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Completed

NCT Number: NCT03823898

Lifestyle Intervention in Overweight Women

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised exercise

Behavioral

Two supervised exercise sessions per week from months 4 to 16

Lifestyle intervention from baseline to 4 months

Behavioral

Lifestyle intervention from baseline to 4 months

Monthly behavioral sessions

Behavioral

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

Primary outcomes

  1. Body weight

    Time frame: 0 months

    A scale (Seca, Hamburg, Germany) was used to assess body weight

  2. Body weight

    Time frame: 4 months

    A scale (Seca, Hamburg, Germany) was used to assess body weight

  3. Body weight

    Time frame: 16 months

    A scale (Seca, Hamburg, Germany) was used to assess body weight

  4. Body weight

    Time frame: 22 months

    A scale (Seca, Hamburg, Germany) was used to assess body weight

Secondary outcomes

  1. Body height

    Time frame: 0 months

    A scale (Seca, Hamburg, Germany) was used to determine body height

  2. total and regional fat and fat-free mass

    Time frame: 0 months

    Dual-energy x-ray absorptiometry (pencil beam mode, QDR-1500 Hologic, United States) was used to assess changes in total and regional fat and fat-free mass.

  3. total and regional fat and fat-free mass

    Time frame: 4 months

    Dual-energy x-ray absorptiometry (pencil beam mode, QDR-1500 Hologic, United States) was used to assess changes in total and regional fat and fat-free mass.

  4. total and regional fat and fat-free mass

    Time frame: 16 months

    Dual-energy x-ray absorptiometry (pencil beam mode, QDR-1500 Hologic, United States) was used to assess changes in total and regional fat and fat-free mass.

  5. Thigh Adipose Tissue

    Time frame: 0 months

    Using the same scan parameters, contiguous 7-mm-thick cross-sectional images of both legs were obtained between the inferior ischial tuberosity and the superior border of the patella. Total/subcutaneous thigh Adipose tissue was measured by axial computerized tomography (Somaton Plus; Siemens, Germany).

  6. Thigh Adipose Tissue

    Time frame: 16 months

    Using the same scan parameters, contiguous 7-mm-thick cross-sectional images of both legs were obtained between the inferior ischial tuberosity and the superior border of the patella. Total/subcutaneous thigh Adipose tissue was measured by axial computerized tomography (Somaton Plus; Siemens, Germany).

  7. Thigh Muscle Distribution

    Time frame: 0 months

    Using the same scan parameters, contiguous 7-mm-thick cross-sectional images of both legs were obtained between the inferior ischial tuberosity and the superior border of the patella. Muscle tissue was measured by axial computerized tomography (Somaton Plus; Siemens, Germany).

  8. Thigh Muscle Distribution

    Time frame: 16 months

    Using the same scan parameters, contiguous 7-mm-thick cross-sectional images of both legs were obtained between the inferior ischial tuberosity and the superior border of the patella. Muscle tissue was measured by axial computerized tomography (Somaton Plus; Siemens, Germany).

  9. Abdominal Adipose Tissue Distribution

    Time frame: 0 months

    With the subjects supine and arms extended above their head, a single cross-sectional axial computerized tomography (Somaton Plus; Siemens, Germany) L4-L5 intervertebral space image was acquired to measure abdominal adipose tissue compartments

  10. Abdominal Adipose Tissue Distribution Changes

    Time frame: 16 months

    With the subjects supine and arms extended above their head, a single cross-sectional axial computerized tomography (Somaton Plus; Siemens, Germany) L4-L5 intervertebral space image was acquired to measure abdominal adipose tissue compartments

  11. triglycerides

    Time frame: 0 months

    An enzymatic colorimetric method was used to determine triglycerides

  12. triglycerides

    Time frame: 16 months

    An enzymatic colorimetric method was used to determine triglycerides

  13. uric acid

    Time frame: 0 months

    An enzymatic colorimetric method was used to determine uric acid

  14. uric acid

    Time frame: 16 months

    An enzymatic colorimetric method was used to determine uric acid

  15. total cholesterol

    Time frame: 0 months

    An enzymatic colorimetric method was used to determine total cholesterol

  16. total cholesterol

    Time frame: 16 months

    An enzymatic colorimetric method was used to determine total cholesterol

  17. low-density lipoprotein cholesterol

    Time frame: 0 months

    An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol

  18. low-density lipoprotein cholesterol

    Time frame: 16 months

    An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol

  19. high-density lipoprotein cholesterol

    Time frame: 0 months

    An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol

  20. high-density lipoprotein cholesterol

    Time frame: 16 months

    An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol

  21. Cardiorespiratory

    Time frame: 0 months

    A graded exercise testing with gases analysis was used to assess cardio-respiratory changes

  22. Cardio-respiratory

    Time frame: 16 months

    A graded exercise testing with gases analysis was used to assess cardio-respiratory changes

  23. Total-body water

    Time frame: 0 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water

  24. Total-body water

    Time frame: 16 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water

  25. Extracellular water

    Time frame: 0 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water

  26. Extracellular water

    Time frame: 16 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water

  27. Intracellular water

    Time frame: 0 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water

  28. Intracellular water

    Time frame: 16 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water

  29. Resistance

    Time frame: 0 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance

  30. Resistance

    Time frame: 16 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance

  31. Reactance

    Time frame: 0 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance

  32. Reactance

    Time frame: 16 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance

  33. Phase angle

    Time frame: 0 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle

  34. Phase angle

    Time frame: 16 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle

  35. Bioelectrical Impedance Vector Analysis

    Time frame: 0 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis

  36. Bioelectrical Impedance Vector Analysis

    Time frame: 16 months

    Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis

  37. Quality of life reported

    Time frame: 0 months

    The quality of life was reported through the SF-36 questionnaire. The SF-36 is a 36-item, generic quality-of-life measure that assesses 8 domains: (1) physical functioning; (2) role limitation due to physical-health problems; (3) bodily pain; (4) general health perceptions; (5) vitality; (6) social functioning; (7) role limitations due to emotional-health problems; and (8) mental health. Social function, vitality, and general health perceptions scales measure both physical and mental health status. All health measures were scored on scales of 0 to 100, with higher scores indicating better health.

  38. Quality of life reported

    Time frame: 4 months

    The quality of life was reported through the SF-36 questionnaire. The SF-36 is a 36-item, generic quality-of-life measure that assesses 8 domains: (1) physical functioning; (2) role limitation due to physical-health problems; (3) bodily pain; (4) general health perceptions; (5) vitality; (6) social functioning; (7) role limitations due to emotional-health problems; and (8) mental health. Social function, vitality, and general health perceptions scales measure both physical and mental health status. All health measures were scored on scales of 0 to 100, with higher scores indicating better health.

  39. Quality of life reported

    Time frame: 16 months

    The quality of life was reported through the SF-36 questionnaire. The SF-36 is a 36-item, generic quality-of-life measure that assesses 8 domains: (1) physical functioning; (2) role limitation due to physical-health problems; (3) bodily pain; (4) general health perceptions; (5) vitality; (6) social functioning; (7) role limitations due to emotional-health problems; and (8) mental health. Social function, vitality, and general health perceptions scales measure both physical and mental health status. All health measures were scored on scales of 0 to 100, with higher scores indicating better health.

  40. Blood pressure

    Time frame: 0 months

    A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure

  41. Blood pressure

    Time frame: 16 months

    A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure

  42. Physical activity

    Time frame: 0 months

    A self-reported measure of physical activity was used, specifically the short-form of the International physical activity questionnaire (IPAQ-SF). The IPAQ-SF records the last 7 day recall for four intensity levels of physical activity which is vigorous-intensity activity, moderate-intensity activity, walking, and sitting. From IPAQ data were converted to Metabolic Equivalent minutes per week (MET-min/week) using the published formulation the Compendium average MET score. Physical activity of low intensity was characterized by activities inducing less than 3 metabolic equivalents (MET), moderate intensity between 3 and 5.9 MET and for vigorous intensity higher than 6 MET. The higher the number of MET, the higher the intensity. The duration of the activities in each intensity were calculated based on the reported time per week. The higher the duration in activities of moderate to vigorous physical activity the highest the physical activity level

  43. Physical activity

    Time frame: 4 months

    A self-reported measure of physical activity was used, specifically the short-form of the International physical activity questionnaire (IPAQ-SF). The IPAQ-SF records the last 7 day recall for four intensity levels of physical activity which is vigorous-intensity activity, moderate-intensity activity, walking, and sitting. From IPAQ data were converted to Metabolic Equivalent minutes per week (MET-min/week) using the published formulation the Compendium average MET score. Physical activity of low intensity was characterized by activities inducing less than 3 metabolic equivalents (MET), moderate intensity between 3 and 5.9 MET and for vigorous intensity higher than 6 MET. The higher the number of MET, the higher the intensity. The duration of the activities in each intensity were calculated based on the reported time per week. The higher the duration in activities of moderate to vigorous physical activity the highest the physical activity level

  44. Physical activity

    Time frame: 16 months

    A self-reported measure of physical activity was used, specifically the short-form of the International physical activity questionnaire (IPAQ-SF). The IPAQ-SF records the last 7 day recall for four intensity levels of physical activity which is vigorous-intensity activity, moderate-intensity activity, walking, and sitting. From IPAQ data were converted to Metabolic Equivalent minutes per week (MET-min/week) using the published formulation the Compendium average MET score. Physical activity of low intensity was characterized by activities inducing less than 3 metabolic equivalents (MET), moderate intensity between 3 and 5.9 MET and for vigorous intensity higher than 6 MET. The higher the number of MET, the higher the intensity. The duration of the activities in each intensity were calculated based on the reported time per week. The higher the duration in activities of moderate to vigorous physical activity the highest the physical activity level

  45. Energy intake

    Time frame: 0 months

    Energy intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their energy intake. Records were turned in and reviewed at the time of laboratory testing for total energy intake. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).

  46. Energy intake

    Time frame: 4 months

    Energy intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their energy intake. Records were turned in and reviewed at the time of laboratory testing for total energy intake. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).

  47. Energy intake

    Time frame: 16 months

    Energy intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their energy intake. Records were turned in and reviewed at the time of laboratory testing for total energy intake. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).

  48. Macro-nutrient

    Time frame: 0 months

    Macro-nutrient intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their food intake. Records were turned in and reviewed at the time of laboratory testing. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).

  49. Macro-nutrient

    Time frame: 4 months

    Macro-nutrient intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their food intake. Records were turned in and reviewed at the time of laboratory testing. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).

  50. Macro-nutrient

    Time frame: 16 months

    Macro-nutrient intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their food intake. Records were turned in and reviewed at the time of laboratory testing. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).

  51. Micro-nutrient

    Time frame: 0 months

    Micronutrient intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their food intake. Records were turned in and reviewed at the time of laboratory testing. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).

  52. Micro-nutrient

    Time frame: 4 months

    Micronutrient intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their food intake. Records were turned in and reviewed at the time of laboratory testing. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).

  53. Micro-nutrient

    Time frame: 16 months

    Micronutrient intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their food intake. Records were turned in and reviewed at the time of laboratory testing. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).

  54. Resting Metabolic rate

    Time frame: 0 months

    Indirect calorimetry for determining resting metabolic rate

  55. Resting Metabolic rate

    Time frame: 16 months

    Indirect calorimetry for determining resting metabolic rate

  56. Anthropometric (circumferences)

    Time frame: 0 months

    An anthropometric tape was used to measure body circumferences

  57. Anthropometric (circumferences)

    Time frame: 4 months

    An anthropometric tape was used to measure body circumferences

  58. Anthropometric (circumferences)

    Time frame: 16 months

    An anthropometric tape was used to measure body circumferences

  59. Anthropometric (skinfolds)

    Time frame: 0 months

    A caliper was used to measure skinfolds

  60. Anthropometric (skinfolds)

    Time frame: 4 months

    A caliper was used to measure skinfolds

  61. Anthropometric (skinfolds)

    Time frame: 16 months

    A caliper was used to measure skinfolds

  62. Fasting insulin

    Time frame: 0 months

    Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin

  63. Fasting insulin

    Time frame: 16 months

    Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin

  64. Fasting glycemia

    Time frame: 0 months

    Fasting glycemia was assessed by hexokinase method

  65. Fasting glycemia

    Time frame: 16 months

    Fasting glycemia was assessed by hexokinase method

  66. Interleukin-6

    Time frame: 0 months

    Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay

  67. Interleukin-6

    Time frame: 16 months

    Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay

  68. Tumor necrosis factor-alpha

    Time frame: 0 months

    Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle

  69. Tumor necrosis factor-alpha

    Time frame: 16 months

    Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle

  70. Plasminogen activator inhibitor-1

    Time frame: 0 months

    Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)

  71. Plasminogen activator inhibitor-1

    Time frame: 16 months

    Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)

  72. fibrinogen concentrations

    Time frame: 0 months

    Fibrinogen concentrations were measured by clotting time

  73. fibrinogen concentrations

    Time frame: 16 months

    Fibrinogen concentrations were measured by clotting time

  74. Hemoglobin A1c

    Time frame: 0 months

    Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)

  75. Hemoglobin A1c

    Time frame: 16 months

    Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)

  76. serum adiponectin concentration

    Time frame: 0 months

    Serum adiponectin concentration was measured by radioimmunoassay (RIA)

  77. serum adiponectin concentration

    Time frame: 16 months

    Serum adiponectin concentration was measured by radioimmunoassay (RIA)

  78. serum leptin concentration

    Time frame: 0 months

    Serum leptin concentration was measured by radioimmunoassay (RIA)

  79. serum leptin concentration

    Time frame: 16 months

    Serum leptin concentration was measured by radioimmunoassay (RIA)

  80. urine cortisol

    Time frame: 0 months

    Urine cortisol was measured by radioimmunoassay (RIA)

  81. urine cortisol

    Time frame: 16 months

    Urine cortisol was measured by radioimmunoassay (RIA)

  82. microalbuminuria

    Time frame: 0 months

    Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay

  83. microalbuminuria

    Time frame: 16 months

    Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay

  84. C-reactive protein

    Time frame: 0 months

    C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay

  85. C-reactive protein

    Time frame: 16 months

    C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay

  86. apolipoprotein A1

    Time frame: 0 months

    Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay

  87. apolipoprotein A1

    Time frame: 16 months

    Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay

  88. apolipoprotein B100

    Time frame: 0 months

    Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay

  89. apolipoprotein B100

    Time frame: 16 months

    Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay

  90. Alanine aminotransferase

    Time frame: 0 months

    Alanine aminotransferase was determined by a kinetic method

  91. Alanine aminotransferase

    Time frame: 16 months

    Alanine aminotransferase was determined by a kinetic method

  92. Aspartate aminotransferase

    Time frame: 0 months

    Aspartate aminotransferase was determined by a kinetic method

  93. Aspartate aminotransferase

    Time frame: 16 months

    Aspartate aminotransferase was determined by a kinetic method

Sponsors and collaborators

Lead sponsor

Faculdade de Motricidade Humana

Other

Registry information

Official study title

Lifestyle Intervention in Overweight and Obese Premenopausal Women

Acronym: PESO

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Jan 31, 2019
Registry last updated
Feb 27, 2019

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View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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