Nutrition and Physical Activity for Obesity

Obesity Clinical Trial

— PRONAF  

Official title:

Nutrition and Physical Activity Programs for Obesity Treatment (PRONAF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116856
• Other study ID #: PRONAF
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: October 2019
• Source: Universidad Politecnica de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

For Overweight phase:

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.

• 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.

For Obese phase:

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Exercise
Different groups will carry out different exercise protocols during 16 weeks under the same nutritional intervention.

Locations

Country	Name	City	State
Spain	Facultad de Ciencias de la Actividad Física y del Deporte	Madrid
Spain	Pedro J. Benito Peinado	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Universidad Politecnica de Madrid	Hospital Universitario La Paz, Hospital Universitario Marqués de Valdecilla, Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition		After 16 weeks of intervention
Primary	Health status		After 16 weeks of intervention
Primary	Cardiorespiratory fitness		After 16 weeks of intervention
Secondary	Quality of life		After 16 weeks of intervention

External Links

•   Main URL of the project