Lifestyle Intervention in Overweight Women
- Conditions
- Physical ActivityBehavior, HealthNutritional and Metabolic DiseaseObesityLifestyle, SedentaryCardiovascular Risk FactorWeight Loss
- Interventions
- Behavioral: Lifestyle intervention from baseline to 4 monthsBehavioral: Supervised exerciseBehavioral: Monthly behavioral sessions
- Registration Number
- NCT03823898
- Lead Sponsor
- Faculdade de Motricidade Humana
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- older than 24 years,
- be premenopausal and not currently pregnant,
- BMI higher than 24.9 kg/m2,
- free from major disease
- Not meeting the inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Lifestyle intervention from baseline to 4 months Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants received no intervention Monthly behavioral sessions 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 Supervised exercise 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. Supervised exercise Lifestyle intervention from baseline to 4 months 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. Supervised exercise Monthly behavioral sessions 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. Monthly behavioral sessions Lifestyle intervention from baseline to 4 months 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
- Primary Outcome Measures
Name Time Method Body weight 22 months A scale (Seca, Hamburg, Germany) was used to assess body weight
- Secondary Outcome Measures
Name Time Method Body height 0 months A scale (Seca, Hamburg, Germany) was used to determine body height
total and regional fat and fat-free mass 16 months Dual-energy x-ray absorptiometry (pencil beam mode, QDR-1500 Hologic, United States) was used to assess changes in total and regional fat and fat-free mass.
Thigh Adipose Tissue 16 months Using the same scan parameters, contiguous 7-mm-thick cross-sectional images of both legs were obtained between the inferior ischial tuberosity and the superior border of the patella. Total/subcutaneous thigh Adipose tissue was measured by axial computerized tomography (Somaton Plus; Siemens, Germany).
Thigh Muscle Distribution 16 months Using the same scan parameters, contiguous 7-mm-thick cross-sectional images of both legs were obtained between the inferior ischial tuberosity and the superior border of the patella. Muscle tissue was measured by axial computerized tomography (Somaton Plus; Siemens, Germany).
Abdominal Adipose Tissue Distribution 0 months With the subjects supine and arms extended above their head, a single cross-sectional axial computerized tomography (Somaton Plus; Siemens, Germany) L4-L5 intervertebral space image was acquired to measure abdominal adipose tissue compartments
uric acid 16 months An enzymatic colorimetric method was used to determine uric acid
Abdominal Adipose Tissue Distribution Changes 16 months With the subjects supine and arms extended above their head, a single cross-sectional axial computerized tomography (Somaton Plus; Siemens, Germany) L4-L5 intervertebral space image was acquired to measure abdominal adipose tissue compartments
triglycerides 16 months An enzymatic colorimetric method was used to determine triglycerides
total cholesterol 16 months An enzymatic colorimetric method was used to determine total cholesterol
Total-body water 16 months Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water
low-density lipoprotein cholesterol 16 months An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol
high-density lipoprotein cholesterol 16 months An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol
Cardiorespiratory 0 months A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
Cardio-respiratory 16 months A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
Extracellular water 16 months Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water
Intracellular water 16 months Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water
Resistance 16 months Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance
Reactance 16 months Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance
Phase angle 16 months Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle
Bioelectrical Impedance Vector Analysis 16 months Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis
Quality of life reported 16 months The quality of life was reported through the SF-36 questionnaire. The SF-36 is a 36-item, generic quality-of-life measure that assesses 8 domains: (1) physical functioning; (2) role limitation due to physical-health problems; (3) bodily pain; (4) general health perceptions; (5) vitality; (6) social functioning; (7) role limitations due to emotional-health problems; and (8) mental health. Social function, vitality, and general health perceptions scales measure both physical and mental health status. All health measures were scored on scales of 0 to 100, with higher scores indicating better health.
Blood pressure 16 months A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure
Macro-nutrient 16 months Macro-nutrient intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their food intake. Records were turned in and reviewed at the time of laboratory testing. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).
Resting Metabolic rate 16 months Indirect calorimetry for determining resting metabolic rate
Interleukin-6 16 months Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay
Tumor necrosis factor-alpha 16 months Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle
fibrinogen concentrations 16 months Fibrinogen concentrations were measured by clotting time
Micro-nutrient 16 months Micronutrient intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their food intake. Records were turned in and reviewed at the time of laboratory testing. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).
Plasminogen activator inhibitor-1 16 months Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)
Hemoglobin A1c 16 months Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)
microalbuminuria 16 months Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
C-reactive protein 16 months C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Physical activity 16 months A self-reported measure of physical activity was used, specifically the short-form of the International physical activity questionnaire (IPAQ-SF). The IPAQ-SF records the last 7 day recall for four intensity levels of physical activity which is vigorous-intensity activity, moderate-intensity activity, walking, and sitting. From IPAQ data were converted to Metabolic Equivalent minutes per week (MET-min/week) using the published formulation the Compendium average MET score. Physical activity of low intensity was characterized by activities inducing less than 3 metabolic equivalents (MET), moderate intensity between 3 and 5.9 MET and for vigorous intensity higher than 6 MET. The higher the number of MET, the higher the intensity. The duration of the activities in each intensity were calculated based on the reported time per week. The higher the duration in activities of moderate to vigorous physical activity the highest the physical activity level
Anthropometric (circumferences) 16 months An anthropometric tape was used to measure body circumferences
Fasting glycemia 16 months Fasting glycemia was assessed by hexokinase method
apolipoprotein B100 16 months Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Energy intake 16 months Energy intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their energy intake. Records were turned in and reviewed at the time of laboratory testing for total energy intake. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).
Anthropometric (skinfolds) 16 months A caliper was used to measure skinfolds
Fasting insulin 16 months Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin
urine cortisol 16 months Urine cortisol was measured by radioimmunoassay (RIA)
serum adiponectin concentration 16 months Serum adiponectin concentration was measured by radioimmunoassay (RIA)
serum leptin concentration 16 months Serum leptin concentration was measured by radioimmunoassay (RIA)
apolipoprotein A1 16 months Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Alanine aminotransferase 16 months Alanine aminotransferase was determined by a kinetic method
Aspartate aminotransferase 16 months Aspartate aminotransferase was determined by a kinetic method
Trial Locations
- Locations (1)
Faculdade de Motricidade Humana
🇵🇹Oeiras, Cruz-Quebrada, Portugal