Clinical trial

External Body Weight Effects on Body Weight in Adults With Grade II and III Obesity

Opening soon · Not applicable · 1 countries · Registry ID NCT06619028

Opening soonNot applicableInterventional

What this study is about

Obesity is a growing problem in industrialized societies. This condition is associated with an increase in metabolic and cardiovascular diseases. Its cause is multifactorial, influenced by the environment, excessive calorie consumption, insufficient physical activity, sedentary lifestyle and alterations in energy metabolism. In this context, the hormone leptin, responsible for regulating appetite and body weight, presents resistance in people with obesity, altering the metabolic balance. Recent research has explored the concept of the "gravitostat", a system that responds to the mechanical stimulus of standing upright, as a promising approach in the regulation of body weight. Animal and human studies have shown positive results in weight loss and body recomposition using this system. However, more research is needed to evaluate the clinical applicability and effectiveness of the gravitostat in the management of obesity. For this reason, the present study is proposed, with a prospective longitudinal controlled design in the use of external body weight (where the patients are their own control: intrasubject controlled study) during 4 weeks, with a previous control period of 4 weeks and a follow-up of 4 weeks. The proposed objectives are to analyze the effectiveness of the use of external weight in the regulation of body weight, body composition and analytical parameters in people with grade II and III obesity. In this way, to analyze the clinical applicability of the gravitostat in the management of patients with this metabolic pathology.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity Prevention, Obesity

Full registry criteria

Inclusion Criteria: * Age\>18 years * BMI (≥35) * Compliance at intervention delivery. Exclusion Criteria: * Chronic pathology that may hinder the performance of the intervention * Chronic pain * Regular consumption of pharmacology or supplementation that affects body weight * Inability to perform any physical activity or high risk of suffering adverse effects from the interventibariatric-metabolic surgery * Reduced mobility * Changes of 5kg or more in the last 3 months * Drastic changes in lifestyle habits in the last 3 months (physical activity, eating habits, nicotine or alcohol consumption) * Apparent risk of not being able to complete the study intervention (at the principal investigator\'s discretion) * Pregnancy

Treatments and study arms

Weighted vest

Device

During the intervention period, the participants will be exposed to an external load, by means of a weighted vest of 10% of their body weight, for a minimum of 8 hours per day for 4 weeks. In the first phase of the study, participants will be followed without changes in their lifestyle as a control. During the intervention they will be instructed to perform their usual activities with the vest, without further alterations in their lifestyle. This will be followed by a 4-week follow-up period without the use of the weighted vest.

Primary outcomes

Body weightFrom enrollment to the end of treatment at 12 weeks

Measured fasting weight by electronic scale (BC-545N Tanita)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

EUGimbernat🇪🇸 Sant Cugat del Vallès, Barcelona, Spain

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Manuel Garcia-San-Emeterio, PhD StudentContact

Email · Call +34689608040