<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03823898</url>
  </required_header>
  <id_info>
    <org_study_id>PESO-2002</org_study_id>
    <nct_id>NCT03823898</nct_id>
  </id_info>
  <brief_title>Lifestyle Intervention in Overweight Women</brief_title>
  <acronym>PESO</acronym>
  <official_title>Lifestyle Intervention in Overweight and Obese Premenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculdade de Motricidade Humana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculdade de Motricidade Humana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Exercise and Obesity Health Promotion (PESO) program is a randomized controlled trial&#xD;
      designed to analyze the effects of a lifestyle intervention in weight management and&#xD;
      health-related parameters of overweight and obese premenopausal women&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The PESO (Exercise and Obesity Health Promotion Program) is a program of weight control and&#xD;
      exercise promotion for overweight and obese premenopausal women, developed by specialists in&#xD;
      exercise, nutrition, and psychology, under medical supervision. It is a program that promotes&#xD;
      the autonomy of the participants and the permanent modification of their habits and&#xD;
      lifestyles, without the use of drugs or any other products, devices, or techniques of&#xD;
      &quot;slimming&quot;.&#xD;
&#xD;
      Participants in the PESO Program were able to enjoy a regular and multifaceted group program,&#xD;
      aiming to increase knowledge about permanent body weight control, increased motivation and&#xD;
      practice of physical activity and exercise, and improved habits food and nutrition. Increases&#xD;
      in functional mobility, metabolic health, quality of life and the physical and mental&#xD;
      well-being of the participants are central priorities of this Program.&#xD;
&#xD;
      The PESO Program was conducted in a university context and was led by teachers and&#xD;
      researchers from the Faculty of Human Motors and other national and foreign institutions. The&#xD;
      program is not for commercial purposes, it does not entail financial costs for the&#xD;
      participants and it is involved in a wide range of scientific research projects, which have&#xD;
      been recognized by individuals and external entities as relevant and of interest to the&#xD;
      general population and the community in particular.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2002</start_date>
  <completion_date type="Actual">December 1, 2003</completion_date>
  <primary_completion_date type="Actual">July 1, 2003</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A clinical trial with three-arm</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes assessor are masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Body weight</measure>
    <time_frame>0 months</time_frame>
    <description>A scale (Seca, Hamburg, Germany) was used to assess body weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body weight</measure>
    <time_frame>4 months</time_frame>
    <description>A scale (Seca, Hamburg, Germany) was used to assess body weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body weight</measure>
    <time_frame>16 months</time_frame>
    <description>A scale (Seca, Hamburg, Germany) was used to assess body weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body weight</measure>
    <time_frame>22 months</time_frame>
    <description>A scale (Seca, Hamburg, Germany) was used to assess body weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body height</measure>
    <time_frame>0 months</time_frame>
    <description>A scale (Seca, Hamburg, Germany) was used to determine body height</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total and regional fat and fat-free mass</measure>
    <time_frame>0 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total and regional fat and fat-free mass</measure>
    <time_frame>4 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total and regional fat and fat-free mass</measure>
    <time_frame>16 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh Adipose Tissue</measure>
    <time_frame>0 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh Adipose Tissue</measure>
    <time_frame>16 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh Muscle Distribution</measure>
    <time_frame>0 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh Muscle Distribution</measure>
    <time_frame>16 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal Adipose Tissue Distribution</measure>
    <time_frame>0 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal Adipose Tissue Distribution Changes</measure>
    <time_frame>16 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>triglycerides</measure>
    <time_frame>0 months</time_frame>
    <description>An enzymatic colorimetric method was used to determine triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>triglycerides</measure>
    <time_frame>16 months</time_frame>
    <description>An enzymatic colorimetric method was used to determine triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>uric acid</measure>
    <time_frame>0 months</time_frame>
    <description>An enzymatic colorimetric method was used to determine uric acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>uric acid</measure>
    <time_frame>16 months</time_frame>
    <description>An enzymatic colorimetric method was used to determine uric acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total cholesterol</measure>
    <time_frame>0 months</time_frame>
    <description>An enzymatic colorimetric method was used to determine total cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total cholesterol</measure>
    <time_frame>16 months</time_frame>
    <description>An enzymatic colorimetric method was used to determine total cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>low-density lipoprotein cholesterol</measure>
    <time_frame>0 months</time_frame>
    <description>An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>low-density lipoprotein cholesterol</measure>
    <time_frame>16 months</time_frame>
    <description>An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>high-density lipoprotein cholesterol</measure>
    <time_frame>0 months</time_frame>
    <description>An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>high-density lipoprotein cholesterol</measure>
    <time_frame>16 months</time_frame>
    <description>An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory</measure>
    <time_frame>0 months</time_frame>
    <description>A graded exercise testing with gases analysis was used to assess cardio-respiratory changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardio-respiratory</measure>
    <time_frame>16 months</time_frame>
    <description>A graded exercise testing with gases analysis was used to assess cardio-respiratory changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total-body water</measure>
    <time_frame>0 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total-body water</measure>
    <time_frame>16 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extracellular water</measure>
    <time_frame>0 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extracellular water</measure>
    <time_frame>16 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intracellular water</measure>
    <time_frame>0 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intracellular water</measure>
    <time_frame>16 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resistance</measure>
    <time_frame>0 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resistance</measure>
    <time_frame>16 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactance</measure>
    <time_frame>0 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactance</measure>
    <time_frame>16 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase angle</measure>
    <time_frame>0 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase angle</measure>
    <time_frame>16 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bioelectrical Impedance Vector Analysis</measure>
    <time_frame>0 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bioelectrical Impedance Vector Analysis</measure>
    <time_frame>16 months</time_frame>
    <description>Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life reported</measure>
    <time_frame>0 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life reported</measure>
    <time_frame>4 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life reported</measure>
    <time_frame>16 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>0 months</time_frame>
    <description>A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>16 months</time_frame>
    <description>A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>0 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>4 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>16 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy intake</measure>
    <time_frame>0 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy intake</measure>
    <time_frame>4 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy intake</measure>
    <time_frame>16 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macro-nutrient</measure>
    <time_frame>0 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macro-nutrient</measure>
    <time_frame>4 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macro-nutrient</measure>
    <time_frame>16 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Micro-nutrient</measure>
    <time_frame>0 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Micro-nutrient</measure>
    <time_frame>4 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Micro-nutrient</measure>
    <time_frame>16 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting Metabolic rate</measure>
    <time_frame>0 months</time_frame>
    <description>Indirect calorimetry for determining resting metabolic rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting Metabolic rate</measure>
    <time_frame>16 months</time_frame>
    <description>Indirect calorimetry for determining resting metabolic rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric (circumferences)</measure>
    <time_frame>0 months</time_frame>
    <description>An anthropometric tape was used to measure body circumferences</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric (circumferences)</measure>
    <time_frame>4 months</time_frame>
    <description>An anthropometric tape was used to measure body circumferences</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric (circumferences)</measure>
    <time_frame>16 months</time_frame>
    <description>An anthropometric tape was used to measure body circumferences</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric (skinfolds)</measure>
    <time_frame>0 months</time_frame>
    <description>A caliper was used to measure skinfolds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric (skinfolds)</measure>
    <time_frame>4 months</time_frame>
    <description>A caliper was used to measure skinfolds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric (skinfolds)</measure>
    <time_frame>16 months</time_frame>
    <description>A caliper was used to measure skinfolds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting insulin</measure>
    <time_frame>0 months</time_frame>
    <description>Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting insulin</measure>
    <time_frame>16 months</time_frame>
    <description>Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glycemia</measure>
    <time_frame>0 months</time_frame>
    <description>Fasting glycemia was assessed by hexokinase method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glycemia</measure>
    <time_frame>16 months</time_frame>
    <description>Fasting glycemia was assessed by hexokinase method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin-6</measure>
    <time_frame>0 months</time_frame>
    <description>Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin-6</measure>
    <time_frame>16 months</time_frame>
    <description>Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor necrosis factor-alpha</measure>
    <time_frame>0 months</time_frame>
    <description>Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor necrosis factor-alpha</measure>
    <time_frame>16 months</time_frame>
    <description>Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasminogen activator inhibitor-1</measure>
    <time_frame>0 months</time_frame>
    <description>Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasminogen activator inhibitor-1</measure>
    <time_frame>16 months</time_frame>
    <description>Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fibrinogen concentrations</measure>
    <time_frame>0 months</time_frame>
    <description>Fibrinogen concentrations were measured by clotting time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fibrinogen concentrations</measure>
    <time_frame>16 months</time_frame>
    <description>Fibrinogen concentrations were measured by clotting time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>0 months</time_frame>
    <description>Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>16 months</time_frame>
    <description>Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum adiponectin concentration</measure>
    <time_frame>0 months</time_frame>
    <description>Serum adiponectin concentration was measured by radioimmunoassay (RIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum adiponectin concentration</measure>
    <time_frame>16 months</time_frame>
    <description>Serum adiponectin concentration was measured by radioimmunoassay (RIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum leptin concentration</measure>
    <time_frame>0 months</time_frame>
    <description>Serum leptin concentration was measured by radioimmunoassay (RIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum leptin concentration</measure>
    <time_frame>16 months</time_frame>
    <description>Serum leptin concentration was measured by radioimmunoassay (RIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urine cortisol</measure>
    <time_frame>0 months</time_frame>
    <description>Urine cortisol was measured by radioimmunoassay (RIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urine cortisol</measure>
    <time_frame>16 months</time_frame>
    <description>Urine cortisol was measured by radioimmunoassay (RIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microalbuminuria</measure>
    <time_frame>0 months</time_frame>
    <description>Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microalbuminuria</measure>
    <time_frame>16 months</time_frame>
    <description>Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>0 months</time_frame>
    <description>C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>16 months</time_frame>
    <description>C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apolipoprotein A1</measure>
    <time_frame>0 months</time_frame>
    <description>Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apolipoprotein A1</measure>
    <time_frame>16 months</time_frame>
    <description>Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apolipoprotein B100</measure>
    <time_frame>0 months</time_frame>
    <description>Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apolipoprotein B100</measure>
    <time_frame>16 months</time_frame>
    <description>Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine aminotransferase</measure>
    <time_frame>0 months</time_frame>
    <description>Alanine aminotransferase was determined by a kinetic method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine aminotransferase</measure>
    <time_frame>16 months</time_frame>
    <description>Alanine aminotransferase was determined by a kinetic method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate aminotransferase</measure>
    <time_frame>0 months</time_frame>
    <description>Aspartate aminotransferase was determined by a kinetic method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate aminotransferase</measure>
    <time_frame>16 months</time_frame>
    <description>Aspartate aminotransferase was determined by a kinetic method</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Loss</condition>
  <condition>Lifestyle, Sedentary</condition>
  <condition>Physical Activity</condition>
  <condition>Nutritional and Metabolic Disease</condition>
  <condition>Behavior, Health</condition>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>Supervised exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants received no intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monthly behavioral sessions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
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</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervised exercise</intervention_name>
    <description>Two supervised exercise sessions per week from months 4 to 16</description>
    <arm_group_label>Supervised exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle intervention from baseline to 4 months</intervention_name>
    <description>Lifestyle intervention from baseline to 4 months</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Monthly behavioral sessions</arm_group_label>
    <arm_group_label>Supervised exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Monthly behavioral sessions</intervention_name>
    <description>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</description>
    <arm_group_label>Monthly behavioral sessions</arm_group_label>
    <arm_group_label>Supervised exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than 24 years,&#xD;
&#xD;
          -  be premenopausal and not currently pregnant,&#xD;
&#xD;
          -  BMI higher than 24.9 kg/m2,&#xD;
&#xD;
          -  free from major disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not meeting the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luís B Sardinha, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Faculdade Motricidade Humana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculdade de Motricidade Humana</name>
      <address>
        <city>Oeiras</city>
        <state>Cruz-Quebrada</state>
        <zip>1409-002</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Faculdade de Motricidade Humana</investigator_affiliation>
    <investigator_full_name>Luís Bettencourt Sardinha</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>body composition</keyword>
  <keyword>weight management</keyword>
  <keyword>cardiovascular and metabolic markers</keyword>
  <keyword>Behavioral change</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans for IPD</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03823898
org study id: PESO-2002
nct id: NCT03823898
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A clinical trial with three-arm
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Outcomes assessor are masked
measure: Body weight
time frame: 0 months
description: A scale (Seca, Hamburg, Germany) was used to assess body weight
measure: Body weight
time frame: 4 months
description: A scale (Seca, Hamburg, Germany) was used to assess body weight
measure: Body weight
time frame: 16 months
description: A scale (Seca, Hamburg, Germany) was used to assess body weight
measure: Body weight
time frame: 22 months
description: A scale (Seca, Hamburg, Germany) was used to assess body weight
measure: Body height
time frame: 0 months
description: A scale (Seca, Hamburg, Germany) was used to determine body height
measure: total and regional fat and fat-free mass
time frame: 0 months
description: 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.
measure: total and regional fat and fat-free mass
time frame: 4 months
description: 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.
measure: total and regional fat and fat-free mass
time frame: 16 months
description: 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.
measure: Thigh Adipose Tissue
time frame: 0 months
description: 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).
measure: Thigh Adipose Tissue
time frame: 16 months
description: 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).
measure: Thigh Muscle Distribution
time frame: 0 months
description: 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).
measure: Thigh Muscle Distribution
time frame: 16 months
description: 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).
measure: Abdominal Adipose Tissue Distribution
time frame: 0 months
description: 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
measure: Abdominal Adipose Tissue Distribution Changes
time frame: 16 months
description: 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
measure: triglycerides
time frame: 0 months
description: An enzymatic colorimetric method was used to determine triglycerides
measure: triglycerides
time frame: 16 months
description: An enzymatic colorimetric method was used to determine triglycerides
measure: uric acid
time frame: 0 months
description: An enzymatic colorimetric method was used to determine uric acid
measure: uric acid
time frame: 16 months
description: An enzymatic colorimetric method was used to determine uric acid
measure: total cholesterol
time frame: 0 months
description: An enzymatic colorimetric method was used to determine total cholesterol
measure: total cholesterol
time frame: 16 months
description: An enzymatic colorimetric method was used to determine total cholesterol
measure: low-density lipoprotein cholesterol
time frame: 0 months
description: An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol
measure: low-density lipoprotein cholesterol
time frame: 16 months
description: An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol
measure: high-density lipoprotein cholesterol
time frame: 0 months
description: An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol
measure: high-density lipoprotein cholesterol
time frame: 16 months
description: An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol
measure: Cardiorespiratory
time frame: 0 months
description: A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
measure: Cardio-respiratory
time frame: 16 months
description: A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
measure: Total-body water
time frame: 0 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water
measure: Total-body water
time frame: 16 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water
measure: Extracellular water
time frame: 0 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water
measure: Extracellular water
time frame: 16 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water
measure: Intracellular water
time frame: 0 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water
measure: Intracellular water
time frame: 16 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water
measure: Resistance
time frame: 0 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance
measure: Resistance
time frame: 16 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance
measure: Reactance
time frame: 0 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance
measure: Reactance
time frame: 16 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance
measure: Phase angle
time frame: 0 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle
measure: Phase angle
time frame: 16 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle
measure: Bioelectrical Impedance Vector Analysis
time frame: 0 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis
measure: Bioelectrical Impedance Vector Analysis
time frame: 16 months
description: Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis
measure: Quality of life reported
time frame: 0 months
description: 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.
measure: Quality of life reported
time frame: 4 months
description: 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.
measure: Quality of life reported
time frame: 16 months
description: 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.
measure: Blood pressure
time frame: 0 months
description: A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure
measure: Blood pressure
time frame: 16 months
description: A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure
measure: Physical activity
time frame: 0 months
description: 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
measure: Physical activity
time frame: 4 months
description: 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
measure: Physical activity
time frame: 16 months
description: 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
measure: Energy intake
time frame: 0 months
description: 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).
measure: Energy intake
time frame: 4 months
description: 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).
measure: Energy intake
time frame: 16 months
description: 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).
measure: Macro-nutrient
time frame: 0 months
description: 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).
measure: Macro-nutrient
time frame: 4 months
description: 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).
measure: Macro-nutrient
time frame: 16 months
description: 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).
measure: Micro-nutrient
time frame: 0 months
description: 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).
measure: Micro-nutrient
time frame: 4 months
description: 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).
measure: Micro-nutrient
time frame: 16 months
description: 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).
measure: Resting Metabolic rate
time frame: 0 months
description: Indirect calorimetry for determining resting metabolic rate
measure: Resting Metabolic rate
time frame: 16 months
description: Indirect calorimetry for determining resting metabolic rate
measure: Anthropometric (circumferences)
time frame: 0 months
description: An anthropometric tape was used to measure body circumferences
measure: Anthropometric (circumferences)
time frame: 4 months
description: An anthropometric tape was used to measure body circumferences
measure: Anthropometric (circumferences)
time frame: 16 months
description: An anthropometric tape was used to measure body circumferences
measure: Anthropometric (skinfolds)
time frame: 0 months
description: A caliper was used to measure skinfolds
measure: Anthropometric (skinfolds)
time frame: 4 months
description: A caliper was used to measure skinfolds
measure: Anthropometric (skinfolds)
time frame: 16 months
description: A caliper was used to measure skinfolds
measure: Fasting insulin
time frame: 0 months
description: Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin
measure: Fasting insulin
time frame: 16 months
description: Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin
measure: Fasting glycemia
time frame: 0 months
description: Fasting glycemia was assessed by hexokinase method
measure: Fasting glycemia
time frame: 16 months
description: Fasting glycemia was assessed by hexokinase method
measure: Interleukin-6
time frame: 0 months
description: Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay
measure: Interleukin-6
time frame: 16 months
description: Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay
measure: Tumor necrosis factor-alpha
time frame: 0 months
description: Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle
measure: Tumor necrosis factor-alpha
time frame: 16 months
description: Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle
measure: Plasminogen activator inhibitor-1
time frame: 0 months
description: Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)
measure: Plasminogen activator inhibitor-1
time frame: 16 months
description: Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)
measure: fibrinogen concentrations
time frame: 0 months
description: Fibrinogen concentrations were measured by clotting time
measure: fibrinogen concentrations
time frame: 16 months
description: Fibrinogen concentrations were measured by clotting time
measure: Hemoglobin A1c
time frame: 0 months
description: Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)
measure: Hemoglobin A1c
time frame: 16 months
description: Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)
measure: serum adiponectin concentration
time frame: 0 months
description: Serum adiponectin concentration was measured by radioimmunoassay (RIA)
measure: serum adiponectin concentration
time frame: 16 months
description: Serum adiponectin concentration was measured by radioimmunoassay (RIA)
measure: serum leptin concentration
time frame: 0 months
description: Serum leptin concentration was measured by radioimmunoassay (RIA)
measure: serum leptin concentration
time frame: 16 months
description: Serum leptin concentration was measured by radioimmunoassay (RIA)
measure: urine cortisol
time frame: 0 months
description: Urine cortisol was measured by radioimmunoassay (RIA)
measure: urine cortisol
time frame: 16 months
description: Urine cortisol was measured by radioimmunoassay (RIA)
measure: microalbuminuria
time frame: 0 months
description: Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
measure: microalbuminuria
time frame: 16 months
description: Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
measure: C-reactive protein
time frame: 0 months
description: C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
measure: C-reactive protein
time frame: 16 months
description: C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
measure: apolipoprotein A1
time frame: 0 months
description: Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
measure: apolipoprotein A1
time frame: 16 months
description: Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
measure: apolipoprotein B100
time frame: 0 months
description: Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
measure: apolipoprotein B100
time frame: 16 months
description: Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
measure: Alanine aminotransferase
time frame: 0 months
description: Alanine aminotransferase was determined by a kinetic method
measure: Alanine aminotransferase
time frame: 16 months
description: Alanine aminotransferase was determined by a kinetic method
measure: Aspartate aminotransferase
time frame: 0 months
description: Aspartate aminotransferase was determined by a kinetic method
measure: Aspartate aminotransferase
time frame: 16 months
description: Aspartate aminotransferase was determined by a kinetic method
arm group label: Supervised exercise
arm group type: Experimental
description: 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.
arm group label: Control Group
arm group type: Active Comparator
description: Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants received no intervention
arm group label: Monthly behavioral sessions
arm group type: Experimental
description: 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
intervention type: Behavioral
intervention name: Supervised exercise
description: Two supervised exercise sessions per week from months 4 to 16
arm group label: Supervised exercise
intervention type: Behavioral
intervention name: Lifestyle intervention from baseline to 4 months
description: Lifestyle intervention from baseline to 4 months
arm group label: Control Group
arm group label: Monthly behavioral sessions
arm group label: Supervised exercise
intervention type: Behavioral
intervention name: Monthly behavioral sessions
description: 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
arm group label: Monthly behavioral sessions
arm group label: Supervised exercise
criteria: 
gender: Female
minimum age: 24 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luís B Sardinha, PhD
role: Study Director
affiliation: Faculdade Motricidade Humana
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Faculdade de Motricidade Humana
investigator full name: Luís Bettencourt Sardinha
investigator title: Principal investigator
mesh term: Overweight
mesh term: Metabolic Diseases
mesh term: Weight Loss
sharing ipd: No
ipd description: No plans for IPD