Lifestyle Intervention in Overweight Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lifestyle Intervention in Overweight and Obese Premenopausal Women

Conditions
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Obesity, Weight Loss, Lifestyle, Sedentary, Physical Activity, Nutritional and Metabolic Disease, Behavior, Health, Cardiovascular Risk Factor

Intervention / Treatment
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* Behavioral: Supervised exercise
* Behavioral: Lifestyle intervention from baseline to 4 months
* Behavioral: Monthly behavioral sessions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A clinical trial with three-arm
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised exercise<br>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<br>* Two supervised exercise sessions per week from months 4 to 16<br>Behavioral: Lifestyle intervention from baseline to 4 months<br>* Lifestyle intervention from baseline to 4 months<br>Behavioral: Monthly behavioral sessions<br>* 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<br>|
| Active Comparator: Control Group<br>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<br>* Lifestyle intervention from baseline to 4 months<br>|
| Experimental: Monthly behavioral sessions<br>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<br>* Lifestyle intervention from baseline to 4 months<br>Behavioral: Monthly behavioral sessions<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | A scale (Seca, Hamburg, Germany) was used to assess body weight | 0 months | 
| Body weight | A scale (Seca, Hamburg, Germany) was used to assess body weight | 4 months | 
| Body weight | A scale (Seca, Hamburg, Germany) was used to assess body weight | 16 months | 
| Body weight | A scale (Seca, Hamburg, Germany) was used to assess body weight | 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body height | A scale (Seca, Hamburg, Germany) was used to determine body height | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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 | 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 | 16 months | 
| triglycerides | An enzymatic colorimetric method was used to determine triglycerides | 0 months | 
| triglycerides | An enzymatic colorimetric method was used to determine triglycerides | 16 months | 
| uric acid | An enzymatic colorimetric method was used to determine uric acid | 0 months | 
| uric acid | An enzymatic colorimetric method was used to determine uric acid | 16 months | 
| total cholesterol | An enzymatic colorimetric method was used to determine total cholesterol | 0 months | 
| total cholesterol | An enzymatic colorimetric method was used to determine total cholesterol | 16 months | 
| low-density lipoprotein cholesterol | An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol | 0 months | 
| low-density lipoprotein cholesterol | An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol | 16 months | 
| high-density lipoprotein cholesterol | An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol | 0 months | 
| high-density lipoprotein cholesterol | An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol | 16 months | 
| Cardiorespiratory | A graded exercise testing with gases analysis was used to assess cardio-respiratory changes | 0 months | 
| Cardio-respiratory | A graded exercise testing with gases analysis was used to assess cardio-respiratory changes | 16 months | 
| Total-body water | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water | 0 months | 
| Total-body water | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water | 16 months | 
| Extracellular water | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water | 0 months | 
| Extracellular water | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water | 16 months | 
| Intracellular water | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water | 0 months | 
| Intracellular water | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water | 16 months | 
| Resistance | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance | 0 months | 
| Resistance | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance | 16 months | 
| Reactance | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance | 0 months | 
| Reactance | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance | 16 months | 
| Phase angle | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle | 0 months | 
| Phase angle | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle | 16 months | 
| Bioelectrical Impedance Vector Analysis | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis | 0 months | 
| Bioelectrical Impedance Vector Analysis | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis | 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. | 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. | 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. | 16 months | 
| Blood pressure | A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure | 0 months | 
| Blood pressure | A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure | 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 | 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 | 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 | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 16 months | 
| Resting Metabolic rate | Indirect calorimetry for determining resting metabolic rate | 0 months | 
| Resting Metabolic rate | Indirect calorimetry for determining resting metabolic rate | 16 months | 
| Anthropometric (circumferences) | An anthropometric tape was used to measure body circumferences | 0 months | 
| Anthropometric (circumferences) | An anthropometric tape was used to measure body circumferences | 4 months | 
| Anthropometric (circumferences) | An anthropometric tape was used to measure body circumferences | 16 months | 
| Anthropometric (skinfolds) | A caliper was used to measure skinfolds | 0 months | 
| Anthropometric (skinfolds) | A caliper was used to measure skinfolds | 4 months | 
| Anthropometric (skinfolds) | A caliper was used to measure skinfolds | 16 months | 
| Fasting insulin | Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin | 0 months | 
| Fasting insulin | Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin | 16 months | 
| Fasting glycemia | Fasting glycemia was assessed by hexokinase method | 0 months | 
| Fasting glycemia | Fasting glycemia was assessed by hexokinase method | 16 months | 
| Interleukin-6 | Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay | 0 months | 
| Interleukin-6 | Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay | 16 months | 
| Tumor necrosis factor-alpha | Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle | 0 months | 
| Tumor necrosis factor-alpha | Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle | 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) | 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) | 16 months | 
| fibrinogen concentrations | Fibrinogen concentrations were measured by clotting time | 0 months | 
| fibrinogen concentrations | Fibrinogen concentrations were measured by clotting time | 16 months | 
| Hemoglobin A1c | Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC) | 0 months | 
| Hemoglobin A1c | Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC) | 16 months | 
| serum adiponectin concentration | Serum adiponectin concentration was measured by radioimmunoassay (RIA) | 0 months | 
| serum adiponectin concentration | Serum adiponectin concentration was measured by radioimmunoassay (RIA) | 16 months | 
| serum leptin concentration | Serum leptin concentration was measured by radioimmunoassay (RIA) | 0 months | 
| serum leptin concentration | Serum leptin concentration was measured by radioimmunoassay (RIA) | 16 months | 
| urine cortisol | Urine cortisol was measured by radioimmunoassay (RIA) | 0 months | 
| urine cortisol | Urine cortisol was measured by radioimmunoassay (RIA) | 16 months | 
| microalbuminuria | Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay | 0 months | 
| microalbuminuria | Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay | 16 months | 
| C-reactive protein | C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay | 0 months | 
| C-reactive protein | C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay | 16 months | 
| apolipoprotein A1 | Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay | 0 months | 
| apolipoprotein A1 | Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay | 16 months | 
| apolipoprotein B100 | Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay | 0 months | 
| apolipoprotein B100 | Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay | 16 months | 
| Alanine aminotransferase | Alanine aminotransferase was determined by a kinetic method | 0 months | 
| Alanine aminotransferase | Alanine aminotransferase was determined by a kinetic method | 16 months | 
| Aspartate aminotransferase | Aspartate aminotransferase was determined by a kinetic method | 0 months | 
| Aspartate aminotransferase | Aspartate aminotransferase was determined by a kinetic method | 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, body composition, weight management, cardiovascular and metabolic markers, Behavioral change, Exercise