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Lifestyle Intervention in Overweight Women (PESO)

Primary Purpose

Obesity, Weight Loss, Lifestyle, Sedentary

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Supervised exercise
Lifestyle intervention from baseline to 4 months
Monthly behavioral sessions
Sponsored by
Faculdade de Motricidade Humana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring obesity, body composition, weight management, cardiovascular and metabolic markers, Behavioral change, Exercise

Eligibility Criteria

24 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Faculdade de Motricidade Humana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Supervised exercise

Control Group

Monthly behavioral sessions

Arm 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.

Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants received no intervention

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body height
A scale (Seca, Hamburg, Germany) was used to determine body height
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.
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.
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.
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).
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).
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).
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).
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
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
triglycerides
An enzymatic colorimetric method was used to determine triglycerides
triglycerides
An enzymatic colorimetric method was used to determine triglycerides
uric acid
An enzymatic colorimetric method was used to determine uric acid
uric acid
An enzymatic colorimetric method was used to determine uric acid
total cholesterol
An enzymatic colorimetric method was used to determine total cholesterol
total cholesterol
An enzymatic colorimetric method was used to determine total cholesterol
low-density lipoprotein cholesterol
An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol
low-density lipoprotein cholesterol
An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol
high-density lipoprotein cholesterol
An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol
high-density lipoprotein cholesterol
An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol
Cardiorespiratory
A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
Cardio-respiratory
A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
Total-body water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water
Total-body water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water
Extracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water
Extracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water
Intracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water
Intracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water
Resistance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance
Resistance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance
Reactance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance
Reactance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance
Phase angle
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle
Phase angle
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle
Bioelectrical Impedance Vector Analysis
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis
Bioelectrical Impedance Vector Analysis
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis
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.
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.
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.
Blood pressure
A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure
Blood pressure
A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure
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
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
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
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).
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).
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).
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).
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).
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).
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).
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).
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).
Resting Metabolic rate
Indirect calorimetry for determining resting metabolic rate
Resting Metabolic rate
Indirect calorimetry for determining resting metabolic rate
Anthropometric (circumferences)
An anthropometric tape was used to measure body circumferences
Anthropometric (circumferences)
An anthropometric tape was used to measure body circumferences
Anthropometric (circumferences)
An anthropometric tape was used to measure body circumferences
Anthropometric (skinfolds)
A caliper was used to measure skinfolds
Anthropometric (skinfolds)
A caliper was used to measure skinfolds
Anthropometric (skinfolds)
A caliper was used to measure skinfolds
Fasting insulin
Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin
Fasting insulin
Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin
Fasting glycemia
Fasting glycemia was assessed by hexokinase method
Fasting glycemia
Fasting glycemia was assessed by hexokinase method
Interleukin-6
Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay
Interleukin-6
Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay
Tumor necrosis factor-alpha
Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle
Tumor necrosis factor-alpha
Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle
Plasminogen activator inhibitor-1
Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)
Plasminogen activator inhibitor-1
Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)
fibrinogen concentrations
Fibrinogen concentrations were measured by clotting time
fibrinogen concentrations
Fibrinogen concentrations were measured by clotting time
Hemoglobin A1c
Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)
Hemoglobin A1c
Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)
serum adiponectin concentration
Serum adiponectin concentration was measured by radioimmunoassay (RIA)
serum adiponectin concentration
Serum adiponectin concentration was measured by radioimmunoassay (RIA)
serum leptin concentration
Serum leptin concentration was measured by radioimmunoassay (RIA)
serum leptin concentration
Serum leptin concentration was measured by radioimmunoassay (RIA)
urine cortisol
Urine cortisol was measured by radioimmunoassay (RIA)
urine cortisol
Urine cortisol was measured by radioimmunoassay (RIA)
microalbuminuria
Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
microalbuminuria
Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
C-reactive protein
C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
C-reactive protein
C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
apolipoprotein A1
Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
apolipoprotein A1
Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
apolipoprotein B100
Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
apolipoprotein B100
Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Alanine aminotransferase
Alanine aminotransferase was determined by a kinetic method
Alanine aminotransferase
Alanine aminotransferase was determined by a kinetic method
Aspartate aminotransferase
Aspartate aminotransferase was determined by a kinetic method
Aspartate aminotransferase
Aspartate aminotransferase was determined by a kinetic method

Full Information

First Posted
January 27, 2019
Last Updated
February 25, 2019
Sponsor
Faculdade de Motricidade Humana
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1. Study Identification

Unique Protocol Identification Number
NCT03823898
Brief Title
Lifestyle Intervention in Overweight Women
Acronym
PESO
Official Title
Lifestyle Intervention in Overweight and Obese Premenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2002 (Actual)
Primary Completion Date
July 1, 2003 (Actual)
Study Completion Date
December 1, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Motricidade Humana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, Lifestyle, Sedentary, Physical Activity, Nutritional and Metabolic Disease, Behavior, Health, Cardiovascular Risk Factor
Keywords
obesity, body composition, weight management, cardiovascular and metabolic markers, Behavioral change, Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A clinical trial with three-arm
Masking
Outcomes Assessor
Masking Description
Outcomes assessor are masked
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised exercise
Arm Type
Experimental
Arm 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 Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants received no intervention
Arm Title
Monthly behavioral sessions
Arm Type
Experimental
Arm 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(s)
Supervised exercise
Intervention Description
Two supervised exercise sessions per week from months 4 to 16
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention from baseline to 4 months
Intervention Description
Lifestyle intervention from baseline to 4 months
Intervention Type
Behavioral
Intervention Name(s)
Monthly behavioral sessions
Intervention 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
Primary Outcome Measure Information:
Title
Body weight
Description
A scale (Seca, Hamburg, Germany) was used to assess body weight
Time Frame
0 months
Title
Body weight
Description
A scale (Seca, Hamburg, Germany) was used to assess body weight
Time Frame
4 months
Title
Body weight
Description
A scale (Seca, Hamburg, Germany) was used to assess body weight
Time Frame
16 months
Title
Body weight
Description
A scale (Seca, Hamburg, Germany) was used to assess body weight
Time Frame
22 months
Secondary Outcome Measure Information:
Title
Body height
Description
A scale (Seca, Hamburg, Germany) was used to determine body height
Time Frame
0 months
Title
total and regional fat and fat-free mass
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.
Time Frame
0 months
Title
total and regional fat and fat-free mass
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.
Time Frame
4 months
Title
total and regional fat and fat-free mass
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.
Time Frame
16 months
Title
Thigh Adipose Tissue
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).
Time Frame
0 months
Title
Thigh Adipose Tissue
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).
Time Frame
16 months
Title
Thigh Muscle Distribution
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).
Time Frame
0 months
Title
Thigh Muscle Distribution
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).
Time Frame
16 months
Title
Abdominal Adipose Tissue Distribution
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
Time Frame
0 months
Title
Abdominal Adipose Tissue Distribution Changes
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
Time Frame
16 months
Title
triglycerides
Description
An enzymatic colorimetric method was used to determine triglycerides
Time Frame
0 months
Title
triglycerides
Description
An enzymatic colorimetric method was used to determine triglycerides
Time Frame
16 months
Title
uric acid
Description
An enzymatic colorimetric method was used to determine uric acid
Time Frame
0 months
Title
uric acid
Description
An enzymatic colorimetric method was used to determine uric acid
Time Frame
16 months
Title
total cholesterol
Description
An enzymatic colorimetric method was used to determine total cholesterol
Time Frame
0 months
Title
total cholesterol
Description
An enzymatic colorimetric method was used to determine total cholesterol
Time Frame
16 months
Title
low-density lipoprotein cholesterol
Description
An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol
Time Frame
0 months
Title
low-density lipoprotein cholesterol
Description
An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol
Time Frame
16 months
Title
high-density lipoprotein cholesterol
Description
An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol
Time Frame
0 months
Title
high-density lipoprotein cholesterol
Description
An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol
Time Frame
16 months
Title
Cardiorespiratory
Description
A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
Time Frame
0 months
Title
Cardio-respiratory
Description
A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
Time Frame
16 months
Title
Total-body water
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water
Time Frame
0 months
Title
Total-body water
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water
Time Frame
16 months
Title
Extracellular water
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water
Time Frame
0 months
Title
Extracellular water
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water
Time Frame
16 months
Title
Intracellular water
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water
Time Frame
0 months
Title
Intracellular water
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water
Time Frame
16 months
Title
Resistance
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance
Time Frame
0 months
Title
Resistance
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance
Time Frame
16 months
Title
Reactance
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance
Time Frame
0 months
Title
Reactance
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance
Time Frame
16 months
Title
Phase angle
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle
Time Frame
0 months
Title
Phase angle
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle
Time Frame
16 months
Title
Bioelectrical Impedance Vector Analysis
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis
Time Frame
0 months
Title
Bioelectrical Impedance Vector Analysis
Description
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis
Time Frame
16 months
Title
Quality of life reported
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.
Time Frame
0 months
Title
Quality of life reported
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.
Time Frame
4 months
Title
Quality of life reported
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.
Time Frame
16 months
Title
Blood pressure
Description
A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure
Time Frame
0 months
Title
Blood pressure
Description
A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure
Time Frame
16 months
Title
Physical activity
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
Time Frame
0 months
Title
Physical activity
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
Time Frame
4 months
Title
Physical activity
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
Time Frame
16 months
Title
Energy intake
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).
Time Frame
0 months
Title
Energy intake
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).
Time Frame
4 months
Title
Energy intake
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).
Time Frame
16 months
Title
Macro-nutrient
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).
Time Frame
0 months
Title
Macro-nutrient
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).
Time Frame
4 months
Title
Macro-nutrient
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).
Time Frame
16 months
Title
Micro-nutrient
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).
Time Frame
0 months
Title
Micro-nutrient
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).
Time Frame
4 months
Title
Micro-nutrient
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).
Time Frame
16 months
Title
Resting Metabolic rate
Description
Indirect calorimetry for determining resting metabolic rate
Time Frame
0 months
Title
Resting Metabolic rate
Description
Indirect calorimetry for determining resting metabolic rate
Time Frame
16 months
Title
Anthropometric (circumferences)
Description
An anthropometric tape was used to measure body circumferences
Time Frame
0 months
Title
Anthropometric (circumferences)
Description
An anthropometric tape was used to measure body circumferences
Time Frame
4 months
Title
Anthropometric (circumferences)
Description
An anthropometric tape was used to measure body circumferences
Time Frame
16 months
Title
Anthropometric (skinfolds)
Description
A caliper was used to measure skinfolds
Time Frame
0 months
Title
Anthropometric (skinfolds)
Description
A caliper was used to measure skinfolds
Time Frame
4 months
Title
Anthropometric (skinfolds)
Description
A caliper was used to measure skinfolds
Time Frame
16 months
Title
Fasting insulin
Description
Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin
Time Frame
0 months
Title
Fasting insulin
Description
Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin
Time Frame
16 months
Title
Fasting glycemia
Description
Fasting glycemia was assessed by hexokinase method
Time Frame
0 months
Title
Fasting glycemia
Description
Fasting glycemia was assessed by hexokinase method
Time Frame
16 months
Title
Interleukin-6
Description
Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay
Time Frame
0 months
Title
Interleukin-6
Description
Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay
Time Frame
16 months
Title
Tumor necrosis factor-alpha
Description
Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle
Time Frame
0 months
Title
Tumor necrosis factor-alpha
Description
Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle
Time Frame
16 months
Title
Plasminogen activator inhibitor-1
Description
Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)
Time Frame
0 months
Title
Plasminogen activator inhibitor-1
Description
Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA)
Time Frame
16 months
Title
fibrinogen concentrations
Description
Fibrinogen concentrations were measured by clotting time
Time Frame
0 months
Title
fibrinogen concentrations
Description
Fibrinogen concentrations were measured by clotting time
Time Frame
16 months
Title
Hemoglobin A1c
Description
Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)
Time Frame
0 months
Title
Hemoglobin A1c
Description
Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)
Time Frame
16 months
Title
serum adiponectin concentration
Description
Serum adiponectin concentration was measured by radioimmunoassay (RIA)
Time Frame
0 months
Title
serum adiponectin concentration
Description
Serum adiponectin concentration was measured by radioimmunoassay (RIA)
Time Frame
16 months
Title
serum leptin concentration
Description
Serum leptin concentration was measured by radioimmunoassay (RIA)
Time Frame
0 months
Title
serum leptin concentration
Description
Serum leptin concentration was measured by radioimmunoassay (RIA)
Time Frame
16 months
Title
urine cortisol
Description
Urine cortisol was measured by radioimmunoassay (RIA)
Time Frame
0 months
Title
urine cortisol
Description
Urine cortisol was measured by radioimmunoassay (RIA)
Time Frame
16 months
Title
microalbuminuria
Description
Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time Frame
0 months
Title
microalbuminuria
Description
Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time Frame
16 months
Title
C-reactive protein
Description
C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time Frame
0 months
Title
C-reactive protein
Description
C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time Frame
16 months
Title
apolipoprotein A1
Description
Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time Frame
0 months
Title
apolipoprotein A1
Description
Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time Frame
16 months
Title
apolipoprotein B100
Description
Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time Frame
0 months
Title
apolipoprotein B100
Description
Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Time Frame
16 months
Title
Alanine aminotransferase
Description
Alanine aminotransferase was determined by a kinetic method
Time Frame
0 months
Title
Alanine aminotransferase
Description
Alanine aminotransferase was determined by a kinetic method
Time Frame
16 months
Title
Aspartate aminotransferase
Description
Aspartate aminotransferase was determined by a kinetic method
Time Frame
0 months
Title
Aspartate aminotransferase
Description
Aspartate aminotransferase was determined by a kinetic method
Time Frame
16 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luís B Sardinha, PhD
Organizational Affiliation
Faculdade Motricidade Humana
Official's Role
Study Director
Facility Information:
Facility Name
Faculdade de Motricidade Humana
City
Oeiras
State/Province
Cruz-Quebrada
ZIP/Postal Code
1409-002
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plans for IPD

Learn more about this trial

Lifestyle Intervention in Overweight Women

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