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Nutrition and Physical Activity for Obesity

Nutrition and Physical Activity Programs for Obesity Treatment (PRONAF)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01116856
Acronym
PRONAF
Enrollment
240
Registered
2010-05-05
Start date
2009-01-31
Completion date
2011-12-31
Last updated
2019-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Exercise, Training, Obesity, Overweight, Body composition, Lipidic profile, Nutrition, Polymorphisms

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.

Interventions

OTHERExercise

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

Sponsors

Universidad Complutense de Madrid
CollaboratorOTHER
Hospital Universitario La Paz
CollaboratorOTHER
Hospital Universitario Marqués de Valdecilla
CollaboratorOTHER
Universidad Politecnica de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Two phases, the first for overweight, and the second for obese people

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
Body compositionAfter 16 weeks of intervention
Health statusAfter 16 weeks of intervention
Cardiorespiratory fitnessAfter 16 weeks of intervention

Secondary

MeasureTime frame
Quality of lifeAfter 16 weeks of intervention

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026