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ObesityPRONAFNCT01116856

Nutrition and Physical Activity for Obesity

A study testing Exercise in people with Obesity and Overweight, run by Universidad Politecnica de Madrid at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
2 sitesSpain
Study dates
Jan 2009to Dec 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).
Show all 16Show fewer
  • 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).
  • 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).

Who cannot join

  • 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).
Show all 39Show fewer
  • 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:
  • 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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Pedro J. Benito Peinado

    Madrid, 28080

  • Facultad de Ciencias de la Actividad Física y del Deporte

    Madrid, 28939

Other trials in Spain

About this study

Official title: Nutrition and Physical Activity Programs for Obesity Treatment (PRONAF)

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.
Conditions
Obesity, Overweight
Being tested
Exercise
Keywords
Exercise, Training, Obesity, Overweight, Body composition, Lipidic profile, Nutrition, Polymorphisms
Medical subject headings
Obesity, Overweight, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

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

Study groups in NCT01116856
Study groupRoleWhat they receive
NutritionExperimentalThis groups will follow a diet.
Receives: Other: Exercise
Nutrition + resistance trainingExperimentalIn this group, nutrition and resistance training will be combined.
Receives: Other: Exercise
Nutrition + aerobic trainingExperimentalIn this group nutrition and aerobic training will be combined.
Receives: Other: Exercise
Nutrition + mixed trainingExperimentalIn this group the nutrition will be combined with 50% of resistance training plus 50% of aerobic training.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body composition

    Measured: After 16 weeks of intervention

  2. Health status

    Measured: After 16 weeks of intervention

  3. Cardiorespiratory fitness

    Measured: After 16 weeks of intervention

Secondary outcomes (1)

  1. Quality of life

    Measured: After 16 weeks of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionJan 2010
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two phases, the first for overweight, and the second for obese people
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01116856
Sponsor's protocol ID
PRONAF
Acronym
PRONAF
Status last verified
Oct 2019
First submitted
30 Apr 2010
Last updated
4 Oct 2019
Results posted
No
Data monitoring committee
No

Publications

  • Cupeiro R, Benito P, Amigo T, Gonzalez-Lamuno D. The association of SLC16A1 (MCT1) gene polymorphism with body composition changes during weight loss interventions: A randomized trial with sex-dependent analysis. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-12. doi: 10.1139/apnm-2024-0246.

    PubMed 39787575

  • Benito PJ, Lopez-Plaza B, Bermejo LM, Peinado AB, Cupeiro R, Butragueno J, Rojo-Tirado MA, Gonzalez-Lamuno D, Gomez-Candela C, On Behalf Of The Pronaf Study Group. Strength plus Endurance Training and Individualized Diet Reduce Fat Mass in Overweight Subjects: A Randomized Clinical Trial. Int J Environ Res Public Health. 2020 Apr 10;17(7):2596. doi: 10.3390/ijerph17072596.

    PubMed 32290136

  • Benito PJ, Cupeiro R, Peinado AB, Rojo MA, Maffulli N; PRONAF Study Group. Influence of previous body mass index and sex on regional fat changes in a weight loss intervention. Phys Sportsmed. 2017 Nov;45(4):450-457. doi: 10.1080/00913847.2017.1380500. Epub 2017 Oct 5.

    PubMed 28914104

  • Castro EA, Judice PB, Silva AM, Teixeira PJ, Benito PJ. Sedentary behavior and compensatory mechanisms in response to different doses of exercise-a randomized controlled trial in overweight and obese adults. Eur J Clin Nutr. 2017 Dec;71(12):1393-1398. doi: 10.1038/ejcn.2017.84. Epub 2017 May 31.

    PubMed 28561039

  • Benito PJ, Alvarez-Sanchez M, Diaz V, Morencos E, Peinado AB, Cupeiro R, Maffulli N; PRONAF Study Group. Cardiovascular Fitness and Energy Expenditure Response during a Combined Aerobic and Circuit Weight Training Protocol. PLoS One. 2016 Nov 10;11(11):e0164349. doi: 10.1371/journal.pone.0164349. eCollection 2016.

    PubMed 27832062

  • Benito PJ, Bermejo LM, Peinado AB, Lopez-Plaza B, Cupeiro R, Szendrei B, Calderon FJ, Castro EA, Gomez-Candela C; PRONAF Study Group. Change in weight and body composition in obese subjects following a hypocaloric diet plus different training programs or physical activity recommendations. J Appl Physiol (1985). 2015 Apr 15;118(8):1006-13. doi: 10.1152/japplphysiol.00928.2014. Epub 2015 Feb 26.

    PubMed 25722378

  • Rojo-Tirado MA, Benito PJ, Atienza D, Rincon E, Calderon FJ. Effects of age, sex, and treatment on weight-loss dynamics in overweight people. Appl Physiol Nutr Metab. 2013 Sep;38(9):967-76. doi: 10.1139/apnm-2012-0441. Epub 2013 Apr 30.

    PubMed 23905663

  • Morencos E, Romero B, Peinado AB, Gonzalez-Gross M, Fernandez C, Gomez-Candela C, Benito PJ; PRONAF study group. Effects of dietary restriction combined with different exercise programs or physical activity recommendations on blood lipids in overweight adults. Nutr Hosp. 2012 Nov-Dec;27(6):1916-27. doi: 10.3305/nh.2012.27.6.6057.

    PubMed 23588439

  • Zapico AG, Benito PJ, Gonzalez-Gross M, Peinado AB, Morencos E, Romero B, Rojo-Tirado MA, Cupeiro R, Szendrei B, Butragueno J, Bermejo M, Alvarez-Sanchez M, Garcia-Fuentes M, Gomez-Candela C, Bermejo LM, Fernandez-Fernandez C, Calderon FJ. Nutrition and physical activity programs for obesity treatment (PRONAF study): methodological approach of the project. BMC Public Health. 2012 Dec 21;12:1100. doi: 10.1186/1471-2458-12-1100.

    PubMed 23259716

  • Loria-Kohen V, Fernandez-Fernandez C, Bermejo LM, Morencos E, Romero-Moraleda B, Gomez-Candela C. Effect of different exercise modalities plus a hypocaloric diet on inflammation markers in overweight patients: a randomised trial. Clin Nutr. 2013 Aug;32(4):511-8. doi: 10.1016/j.clnu.2012.10.015. Epub 2012 Nov 6.

    PubMed 23177481

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Obesity and Overweight, run by Universidad Politecnica de Madrid at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition (time frame: After 16 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01116856, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.

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