Nutrition and Physical Activity Programs for Obesity Treatment (PRONAF)

Universidad Politecnica de Madrid2 sites in 1 country240 target enrollmentJanuary 2009

ConditionsObesity Overweight

Overview

Phase: N/A
Intervention: Not specified
Conditions: Obesity
Sponsor: Universidad Politecnica de Madrid
Enrollment: 240
Locations: 2
Primary Endpoint: Health status
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

At the present time, scientific consensus exists on obesity multifactorial etiopatogenia. As well, professionals and researchers agree that the treatment must approach several scopes, such as dietetic, physical activity, pharmacologic and surgical. These two last ones should not be the first election and must be reserved for those cases of morbid obesities or in case the previous ones have failed. The combination of diet and exercise is still not sufficiently studied, in special, the addition of strength training, as we propose in this project, for which established intervention protocols do not exist, and that could suppose an additional benefit in the reduction of risk factors.

Therefore, the objectives that we aim in this project are enumerated below:

To discover which are the most effective training protocols and to determine what type of exercise combined with nutrition is more appropriate for obesity intervention programs.
To establish the relationship between markers related with cardiovascular risk (adopokines and lipid profile) and the different intervention protocols proposed.
To describe the influence of nine genetic polymorphisms (selected by their relationship with the energy expense and the physical yield) on the effect of different training protocols.
To determine how important is body composition (fat mass and muscle mass mainly) in total daily energy expenditure.
To establish rules of nutritional and exercise intervention that can be applied in public and private training centers. If the proposed objectives are fulfilled, this would contribute to an improvement in patients health in long term, along with an enormous saving in public health. Therefore, the purpose of this project is to propose new lines of intervention in overweight and obese adults that, until now, little have been investigated. This way, resistance training is proposed in combination with cardiovascular training and endocrinologic treatment. It fits to emphasize that, as far as we know, it is the first project of these characteristics, that puts in touch the public and private sector (hospitals, universities and fitness area), to establish standardized relations protocols to allow a close pursuit of obese patients.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

December 2011

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidad Politecnica de Madrid

Responsible Party

Principal Investigator

Pedro JoseBenito Peinado

PhD

Universidad Politecnica de Madrid

Eligibility Criteria

Inclusion Criteria

•Volunteers: men and women from Comunidad de Madrid (Zone 5 of Health System) who sign the informed consent.
•Ages 18 - 50 years old.
•Pre-menopausal.
•Body mass index (BMI) of 25 - 30 kg•m-2 (both included).
•Able to attend exercise classes 3 times per week (Monday, Wednesday and Friday). No plans for excessive travel. No plans to move from area for study period (January 2010 - June 2010, both included).
•Able to follow the nutritional treatment (avoid medication or substances known to interfere with body weight regulation, including anti-depressive medication, diuretics, etc., 15 days before study starts).
•Willing to not participate in other formal or informal weight loss program during the period of the study.
•Sedentary (less than once a week of training or two hours of physical activity class).

Exclusion Criteria

•Smoking within six months, or use of tobacco or nicotine product.
•Women with irregular menstrual cycle (except with hormone therapy).
•Following a weight loss diet, vegetarians or food restriction due to religion.
•Self-reported weight loss or gain \>5% in past 6 months.
•Are not pregnant, or haven´t been in the past six months. Are not currently nursing or planning to become pregnant during the study period (year 2010).
•Need a special diet by associated disease (celiac disease or chronic renal insufficiency).
•Have metabolic syndrome or fulfill three or more of the following criteria: abdominal obesity (waist diameter \> 102 cm in men and \> 88 cm in women), blood pressure ≥ 130/85 mm Hg, basal glycemia ≥ 110 mg/dL, triglyceride level \> 150 mg/dL and C-HDL \< 40 mg/dL in women and \< 50 mg/dL in men.
•Diabetes.
•Anemia (Hct \< 37%).
•Uncontrolled high blood pressure (Systolic \> 160 mm Hg or diastolic \> 100 mm Hg in rest). Current use of more than one anti-hypertensive medication.