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Clinical Trials/NCT03823898
NCT03823898
Completed
N/A

Lifestyle Intervention in Overweight and Obese Premenopausal Women

Faculdade de Motricidade Humana1 site in 1 country150 target enrollmentJanuary 2, 2002

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
Faculdade de Motricidade Humana
Enrollment
150
Locations
1
Primary Endpoint
Body weight
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2002
End Date
December 1, 2003
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Luís Bettencourt Sardinha

Principal investigator

Faculdade de Motricidade Humana

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

Outcomes

Primary Outcomes

Body weight

Time Frame: 22 months

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

Secondary Outcomes

  • Body height(0 months)
  • total and regional fat and fat-free mass(16 months)
  • Thigh Adipose Tissue(16 months)
  • Thigh Muscle Distribution(16 months)
  • Abdominal Adipose Tissue Distribution(0 months)
  • uric acid(16 months)
  • Abdominal Adipose Tissue Distribution Changes(16 months)
  • triglycerides(16 months)
  • total cholesterol(16 months)
  • low-density lipoprotein cholesterol(16 months)
  • high-density lipoprotein cholesterol(16 months)
  • Cardiorespiratory(0 months)
  • Cardio-respiratory(16 months)
  • Total-body water(16 months)
  • Extracellular water(16 months)
  • Intracellular water(16 months)
  • Resistance(16 months)
  • Reactance(16 months)
  • Phase angle(16 months)
  • Bioelectrical Impedance Vector Analysis(16 months)
  • Quality of life reported(16 months)
  • Blood pressure(16 months)
  • Macro-nutrient(16 months)
  • Resting Metabolic rate(16 months)
  • Interleukin-6(16 months)
  • Tumor necrosis factor-alpha(16 months)
  • fibrinogen concentrations(16 months)
  • Micro-nutrient(16 months)
  • Plasminogen activator inhibitor-1(16 months)
  • Hemoglobin A1c(16 months)
  • microalbuminuria(16 months)
  • C-reactive protein(16 months)
  • Physical activity(16 months)
  • Anthropometric (circumferences)(16 months)
  • Fasting glycemia(16 months)
  • apolipoprotein B100(16 months)
  • Energy intake(16 months)
  • Anthropometric (skinfolds)(16 months)
  • Fasting insulin(16 months)
  • urine cortisol(16 months)
  • serum adiponectin concentration(16 months)
  • serum leptin concentration(16 months)
  • apolipoprotein A1(16 months)
  • Alanine aminotransferase(16 months)
  • Aspartate aminotransferase(16 months)

Study Sites (1)

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