Lifestyle Intervention in Overweight Women (PESO)

Lifestyle Intervention in Overweight and Obese Premenopausal 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

Study Overview

• Status: Completed
• Conditions: Obesity; Physical Activity; Weight Loss; Cardiovascular Risk Factor; Behavior, Health; Nutritional and Metabolic Disease; Lifestyle, Sedentary
• Intervention / Treatment: Behavioral: Supervised exercise; Behavioral: Lifestyle intervention from baseline to 4 months; Behavioral: Monthly behavioral sessions

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Cruz-Quebrada
    • Oeiras, Cruz-Quebrada, Portugal, 1409-002
      • Faculdade de Motricidade Humana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised exercise; Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants were involved in two supervised exercise sessions per week plus healthy lifestyle interactive sessions. The experimental intervention consisted of: a) monthly behavioral sessions consisted of lifestyle interactive sessions took place monthly and covered and followed contents that were addressed during the first 4 months of the study; b) The supervised exercise sessions were prescribed using an aerobic mode performed at a moderate-to-vigorous intensity during 45 minutes, twice a week, preferably during the weekends.	Behavioral: Supervised exercise; Two supervised exercise sessions per week from months 4 to 16; Behavioral: Lifestyle intervention from baseline to 4 months; Lifestyle intervention from baseline to 4 months; Behavioral: 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
Active Comparator: Control Group; Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants received no intervention	Behavioral: Lifestyle intervention from baseline to 4 months; Lifestyle intervention from baseline to 4 months
Experimental: Monthly behavioral sessions; Participants in this group received a lifestyle intervention from baseline to 4 months and then from 4 to 16 months participants were involved in non-supervised exercise group sessions with monthly behavioral sessions. The experimental intervention consisted of monthly behavioral sessions consisted of lifestyle interactive sessions took place monthly and covered and followed contents that were addressed during the first 4 months of the study	Behavioral: Lifestyle intervention from baseline to 4 months; Lifestyle intervention from baseline to 4 months; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Faculdade de Motricidade Humana
• Investigators: Study Director: Luís B Sardinha, PhD, Faculdade Motricidade Humana

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2002
• Primary Completion (Actual): July 1, 2003
• Study Completion (Actual): December 1, 2003

Study Registration Dates

• First Submitted: January 27, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; obesity; body composition; weight management; Behavioral change; cardiovascular and metabolic markers
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight; Metabolic Diseases
• Other Study ID Numbers: PESO-2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans for IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No