An interventional study of Active transcranial direct current stimulation (tDCS) and Hypocaloric diet in Obesity, sponsored by University of Sao Paulo. Completed at 3 sites in 2 countries. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
The overall goal of this proposal is to evaluate the efficacy of transcranial direct current stimulation (tDCS), a noninvasive neuromodulation technique, to facilitate weight loss and weight loss maintenance in obesity. This is a novel clinical research study that examines the therapeutic potential of an innovative biomedical treatment for weight loss.
The hypothesis is that tDCS will successfully engage prefrontal-related neurobehavioral cognitive control systems, resulting in decreased eating disinhibition and therefore facilitation of weight loss and weight loss maintenance. To test this hypothesis, a 6-month randomized, sham-controlled, double-blind, intervention study was designed. Subjects will undergo an intervention with the following components/phases:
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Active transcranial direct current stimulation (tDCS) and hypocaloric diet.
Device: Active transcranial direct current stimulation (tDCS) · Other: Hypocaloric diet
Sham transcranial direct current stimulation (tDCS) and hypocaloric diet.
Other: Hypocaloric diet · Other: Sham transcranial direct current stimulation (tDCS)
Participants will receive 10 daily sessions (phase 2) and 3 times a week (phase 3) of tDCS (2mA, 30 min per session). The tDCS montage will target the left dorsolateral prefrontal cortex (DLPFC) (anode: F3 based on the 10:20 system; cathode over the right supraorbital area). For stimulation the investigators will use 5x5cm sponge pads that will be soaked in 0.9% saline during the sessions.
During phase 3, participants will undergo a supervised hypocaloric diet intervention for 2 weeks based on a low-calorie diet (LCD) providing a hypocaloric diet based in 20% reduction from total energy expenditure (TEE). The diet will be individualized on the basis of physical activity levels, age for each participant. This intervention will be be conducted at an inpatient, well-controlled setting to guarantee adherence to the diet. Here the diet intervention will be administered in combination with tDCS. tDCS will be applied every other day (Monday, Wednesday, Friday) over the course of these two weeks.
Subjects in the control group will receive sham stimulation (placebo) (similar procedure and duration as real tDCS, but here electric current flows for 30 s only, to mimic the subjective sensations that occur with active tDCS).
Body weight
The primary outcome will be change in body weight after two weeks intervention (tDCS alone) versus baseline (day 1), the change in body weight between the beginning and the end of the inpatient period (tDCS plus hypocaloric diet), and the change in body weight throughout follow-up (6 months), i.e. between the end of the tDCS intervention (end of the inpatient phase) and the end of the study.
Time frame: 6 months
Appetite visual analogue scale
The investigators will analyse changes in appetite during the different phases of the study: phase 1 (target engagement), phase 2 (tDCS-only effect), phase 3 (tDCS plus diet effect), phase 4 (follow-up) using the visual analogue scale.
Time frame: 6 months
Eating behavior questionnaire
The investigators will analyse changes in eating behavior during the different phases of the study: phase 1 (target engagement), phase 2 (tDCS-only effect), phase 3 (tDCS plus diet effect), phase 4 (follow-up) using the three-factor eating and food craving questionnaires.
Time frame: 6 months
Cognitive performance in a food modified working memory test
The investigators will compare accuracy and reaction times before and after the 2 weeks with tDCS only. To evaluate working memory performance an N-back task will be used.
Time frame: 2 weeks
Plan to share: No
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo