Metabolic risk management, physical exercise and lifestyle counselling in low-active adults: controlled randomized trial (BELLUGAT).

BACKGROUND: The primary aim of this study is to evaluate the effectiveness of different doses (intensity) of supervised exercise training - concomitant with lifestyle counselling - as a primary care intervention tool for the management of metabolic syndrome risk factors in low-active adults with one or more such factors (programme name in Catalan: Bellugat de CAP a peus). METHODS/DESIGN: Three-arm, randomized controlled clinical trial implemented in the primary care setting, with a duration of 40 weeks (16 weeks intervention and 24-week follow-up). Adults aged 30 to 55 years with metabolic risk factors will be randomized into three intervention groups: 1) aerobic interval training (16 supervised training lessons) plus a healthy lifestyle counselling programme (6 group and 3 individual meetings); 2) low-to-moderate intensity continuous training (16 supervised training lessons) plus the same counselling programme; or 3) the counselling- programme without any supervised physical exercise. The main output variables assessed will be risk factors for metabolic syndrome (waist circumference, blood pressure, and levels of plasma triglycerides, high-density lipoproteins and glucose), systemic inflammation, cardiorespiratory fitness, physical activity and sedentary behaviour, dietary habits, health-related quality of life, self-efficacy and empowerment. Economic factors will also be analysed in order to determine the cost-effectiveness of the programme. These variables will be assessed three times during the study: at baseline, at the end of the intervention, and at follow-up. We estimate to recruit 35 participants per group. DISCUSSION: The results of this study will provide insight into the immediate and medium-term effects on metabolic risk and lifestyle of a combined approach involving aerobic interval training and a multidisciplinary behavioural intervention. If effective, the proposed intervention would provide both researchers and practitioners in this field with a platform on which to develop similar intervention programmes for tackling the repercussions of an unhealthy lifestyle. TRIAL REGISTRATION: Clinical trials.gov. NTC02832453 . Registered 6 July 2016 (retrospectively registered).

Semisupervised Physical Exercise and Lifestyle Counseling in Cardiometabolic Risk Management in Sedentary Adults: Controlled Randomized Trial (BELLUGAT).

BACKGROUND: The purpose of this study was to evaluate the feasibility and effectiveness of a high-intensity semisupervised exercise program alongside lifestyle counseling as an intervention for managing cardiometabolic risk in sedentary adults. METHODS: A 40-week 3-arm randomized controlled clinical trial (16-wk intervention and 24-wk follow-up) was used. Seventy-five sedentary adults (34-55 y) with at least 1 cardiometabolic risk factor were randomized into one of the following arms: (1) aerobic interval training (AIT) plus lifestyle counseling (n = 25), (2) low- to moderate-intensity continuous training plus lifestyle counseling (traditional continuous training, TCT) (n = 27), or (3) lifestyle counseling alone (COU) (n = 23). Metabolic syndrome severity scores, accelerometer-based physical activity, and self-reported dietary habits were assessed at baseline, after the intervention, and at follow-up. RESULTS: AIT was well accepted with high enjoyment scores. All groups showed similar improvements in metabolic syndrome severity scores (standardized effect size = 0.46) and dietary habits (standardized effect size = 0.30). Moderate to vigorous physical activity increased in all study groups, with the number of responders higher in AIT and TCT groups (50%) than in COU group (21%). Both AIT and TCT had a greater impact on sedentary behavior than COU (63.5% vs 30.4% responders). CONCLUSIONS: AIT appears to be a feasible and effective strategy in sedentary individuals with cardiometabolic risk factors. AIT could be included in intervention programs tackling unhealthy lifestyles.

Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial.

INTRODUCTION: Treatment of childhood obesity is a complex challenge for primary health care professionals. OBJECTIVES: To evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake. METHODS: Randomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group) or usual advice from their paediatrician on healthy eating and physical activity. Anthropometric parameters, objectively measured sedentary and physical activity behaviours, and dietary intake were evaluated pre- and post-intervention. RESULTS: At the end of the study period, both groups achieved a similar decrease in body mass index (BMIsd) compared to baseline. Nereu Program participants (n = 54) showed greater increases in moderate-intense physical activity (+6.27% vs. -0.61%, p<0.001) and daily fruit servings (+0.62 vs. +0.13, p<0.026), and decreased daily soft drinks consumption (-0.26 vs. -0.02, p<0.047), respectively, compared to the counselling group (n = 59). CONCLUSIONS: At the end of the 8-month intervention, participants in the Nereu Program group showed improvement in physical activity and dietary behaviours, compared to the counselling group. TRIAL REGISTRATION: ClinicalTrials.gov NCT01878994.