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Nutrition and Physical Activity for Obesity (PRONAF)

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ClinicalTrials.gov Identifier: NCT01116856
Recruitment Status : Unknown
Verified September 2010 by Universidad Politecnica de Madrid.
Recruitment status was:  Recruiting
First Posted : May 5, 2010
Last Update Posted : September 30, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Other: Exercise Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nutrition and Physical Activity Programs for Obesity Treatment (PRONAF)
Study Start Date : January 2009
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nutrition
This groups will follow a diet.
Other: Exercise
Different groups will carry out different exercise protocols during 16 weeks under the same nutritional intervention.
Experimental: Nutrition + resistance training
In this group, nutrition and resistance training will be combined.
Other: Exercise
Different groups will carry out different exercise protocols during 16 weeks under the same nutritional intervention.
Experimental: Nutrition + aerobic training
In this group nutrition and aerobic training will be combined.
Other: Exercise
Different groups will carry out different exercise protocols during 16 weeks under the same nutritional intervention.
Experimental: Nutrition + mixed training
In this group the nutrition will be combined with 50% of resistance training plus 50% of aerobic training.
Other: Exercise
Different groups will carry out different exercise protocols during 16 weeks under the same nutritional intervention.

Outcome Measures

Primary Outcome Measures :
  1. Body composition [ Time Frame: After 16 weeks of intervention ]
  2. Health status [ Time Frame: After 16 weeks of intervention ]
  3. Cardiorespiratory fitness [ Time Frame: After 16 weeks of intervention ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: After 16 weeks of intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 30 - 35 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 2011 - June 2011, 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 2011).
  • 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.
  • Substance abuse (drugs, alcohol…). High or moderate consumes of alcohol. More than 2 glasses to the day of any alcoholic substance. Current use of diuretics, beta blockers, steroids or blood thinners.
  • Contraindication to exercise. Alterations, syndromes or diseases detected by electrocardiogram (EKG) o echocardiography. Have injuries o pathologies of the locomotive apparatus that prevent the correct execution of the exercises of the program. Any illness that would prevent participation in a moderate-intense exercise program.
  • Have had cancer in the past 5 years, except skin cancer.
  • Coronary artery disease, liver disease, pulmonary disease, renal disease or other systemic disorders.
  • History or evidence of cardiovascular disease, alterations, syndromes or other mayor chronic illness. Have history of heart disease, heart attacks or heart surgery.
  • Have any illness known to interfere with body weight loss: clinical depression, eating disorder (anorexia, bulimia, etc.), psychological diseases (schizophrenia, etc.), dementia or cognitive function decreased, hypothyroidism no controlled or history of genetic or chromosomal disorder.
  • Have had bariatric surgery or stomach bypass surgery.
  • Gross physical impairment.
  • Blindness or retinopathy.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116856

Contact: Pedro J Benito, PhD +34 91 336 40 53 pedroj.benito@upm.es

Pedro J. Benito Peinado Recruiting
Madrid, Spain, 28080
Contact       pronaf.upm@gmail.com   
Principal Investigator: Pedro J Benito, Ph. D.         
Facultad de Ciencias de la Actividad Física y del Deporte Recruiting
Madrid, Spain, 28939
Contact: Pedro J Benito, PhD    +34913364070    pedroj.benito@upm.es   
Sponsors and Collaborators
Universidad Politecnica de Madrid
Universidad Complutense de Madrid
Hospital Universitario La Paz
Hospital Universitario Marqués de Valdecilla
Principal Investigator: Pedro J Benito, PhD Department of Health and Human Performance, Universidad Politécnica de Madrid
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pedro J. Benito, Universidad Politécnica de Madrid
ClinicalTrials.gov Identifier: NCT01116856     History of Changes
Other Study ID Numbers: PRONAF
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: September 30, 2010
Last Verified: September 2010

Keywords provided by Universidad Politecnica de Madrid:
Body composition
Lipidic profile

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms