Lifestyle Intervention in Overweight Women

Obesity Clinical Trial

— PESO  

Official title:

Lifestyle Intervention in Overweight and Obese Premenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823898
• Other study ID #: PESO-2002
• Status: Completed
• Phase: N/A
• Start date: January 2, 2002
• Est. completion date: December 1, 2003

Study information

• Verified date: February 2019
• Source: Faculdade de Motricidade Humana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Exercise and Obesity Health Promotion (PESO) program is a randomized controlled trial designed to analyze the effects of a lifestyle intervention in weight management and health-related parameters of overweight and obese premenopausal women

Description:

The PESO (Exercise and Obesity Health Promotion Program) is a program of weight control and exercise promotion for overweight and obese premenopausal women, developed by specialists in exercise, nutrition, and psychology, under medical supervision. It is a program that promotes the autonomy of the participants and the permanent modification of their habits and lifestyles, without the use of drugs or any other products, devices, or techniques of "slimming".

Participants in the PESO Program were able to enjoy a regular and multifaceted group program, aiming to increase knowledge about permanent body weight control, increased motivation and practice of physical activity and exercise, and improved habits food and nutrition. Increases in functional mobility, metabolic health, quality of life and the physical and mental well-being of the participants are central priorities of this Program.

The PESO Program was conducted in a university context and was led by teachers and researchers from the Faculty of Human Motors and other national and foreign institutions. The program is not for commercial purposes, it does not entail financial costs for the participants and it is involved in a wide range of scientific research projects, which have been recognized by individuals and external entities as relevant and of interest to the general population and the community in particular.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 1, 2003
• Est. primary completion date: July 1, 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 24 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Supervised exercise
Two supervised exercise sessions per week from months 4 to 16
• Lifestyle intervention from baseline to 4 months
Lifestyle intervention from baseline to 4 months
• Monthly behavioral sessions
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

Locations

Country	Name	City	State
Portugal	Faculdade de Motricidade Humana	Oeiras	Cruz-Quebrada

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Motricidade Humana

Country where clinical trial is conducted

Portugal, 

Outcome

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