ObesityPESONCT03823898
Lifestyle Intervention in Overweight Women
A study testing Supervised exercise, Lifestyle intervention from baseline to 4 months and Monthly behavioral sessions in people with Obesity and Weight Loss, run by Faculdade de Motricidade Humana at 1 site in Portugal.
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 Read more about this study
- Who is it for?
- Ages 24 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, Lifestyle, Sedentary
- What is being tested?
- Supervised exercise, Lifestyle intervention from baseline to 4 months and Monthly behavioral sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jan 2002to 1 Dec 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- older than 24 years,
- be premenopausal and not currently pregnant,
- BMI higher than 24.9 kg/m2,
- free from major disease
Who cannot join
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Motricidade Humana
Oeiras, Cruz-Quebrada, 1409-002
About this study
Official title: 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
Read the 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.
- Conditions
- Obesity, Weight Loss, Lifestyle, Sedentary, Physical Activity, Nutritional and Metabolic Disease, Behavior, Health
- Being tested
- Supervised exercise, Lifestyle intervention from baseline to 4 months, Monthly behavioral sessions
- Keywords
- obesity, body composition, weight management, cardiovascular and metabolic markers, Behavioral change, Exercise
- Medical subject headings
- Obesity, Weight Loss, Sedentary Behavior, Motor Activity, Metabolic Diseases, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exerciseBehavioural
Two supervised exercise sessions per week from months 4 to 16
Lifestyle intervention from baseline to 4 monthsBehavioural
Lifestyle intervention from baseline to 4 months
Monthly behavioral sessionsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise | Experimental | 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. Receives: Behavioral: Supervised exercise; Behavioral: Lifestyle intervention from baseline to 4 months; Behavioral: Monthly behavioral sessions |
| Control Group | Active comparator | Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants received no intervention Receives: Behavioral: Lifestyle intervention from baseline to 4 months |
| Monthly behavioral sessions | Experimental | 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 Receives: Behavioral: Lifestyle intervention from baseline to 4 months; Behavioral: Monthly behavioral sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
A scale (Seca, Hamburg, Germany) was used to assess body weight
Measured: 0 months
Body weight
A scale (Seca, Hamburg, Germany) was used to assess body weight
Measured: 4 months
Body weight
A scale (Seca, Hamburg, Germany) was used to assess body weight
Measured: 16 months
Body weight
A scale (Seca, Hamburg, Germany) was used to assess body weight
Measured: 22 months
Secondary outcomes (93)
Body height
A scale (Seca, Hamburg, Germany) was used to determine body height
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 16 months
triglycerides
An enzymatic colorimetric method was used to determine triglycerides
Measured: 0 months
triglycerides
An enzymatic colorimetric method was used to determine triglycerides
Measured: 16 months
uric acid
An enzymatic colorimetric method was used to determine uric acid
Measured: 0 months
uric acid
An enzymatic colorimetric method was used to determine uric acid
Measured: 16 months
total cholesterol
An enzymatic colorimetric method was used to determine total cholesterol
Measured: 0 months
total cholesterol
An enzymatic colorimetric method was used to determine total cholesterol
Measured: 16 months
low-density lipoprotein cholesterol
An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol
Measured: 0 months
low-density lipoprotein cholesterol
An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol
Measured: 16 months
high-density lipoprotein cholesterol
An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol
Measured: 0 months
high-density lipoprotein cholesterol
An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol
Measured: 16 months
Cardiorespiratory
A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
Measured: 0 months
Cardio-respiratory
A graded exercise testing with gases analysis was used to assess cardio-respiratory changes
Measured: 16 months
Total-body water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water
Measured: 0 months
Total-body water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water
Measured: 16 months
Extracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water
Measured: 0 months
Extracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water
Measured: 16 months
Intracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water
Measured: 0 months
Intracellular water
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water
Measured: 16 months
Resistance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance
Measured: 0 months
Resistance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance
Measured: 16 months
Reactance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance
Measured: 0 months
Reactance
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance
Measured: 16 months
Phase angle
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle
Measured: 0 months
Phase angle
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle
Measured: 16 months
Bioelectrical Impedance Vector Analysis
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis
Measured: 0 months
Bioelectrical Impedance Vector Analysis
Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 months
Blood pressure
A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure
Measured: 0 months
Blood pressure
A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 16 months
Resting Metabolic rate
Indirect calorimetry for determining resting metabolic rate
Measured: 0 months
Resting Metabolic rate
Indirect calorimetry for determining resting metabolic rate
Measured: 16 months
Anthropometric (circumferences)
An anthropometric tape was used to measure body circumferences
Measured: 0 months
Anthropometric (circumferences)
An anthropometric tape was used to measure body circumferences
Measured: 4 months
Anthropometric (circumferences)
An anthropometric tape was used to measure body circumferences
Measured: 16 months
Anthropometric (skinfolds)
A caliper was used to measure skinfolds
Measured: 0 months
Anthropometric (skinfolds)
A caliper was used to measure skinfolds
Measured: 4 months
Anthropometric (skinfolds)
A caliper was used to measure skinfolds
Measured: 16 months
Fasting insulin
Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin
Measured: 0 months
Fasting insulin
Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin
Measured: 16 months
Fasting glycemia
Fasting glycemia was assessed by hexokinase method
Measured: 0 months
Fasting glycemia
Fasting glycemia was assessed by hexokinase method
Measured: 16 months
Interleukin-6
Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay
Measured: 0 months
Interleukin-6
Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay
Measured: 16 months
Tumor necrosis factor-alpha
Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle
Measured: 0 months
Tumor necrosis factor-alpha
Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle
Measured: 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)
Measured: 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)
Measured: 16 months
fibrinogen concentrations
Fibrinogen concentrations were measured by clotting time
Measured: 0 months
fibrinogen concentrations
Fibrinogen concentrations were measured by clotting time
Measured: 16 months
Hemoglobin A1c
Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)
Measured: 0 months
Hemoglobin A1c
Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC)
Measured: 16 months
serum adiponectin concentration
Serum adiponectin concentration was measured by radioimmunoassay (RIA)
Measured: 0 months
serum adiponectin concentration
Serum adiponectin concentration was measured by radioimmunoassay (RIA)
Measured: 16 months
serum leptin concentration
Serum leptin concentration was measured by radioimmunoassay (RIA)
Measured: 0 months
serum leptin concentration
Serum leptin concentration was measured by radioimmunoassay (RIA)
Measured: 16 months
urine cortisol
Urine cortisol was measured by radioimmunoassay (RIA)
Measured: 0 months
urine cortisol
Urine cortisol was measured by radioimmunoassay (RIA)
Measured: 16 months
microalbuminuria
Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Measured: 0 months
microalbuminuria
Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Measured: 16 months
C-reactive protein
C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Measured: 0 months
C-reactive protein
C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Measured: 16 months
apolipoprotein A1
Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Measured: 0 months
apolipoprotein A1
Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Measured: 16 months
apolipoprotein B100
Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Measured: 0 months
apolipoprotein B100
Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay
Measured: 16 months
Alanine aminotransferase
Alanine aminotransferase was determined by a kinetic method
Measured: 0 months
Alanine aminotransferase
Alanine aminotransferase was determined by a kinetic method
Measured: 16 months
Aspartate aminotransferase
Aspartate aminotransferase was determined by a kinetic method
Measured: 0 months
Aspartate aminotransferase
Aspartate aminotransferase was determined by a kinetic method
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start2 Jan 2002
- Primary completion1 Jul 2003
- Study completion1 Dec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A clinical trial with three-arm
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Motricidade Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luís Bettencourt Sardinha, Faculdade de Motricidade Humana
- Investigators
- Luís B Sardinha, PhD, Study director, Faculdade Motricidade Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823898
- Sponsor's protocol ID
- PESO-2002
- Acronym
- PESO
- Status last verified
- Feb 2019
- First submitted
- 27 Jan 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans for IPD
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention in Overweight and Obese Premenopausal Women
- ClinicalTrials.gov ID
- NCT03823898
- Acronym / sponsor ID
- PESO / PESO-2002
- Conditions
- Obesity, Weight Loss, Lifestyle, Sedentary, Physical Activity, Nutritional and Metabolic Disease, Behavior, Health
- Keywords
- obesity, body composition, weight management, cardiovascular and metabolic markers, Behavioral change, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Faculdade de Motricidade HumanaUniversity, hospital or other
- Study start
- 2 Jan 2002 (actual)
- Primary completion
- 1 Jul 2003 (actual)
- Study completion
- 1 Dec 2003 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A clinical trial with three-arm
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise | Experimental | Behavioral: Supervised exercise, Behavioral: Lifestyle intervention from baseline to 4 months, Behavioral: Monthly behavioral sessionsParticipants 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. |
| Control Group | Active comparator | Behavioral: Lifestyle intervention from baseline to 4 monthsParticipants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants received no intervention |
| Monthly behavioral sessions | Experimental | Behavioral: Lifestyle intervention from baseline to 4 months, Behavioral: Monthly behavioral sessionsParticipants 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 |
Who may qualify
- Ages
- 24 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- older than 24 years,
- be premenopausal and not currently pregnant,
- BMI higher than 24.9 kg/m2,
- free from major disease
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exerciseTwo supervised exercise sessions per week from months 4 to 16 | Behavioural | Supervised exercise |
| Lifestyle intervention from baseline to 4 monthsLifestyle intervention from baseline to 4 months | Behavioural | Control Group, Monthly behavioral sessions, Supervised exercise |
| Monthly behavioral sessionsMonthly 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 | Behavioural | Monthly behavioral sessions, Supervised exercise |
Primary outcome
Body weight
Time frame: 0 months
A scale (Seca, Hamburg, Germany) was used to assess body weight
Body weight
Time frame: 4 months
A scale (Seca, Hamburg, Germany) was used to assess body weight
Body weight
Time frame: 16 months
A scale (Seca, Hamburg, Germany) was used to assess body weight
Body weight
Time frame: 22 months
A scale (Seca, Hamburg, Germany) was used to assess body weight
93 secondary outcomes
Body height
Time frame: 0 months
total and regional fat and fat-free mass
Time frame: 0 months
total and regional fat and fat-free mass
Time frame: 4 months
total and regional fat and fat-free mass
Time frame: 16 months
Thigh Adipose Tissue
Time frame: 0 months
Thigh Adipose Tissue
Time frame: 16 months
Thigh Muscle Distribution
Time frame: 0 months
Thigh Muscle Distribution
Time frame: 16 months
Abdominal Adipose Tissue Distribution
Time frame: 0 months
Abdominal Adipose Tissue Distribution Changes
Time frame: 16 months
triglycerides
Time frame: 0 months
triglycerides
Time frame: 16 months
uric acid
Time frame: 0 months
uric acid
Time frame: 16 months
total cholesterol
Time frame: 0 months
total cholesterol
Time frame: 16 months
low-density lipoprotein cholesterol
Time frame: 0 months
low-density lipoprotein cholesterol
Time frame: 16 months
high-density lipoprotein cholesterol
Time frame: 0 months
high-density lipoprotein cholesterol
Time frame: 16 months
Cardiorespiratory
Time frame: 0 months
Cardio-respiratory
Time frame: 16 months
Total-body water
Time frame: 0 months
Total-body water
Time frame: 16 months
Extracellular water
Time frame: 0 months
Extracellular water
Time frame: 16 months
Intracellular water
Time frame: 0 months
Intracellular water
Time frame: 16 months
Resistance
Time frame: 0 months
Resistance
Time frame: 16 months
Reactance
Time frame: 0 months
Reactance
Time frame: 16 months
Phase angle
Time frame: 0 months
Phase angle
Time frame: 16 months
Bioelectrical Impedance Vector Analysis
Time frame: 0 months
Bioelectrical Impedance Vector Analysis
Time frame: 16 months
Quality of life reported
Time frame: 0 months
Quality of life reported
Time frame: 4 months
Quality of life reported
Time frame: 16 months
Blood pressure
Time frame: 0 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: No. No plans for IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luís B Sardinha, PhD study director
Faculdade Motricidade Humana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise, Lifestyle intervention from baseline to 4 months and Monthly behavioral sessions in people with Obesity and Weight Loss, run by Faculdade de Motricidade Humana at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 0 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.