Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol

Abstract

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

Recording daily routines with guidance on healthy lifestyle to improve health parameters in children and their families

“…However, in order to successfully promote health in childhood, efforts should not only come from families, but also from society in general [14][15][16] . Accordingly to Serra-Paya 17 , interventional programs that focus on changing family lifestyles seem to be the most effective strategies to increase physical activity and healthier nutritional choices than traditional interventions (e.g., 10 min consultations with doctors and nurses). Moreover, in order for children to acquire healthy habits, a motivational program that encourages active participation in changing habits must be implemented.…”

Promoción de la salud y prescripción de ejercicio físico desde centros de atención primaria. Justificació y diseño del Programa CAMINEM

“…El marco de evaluación RE-AIM (representatividad y alcance, eficacia o efectividad, adopción, implementación y mantenimiento) (Estabrooks & Gyurcsik, 2003;Glasgow, Vogt, & Bolas, 1999) surgió para estimar el impacto que tienen las intervenciones en salud pública, y se considera válido para evaluar la aplicabilidad de intervenciones de AF en el ámbito comunitario, como pueden ser los CAP (Estabrooks & Gyurcsik, 2003;Fortier et al, 2007;Gaglio, Shoup, & Glasgow, 2013;Paez et al, 2014). Últimamente se pueden encontrar intervenciones clínicas desarrolladas en algún CAP del estado español (Garcia-Ortiz et al, 2010;Giné-Garriga et al, 2013;Grandes, Sanchez, Montoya, Ortega Sanchez-Pinilla, & Torcal, 2011;Gusi, Reyes, Gonzalez-Guerrero, Herrera, & Garcia, 2008;Martin-Borras et al, 2014;Pardo et al, 2014;Serra-Paya et al, 2013), pero ninguno de ellos evalúa su aplicabilidad (validez externa), entendida como el punto en que una intervención se podría implementar en un contexto concreto más allá del diseño experimental (Wang, Moss, & Hiller, 2006).…”

“…The RE-AIM (Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance) framework (Estabrooks & Gyurcsik, 2003;Glasgow, Vogt, & Boles, 1999) was first designed to estimate the public health impact of an intervention and it has been accepted to target the feasibility of HEPA interventions in community settings, such as PHC centers (Estabrooks & Gyurcsik, 2003;Fortier et al, 2007;Gaglio, Shoup, & Glasgow, 2013;Paez et al, 2014). Recently, pragmatic trials are being conducted in Spanish PHC settings (Garcia-Ortiz et al, 2010;Giné-Garriga et al, 2013;Grandes, Sanchez, Montoya, Ortega Sanchez-Pinilla, & Torcal, 2011;Gusi, Reyes, Gonzalez-Guerrero, Herrera, & Garcia, 2008;Martin-Borras et al, 2014;Pardo et al, 2014;Serra-Paya et al, 2013) but none targets its feasibility (i.e., external validity), understood as the extent to which the intervention process could be implemented in the local setting (Wang, Moss, & Hiller, 2006).…”

An After-School, high-intensity, interval physical activity programme improves health-related fitness in children

“…This study was designed to determine the effects of a moderate-intensity PA and a high-intensity interval PA program on the health-related fitness of school children. As markers of health and fitness, we used the Alpha-fitness battery of tests designed for children and adolescents [37][38][39] along with several other frequently used markers. A further objective of this study was to assess the use of the Alpha-fitness test battery and of the indicators, VO 2 m ax, excess post-exercise oxygen consumption (EPOC) and mean propulsive velocity of the lower trunk (MVprop) in school children.…”