Effectiveness and process evaluation in obesity and type 2 diabetes prevention programs in children: a systematic review and meta-analysis

Background: Obesity in children is one of the most severe public health challenges of the current century and Type 2 Diabetes Mellitus (T2DM) frequency is also escalating. More so, the importance of process evaluation (PE) in complex interventions is increasingly recognized. The present review, aims to identify the effectiveness in terms of body composition parameters in a generation of articles to prevent obesity and T2DM in children. We hypothesise that those studies reporting PE applying the latest implementation guidelines suggested by the researchers would potentially show positive changes in body composition compared to those not reporting it. Additionally, we will evaluate the implementation degree of PE in those articles considering it and describe the PE subcomponents. Lastly, we aim to assess the intervention target used and its results. Methods: A literature review was performed in parallel by 2 independent reviewers. A final number of 41 studies were selected for inclusion criteria. Results: Meta-analysis of BMI and zBMI found non-significant effects of the proposed interventions. Sub-group analysis revealed only a significant effect in studies which performed PE. Moreover, PE was reported in 42% effective studies and 57% non-effective studies. Fidelity and satisfaction were the most implemented PE subcomponents, although there was a generally low grade of PE use (7/41). The highest proportion of effectiveness (83%) was shown in interventions of physical activity alone while the intervention most used was 3-arm target (diet, PA and BS). Conclusions: Overall, obesity and T2DM prevention studies included in this review are not effective in terms of BMI and zBMI. Those studies performing PE reported to be effective in terms of BMI, while studies not reporting PE did not have positive results in terms of BMI and zBMI. In addition, none of the intervention studies included all PE indicators and most studies, which included PE in their interventions, did not provide full report of the PE components, according to the guidelines used for the present review. PROSPERO registration number: CRD42018093667

Effect of Lifestyle Intervention in the Concentration of Adipoquines and Branched Chain Amino Acids in Subjects with High Risk of Developing Type 2 Diabetes: Feel4Diabetes Study

Introduction: The global prevalence of type 2 diabetes (T2D) is increasing rapidly, especially in low- and middle-income countries and has a high number of associated comorbidities. Plasmatic concentrations of branched chain amino acids (BCAA) and retinol-binding protein 4 (RBP4) have been shown to be elevated in T2D subjects in cross-sectional studies. However, the effect of lifestyle community-based interventions on BCAA and RBP4 concentrations has not yet been analyzed. Material and methods: The Feel4Diabetes study is a school and community-based intervention that identified 360 European families with a high risk of developing T2D according to the FINDRISC questionnaire. Families were randomized in control and intervention groups were followed-up from 2016 to 2018. In the Spanish families, the concentration of BCAA and RBP4 was determined in 266 subjects (115 control and 151 intervention group) that attended the three time-point assessments by colorimetric and ELISA reaction, respectively. Results: Baseline BCAA levels showed positive correlations with the FINDRISC score and glucose impairment (baseline glucose, insulin, and glycated hemoglobin), body mass index, and body weight. The participants receiving the community-based intervention showed a significant decrease in glycated hemoglobin and BCAA levels compared to the control group (p = 0.011 and p < 0.001, respectively). However, baseline RBP4 did not show significant correlations with anthropometric and glycemic parameters, and no significant change was observed in anthropometric parameters and RBP4 concentrations throughout the follow-up. Conclusion: A community-based intervention on lifestyle led to a significant reduction in BCAA levels regardless of weight loss. These findings suggest that this interventional approach could be promising in T2D prevention

Determinants of longitudinal changes in cardiometabolic risk in adolescents with overweight/obesity: the EVASYON study

We investigated which determinants (socioeconomic, early life factors, body composition changes, fitness changes and/or physical activity changes) best predicted longitudinal outcomes in cardiometabolic risk profile (Z-score change) in adolescents with OW/OB who underwent a 13-month multidisciplinary lifestyle intervention. A total of 165 adolescents (13-16 y; 46% boys) from the EVASYON study were included. Socioeconomic variables and early life factors were obtained from the medical records. Body composition was assessed using anthropometry. Fitness and physical activity were measured with field-based tests and questionnaires. Cardiometabolic risk factors (fasting glucose, HDL cholesterol, triglycerides, blood pressure and waist circumference) were derived from standard methods in the hospital. Body weight changes, sex and mother''s education were selected in the stepwise process as the most important determinants of changes in cardiometabolic risk profile (R2 = 0.26, p = 0.002; R2 = 0.14, p = 0.013; and R2 = 0.14, p = 0.017, respectively). Both boys and girls showed a lower cardiometabolic risk score with the reduction in body weight (r = 0.535, p = 0.009 and r = 0.506, p = 0.005, respectively). There was no interaction between sex and body weight change (p = 0.614). In conclusion, the simple measure of changes in body weight should be considered to track changes in cardiometabolic risk profile in adolescents with OW/OB

Dairy consumption at snack meal occasions and the overall quality of diet during childhood. Prospective and cross-sectional analyses from the IDEFICS/I.Family cohort

There is scarce information on the influence of dairy consumption between main meals on the overall diet quality through childhood, constituting the main aim of this research. From the Identification and prevention of Dietary-and lifestyle induced health EFfects In Children and infantS (IDEFICS) study, and based on the data availability in each period due to drop outs, 8807 children aged 2 to 9.9 years from eight European countries at baseline (T0: 2007–2008); 5085 children after two years (T1); and 1991 after four years (T3), were included in these analyses. Dietary intake and the Diet Quality Index (DQI) were assessed by two 24 hours dietary recalls (24-HDR) and food frequency questionnaire. Consumption of milk and yogurt (p = 0.04) and cheese (p < 0.001) at snack meal occasions was associated with higher DQI scores in T0; milk and yogurt (p < 0.001), and cheese (p < 0.001) in T1; and cheese (p = 0.05) in T3. Consumers of milk (p = 0.02), yogurt (p < 0.001), or cheese (p < 0.001) throughout T0 and T1 at all snack moments had significantly higher scores of DQI compared to non-consumers. This was also observed with the consumption of cheese between T1 and T3 (p = 0.03). Consumption of dairy products at snack moments through childhood is associated with a better overall diet quality, being a good strategy to improve it in this period

Associations between insulin resistance and three B-vitamins in european adolescents: The HELENA study

Objective: To assess whether adolescents with high body mass index (BMI), or fat mass index (FMI), in combination with insulin resistance (assessed with the Homeostatic Model Assessment [HOMA] index), had also lower blood vitamin B6, folate and vitamin B12 concentrations. Methods and materials: Six hundred and fifteen adolescents from the Healthy Lifestyle in Europe by Nutrition in Adolescence (HELENA) study, with data on B-vitamins (both intakes and status), and BMI, FMI, HOMA, were selected. Intakes were assessed by two non-consecutive 24-h recalls. B-vitamins biomarkers were measured by chromatography and immunoassay. Analysis of covariance was applied to elucidate the differences in B-vitamins between combinations of groups defined according to the median of the z-scores of markers of body composition and insulin sensitivity. Results: When considering energy intakes and education of the mother in the model, in females, vitamin B6 intakes were higher in the high BMI/ high HOMA group than in the high BMI-low HOMA group. Similarly, vitamin B6 intakes were higher in the high FMI/high HOMA group than in the low FMI/low HOMA group. Plasma vitamin B12 was significantly lower in males in the high FMI/high HOMA group than in the low FMI/low HOMA group, keeping also significant their trends throughout the groups, a fact that can be observed also for females (p &lt; 0.05). Conclusion: Adolescents with combined higher adiposity and higher HOMA insulin sensitivity showed lower vitamin B12 plasma concentrations. These differences do not seem to be explained by dietary vitamin B12 intake

Do physical activity and screen time mediate the association between European fathers' and their children's weight status? Cross-sectional data from the Feel4Diabetes-study

BACKGROUND: Most research on parenting and childhood obesity and obesity-related behaviours has focused on mothers while fathers have been underrepresented. Yet, recent literature has suggested that fathers uniquely influence their children''s lifestyle behaviours, and hence could also affect their weight status, but this has not yet been scientifically proven. Therefore, the present study aimed to determine whether the association between fathers'' weight status and their children''s weight status is mediated by fathers'' and children''s movement behaviours (i.e. physical activity (PA) and screen time (ST)). METHODS: Cross-sectional data of 899 European fathers and their children were analyzed. Fathers/male caregivers (mean age =¿43.79¿±¿5.92¿years, mean BMI =¿27.08¿±¿3.95) completed a questionnaire assessing their own and their children''s (mean age =¿8.19¿±¿0.99¿years, 50.90% boys, mean BMIzscore =¿0.44¿±¿1.07) movement behaviours. Body Mass Index (BMI, in kg/m2) was calculated based on self-reported (fathers) and objectively measured (children) height and weight. For children, BMI z-scores (SD scores) were calculated to obtain an optimal measure for their weight status. Serial mediation analyses were performed using IBM SPSS 25.0 Statistics for Windows to test whether the association between fathers'' BMI and children''s BMI is mediated by fathers'' PA and children''s PA (model 1) and fathers'' ST and children''s ST (model 2), respectively. RESULTS: The present study showed a (partial) mediation effect of fathers'' PA and children''s PA (but not father''s ST and children''s ST) on the association between fathers'' BMI and children''s BMI (model for PA; coefficient: 0.001, 95% CI: [0.0001, 0.002]; model for ST; coefficient: 0.001, 95% CI: [0.000, 0.002]). Furthermore, fathers'' movement behaviours (PA and ST) were positively associated with their children''s movement behaviours (PA and ST) (model for PA, coefficient: 0.281, SE: 0.023, p <¿0.001; model for ST, coefficient: 0.345, SE: 0.025, p¿<¿0.001). CONCLUSIONS: These findings indicate that the influence of fathers on their children''s weight status partially occurs through the association between fathers'' PA and children''s PA (but not their ST). As such, intervening by focusing on PA of fathers but preferably of both members of the father-child dyad (e.g. engaging fathers and their children in co-PA) might be a novel and potentially effective strategy for interventions aiming to prevent childhood overweight and obesity. Longitudinal studies or intervention studies confirming these findings are however warranted to make meaningful recommendations for health intervention and policy. TRIAL REGISTRATION: The Feel4Diabetes-study is registered with the clinical trials registry http://clinicaltrials.gov , ID: 643708

The effect of a cluster-randomized controlled trial on lifestyle behaviors among families at risk for developing type 2 diabetes across Europe: the Feel4Diabetes-study

Background: This study investigated the effect of the Feel4Diabetes-intervention, a 2-year multilevel intervention, on energy balance-related behaviors among European families at risk for developing type 2 diabetes. Intervention effects on self-reported physical activity, sedentary behavior and eating behaviors were investigated across and within the participating countries: Belgium, Finland, Greece, Spain, Hungary and Bulgaria. Methods: Families were recruited through schools, located in low socio-economic status areas. In total, 4484 families at risk for developing type 2 diabetes were selected using the FINDRISC-questionnaire. Parents’ and children’s energy balance-related behaviors data were collected by questionnaires at three time points (baseline, mid- and post intervention). Families assigned to the intervention group were invited to participate in a 2-year school-, community-, and family-based intervention to promote a healthier lifestyle, including counseling sessions (first intervention year) and text messages (second intervention year). Families assigned to the control group received standard care, including medical check-up results and recommendations and tips regarding a healthy lifestyle. To assess the intervention-effects, Mixed Models were conducted using the R-Package “lmer “with R v3.2. Results: Significant intervention effects were found on a certain number of families’ lifestyle behaviors. Significant favorable intervention effects were detected on parents’ water consumption and consumption of fruit and vegetables, and on children’s consumption of sweets and moderate-to-vigorous physical activity. Analyses by country revealed significant favorable intervention effects on water consumption and on moderate-to-vigorous physical activity in Belgian parents and on fruit and vegetable consumption among Belgian children, on sweets consumption among Spanish parents and children, and on moderate-to-vigorous physical activity among Finnish children. Unfavorable intervention effects were found on the consumption of soft drinks and sugar-containing juices among Hungarian children and parents, while when examining the intervention effects for the overall population and per country, 10 from the 112 investigated outcome variables were improved in the intervention group compared to the control group (9%). Conclusions: The Feel4Diabetes-intervention managed to improve a certain number of targeted lifestyle behaviors while the intervention was not effective on a large number of targeted lifestyle behaviors. The findings of the current study are encouraging, but further research is needed on how we can further improve effectiveness of lifestyle interventions to prevent type 2 diabetes in families at risk. Trial registration: The Feel4Diabetes-study is registered with the clinical trials registry http://clinicaltrials.gov, ID: 643708. © 2021, The Author(s)

Design of the nutritional therapy for overweight and obese Spanish adolescents conducted by registered dieticians: the EVASYON study

Background: Dietary treatment for obese adolescents should aim to ensure adequate growth and development, by reducing excessive fat mass accumulation, avoiding loss of lean body mass, improving well-being and selfesteem and preventing cyclical weight regain. The aim of this article is to describe the dietary intervention design and the methods used to evaluate nutritional knowledge and behavior in the EVASYON study (Development, implementation and evaluation of the efficacy of a therapeutic programme for overweight/obese adolescents). Methods/design: EVASYON is a multi-centre study conducted in 5 Spanish hospital settings (Granada, Madrid, Pamplona, Santander and Zaragoza), where 204 overweight/obese Spanish adolescents were treated in groups of 9 to 11 subjects over 20 visits. The study was implemented in two stages: an intensive, calorie-restricted period for the first 9 weeks, and an extensive body-weight follow-up period for the last 11 months. A moderate energy intake restriction was applied in the intensive period according to the degree of obesity, on the basis of a balanced diet supplying 50-55% of daily energy as carbohydrates; 30-35% as fats and 10-15% as proteins. In the intensive period, adolescents were prescribed both a fixed full-day meal plan for the first three weeks and a full day meal plan with different food-choices for 6 weeks. Later, adolescents received a flexible meal plan based on food exchanges for the follow-up period until the end of the trial. Data on food intake, dietary and meal-related habits and behavior were collected by means of dietary questionnaires. To analyse nutritional knowledge, adolescents were examined regarding nutrient concepts and food items for a healthy diet with the appropriate tools. Participants were given nutritional information with complementary teaching material, which was available on the EVASYON website (www.estudioevasyon.com). Discussion: The dietary intervention of the EVASYON programme with a moderate calorie restriction for a limi - ted period of time could be a good strategy in treating overweight and obese adolescents and that will be tested further. Moreover, combining fixed plan with free-choice menus may help adolescents and their families to make right decisions for every day meals

Valoración del cambio de composición corporal en adolescentes con sobrepeso y obesidad incluidos en un tratamiento multidisciplinar: Estudio EVASYON

La adolescencia se considera una etapa vulnerable desde el punto de vista nutricional. La obesidad en la infancia y adolescencia se considera una enfermedad compleja, que preocupa tanto a padres como a profesionales sanitaros debido a su alta prevalencia y a sus consecuencias en la edad adulta. Por ello, los objetivos generales de este trabajo son: 1) valorar los índices antropométricos sencillos como predictores de los cambios de grasa corporal, empleando absorciometría dual de rayos X como método de referencia; 2) identificar los predictores cognitivos y conductuales del abandono de un estudio de intervención, y calcular la tasa de abandono; 3) valorar los cambios de composición corporal en niños y adolescentes, empleando diferentes métodos de composición corporal; y 4) valorar si el cumplimiento de la intervención dietética y el índice de calidad de la dieta son predictores de los cambios de composición corporal durante un seguimiento de 13 meses de una intervención multidisciplinar..

Lipidemic profile changes over a two-year intervention period : who benefited most from the Feel4Diabetes program?

Identification of participants' characteristics who benefited most from large community-based intervention studies may guide future prevention initiatives in order to maximize their effectiveness. The current study aimed to examine the socio-demographic, anthropometric, and behavioral characteristics, as well as the health and eating perceptions of those who improved their lipidemic profile, in the Feel4Diabetes early screening and prevention program. In the present analyses, 1773 adults from families at high risk for developing type 2 diabetes mellitus (T2DM) were enrolled, receiving either the standard care or the more intensive intervention, and 33.3-55.2% of them improved one or more of their lipidemic indices by >5%. Women, people living in Southeastern Europe, coming from two-parent families, having higher financial security, educational level and better diet quality were associated with a 27-64% higher likelihood for benefiting from the program regarding one or more of their lipidemic profile indices. Participants who were overweight or obese (especially with central obesity), employed, with prolonged sedentary behavior, prone to emotional eating and perceiving their weight status as lower than their actual weight were 24-43% less likely to have benefited. These findings should guide future interventions, prioritizing regions in greater need, and being tailor-made to specific population characteristics in order to further improve their effectiveness