet, physical activity and behavioural change have shown limited improvement to body mass index (BMI). However, the impact of psychotherapy is poorly explored. This systematic review aims to assess the effects of psychotherapeutic approaches for children with all degrees of overweight. METHODS AND ANALYSIS: We will include randomised clinical trials involving children and adolescents between 0 and 18 years with overweight and obesity, irrespective of publication type, year, status or language up to April 2020. Psychotherapy will be compared with no intervention; wait list control; treatment as usual; sham psychotherapy or pharmaceutical placebo. The following databases will be searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, MEDLINE, Embase, PsycINFO, PubMed, Web of Science, CINAHL and LILACS. Primary outcomes will be BMI z-score, quality of life measured by a validated scale and proportion of patients with serious adverse events. Secondary outcomes will be body weight, self-esteem, anxiety, depression and proportion of patients with non-serious adverse events. Exploratory outcomes will be body fat, muscle mass and serious adverse events. Study inclusion, data extraction and bias risk assessments will be conducted independently by at least two authors. We will assess risk of bias according to Cochrane guidelines and the Cochrane Effective Practice and Organisation of Care guidance. We will use meta-analysis and control risks of random errors with Trial Sequential Analysis. The quality of the evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation Tool. The systematic review will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane guidelines. ETHICS AND DISSEMINATION: As individual patient data will not be included, we do not require ethics approval. This review will be published in a peer review journal. PROSPERO REGISTRATION NUMBER: CRD42018086458.

Health apps targeting children with overweight-a protocol for a systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials.

BACKGROUND: The prevalence of overweight is increasing worldwide in children. Multi-component interventions incorporating diet, physical activity, and behavioural change have been shown to reduce body mass index (BMI). Whilst many children have their own smartphone, the clinical effects of using smartphone applications (apps) for overweight are unknown. This systematic review aims to ascertain the effects of mHealth apps in children with overweight. METHODS: We will include randomised clinical trials irrespective of publication type, year, status, or language. Children between 0 and 18 years with overweight will be included. We will compare apps targeting overweight versus sham app, no app, or usual intervention. No distinction about operative system will be considered (i.e. Android, iOS, and Window Mobile will be included). The following databases will be searched: The Cochrane Library, Excerpta Medica database (Embase), PsycINFO, PubMed, IEEE Explore, Web of Science, CINAHL, and LILACS. Primary outcomes will be body weight, quality of life, and serious adverse event. Secondary outcomes will be self-efficacy, anxiety, depression, and adverse event not considered serious. Trial inclusion, data extraction, and bias risk assessment will be conducted independently by at least two authors. We will assess risk of bias through eight domains and control risks of random errors with Trial Sequential Analysis. The quality of the evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation Tool (GRADE). DISCUSSION: We will provide evidence of the beneficial and harmful effects of smartphone apps for children with overweight and highlight any gaps in the evidence in order to shape future potential interventions. By only including randomised clinical trials, we know that we bias our review towards benefits. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019120210.

Promoting healthy teenage behaviour across three European countries through the use of a novel smartphone technology platform, PEGASO fit for future: study protocol of a quasi-experimental, controlled, multi-Centre trial.

BACKGROUND: Behaviour change interventions targeting physical activity, diet, sleep and sedentary behaviour of teenagers show promise when delivered through smartphones. However, to date there is no evidence of effectiveness of multicomponent smartphone-based interventions. Utilising a user-centred design approach, we developed a theory-based, multi-dimensional system, PEGASO Fit For Future (PEGASO F4F), which exploits sophisticated game mechanics involving smartphone applications, a smartphone game and activity sensors to motivate teenagers to take an active role in adopting and maintaining a healthy lifestyle. This paper describes the study protocol to assess the feasibility, usability and effectiveness (knowledge/awareness and behavioural change in lifestyle) of the PEGASO system. METHODS: We are conducting a quasi-experimental controlled cluster trial in 4 sites in Spain, Italy, and UK (England, Scotland) over 6 months. We plan to recruit 525, in a 2:1 basis, teenagers aged 13-16 years from secondary schools. The intervention group is provided with the PEGASO system whereas the comparison group continues their usual educational routine. Outcomes include feasibility, acceptance, and usability of the PEGASO system as well as between and within group changes in motivation, self-reported diet, physical activity, sedentary and sleeping behaviour, anthropometric measures and knowledge about a healthy lifestyle. DISCUSSION: PEGASO F4F will provide evidence into the cross-cultural similarities and differences in the feasibility, acceptability and usability of a multi-dimensional smartphone based behaviour change intervention for teenagers. The study will explore facilitating factors, challenges and barriers of engaging teenagers to adapt and maintain a healthy lifestyle when using smartphone technology. Positive results from this ICT based multi component intervention may have significant implications both at clinical level, improving teenagers health and at public health level since it can present an influential tool against the development of chronic disease during adulthood. TRIAL REGISTRATION: https://clinicaltrials.gov Registration number: NCT02930148, registered 4 October 2016.

Group and individual agreement between field and dual X-ray absorptiometry-based body composition techniques in children from standard schools and a sports academy.

Percentage fat (%FM) and fat-free mass (FFM) were measured in 37 children from a sports academy and in 71 children from standard schools with dual x-ray absorptiometry (DXA) and bioelectrical impedance analysis (BIA) using the manufacturer's equation (Tanita) and an ethnic-specific prediction equation (Haroun). In the standard school, BIA overestimated FFM and underestimated %FM by a mean of 2.5 kg and 5.2%, respectively, using the Tanita equation. In girls from the sports academy, the Tanita equation underestimated FFM and overestimated %FM compared with DXA (mean difference BIA-DXA; FFM: -1.3 kg; %FM: 1.8%). The Haroun equation improved mean agreement between BIA and DXA in children (11 to 15 years) from the sports academy and for boys from standard schools, but reduced accuracy on individual assessments. These results have important practice implications for dietetics practitioners specializing in sports nutrition and exercise trainers.

Body composition and nutritional intake in children with chronic kidney disease.

The aim of this study was to assess body composition in children with chronic renal failure (CRF) and post renal transplantation (Tx), and to compare it to body mass index (BMI) and nutritional intake. Dietary assessment using 3-day diaries, total and regional body composition assessment by dual x-ray energy absorptiometry of 50 CRF children (29M, 21F), median age 8.9 yrs and 50 Tx children (32M, 18F), median age 12.9 yrs. BMI, percentage fat mass (%FM) and lean mass (LM) were corrected for height and expressed as SDS (HSDS). In both groups, BMIHSDS was lower than %FMHSDS and higher than LMHSDS (p<0.05). In the Tx group, there were associations on bivariate analysis between energy & protein intake and BMIHSDS & %FMHSDS (r,0.5, p<0.05), and between LMHSDS and protein intake (r,0.5, p<0.05). On multivariate analysis, there was an association between LMHSDS and time since transplantation (r,-0.4, p<0.05). Children in the CRF and Tx groups had a high percentage predicted trunk:leg FM ratio of 148% and 157%, respectively. Children with CRF and Tx have discordant body composition with a relatively high FM and low LM, which is not reflected by BMI. In addition, they appear to have an increased level of central adiposity that may predispose them to increased morbidity in later life.

Bone mineral content, corrected for height or bone area, measured by DXA is not reduced in children with chronic renal disease or in hypoparathyroidism.

The combination of poor growth and parathyroid and mineral disorders complicates the diagnosis of renal bone disease in children with chronic renal insufficiency (CRI), and the role of dual X-ray absorptiometry (DXA) is unclear. We aimed to examine the role of DXA in assessing variation in size-adjusted bone mineral content (BMC) in children with CRI and compare it with a cohort with hypoparathyroidism (HPT) and pseudo-hypoparathyroidism (PHPIa). In 29 patients with CRI (21 male) with a median age of 11 years (10th, 90th centiles 4.4, 14.6) and 10 patients with HPT and PHPIa (three male), with a median age of 13.7 years (7, 16) lumbar spine (LS) and total body (TB) BMC were measured by DXA. Age-, gender- and height-matched data allowed calculation of percentage predicted bone area for age and gender (pBAr) and percentage predicted BMC for bone area and height. In the CRI group, the median glomerular filtration rate (GFR) was 27.4 ml/min per 1.73 m2 (7.1, 69.5), and the median duration of illness was 9.3 years (2.1, 12.1). Median height standard deviation score (Ht SDS) was -1.6 (-3.0, 0.3), and, as expected, median LS and TB pBAr were low at 82% (68, 974) and 76% (63, 92), respectively. LS and TB predicted BMC (pBMC) SDS (corrected for bone size) were generally high, with a median value of 0.4 (-0.9, 1.4) and 0.4 (-0.1,0.9), respectively. Analysis of the prepubertal subset of children (n=15) showed that median percentage predicted LS BMC for height was 104% (80, 116), whereas the median TB BMC for height was 96% (74, 108). Median Ht SDS of the HPT and PHPIa cohort was -0.3 (-2.9, 0.3) and median LS and TB pBAr were 90% (66, 100) and 91% (76, 98), respectively. Median LS and TB pBMC SDS were 0.6 (-0.4, 1.8) and 0.7 (0.3, 1.1), respectively. Median percentage predicted LS and TB BMC for height were 102% (82, 114) and 102% (92, 122). There was no relationship between pBMC SDS and duration of illness, GFR, vitamin D dose, serum intact parathyroid hormone (PTH), serum calcium/phosphate product or serum total alkaline phosphatase (ALP) in the CRI or the HPT cohort. However, one of the highest pBMC SDSs was recorded in a child with PHPIa before she started on any treatment. In children with CRI, BMC, when adjusted for co-existing growth retardation, is similar to that observed in children with hypoparathyroidism. The correct reading of BMC needs a correction for bone size.