Overweight and Obesity Clinical Trial
Official title:
Effectiveness of a Cognitive Training Therapy for Overweight/Obesity Treatment: A Randomized Clinical Trial.
This randomized clinical trial was carried out from January 2017 to December 2017 at the
facilities of the Catholic University of Murcia. Written informed consent was required from
each patient. The protocols of the present clinical trial follow the CONSORT standards. To
measure the impact of cognitive training on weight loss in overweight / obese subjects, a
double-blind study (de facto masking) was designed.
Both the participants and the statistical assessors were unaware of the study hypothesis.
Participants were unaware of treatments and possible assignments between groups, and only
those subjects who were randomly assigned to the cognitive training group were informed that
such training was part of dietary therapy.
The principal investigator of the present study (J.J.H.M.) carried out the randomization,
with the assistance of the Microsoft Excell program, with the help of a macro designed in
Visual Basic® for that purpose.
The randomization divided the subjects into two groups, as they were treated with a
hypocaloric diet plus 12 nutrition education sessions (CONTROL group) or a group that were
treated with a hypocaloric diet plus 12 sessions of cognitive training (COGNITIVE group).
In order to obtain a similar size in both groups, a randomization in blocks with a 1: 1
allocation ratio was performed.
Cognitive performance measures were performed before and after training. One week before the
beginning of the cognitive and dietary intervention, the participants performed a series of
cognitive tests. After 12 weeks of both dietary and cognitive intervention, participants were
reexamined to measure performance on neurocognitive tests.
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