Metabolic Syndrome Clinical Trial
Official title:
Clinical and Metabolic Efficacy of the Motivational Approach, Coordinated Between Primary Care and the Clinical Health Services for Childhood Obesity Treatment: Randomized Clinical Trial
The treatment of childhood obesity is challenging. Although dietary and physical activity
recommendations are widely known, the willingness to change lifestyles within the family is
not easy to be achieved. Motivational interviewing has been shown as a possibly effective
method to increase adherence to dietary recommendations in the obese adult.
There is scarce evidence showing whether implementing a motivational interview in obese
children could be effective.
The aim of this clinical trial is assessing the effect of a motivational interview,
coordinated between the clinical and primary care services on 8 to 14 years old obese
children.
In a recent study, the investigators have demonstrated that the motivational therapy approach
to treat childhood obesity is highly effective at clinical and metabolic levels. This
efficacy has been proved in a clinical outpatient setting. However, a standardized
collaborative approach between the clinic and the primary care services would allow a faster
and easier approach to childhood obesity treatment. Furthermore, this motivational and
educational intervention would benefit from the current technologic facilities, the long term
effect of the education at group level, in terms of food shopping plan, healthy, fast and
easy cooking methods.
The aim of this clinical trial is to test the efficacy of a multicomponent motivational
intervention for the treatment of childhood obesity, coordinated between primary care and
hospital specialized services, integrating motivational individual interviews, educational
groups and eHealth tools (wearable), compared to the usual intervention performed in
paediatrics.
The design will be a clustered randomized control trial, with an intervention group that will
receive a multicomponent motivational and educational plan which will be compared to a
control group receiving the usual recommendations performed in primary care centres (n=167
per group). The treatment of both study groups will last 12 months and will be performed at
the primary care centres. In parallel, the study team will validate the methodology used to
assess body composition in obese children as well as the changes produced by the
intervention.
Children assigned to the control group receive advices as recommended by the Clinical
Practice Guidelines (17). At visits, the family receive explanations about carrying out a
balanced diet, divided into 5 meals, in order to provide a moderate energy intake reduction.
An increase in physical activity, both in terms of leisure activity, as sports regular
practise are recommended. Monthly visits are organized in which weight and height are
measured, and compliance with recommendations are actually taking place.
Children assigned to the intervention group receive similar recommendations to those in the
control group but under a motivational interview schema. This means that each visit,
objectives from the last visit are fulfiled, the therapists try to make the family
recongnizing the changes to be done by themselves, rather than imposing by demonstrating
ambivalences, and objectives for the next visit are agreed. Furthermore, three workshops as
group therapy are organized with the following topics: 1. Increasing physical actty sing an
eHEalth monitor, 2. Food choices and dietary balance, and 3. Cooking methods.
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