Interdisciplinary Weight Loss Therapy Associate With the Use of Interactive Digital Technology as Adjuvant Tool to the Clinical Practices in Obesity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Body Lean mass (kg)
研究概览
简要总结
Obesity is a complex disease associate to metabolic alterations, which may lead to cardiometabolic risk in women with obesity. The use of interactive digital technology as adjuvante tool to the clinical practices in weight loss therapy emerges as an innovative strategy. However, it was note fully investigated if this kind of approach can contribute to improve inflammatory state and metabolic alterations in obese population.
详细描述
This study consists in a 12-week clinical interdisciplinary weight loss therapy, with endocrinologist, nutritionist, psychologist and exercise physiologist to evaluate the effects of clinical interdisciplinary therapy associated to use the eletronic means on inflammatory biomarkers and metabolic alterations in women with obesity.
The present study was composed by a sample of obese women (20 to 45 years old), recruited through advertisements in the media (newspapers, magazines, radio, television and social media - Twitter®, Facebook® and Instagram®). The volunteers lived in the city of São Paulo or nearby, so they could attend monthly the University on the days of the clinical, nutritional, psychological and exercise evaluations, counseling, educational sessions and motivational strategies supporting adherence. To complete the Education Behaviors Program the volunteers follow weekly the instructions found in the Platform #12Semanas®. All participants met the inclusion criteria for the obesity profile according to the World Health Organization (WHO), presenting Body Mass Index (BMI) values above 30 kg/m². Patients with any pathology that could compromise the results of the study (heart disease, musculoskeletal deformities, diseases related to the immune system, genetic, metabolic or endocrine diseases, identified by the physician) were not included in the study. Anthropometric measures, body composition by bio-impedance and bood samples were collected to serum analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •obesity diagnosis;
- •body mass index (BMI) values above 30 kg/m²
- •aged 20-45 years
排除标准
- •presence of heart diseases
- •musculoskeletal deformities
- •diseases related to the immune system
研究组 & 干预措施
Cardiometabolic risk in women with obesity
The use of interactive digital technology as adjuvant tool to the clinical practices in weight loss therapy emerges as an innovative strategy. However. it was note fully investigated if this can contribute to decrease inflammatory markers in obese women. In the present investigate it was amied to evaluate the effects of clinical approach associated to use of electronic means on inflammatory markers in women with obesity.
干预措施: Interdisciplinary intervention in obesity (Other)
结局指标
主要结局
Body Lean mass (kg)
时间窗: 12 weeks
Body lean mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
Basal Metabolic Rate (KJ/day)
时间窗: 12 weeks
Basal Metabolic Rate was estimated by Bio-impedance meter (BIA) - device BIODYNAMICS 310e (TBW®).
Insulin Concentration
时间窗: 12 weeks
Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). Insulin concentration were available by commercial kits. Insulin resistance was assessed using the homeostasis model assessment-insulin resistance (HOMA-IR). The cutoff value determined for Brazilian population is HOMA-IR\>2.71 for classifying the subjects with insulin resistance.
Human Fibroblast Growth Factor 21
时间窗: 12 weeks
Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). The assays of Human Fibroblast Growth Factor 21 (FGF-21) concentration were determined by ELISA.
Adiponectin
时间窗: 12 weeks
Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). The assays of adiponectin concentration were determined by ELISA.
Atrial Natriuretic Peptide
时间窗: 12 weeks
Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). The assays of atrial natriuretic peptide (ANP) concentration were determined by ELISA.
Leptin
时间窗: 12 weeks
Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). The assays of leptin concentration were determined by ELISA.
Body weight (kg)
时间窗: 12 weeks
Body weight was measured using light clothes and barefoot on a Filizola® scale to 0,1kg and capacity of 180kg.
Body Fat mass (kg)
时间窗: 12 weeks
Body fat mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
Glucose Concentration
时间窗: 12 weeks
Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). Glucose concentration were available by commercial kits.
次要结局
未报告次要终点
研究者
Ana R. Damaso
Professor
Federal University of São Paulo