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A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis.
Alexopoulos, A, Dakoutrou, M, Nasi, L, Thanopoulou, I, Kakourou, T, Kontara, L, Douladiris, N, Galani, M, Xepapadaki, P, Doxani, C, et al
Pediatric dermatology. 2023;(1):78-83
Abstract
BACKGROUND Ectoine is a widespread osmolyte enabling halophilic bacteria to withstand high osmotic stress that has many potential applications ranging from cosmetics to its use as a therapeutic agent. OBJECTIVE The aim of this study was to compare the efficacy and tolerability of ectoine 1% and hyaluronic acid 0.1% containing (EHA) cream with a vehicle cream in children with mild-to-moderate atopic dermatitis (AD). METHODS A randomized, controlled, observer-blind, multicenter clinical trial was conducted in children aged 2-18 years, diagnosed with mild-to-moderate AD (SCORAD ≤20). Patients were randomized to either receiving EHA cream or vehicle cream twice daily for 4 weeks. The primary outcome measure was the mean change in objective SCORAD from baseline to the final visit. The secondary outcome measures included the mean change in Investigator's Global Assessment score, patient's judgment of efficacy and patient's assessment of pruritus. Safety of EHA cream was also assessed. RESULTS A total of 70 patients (35 in each group) were randomized and 57 were included in the final analysis set. Based on SCORAD measurements, patients using EHA cream achieved superior clinical improvement compared to the control group at 28 days (p < .001). EHA cream was also superior to the vehicle cream regarding all secondary outcome measures. Eight (23.5%) patients receiving EHA cream and two (5.7%) patients receiving vehicle cream experienced mild cutaneous adverse events (AEs). CONCLUSIONS In children 2-18 years old with mild-to-moderate AD, EHA cream was superior to vehicle cream, with minor AEs.
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Effects of Three Different Family-Based Interventions in Overweight and Obese Children: The "4 Your Family" Randomized Controlled Trial.
Varagiannis, P, Magriplis, E, Risvas, G, Vamvouka, K, Nisianaki, A, Papageorgiou, A, Pervanidou, P, Chrousos, GP, Zampelas, A
Nutrients. 2021;(2)
Abstract
Childhood overweight and obesity prevalence has risen dramatically in the past decades, and family-based interventions may be an effective method to improve children's eating behaviors. This study aimed to evaluate the effectiveness of three different family-based interventions: group-based, individual-based, or by website approach. Parents and school aged overweight or obese children, 8-12 years of age, were eligible for the study. A total of 115 children were randomly allocated in one of the three interventions, and 91 completed the study (79% compliance); Group 1 (n = 36) received group-based interventions by various experts; Group 2 (n = 30) had interpersonal family meetings with a dietitian; and Group 3 (n = 25) received training through a specifically developed website. Anthropometric, dietary, physical activity, and screen time outcomes were measured at baseline and at the end of the study. Within-group comparisons indicated significant improvement in body weight, body mass index (BMI)-z-score, physical activity, and screen time from baseline in all three study groups (p < 0.05). Furthermore, total body fat percentage (%TBF) was also decreased in Groups 2 and 3. Between-group differences varied with body weight and %TBF change, being larger in Group 3 compared to Groups 1 and 2, in contrast to BMI-z-score, screen time, and health behaviors, which were significantly larger in Group 2 than the other two groups. In conclusion, personalized family-based interventions are recommended to successfully improve children's lifestyle and body weight status.
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The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial.
Charalampopoulou, M, Bacopoulou, F, Syrigos, KN, Filopoulos, E, Chrousos, GP, Darviri, C
Breast (Edinburgh, Scotland). 2020;:210-218
Abstract
INTRODUCTION Breast cancer patients undergo extended treatments that affect their psychological state and quality of life. There is a lack of studies examining the effects of holistic stress management interventions (that combine stress perception, cognitive and lifestyle interventions) on mental health and biological indices (e.g. cortisol concentrations) of breast cancer patients. MATERIALS AND METHODS This pilot randomized controlled trial provided the first assessment of the effects of a novel, cognitive-based intervention, the Pythagorean Self-Awareness Intervention (PSAI), on psychological symptoms, quality of life, sleep quality and lifestyle as well as on stress-related biological measures of breast cancer patients undergoing adjuvant therapy. Standardized questionnaires were administered at baseline and 8-weeksafter the intervention to evaluate quality of life, stress, depression, and anxiety (primary outcomes). Sleep quality, lifestyle and hair cortisol concentrations were also assessed (secondary outcomes). RESULTS Forty-five breast cancer patients undergoing adjuvant therapy were randomly assigned to the PSAI group (n = 25) or the control group (n = 20).Women in the PSAI group reported significant improvements post-intervention in total Quality of Life, specific aspects of Quality of Life [Physical well-being, Social well-being, Emotional well-being, Functional well-being, Breast cancer concerns] as well as Perceived stress, depression, anxiety and stress. Improvements in secondary outcomes included increase in sleep quality, empowerment for healthy lifestyle and reduction of hair cortisol concentrations. CONCLUSIONS The PSAI was beneficial as complementary therapy in the women studied. Larger randomized controlled trials with longer follow-up are needed to ascertain these findings.
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Assessment of the Effectiveness of a Computerised Decision-Support Tool for Health Professionals for the Prevention and Treatment of Childhood Obesity. Results from a Randomised Controlled Trial.
Moschonis, G, Michalopoulou, M, Tsoutsoulopoulou, K, Vlachopapadopoulou, E, Michalacos, S, Charmandari, E, Chrousos, GP, Manios, Y
Nutrients. 2019;11(3)
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Obesity is related to the increased risk for chronic diseases and to nutrient insufficiencies, a paradox that has been characterised as the “double burden of malnutrition”. The aim of this study was to examine the effectiveness of a computerised decision-support tool as a means of childhood obesity management. The effectiveness of the decision-support tool was assessed through a pilot randomised controlled intervention trial. The study recruited a total sample of 80 children (obese or overweight) with an age range between 6 and 12 years. The participants were allocated to two study groups – intervention group and control group. Results indicate that a computerised decision-support tool, designed to assist paediatric healthcare professionals in providing personalised nutrition and lifestyle optimisation recommendations to overweight or obese children and their parents, can result in favourable changes to certain dietary intake and anthropometric indices in the children that received the intervention. Authors conclude that the computerised decision-support tool resulted in improvement of the children’s dietary intake and body mass index. Hence, the tool can support clinicians to improve the effectiveness of care.
Abstract
We examined the effectiveness of a computerised decision-support tool (DST), designed for paediatric healthcare professionals, as a means to tackle childhood obesity. A randomised controlled trial was conducted with 65 families of 6⁻12-year old overweight or obese children. Paediatricians, paediatric endocrinologists and a dietitian in two children's hospitals implemented the intervention. The intervention group (IG) received personalised meal plans and lifestyle optimisation recommendations via the DST, while families in the control group (CG) received general recommendations. After three months of intervention, the IG had a significant change in dietary fibre and sucrose intake by 4.1 and -4.6 g/day, respectively. In addition, the IG significantly reduced consumption of sweets (i.e., chocolates and cakes) and salty snacks (i.e., potato chips) by -0.1 and -0.3 portions/day, respectively. Furthermore, the CG had a significant increase of body weight and waist circumference by 1.4 kg and 2.1 cm, respectively, while Body Mass Index (BMI) decreased only in the IG by -0.4 kg/m². However, the aforementioned findings did not differ significantly between study groups. In conclusion, these findings indicate the dynamics of the DST in supporting paediatric healthcare professionals to improve the effectiveness of care in modifying obesity-related behaviours. Further research is needed to confirm these findings.
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Pythagorean self-awareness intervention: A novel cognitive stress management technique for body weight control.
Simos, DS, Kokkinos, A, Tentolouris, N, Dimosthenopoulos, C, Mantzou, E, Artemiadis, A, Bacopoulou, F, Nicolaides, NC, Kosta, O, Chrousos, GP, et al
European journal of clinical investigation. 2019;(10):e13164
Abstract
BACKGROUND Over the past decades, the prevalence of obesity has markedly increased worldwide. Stress is recognized as a substantial contributor to increased body weight; therefore, stress management interventions, especially cognitive behavioural, are becoming increasingly popular. The impact of stress management on stress- and obesity-related biomarkers (eg blood lipid profile, HBA1c, inflammatory biomarkers, such as CRP) has been scarcely studied. The aim of this study was to assess the effect of a novel cognitive behavioural stress management intervention, called 'Pythagorean Self-Awareness Intervention' (PSAI), in overweight/obese adults. MATERIALS AND METHODS This was a two-armed 1:1 randomized, nonblind controlled study including overweight/obese individuals. The control group followed a personalized Mediterranean low-calorie diet, and the intervention group followed the same diet in addition to the PSAI intervention for 8 weeks. Measurements included demographic, anthropometric (ie BMI, waist-to-hip ratio), stress (ie perceived stress, salivary cortisol), dietary behaviour (ie emotional eating) and metabolic parameters (ie blood lipid profile, HBA1c, CRP, body composition in fat and water). Outcome per-protocol analysis was performed using mixed linear models adjusted for age and gender. RESULTS A total of 49 of 62 eligible adults were analysed in the study (there were three dropouts in the intervention group and 10 dropouts in the control group); 28 were assigned to the intervention group (mean age 54.7 ± 11.9 years) and 21 to the control group (mean age 51.8 ± 11.9 years). The intervention group showed a statistically significant decrease in perceived stress, cortisol concentrations 30 minutes after awakening, cortisol's area under the curve, BMI, waist-to-hip ratio, restrained, emotional and external eating behaviour, fasting glucose, LDL, triglycerides, HbA1c and body and trunk fat, compared with the control group. Based on the observed effect sizes, clinically meaningful changes may be more evident in stress perception, restrained and external eating behaviour, Hb1ac and trunk fat. The compliance to the PSAI intervention reached 100%, and there were no adverse effects. CONCLUSIONS The PSAI technique may be an effective stress management method for overweight/obese adults. Future and larger randomized controlled studies are needed to allow generalization of these findings.
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Effect of honey on glucose and insulin concentrations in obese girls.
Farakla, I, Koui, E, Arditi, J, Papageorgiou, I, Bartzeliotou, A, Papadopoulos, GE, Mantzou, A, Papathanasiou, C, Dracopoulou, M, Papastamataki, M, et al
European journal of clinical investigation. 2019;(2):e13042
Abstract
BACKGROUND Childhood obesity represents a major health problem of our century. The benefits of natural products, such as honey, in the management of obesity have gained renewed interest. In this study, we investigated the effect of honey on glucose and insulin concentrations in obese prepubertal girls. MATERIALS AND METHODS Thirty healthy obese girls aged 10.55 (±SEM:0.34) years with a mean body mass index (BMI) above the 97th centile for age (28.58 ± 1.40 kg/m2 , BMI z-score 2.96) underwent a standard oral glucose tolerance test (OGTT) followed by an oral honey tolerance test (OHTT) 2 weeks later. Both solutions contained 75 g of glucose. Subsequently, subjects were randomized to receive either 15 g of honey or 15 g of marmalade daily, while both groups complied with dietetic instructions. Six months later all subjects were re-evaluated with an OGTT and an OHTT. RESULTS At the end of the study, all subjects demonstrated a significant reduction in BMI (27.57 ± 1.40, z-score: 2.54 vs 28.58 ± 1.40 kg/m2 , z-score: 2.96, P < 0.001), however, there were no significant differences in BMI and all parameters tested between the group that received honey and the control group. The areas under the concentration-time curve for glucose and insulin for the entire population were significantly lower following ingestion of honey than glucose solution (P < 0.001) both at the beginning and at the end of study. CONCLUSIONS These findings indicate that honey does not have an effect on stimulated plasma glucose and serum insulin concentrations compared with the standard glucose solution in obese prepubertal girls.
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Stress management and dietary counseling in hypertensive patients: a pilot study of additional effect.
Katsarou, AL, Vryonis, MM, Protogerou, AD, Alexopoulos, EC, Achimastos, A, Papadogiannis, D, Chrousos, GP, Darviri, C
Primary health care research & development. 2014;(1):38-45
Abstract
BACKGROUND In Western societies, cardiovascular (CV) disease is the primary cause of mortality, and high blood pressure (BP) is the main reversible factor leading to CV disease. Dietary habits and psychosocial stress contribute to the establishment of hypertension, while its role in the control of high BP is currently examined. In this study, we examined the effect and feasibility of a combined intervention of dietary education and stress management on the control of hypertension. METHODOLOGY A randomized, controlled pilot study was designed to evaluate the effect of combined education on stress management techniques and dietary habits (Mediterranean diet principle) on office BP after eight weeks. RESULTS Of the 45 randomized subjects, 36 were included in the final analysis (control group = 20 (age: 67 ± 12 years, 31.8%, males) and intervention group = 16 (age: 62 ± 12 years, 47%, males)). CV disease risk factors (except smoking), BP, dietary habits, perceived stress and physical activity (all assessed with validated questionnaires) were similar between the two groups at baseline. After eight weeks, office BP (systolic and diastolic) and perceived stress were significantly reduced, whereas the adherence in Mediterranean diet principle was significantly increased, but only in the intervention group. CONCLUSIONS A combined intervention of stress management techniques and Mediterranean diet education seems to be beneficial for BP reduction. Such interventions could possibly serve as a complementary treatment along with drug therapy or in the early treatment of high normal BP. A call to action for designing epidemiological studies and evaluating the efficacy of such non-pharmacological treatment strategies is therefore warranted.
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Stress management can facilitate weight loss in Greek overweight and obese women: a pilot study.
Christaki, E, Kokkinos, A, Costarelli, V, Alexopoulos, EC, Chrousos, GP, Darviri, C
Journal of human nutrition and dietetics : the official journal of the British Dietetic Association. 2013;:132-9
Abstract
BACKGROUND Stress and negative emotions have been shown to be critical factors in inducing overeating as a form of maladaptive coping in obese people. METHODS The present study aimed to evaluate the efficacy of an 8-week stress management programme that includes progressive muscle relaxation (PMR) and diaphragmatic breathing on weight loss and eating behaviour in a sample of overweight and obese women who started a weight-loss programme. A total of 34 women with a mean (SD) body mass index of 38.17 (7.19) kg m(-) ² and mean (SD) age 47.35 (11.64) years were recruited from the outpatients Obesity Clinic of a public hospital in Athens. Participants were randomly assigned into a Stress Management (SM) and a control group. Anthropometric measurements were taken before and after the intervention, and the participants completed the following questionnaires: Dutch Eating Behaviour Questionnaire (DEBQ), Eating Attitudes Test (Eat-26), Health Locus of Control (HLC) and Perceived Stress Scale (PSS) before and after the intervention. RESULTS The findings indicated a significant improvement in weight loss in the SM group [4.44 (0.83) kg] after intervention compared to the control group [1.38 (0.78) kg] (P < 0.05). A higher restrained eating behaviour was observed in the SM group after intervention compared to the control group, although there was no significant difference in perceived stress levels. CONCLUSIONS The intervention group showed greater weight reduction, possibly because of the stress management programme, and a greater dietary restraint was demonstrated by them compared to the control group. It is likely that stress management could facilitate weight loss in obese women; however, more studies are needed to confirm this hypothesis.
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Hypovitaminosis D associations with adverse metabolic parameters are accentuated in patients with Type 2 diabetes mellitus: a body mass index-independent role of adiponectin?
Al-Daghri, NM, Al-Attas, OS, Alokail, MS, Alkharfy, KM, Al-Othman, A, Draz, HM, Yakout, SM, Al-Saleh, Y, Al-Yousef, M, Sabico, S, et al
Journal of endocrinological investigation. 2013;(1):1-6
Abstract
BACKGROUND Hypovitaminosis D has been associated with an increased prevalence of Type 2 diabetes mellitus (DMT2) and metabolic syndrome manifestations. The purpose of this study was to examine the association between 25-hydroxy-vitamin D (25-OH-VitD) levels and indices of insulin resistance (IR), including adipocytokines, in a Saudi population with or without DMT2. SUBJECTS AND METHODS A total of 266 subjects (153 DMT2 and 113 healthy controls) aged 26-80 yr were randomly selected from the existing Biomarkers Screening in Riyadh Program (RIYADH Cohort). Subjects were assessed clinically, anthropometry was performed, morning blood chemistries, including fasting glucose (FG), triglycerides, total cholesterol, LDL cholesterol (LDL-C), and HDL cholesterol were obtained. Homeostasis model assessment of IR (HOMA-IR) was calculated, and serum 25-OH-VitD, leptin, adiponectin, resistin, insulin, high sensitivity CRP (hsCRP), and tumor necrosis factor α concentrations were measured using specific assays. RESULTS In DMT2 subjects, negative correlations between 25-OH-vitD and body mass index (BMI), FG, insulin, HOMA-IR, cholesterol, LDL-C, and hsCRP were observed, while a positive correlation between 25-OH-VitD and adiponectin was detected. The later remained significant after controlling for BMI. Interestingly, only weak and nonsignificant associations between 25-OH-VitD and metabolic parameters were observed in the control group, whereas, when the entire population was examined, negative correlations were evident primarily between 25-OH-VitD and FG, HOMA-IR, total cholesterol, LDL-C. These associations remained significant after controlling for BMI. CONCLUSIONS These results suggest that hypovitaminosis D associations with metabolic disturbances are accentuated in DMT2. The BMIindependent positive correlation between 25-OH-VitD and adiponectin suggests a potential role for this adipocytokine as a link between 25-OH-VitD and IR in patients with DMT2.
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Parental involvement does not augment the effectiveness of an intense behavioral program for the treatment of childhood obesity.
Bathrellou, E, Yannakoulia, M, Papanikolaou, K, Pehlivanidis, A, Pervanidou, P, Kanaka-Gantenbein, C, Tokou, I, Tsiantis, J, Chrousos, GP, Sidossis, LS
Hormones (Athens, Greece). 2010;(2):171-5
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Abstract
OBJECTIVE To evaluate the effectiveness of active parental involvement in a lifestyle intervention for the management of childhood obesity. DESIGN Forty-two overweight children (32 girls and 10 boys), aged 9.2 +/- 0.2 years and with percent overweight 39.8 +/- 2.7%, were randomly allocated either to a child-and-parent group (N = 23) or a child-alone group (N = 19). Both groups attended a 3-month multidisciplinary program extended by booster sessions during follow-up, which involved many cognitive behavioral therapy principles and assigned high self-regulation to the children, but differed in parental involvement. Percent overweight was evaluated at baseline, and at 3, 6, and 18 months thereafter. RESULTS There was no significant interaction between time and group or a significant difference between groups. Percent overweight decreased by 4.9 +/- 1.4 at 18 months (p < 0.001); the reduction occurred during the active phase of the treatment (0-3 months) and was maintained thereafter. CONCLUSION In the setting of the present study, the active parental involvement did not significantly modify the results of lifestyle interventions for children's overweight management.