NCT03749772: COGNI-OB

Cognitive Therapy Plus Dietary Intervention for Obesity Treatment

Completed NA Last updated 21 November 2018

What this trial tests

NA trial testing Cognitive Training in Overweight and Obesity in 100 participants. Completed in 28 February 2017.

Timeline

1 February 2016

Primary endpoint
21 December 2016

28 February 2017

Quick facts

Lead sponsor	Universidad Católica San Antonio de Murcia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	1 February 2016
Primary completion	21 December 2016
Estimated completion	28 February 2017

Drugs / interventions tested

• Cognitive Training

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

Universidad Católica San Antonio de Murcia

Who can join

Adults 18 to 65, any sex, with Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cognitive Training Therapy Improves the Effect of Hypocaloric Treatment on Subjects with Overweight/Obesity: A Randomised Clinical Trial.
   Galindo Muñoz JS, Morillas-Ruiz JM, Gómez Gallego M, Díaz Soler I, et al · · 2019 · cited 9× · PMID 31022980 · DOI 10.3390/nu11040925