An interventional study of Supervised exercise and Lifestyle intervention from baseline to 4 months in Obesity, Weight Loss and Lifestyle, Sedentary, sponsored by Faculdade de Motricidade Humana. Completed at 1 site in Portugal. Open to female participants aged 24 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Faculdade de Motricidade Humana · Not applicable, Interventional, and Prevention
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
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 150 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Faculdade de Motricidade Humana is the lead sponsor of 21 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Supervised exercise · Behavioral: Lifestyle intervention from baseline to 4 months · Behavioral: Monthly behavioral sessions
Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants received no intervention
Behavioral: 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
Behavioral: Lifestyle intervention from baseline to 4 months · Behavioral: Monthly behavioral sessions
Two supervised exercise sessions per week from months 4 to 16
Lifestyle intervention from baseline to 4 months
Monthly behavioral sessions consisted of lifestyle interactive sessions will take place monthly and covered and followed contents that were addressed during the first 4 months of the study
Body weight
A scale (Seca, Hamburg, Germany) was used to assess body weight
Time frame: 0 months
Body weight
A scale (Seca, Hamburg, Germany) was used to assess body weight
Time frame: 4 months
Body weight
A scale (Seca, Hamburg, Germany) was used to assess body weight
Time frame: 16 months
Body weight
A scale (Seca, Hamburg, Germany) was used to assess body weight
Time frame: 22 months
Body height
A scale (Seca, Hamburg, Germany) was used to determine body height
Time frame: 0 months
total and regional fat and fat-free mass
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.
Time frame: 0 months
total and regional fat and fat-free mass
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.
Time frame: 4 months
total and regional fat and fat-free mass
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.
Time frame: 16 months
Thigh Adipose Tissue
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).
Time frame: 0 months
Thigh Adipose Tissue
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).
Time frame: 16 months
Thigh Muscle Distribution
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).
Time frame: 0 months
Thigh Muscle Distribution
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).
Time frame: 16 months
Abdominal Adipose Tissue Distribution
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
Time frame: 0 months
Abdominal Adipose Tissue Distribution Changes
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
Time frame: 16 months
triglycerides
An enzymatic colorimetric method was used to determine triglycerides
Time frame: 0 months
triglycerides
An enzymatic colorimetric method was used to determine triglycerides
Time frame: 16 months
uric acid
An enzymatic colorimetric method was used to determine uric acid
Time frame: 0 months
uric acid
An enzymatic colorimetric method was used to determine uric acid
Time frame: 16 months
total cholesterol
An enzymatic colorimetric method was used to determine total cholesterol
Time frame: 0 months
total cholesterol
An enzymatic colorimetric method was used to determine total cholesterol
Time frame: 16 months
low-density lipoprotein cholesterol
An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol
Time frame: 0 months
low-density lipoprotein cholesterol
An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol
Time frame: 16 months
high-density lipoprotein cholesterol
An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol
Time frame: 0 months
high-density lipoprotein cholesterol
An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol
Time frame: 16 months
Cardiorespiratory
A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
Time frame: 0 months
Cardio-respiratory
A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
Time frame: 16 months
Total-body water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water
Time frame: 0 months
Total-body water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water
Time frame: 16 months
Extracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water
Time frame: 0 months
Extracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water
Time frame: 16 months
Intracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water
Time frame: 0 months
Intracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water
Time frame: 16 months
Resistance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance
Time frame: 0 months
Resistance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance
Time frame: 16 months
Reactance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance
Time frame: 0 months
Reactance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance
Time frame: 16 months
Phase angle
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle
Time frame: 0 months
Phase angle
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle
Time frame: 16 months
Bioelectrical Impedance Vector Analysis
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis
Time frame: 0 months
Bioelectrical Impedance Vector Analysis
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis
Time frame: 16 months
Quality of life reported
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.
Time frame: 0 months
Quality of life reported
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.
Time frame: 4 months
Quality of life reported
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.
Time frame: 16 months
Blood pressure
A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure
Time frame: 0 months
Blood pressure
A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure
Time frame: 16 months
Physical activity
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
Time frame: 0 months
Physical activity
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
Time frame: 4 months
Physical activity
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
Time frame: 16 months
Energy intake
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).
Time frame: 0 months
Energy intake
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).
Time frame: 4 months
Energy intake
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).
Time frame: 16 months
Macro-nutrient
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).
Time frame: 0 months
Macro-nutrient
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).
Time frame: 4 months
Macro-nutrient
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).
Time frame: 16 months
Micro-nutrient
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).
Time frame: 0 months
Micro-nutrient
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).
Time frame: 4 months
Micro-nutrient
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).
Time frame: 16 months
Resting Metabolic rate
Indirect calorimetry for determining resting metabolic rate
Time frame: 0 months
Resting Metabolic rate
Indirect calorimetry for determining resting metabolic rate
Time frame: 16 months
Anthropometric (circumferences)
An anthropometric tape was used to measure body circumferences
Time frame: 0 months
Anthropometric (circumferences)
An anthropometric tape was used to measure body circumferences
Time frame: 4 months
Anthropometric (circumferences)
An anthropometric tape was used to measure body circumferences
Time frame: 16 months
Anthropometric (skinfolds)
A caliper was used to measure skinfolds
Time frame: 0 months
Anthropometric (skinfolds)
A caliper was used to measure skinfolds
Time frame: 4 months
Anthropometric (skinfolds)
A caliper was used to measure skinfolds
Time frame: 16 months
Fasting insulin
Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin
Time frame: 0 months
Fasting insulin
Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin
Time frame: 16 months
Fasting glycemia
Fasting glycemia was assessed by hexokinase method
Time frame: 0 months
Fasting glycemia
Fasting glycemia was assessed by hexokinase method
Time frame: 16 months
Interleukin-6
Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay
Time frame: 0 months
Interleukin-6
Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay
Time frame: 16 months
Tumor necrosis factor-alpha
Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle
Time frame: 0 months
Tumor necrosis factor-alpha
Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle
Time frame: 16 months
Plasminogen activator inhibitor-1
Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)
Time frame: 0 months
Plasminogen activator inhibitor-1
Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)
Time frame: 16 months
fibrinogen concentrations
Fibrinogen concentrations were measured by clotting time
Time frame: 0 months
fibrinogen concentrations
Fibrinogen concentrations were measured by clotting time
Time frame: 16 months
Hemoglobin A1c
Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)
Time frame: 0 months
Hemoglobin A1c
Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)
Time frame: 16 months
serum adiponectin concentration
Serum adiponectin concentration was measured by radioimmunoassay (RIA)
Time frame: 0 months
serum adiponectin concentration
Serum adiponectin concentration was measured by radioimmunoassay (RIA)
Time frame: 16 months
serum leptin concentration
Serum leptin concentration was measured by radioimmunoassay (RIA)
Time frame: 0 months
serum leptin concentration
Serum leptin concentration was measured by radioimmunoassay (RIA)
Time frame: 16 months
urine cortisol
Urine cortisol was measured by radioimmunoassay (RIA)
Time frame: 0 months
urine cortisol
Urine cortisol was measured by radioimmunoassay (RIA)
Time frame: 16 months
microalbuminuria
Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time frame: 0 months
microalbuminuria
Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time frame: 16 months
C-reactive protein
C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time frame: 0 months
C-reactive protein
C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time frame: 16 months
apolipoprotein A1
Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time frame: 0 months
apolipoprotein A1
Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time frame: 16 months
apolipoprotein B100
Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time frame: 0 months
apolipoprotein B100
Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time frame: 16 months
Alanine aminotransferase
Alanine aminotransferase was determined by a kinetic method
Time frame: 0 months
Alanine aminotransferase
Alanine aminotransferase was determined by a kinetic method
Time frame: 16 months
Aspartate aminotransferase
Aspartate aminotransferase was determined by a kinetic method
Time frame: 0 months
Aspartate aminotransferase
Aspartate aminotransferase was determined by a kinetic method
Time frame: 16 months
Plan to share: No — No plans for IPD
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Faculdade de Motricidade Humana