Lifestyle Intervention in Overweight and Obese Premenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
The Exercise and Obesity Health Promotion (PESO) program is a randomized controlled trial designed to analyze the effects of a lifestyle intervention in weight management and health-related parameters of overweight and obese premenopausal women
详细描述
The PESO (Exercise and Obesity Health Promotion Program) is a program of weight control and exercise promotion for overweight and obese premenopausal women, developed by specialists in exercise, nutrition, and psychology, under medical supervision. It is a program that promotes the autonomy of the participants and the permanent modification of their habits and lifestyles, without the use of drugs or any other products, devices, or techniques of "slimming".
Participants in the PESO Program were able to enjoy a regular and multifaceted group program, aiming to increase knowledge about permanent body weight control, increased motivation and practice of physical activity and exercise, and improved habits food and nutrition. Increases in functional mobility, metabolic health, quality of life and the physical and mental well-being of the participants are central priorities of this Program.
The PESO Program was conducted in a university context and was led by teachers and researchers from the Faculty of Human Motors and other national and foreign institutions. The program is not for commercial purposes, it does not entail financial costs for the participants and it is involved in a wide range of scientific research projects, which have been recognized by individuals and external entities as relevant and of interest to the general population and the community in particular.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor are masked
入排标准
- 年龄范围
- 24 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •older than 24 years,
- •be premenopausal and not currently pregnant,
- •BMI higher than 24.9 kg/m2,
- •free from major disease
排除标准
- •Not meeting the inclusion criteria
研究组 & 干预措施
Supervised exercise
Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants were involved in two supervised exercise sessions per week plus healthy lifestyle interactive sessions.
The experimental intervention consisted of: a) monthly behavioral sessions consisted of lifestyle interactive sessions took place monthly and covered and followed contents that were addressed during the first 4 months of the study; b) The supervised exercise sessions were prescribed using an aerobic mode performed at a moderate-to-vigorous intensity during 45 minutes, twice a week, preferably during the weekends.
干预措施: Supervised exercise (Behavioral)
Supervised exercise
Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants were involved in two supervised exercise sessions per week plus healthy lifestyle interactive sessions.
The experimental intervention consisted of: a) monthly behavioral sessions consisted of lifestyle interactive sessions took place monthly and covered and followed contents that were addressed during the first 4 months of the study; b) The supervised exercise sessions were prescribed using an aerobic mode performed at a moderate-to-vigorous intensity during 45 minutes, twice a week, preferably during the weekends.
干预措施: Lifestyle intervention from baseline to 4 months (Behavioral)
Supervised exercise
Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants were involved in two supervised exercise sessions per week plus healthy lifestyle interactive sessions.
The experimental intervention consisted of: a) monthly behavioral sessions consisted of lifestyle interactive sessions took place monthly and covered and followed contents that were addressed during the first 4 months of the study; b) The supervised exercise sessions were prescribed using an aerobic mode performed at a moderate-to-vigorous intensity during 45 minutes, twice a week, preferably during the weekends.
干预措施: Monthly behavioral sessions (Behavioral)
Control Group
Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants received no intervention
干预措施: Lifestyle intervention from baseline to 4 months (Behavioral)
Monthly behavioral sessions
Participants in this group received a lifestyle intervention from baseline to 4 months and then from 4 to 16 months participants were involved in non-supervised exercise group sessions with monthly behavioral sessions.
The experimental intervention consisted of monthly behavioral sessions consisted of lifestyle interactive sessions took place monthly and covered and followed contents that were addressed during the first 4 months of the study
干预措施: Lifestyle intervention from baseline to 4 months (Behavioral)
Monthly behavioral sessions
Participants in this group received a lifestyle intervention from baseline to 4 months and then from 4 to 16 months participants were involved in non-supervised exercise group sessions with monthly behavioral sessions.
The experimental intervention consisted of monthly behavioral sessions consisted of lifestyle interactive sessions took place monthly and covered and followed contents that were addressed during the first 4 months of the study
干预措施: Monthly behavioral sessions (Behavioral)
结局指标
主要结局
Body weight
时间窗: 22 months
A scale (Seca, Hamburg, Germany) was used to assess body weight
次要结局
- Body height(0 months)
- total and regional fat and fat-free mass(16 months)
- Thigh Adipose Tissue(16 months)
- Thigh Muscle Distribution(16 months)
- Abdominal Adipose Tissue Distribution(0 months)
- uric acid(16 months)
- Abdominal Adipose Tissue Distribution Changes(16 months)
- triglycerides(16 months)
- total cholesterol(16 months)
- low-density lipoprotein cholesterol(16 months)
- high-density lipoprotein cholesterol(16 months)
- Cardiorespiratory(0 months)
- Cardio-respiratory(16 months)
- Total-body water(16 months)
- Extracellular water(16 months)
- Intracellular water(16 months)
- Resistance(16 months)
- Reactance(16 months)
- Phase angle(16 months)
- Bioelectrical Impedance Vector Analysis(16 months)
- Quality of life reported(16 months)
- Blood pressure(16 months)
- Macro-nutrient(16 months)
- Resting Metabolic rate(16 months)
- Interleukin-6(16 months)
- Tumor necrosis factor-alpha(16 months)
- fibrinogen concentrations(16 months)
- Micro-nutrient(16 months)
- Plasminogen activator inhibitor-1(16 months)
- Hemoglobin A1c(16 months)
- microalbuminuria(16 months)
- C-reactive protein(16 months)
- Physical activity(16 months)
- Anthropometric (circumferences)(16 months)
- Fasting glycemia(16 months)
- apolipoprotein B100(16 months)
- Energy intake(16 months)
- Anthropometric (skinfolds)(16 months)
- Fasting insulin(16 months)
- urine cortisol(16 months)
- serum adiponectin concentration(16 months)
- serum leptin concentration(16 months)
- apolipoprotein A1(16 months)
- Alanine aminotransferase(16 months)
- Aspartate aminotransferase(16 months)
研究者
Luís Bettencourt Sardinha
Principal investigator
Faculdade de Motricidade Humana