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How Brain Stimulation and Exercise can affect weight and mood in Obese women: a clinical study

Effects of Non-invasive Brain Stimulation combined with Aerobic Exercise on body composition and depressive symptoms in Obese adult women: a randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2v82f8c
Enrollment
Unknown
Registered
2026-01-07
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

This study is a double-blind, randomized, controlled clinical trial with an factorial, exploratory and quantitative approach. A total of 90 volunteers will participate, distributed into 5 groups: Grou
Group 2, 18 women with sham/simulated type electrical stimulation, following the same electrode placement as Group 1/active
Group 3, 18 women with active electrical stimulation + aerobic exercise (treadmill), following the same electrode placement as Group 1/active
Group 4, 18 women with sham/simulated type electrical stimulation + aerobic exercise (treadmill), with sham-type stimulation, following the same electrode placement as Group 1/active
Group 5, 18 women with only aerobic exercise (control) on the treadmill. The study design will encompass 8 experimental sessions (4 weeks) and 1 week follow-up for reassessment, totaling 5 weeks of re

Sponsors

Universidade Federal da Paraíba
Lead Sponsor
Universidade Federal da Paraíba
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Adult women between 18 and 40 years of age, provided menopause has not yet begun; body mass index BMI, between 30 and 34.9 (grade 1 obesity); fat analysis profile by bioimpedance that falls above 28% and no eating disorder behavior in the last 6 months (e.g., bulimia and anorexia); no history of serious psychiatric comorbidities (e.g., schizophrenia, dementia); no use of appetite control medications, antidepressants, weight-loss medications, metabolic accelerators, or diuretics for at least 6 months; no surgery (e.g., bariatric surgery or liposuction) or weight-loss cosmetic procedures within the last 1 year; no metal implants located in the head, cochlear implants, or cardiac pacemakers; not pregnant or lactating; no history of seizures; healthy patients and/or without cardiac, vascular, or decompensated osteomyoarticular disorders that prevent aerobic exercise (e.g., kidney failure, diabetes mellitus); not having exercised regularly for 6 months

Exclusion criteria

Exclusion criteria: Participants who miss two consecutive sessions/assessments or who do not complete the experimental procedures; present any serious illness during the data collection, or choose not to continue in the research (withdrawal)

Design outcomes

Primary

MeasureTime frame
A reduction in total body fat is expected, verified through two measurement methods: bioimpedance and anthropometric measurements, based on a variation of at least 5% in pre- and post-intervention measurements. Values ??measured in percentage, kilograms, millimeters (adipometry), and centimeters (perimetry).;A reduction in depressive symptom scores is expected, as verified by the DASS-21 scale adapted for Portuguese, which assesses three dimensions (depression, anxiety, and stress). A variation of at least 5% should be observed in the pre- and post-intervention measurements.

Secondary

MeasureTime frame
A reduction in the concentration of biomarkers related to lipid profile (triglycerides, total cholesterol and fractions) and metabolic syndrome (glucose, insulin, leptin and adiponectin) is expected, verified through blood collected from a peripheral vein of the upper limb. A variation of at least 5% should be observed in the pre- and post-intervention measurements.;A reduction in the inflammatory response is expected through the following biomarkers: leukocytes, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), total proteins, pro-inflammatory interleukins; and normalization of the nervous system through Brain-Derived Neurotrophic Factor (BDNF) and a reduction in stress measured through cortisol. These data will be verified using blood collected from a peripheral vein in an upper limb. A variation of at least 5% is expected in the pre- and post-intervention measurements.

Countries

Brazil

Contacts

Public ContactGiciane Vieira

Universidade Federal da Paraíba

gicianecvieira@gmail.com+55 (083) 3216-7254

Outcome results

None listed

Source: REBEC (via WHO ICTRP)