IntroductionTreatment of childhood obesity is a complex challenge for primary health care professionals.ObjectivesTo evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake.MethodsRandomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group) or usual advice from their paediatrician on healthy eating and physical activity. Anthropometric parameters, objectively measured sedentary and physical activity behaviours, and dietary intake were evaluated pre- and post-intervention.ResultsAt the end of the study period, both groups achieved a similar decrease in body mass index (BMIsd) compared to baseline. Nereu Program participants (n = 54) showed greater increases in moderate-intense physical activity (+6.27% vs. -0.61%, p<0.001) and daily fruit servings (+0.62 vs. +0.13, p<0.026), and decreased daily soft drinks consumption (-0.26 vs. -0.02, p<0.047), respectively, compared to the counselling group (n = 59).ConclusionsAt the end of the 8-month intervention, participants in the Nereu Program group showed improvement in physical activity and dietary behaviours, compared to the counselling group.Trial RegistrationClinicalTrials.gov NCT01878994
Potassium hydroxide 10% and 15% demonstrated high rates of efficacy in clearing Molluscum contagiosum lesions, with potassium hydroxide 10% being better tolerated.
BackgroundObesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing.The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children’s obesity.Methods/DesignThe study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the end of the intervention (8 months later), 6 and 12 months after the intervention. We have considered necessary to recruit 100 children and divide them in 2 groups of 50 to detect the differences between the groups.DiscussionThis trial will provide new evidence for the long-term effects of childhood obesity management, as well as help to know the impact of the present intervention as a health intervention tool for healthcare centres.Trial registrationClinicalTrials.gov, NCT01878994
BackgroundMolluscum contagiosum is a non-severe pediatric viral infection. Because it is highly contagious and current treatments have negative aesthetic and psychological effects, we want to test an alternative treatment in the primary care setting, consisting of two different concentrations of potassium hydroxide solution.Methods/designThe study design is a double-blind, randomized clinical trial, using three types of topical treatment. The treatment consist of daily applications of potassium hydroxide (KOH) in aqueous solution at 10% and 15% concentration, and a placebo administered in the control group. Four follow-up visits (at 15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and patient tolerance.The main outcome measure of the trial will be the healing rate, defined as lesion disappearance in the affected zones after the topic application of the experimental treatment. Secondary measures will be the principal characteristics and evolution of the affected zone (surface area, number of lesions, size and density of lesions), treatment tolerance (hyperpigmentation, itching, burning, pain), recurrence rate and the natural evolution of lesions in the control group.DiscussionKOH can potentially be an effective and safe treatment for MC in primary care, and can also reduce referrals to dermatologists and hospital pediatric departments. In addition, KOH may be a valid and less expensive alternative to current invasive treatments (surgical excision).Trial RegistrationClinicalTrials.gov: NCT01348386
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