title: Nutrition and physical activity programs for obesity treatment (PRONAF study): methodological approach of the project.
abstract: BACKGROUND
  At present, scientific consensus exists on the multifactorial etiopatogenia of obesity. Both professionals and researchers agree that treatment must also have a multifactorial approach, including diet, physical activity, pharmacology and/or surgical treatment. These two last ones should be reserved for those cases of morbid obesities or in case of failure of the previous ones. The aim of the PRONAF study is to determine what type of exercise combined with caloric restriction is the most appropriate to be included in overweigth and obesity intervention programs, and the aim of this paper is to describe the design and the evaluation methods used to carry out the PRONAF study.
  
  
  METHODS
  One-hundred nineteen overweight (46 males) and 120 obese (61 males) subjects aged 18-50 years were randomly assigned to a strength training group, an endurance training group, a combined strength + endurance training group or a diet and physical activity recommendations group. The intervention period was 22 weeks (in all cases 3 times/wk of training for 22 weeks and 2 weeks for pre and post evaluation). All subjects followed a hypocaloric diet (25-30% less energy intake than the daily energy expenditure estimated by accelerometry). 29-34% of the total energy intake came from fat, 14-20% from protein, and 50-55% from carbohydrates. The mayor outcome variables assesed were, biochemical and inflamatory markers, body composition, energy balance, physical fitness, nutritional habits, genetic profile and quality of life. 180 (75.3%) subjects finished the study, with a dropout rate of 24.7%. Dropout reasons included: personal reasons 17 (28.8%), low adherence to exercise 3 (5.1%), low adherence to diet 6 (10.2%), job change 6 (10.2%), and lost interest 27 (45.8%).
  
  
  CONCLUSIONS
  Feasibility of the study has been proven, with a low dropout rate which corresponds to the estimated sample size. Transfer of knowledge is foreseen as a spin-off, in order that overweight and obese subjects can benefit from the results. The aim is to transfer it to sports centres. Effectiveness on individual health-related parameter in order to determine the most effective training programme will be analysed in forthcoming publications.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01116856.
authors.affiliation: Department of Health and Human Performance, Faculty of Physical Activity and Sport Sciences-INEF, Technical University of Madrid, C/Martín Fierro 7, Madrid 28040, Spain. azapico@edu.ucm.es
authors.forename: Augusto G
authors.initials: AG
authors.lastname: Zapico
authors.forename: Pedro J
authors.initials: PJ
authors.lastname: Benito
authors.forename: Marcela
authors.initials: M
authors.lastname: González-Gross
authors.forename: Ana B
authors.initials: AB
authors.lastname: Peinado
authors.forename: Esther
authors.initials: E
authors.lastname: Morencos
authors.forename: Blanca
authors.initials: B
authors.lastname: Romero
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Rojo-Tirado
authors.forename: Rocio
authors.initials: R
authors.lastname: Cupeiro
authors.forename: Barbara
authors.initials: B
authors.lastname: Szendrei
authors.forename: Javier
authors.initials: J
authors.lastname: Butragueño
authors.forename: Maite
authors.initials: M
authors.lastname: Bermejo
authors.forename: María
authors.initials: M
authors.lastname: Alvarez-Sánchez
authors.forename: Miguel
authors.initials: M
authors.lastname: García-Fuentes
authors.forename: Carmen
authors.initials: C
authors.lastname: Gómez-Candela
authors.forename: Laura M
authors.initials: LM
authors.lastname: Bermejo
authors.forename: Ceila
authors.initials: C
authors.lastname: Fernandez-Fernandez
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Calderón
mesh_terms: D000293:Adolescent; D000328:Adult; D031204:Caloric Restriction; D003131:Combined Modality Therapy / Q000379:methods; D005081:Exercise Therapy / Q000379:methods*; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000178:diet therapy / Q000628:therapy*; D050177:Overweight / Q000178:diet therapy / Q000628:therapy*; D015397:Program Evaluation / Q000379:methods; D012107:Research Design; D055815:Young Adult