Clinical trial NCT03823898: Lifestyle Intervention in Overweight Women
Official title: Lifestyle Intervention in Overweight and Obese Premenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Lifestyle, Sedentary
Physical Activity
Nutritional and Metabolic Disease
Behavior, Health
Cardiovascular Risk Factor
Keywords: obesity
body composition
weight management
cardiovascular and metabolic markers
Behavioral change
Exercise
Lead sponsor: Faculdade de Motricidade Humana
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 150
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A clinical trial with three-arm
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* older than 24 years,
* be premenopausal and not currently pregnant,
* BMI higher than 24.9 kg/m2,
* free from major disease

Exclusion Criteria:

* Not meeting the inclusion criteria

Primary outcomes:
measure: Body weight
timeFrame: 0 months
measure: Body weight
timeFrame: 4 months
measure: Body weight
timeFrame: 16 months
measure: Body weight
timeFrame: 22 months
Secondary outcomes:
measure: Body height
timeFrame: 0 months
measure: total and regional fat and fat-free mass
timeFrame: 0 months
measure: total and regional fat and fat-free mass
timeFrame: 4 months
measure: total and regional fat and fat-free mass
timeFrame: 16 months
measure: Thigh Adipose Tissue
timeFrame: 0 months
measure: Thigh Adipose Tissue
timeFrame: 16 months
measure: Thigh Muscle Distribution
timeFrame: 0 months
measure: Thigh Muscle Distribution
timeFrame: 16 months
measure: Abdominal Adipose Tissue Distribution
timeFrame: 0 months
measure: Abdominal Adipose Tissue Distribution Changes
timeFrame: 16 months
measure: triglycerides
timeFrame: 0 months
measure: triglycerides
timeFrame: 16 months
measure: uric acid
timeFrame: 0 months
measure: uric acid
timeFrame: 16 months
measure: total cholesterol
timeFrame: 0 months
measure: total cholesterol
timeFrame: 16 months
measure: low-density lipoprotein cholesterol
timeFrame: 0 months
measure: low-density lipoprotein cholesterol
timeFrame: 16 months
measure: high-density lipoprotein cholesterol
timeFrame: 0 months
measure: high-density lipoprotein cholesterol
timeFrame: 16 months
measure: Cardiorespiratory
timeFrame: 0 months
measure: Cardio-respiratory
timeFrame: 16 months
measure: Total-body water
timeFrame: 0 months
measure: Total-body water
timeFrame: 16 months
measure: Extracellular water
timeFrame: 0 months
measure: Extracellular water
timeFrame: 16 months
measure: Intracellular water
timeFrame: 0 months
measure: Intracellular water
timeFrame: 16 months
measure: Resistance
timeFrame: 0 months
measure: Resistance
timeFrame: 16 months
measure: Reactance
timeFrame: 0 months
measure: Reactance
timeFrame: 16 months
measure: Phase angle
timeFrame: 0 months
measure: Phase angle
timeFrame: 16 months
measure: Bioelectrical Impedance Vector Analysis
timeFrame: 0 months
measure: Bioelectrical Impedance Vector Analysis
timeFrame: 16 months
measure: Quality of life reported
timeFrame: 0 months
measure: Quality of life reported
timeFrame: 4 months
measure: Quality of life reported
timeFrame: 16 months
measure: Blood pressure
timeFrame: 0 months
measure: Blood pressure
timeFrame: 16 months
measure: Physical activity
timeFrame: 0 months
measure: Physical activity
timeFrame: 4 months
measure: Physical activity
timeFrame: 16 months
measure: Energy intake
timeFrame: 0 months
measure: Energy intake
timeFrame: 4 months
measure: Energy intake
timeFrame: 16 months
measure: Macro-nutrient
timeFrame: 0 months
measure: Macro-nutrient
timeFrame: 4 months
measure: Macro-nutrient
timeFrame: 16 months
measure: Micro-nutrient
timeFrame: 0 months
measure: Micro-nutrient
timeFrame: 4 months
measure: Micro-nutrient
timeFrame: 16 months
measure: Resting Metabolic rate
timeFrame: 0 months
measure: Resting Metabolic rate
timeFrame: 16 months
measure: Anthropometric (circumferences)
timeFrame: 0 months
measure: Anthropometric (circumferences)
timeFrame: 4 months
measure: Anthropometric (circumferences)
timeFrame: 16 months
measure: Anthropometric (skinfolds)
timeFrame: 0 months
measure: Anthropometric (skinfolds)
timeFrame: 4 months
measure: Anthropometric (skinfolds)
timeFrame: 16 months
measure: Fasting insulin
timeFrame: 0 months
measure: Fasting insulin
timeFrame: 16 months
measure: Fasting glycemia
timeFrame: 0 months
measure: Fasting glycemia
timeFrame: 16 months
measure: Interleukin-6
timeFrame: 0 months
measure: Interleukin-6
timeFrame: 16 months
measure: Tumor necrosis factor-alpha
timeFrame: 0 months
measure: Tumor necrosis factor-alpha
timeFrame: 16 months
measure: Plasminogen activator inhibitor-1
timeFrame: 0 months
measure: Plasminogen activator inhibitor-1
timeFrame: 16 months
measure: fibrinogen concentrations
timeFrame: 0 months
measure: fibrinogen concentrations
timeFrame: 16 months
measure: Hemoglobin A1c
timeFrame: 0 months
measure: Hemoglobin A1c
timeFrame: 16 months
measure: serum adiponectin concentration
timeFrame: 0 months
measure: serum adiponectin concentration
timeFrame: 16 months
measure: serum leptin concentration
timeFrame: 0 months
measure: serum leptin concentration
timeFrame: 16 months
measure: urine cortisol
timeFrame: 0 months
measure: urine cortisol
timeFrame: 16 months
measure: microalbuminuria
timeFrame: 0 months
measure: microalbuminuria
timeFrame: 16 months
measure: C-reactive protein
timeFrame: 0 months
measure: C-reactive protein
timeFrame: 16 months
measure: apolipoprotein A1
timeFrame: 0 months
measure: apolipoprotein A1
timeFrame: 16 months
measure: apolipoprotein B100
timeFrame: 0 months
measure: apolipoprotein B100
timeFrame: 16 months
measure: Alanine aminotransferase
timeFrame: 0 months
measure: Alanine aminotransferase
timeFrame: 16 months
measure: Aspartate aminotransferase
timeFrame: 0 months
measure: Aspartate aminotransferase
timeFrame: 16 months
Other outcomes:
Locations:
city: Oeiras
country: Portugal
facility: Faculdade de Motricidade Humana
state: Cruz-Quebrada
Study officials:
affiliation: Faculdade Motricidade Humana
name: Luís B Sardinha, PhD
role: STUDY_DIRECTOR
References: