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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEscoles Universitaries Gimbernat

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age>18 years

BMI (≥35)

Compliance at intervention delivery.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Intervention Group (IG)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Body weight

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

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

Nutritional state

Short Dietary Questionnaire Punctuation: From 0 to 9. Interpretation: Higher results, better adherence with Mediterranean diet. Lower results, worst adherence with Mediterranean diet.

Time frame
From enrollment to the end of treatment at 12 weeks
2

Grip Strength

Measuring tool: Grip Strength Dynamometer Takei T.K.K 5401 Procedure: 3 consecutive measurements with each extremity, taking the mean as reference value for each.

Time frame
From enrollment to the end of treatment at 12 weeks
3

Lower Extremity Strength

30' chair stand-up test Test performed only once, with a 43 cm (17 inches) high chair without armrests.

Time frame
From enrollment to the end of treatment at 12 weeks
4

Activity state

Minnesota Leisure Time Physical Activity Questionnaire No standared punctuation Higher values associated with higher activity state Punctuation registred in minutes, days, months.

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Sponsors and contacts

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Escoles Universitaries Gimbernat

Lead sponsor

Corporacion Parc Tauli

Collaborator

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