Nutrition and physical activity programs for obesity treatment (PRONAF study): methodological approach of the project.

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/DESIGN: 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%). DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01116856.

Effect of different exercise modalities plus a hypocaloric diet on inflammation markers in overweight patients: a randomised trial.

BACKGROUND & AIMS: Inflammation markers (IM) have been associated with the development of chronic diseases. This study compares the effects on IM of three exercise programs combined with a hypocaloric diet. METHODS: 119 overweight participants (73 women, 46 men) aged 18-50 years were randomised into four treatment groups: strength training (S; n = 30), endurance training (E; n = 30), combined S + E (SE; n = 30), and a diet and physical activity recommendations group (D; n = 29). Energy intake, anthropometric variables (AV), training variables (VO2peak, strength index, dynamometric strength index [DSI]) and plasma IM were recorded at baseline and after 22 weeks of treatment. RESULTS: 84 participants completed the study. At 22 weeks, all groups showed a significantly reduced energy intake (P < 0.001) and improved AV (P < 0.001). VO2peak significantly increased in all groups (P < 0.01). DSI increased in the exercise groups only (P < 0.05). Plasma leptin fell significantly (P < 0.001) in the S and E groups, but not significantly in the SE group (P = 0.029) (no significant differences between these groups). Tumour necrosis factor-α (TNF-α), and C-reactive protein (CRP) concentrations decreased in all groups when examined together, but not when examined separately. No significant differences were seen in interleukin-6 (IL-6). CONCLUSIONS: Combining strength or endurance training with a hypocaloric diet improved AV and reduced plasma leptin concentrations. No differences were seen between groups in terms of TNF-α, IL-6 or CRP reduction. This trial was registered at clinical trials.gov as NCT01116856. http://clinicaltrials.gov/.

Evaluation of the usefulness of a low-calorie diet with or without bread in the treatment of overweight/obesity.

BACKGROUND & AIMS: Despite the lack of scientific evidence, bread is one of the most restricted foods in popular hypocaloric diets. The aim of this study was to compare two nutrition strategies (with or without bread) designed to promote weight loss in overweight/obese women. METHODS: A clinical, prospective and randomised study in which 122 women >18 years, BMI ≥ 25 < 40 kg/m(2) were divided into two groups: intervention group (BREAD, n = 61) and control group (NO BREAD, n = 61). Both groups received a low-calorie diet (with or without bread), nutrition education and physical activity guidelines, and were monitored for 16 weeks. RESULTS: 104 women completed the study (48.4 ± 9 years, 29.8 ± 3.5 kg/m(2)). Anthropometric and biochemical markers improved after the intervention without significant differences between groups. BREAD group significantly increased total cereal consumption (3.2 ± 1.3 to 3.7 ± 0.5 servings/day, P < 0.05) and the percentage of energy from carbohydrates (41.2 ± 6.4 vs. 45.9 ± 5.0% P < 0.001) and reduced fat (39.0 ± 6.6 vs. 32.7 ± 5.1% P < 0.001). In contrast, NO BREAD group increased the discrepancy with recommended consumption. NO BREAD group had the most dropouts (21.3% vs. 6.6%, P < 0.05). CONCLUSION: The bread inclusion in a low-calorie diet designed for weight loss favoured a better evolution of dietetic parameters and greater compliance with the diet with fewer dropouts. Registered under ClinicalTrials.gov Identifier no. NCT01223989.