Behavior, Health, Cardiovascular Risk Factor, Lifestyle, Sedentary, Nutritional and Metabolic Disease, Obesity, Physical Activity, Weight Loss
Conditions
Keywords
obesity, body composition, weight management, cardiovascular and metabolic markers, Behavioral change, Exercise
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.
Interventions
BEHAVIORALSupervised exercise
Two supervised exercise sessions per week from months 4 to 16
BEHAVIORALLifestyle intervention from baseline to 4 months
Lifestyle intervention from baseline to 4 months
BEHAVIORALMonthly 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
Sponsors
Faculdade de Motricidade Humana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor are masked
Intervention model description
A clinical trial with three-arm
Eligibility
Sex/Gender
FEMALE
Age
24 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 0 months | A scale (Seca, Hamburg, Germany) was used to assess body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glycemia | 0 months | Fasting glycemia was assessed by hexokinase method |
| Interleukin-6 | 0 months | Interleukin-6 (IL-6) was measured by chemiluminescence immunoassay |
| high-density lipoprotein cholesterol | 0 months | An enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol |
| Cardiorespiratory | 0 months | A graded exercise testing with gases analysis was used to assess cardio-respiratory changes |
| Body height | 0 months | A scale (Seca, Hamburg, Germany) was used to determine body height |
| total and regional fat and fat-free mass | 0 months | Dual-energy x-ray absorptiometry (pencil beam mode, QDR-1500 Hologic, United States) was used to assess changes in total and regional fat and fat-free mass. |
| Thigh Adipose Tissue | 0 months | Using the same scan parameters, contiguous 7-mm-thick cross-sectional images of both legs were obtained between the inferior ischial tuberosity and the superior border of the patella. Total/subcutaneous thigh Adipose tissue was measured by axial computerized tomography (Somaton Plus; Siemens, Germany). |
| Thigh Muscle Distribution | 0 months | Using the same scan parameters, contiguous 7-mm-thick cross-sectional images of both legs were obtained between the inferior ischial tuberosity and the superior border of the patella. Muscle tissue was measured by axial computerized tomography (Somaton Plus; Siemens, Germany). |
| Cardio-respiratory | 16 months | A graded exercise testing with gases analysis was used to assess cardio-respiratory changes |
| Total-body water | 0 months | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess total-body water |
| Extracellular water | 0 months | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess extracellular water |
| Abdominal Adipose Tissue Distribution | 0 months | With the subjects supine and arms extended above their head, a single cross-sectional axial computerized tomography (Somaton Plus; Siemens, Germany) L4-L5 intervertebral space image was acquired to measure abdominal adipose tissue compartments |
| Abdominal Adipose Tissue Distribution Changes | 16 months | With the subjects supine and arms extended above their head, a single cross-sectional axial computerized tomography (Somaton Plus; Siemens, Germany) L4-L5 intervertebral space image was acquired to measure abdominal adipose tissue compartments |
| triglycerides | 0 months | An enzymatic colorimetric method was used to determine triglycerides |
| uric acid | 0 months | An enzymatic colorimetric method was used to determine uric acid |
| total cholesterol | 0 months | An enzymatic colorimetric method was used to determine total cholesterol |
| low-density lipoprotein cholesterol | 0 months | An enzymatic colorimetric method was were used to determine low-density lipoprotein cholesterol |
| Intracellular water | 0 months | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess intracellular water |
| Resistance | 0 months | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess resistance |
| Reactance | 0 months | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess reactance |
| Phase angle | 0 months | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess phase angle |
| Bioelectrical Impedance Vector Analysis | 0 months | Bioelectrical impedance spectroscopy (Hydra 4200 Xitron, United States) was used to assess changes in Bioelectrical Impedance Vector Analysis |
| Quality of life reported | 0 months | The quality of life was reported through the SF-36 questionnaire. The SF-36 is a 36-item, generic quality-of-life measure that assesses 8 domains: (1) physical functioning; (2) role limitation due to physical-health problems; (3) bodily pain; (4) general health perceptions; (5) vitality; (6) social functioning; (7) role limitations due to emotional-health problems; and (8) mental health. Social function, vitality, and general health perceptions scales measure both physical and mental health status. All health measures were scored on scales of 0 to 100, with higher scores indicating better health. |
| Blood pressure | 0 months | A sphygmomanometer was used to determine changes in systolic and diastolic blood pressure |
| Physical activity | 0 months | A self-reported measure of physical activity was used, specifically the short-form of the International physical activity questionnaire (IPAQ-SF). The IPAQ-SF records the last 7 day recall for four intensity levels of physical activity which is vigorous-intensity activity, moderate-intensity activity, walking, and sitting. From IPAQ data were converted to Metabolic Equivalent minutes per week (MET-min/week) using the published formulation the Compendium average MET score. Physical activity of low intensity was characterized by activities inducing less than 3 metabolic equivalents (MET), moderate intensity between 3 and 5.9 MET and for vigorous intensity higher than 6 MET. The higher the number of MET, the higher the intensity. The duration of the activities in each intensity were calculated based on the reported time per week. The higher the duration in activities of moderate to vigorous physical activity the highest the physical activity level |
| Energy intake | 0 months | Energy intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their energy intake. Records were turned in and reviewed at the time of laboratory testing for total energy intake. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA). |
| Macro-nutrient | 0 months | Macro-nutrient intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their food intake. Records were turned in and reviewed at the time of laboratory testing. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA). |
| Micro-nutrient | 0 months | Micronutrient intake was assessed during a 3-day period by a 24-hour diet record. Subjects were instructed regarding portion sizes, supplements, food preparation aspects, and other aspects pertaining to an accurate recording of their food intake. Records were turned in and reviewed at the time of laboratory testing. Dietary records were analyzed using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA). |
| Resting Metabolic rate | 0 months | Indirect calorimetry for determining resting metabolic rate |
| Anthropometric (circumferences) | 0 months | An anthropometric tape was used to measure body circumferences |
| Anthropometric (skinfolds) | 0 months | A caliper was used to measure skinfolds |
| Tumor necrosis factor-alpha | 0 months | Tumor necrosis factor-alpha (TNF-alpha) was measured using a high-sensitivity enzyme linked immunosorbent assay (ELISA) principle |
| Plasminogen activator inhibitor-1 | 0 months | Plasminogen activator inhibitor-1 (PAI-1) was measured in iced citrated plasma using the Coatest PAI method (enzyme immunoassay-EIA) |
| fibrinogen concentrations | 0 months | Fibrinogen concentrations were measured by clotting time |
| Hemoglobin A1c | 0 months | Hemoglobin A1c (Hb A1c) was determined by high-pressure liquid chromatography (HPLC) |
| serum adiponectin concentration | 0 months | Serum adiponectin concentration was measured by radioimmunoassay (RIA) |
| serum leptin concentration | 0 months | Serum leptin concentration was measured by radioimmunoassay (RIA) |
| urine cortisol | 0 months | Urine cortisol was measured by radioimmunoassay (RIA) |
| microalbuminuria | 0 months | Microalbuminuria plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay |
| Fasting insulin | 0 months | Electrochemiluminescence immunoassay (ECLIA) was used to assess fasting insulin |
| apolipoprotein A1 | 0 months | Apolipoprotein A1 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay |
| apolipoprotein B100 | 0 months | Apolipoprotein B100 plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay |
| Alanine aminotransferase | 0 months | Alanine aminotransferase was determined by a kinetic method |
| Aspartate aminotransferase | 0 months | Aspartate aminotransferase was determined by a kinetic method |
| C-reactive protein | 0 months | C-reactive protein plasma concentration was measured by high-sensitivity particle-enhanced turbidimetric assay |
Countries
Portugal
Outcome results
None listed