Clinical Outcomes of Thermal Ablation Re-Treatment of Benign Thyroid Nodules: A Multicenter Study from the Italian Minimally Invasive Treatments of the Thyroid Group.

Background: Thermal ablation (TA) is an established therapeutic option alternative to surgery in patients with solid benign thyroid nodules causing local symptoms. However, a variable part of thyroid nodules remain viable after these nonsurgical treatments, and as many as 15% of nodules treated with TA may require a second treatment over time. This study aimed to evaluate the outcomes of TA re-treatment on symptomatic benign thyroid nodules where the volume decreased by <50% after the first procedure ( = technique inefficacy). Methods: We performed a multicenter retrospective cohort study including patients who underwent re-treatment with TA for benign thyroid nodules, whose volume decreased by <50% after initial treatment. The primary aim was to evaluate volume and volume reduction ratio (VRR) over time and compare the 6- and 12-month VRR after first versus second treatment. The secondary aim was to identify protective or risk factors for technique inefficacy, regrowth, and further treatments, expressed as adjusted hazard ratios (HRs) and confidence interval [CI], after adjustment for sex, age, nodule volume, structure and function, nodule regrowth or symptom relapse, technique used and if the same technique was used for the first and second TA and time between them. Results: We included 135 patients. Re-treatment led to VRR of 50% and 52.2% after 6 and 12 months. VRR after re-treatment was greater than after first treatment in small and medium size nodules (<30 mL), while there were no differences for large nodules (>30 mL). After re-treatment technique inefficacy rate was 51.9%, regrowth rate was 12.6%, and further treatment rate was 15.6%. Radiofrequency ablation (RFA) was protective toward technique inefficacy (HR = 0.40 [CI 0.24-0.65]) and need of further treatments (HR = 0.30 [CI 0.12-0.76]). Large nodule volume (>30 mL) was associated with increased risk of re-treatment (HR = 4.52 [CI 1.38-14.82]). Conclusions: This is the first study evaluating the outcomes of re-treatment on symptomatic benign thyroid nodules with a VRR <50% after the initial TA treatment. Best results were seen in small and medium nodules (<30 mL) and after RFA. Prospective confirmatory studies are needed.

Ultrasound-guided laser ablation of very large benign thyroid nodules: 4-year, retrospective follow-up in 24 patients.

BACKGROUND: Percutaneous, ultrasound-guided laser ablation is a proven management approach for the treatment of Benign Thyroid Nodules (BTN), but only sporadic cases of treatment of large-volume nodules with laser ablation have been reported. The aim of this study was to evaluate the efficacy and safety of laser ablation in the treatment of very large (> 100 mL) thyroid nodules. METHODS: Between 2009 and 2016, 24 patients with very large, BTN received 2-3 sessions of laser ablation over the course of 12 months. Nodule volume was measured before treatment, and at 1 and 4 years. RESULTS: Prior to treatment, median nodule volume was 138 mL (range: 102-289 mL). At 1 year, technique efficacy was achieved in 75% of patients, with median nodule volume significantly reduced to 26 mL (range: 15-31 mL, p < 0.001 vs pretreatment). Volume reduction ratio (VRR) at 1 year was 81%. At 4-year follow-up, median nodule volume was 27 mL (range: 15-33 mL, p < 0.001 vs pretreatment), with a VRR of 80%. Two patients had nodule regrowth > 50% and went to surgery - one patient after 1 year and the other after 3 years. Treatment was well tolerated; there were no major complications, although transient fever occurred in 12% (3/24) of patients and mild-to-moderate pain was experienced by 8% (2/24) of patients. CONCLUSIONS: In this patient series, percutaneous, ultrasound-guided laser ablation of very large thyroid modules provided long-term benefits and the treatment was well tolerated.

Image-guided thermal ablation in autonomously functioning thyroid nodules. A retrospective multicenter three-year follow-up study from the Italian Minimally Invasive Treatment of the Thyroid (MITT) Group.

OBJECTIVES: To report the results of a multicenter retrospective evaluation of the clinical outcomes of thermal ablation (TA) in a large series of autonomously functioning thyroid nodules (AFTN) with a follow-up protracted up to 3 years. METHODS: Patients treated with single TA for an AFTN in Italy were included. Changes in nodule volume, TSH values, and ongoing anti-thyroid therapy were assessed at the 2-, 6-, 12-, 24-, and 36-month follow-up controls. Complications and need of any additional therapy after TA were also registered. RESULTS: A total of 361 patients (244 females, 117 males, median age 58 years, IQR 46-70 years) were included. Nodule volume was significantly reduced at all time points (p < 0.001) (median volume reduction 58% at 6-month and 60% at 12-month). Serum TSH values increased significantly at all time points. After TA, anti-thyroid therapy was withdrawn in 32.5% of patients at 2 months, in 38.9% at 6 months, and in 41.3% at 12 months. A significant difference in the rate of patients who withdrawn medical therapy at 12 months was registered between small (< 10 mL) (74%), medium (49%), or large (> 30 mL) nodules (19%). A single major complication occurred (0.25%). Additional treatments were needed in 34/361 (9.4%) of cases including 4 (1.1%) surgical treatment. CONCLUSIONS: Image-guided thermal ablation offers a further safe and effective therapeutic option in patients with AFTN. Clinical outcomes are significantly more favorable in small than in large size AFTN. KEY POINTS: • Thermal ablations (TA) can be safely and effectively used in patients with autonomously functioning thyroid nodules (AFTN). • TA results in a clinically significant nodule volume reduction that is paralleled by TSH level normalization and anti-thyroid drug therapy discontinuation (after TA anti-thyroid therapy was withdrawn in 41.3% at 12 months). • Clinical outcomes after TA are more favorable in small nodules, and when a large amount of thyroid nodule tissue is ablated.

Percutaneous Ultrasound-Guided Laser Ablation of Benign Thyroid Nodules: Results of 10-Year Follow-Up in 171 Patients.

CONTEXT: Percutaneous, ultrasound-guided laser ablation is effective in nodular thyroid disease. OBJECTIVE: The aim of this study was to evaluate the long-term (10-year) efficacy and safety of laser ablation in the treatment of benign thyroid nodules. METHODS: From 2009 to 2010, 171 patients received a single session of laser ablation. Evaluation of nodule volume was performed before treatment, at 6 months, and every year. RESULTS: Technique efficacy was achieved in 92% of patients at 1 year. Median nodule volume significantly decreased from 16.7 mL (range, 11.0-97.0 mL) at baseline to 5.0 mL (range, 4.1-32.0 mL) at 1 year, a volume reduction ratio (VRR) of 68%. The benefit of the treatment was durable (P < 0.001 vs baseline at all timepoints), with a VRR of 59% after 10 years. No cases of nodule regrowth > 50% were observed at 1 year, although such cases did occur after 4 years (n = 3; 1.7% of the overall cohort) and 7 years (n = 8; 4.7%). There were no further cases of regrowth beyond 7 years. When patients were stratified according to baseline nodule volume (< 15 mL, 15-25 mL, or > 25 mL), durable results were observed across all 3 categories, with the largest, most prolonged effect observed in patients with nodules < 15 mL. Treatment was well tolerated, with only minor, transient complications of fever and local pain, and 98% of patients willing to recommend the treatment. CONCLUSION: Percutaneous, ultrasound-guided laser ablation of benign thyroid nodules provides long-term benefits and the treatment is well tolerated.

Effect of Short Term Intensive Lifestyle Intervention on Hepatic Steatosis Indexes in Adults with Obesity and/or Type 2 Diabetes.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) has an estimated prevalence of 20-30% in the general population and even higher in individuals with metabolic risk factors. The aim of this study was to evaluate the effect of a lifestyle intervention program on surrogate markers of hepatic steatosis in obesity and/or type 2 diabetes patients, enrolled in the C.U.R.I.A.Mo. (Centro Universitario di Ricerca Interdipartimentale Attività Motoria) trial. METHODS: 102 subjects (56 females and 46 males, aged between 23 and 78) with type 2 diabetes, obesity or a BMI of at least 25 kg/m2 with comorbidities, participated in the intensive phase of a multidisciplinary lifestyle intervention program at the Healthy Lifestyle Institute of the University of Perugia (C.U.R.I.A.Mo.). Six indices related to NAFLD (Visceral Adiposity Index, Fatty Liver index, Non-Alcoholic Fatty Liver Disease liver fat score and liver fat equation, hepatic steatosis index and TyG index) were calculated before and after a three-month multidisciplinary lifestyle intervention. RESULTS: The intervention improved the anthropometric and clinical parameters in the total population, the obese and/or diabetics. Data showed a significant weight loss, a reduced waist circumference, triglycerides, and an improvement in Mediterranean diet adherence. Hepatic steatosis indices were significantly reduced in the total population and in different subgroups (males, females, obesity and diabetes).

Combined aerobic and resistance training improves microcirculation in metabolic syndrome.

BACKGROUND: Exercise intervention improves macrovascular function in metabolic syndrome (MeS) patients, but few studies have evaluated the effect of exercise on microcirculatory dysfunction, which plays a key role in the development of MeS and its correlated organ damage. We carried out this intervention study to evaluate the influence of an aerobic and resistance training on skin microvascular reactivity in MeS patients. METHODS: Postocclusive reactive hyperemia (PORH) of the forearm skin was evaluated, by laser-Doppler flowmetry, before and after a 12-week program of aerobic and resistance training in 15 MeS patients referring to our Lipid Metabolism Outpatients Clinic, together with anthropometric, fitness and metabolic parameters; 15 matched MeS patients who did not exercise, served as a control group. The exercise training consisted of 2 sessions/week of aerobic and resistant exercise. RESULTS: Following exercise program, we observed a significant reduction in body weight, fat mass, fasting blood glucose, serum HbA1c and triglycerides, while HDL-cholesterol significantly increased. The exercise-treated group experienced a significant improvement in the area of hyperemia (AH) after PORH, and in all fitness parameters: VO2max, strength on the pulldown lat machine, chest press, leg press and leg extension. A significant correlation emerged between the increase in AH and the reduction in HbA1c and between increase in AH and strength at the chest press, and at the leg extension. CONCLUSIONS: Our study showed that a short-term combined aerobic-resistance training positively affects microvascular reactivity in MeS patients. This improvement is correlated with the reduction of HbA1c and fitness parameters, and particularly with increased muscle strength at the upper and lower limbs.

Physical Activity Modulates the Overexpression of the Inflammatory miR-146a-5p in Obese Patients.

Specific microRNAs (miRs), including the "angio-miR-126" and the "inflamma-miR-146a-5p," have been proposed as biomarkers and even therapeutic targets of obesity-associated metabolic diseases. Physical activity, a key measure of prevention for obesity and its complications, is reported to influence the expression of these miRs. In this study, we investigate whether a physical activity program proven to improve metabolic parameters in obese patients can correct the circulating levels of these miRs. Plasma miR-126 and miR-146a-5p were measured in a cohort of obese patients (n = 31, 16F + 15M) before and after the 3-month physical activity program of the CURIAMO trial (registration number for clinical trials: ACTRN12611000255987) and in 37 lean controls (24F + 13M). miR-146a-5p, but not miR-126, was significantly increased in obese patients as compared with lean controls and decreased in approximately two-thirds of the participants post-intervention with a response that positively correlated with pre-intervention levels of this miR. Waist circumference, the inflammatory cytokine IL-8 and lipid parameters, principally total cholesterol, showed the strongest correlation with both the baseline levels and post-intervention correction of miR-146a-5p. Post-hoc analysis of experimental data supports the use of miR-146a-5p as a biomarker and predictor of the clinical response to physical activity in obese patients. Furthermore, miR-146a-5p expression was confirmed to increase together with that of the inflammatory genes TLR4, NF-κB, IL-6, and TNF-α in LPS-stimulated human mononuclear leukocytes. In conclusion, the inflamma-miR-146a-5p can serve as a personalized predictor of clinical outcome in obese patients entering physical activity weight-reduction programs. © 2018 IUBMB Life, 70(10):1012-1022, 2018.

A single session of laser ablation for toxic thyroid nodules: three-year follow-up results.

PURPOSE: To confirm the effectiveness of laser ablation on toxic nodules in a large population with three years of follow-up. MATERIAL AND METHODS: Between 2009 and 2014, we treated 82 patients with hyperthyroidism related to the presence of a toxic nodular goitre. Patients were pre-treated pharmacologically with methimazole prior to single session of laser ablation (LA) and then followed up every 3 months with FT4 and TSH blood tests as well as ultrasound examination of the nodules treated. RESULTS: All patients responded to the treatment. The median nodule volume decreased from 12 ml (range 5-118 ml) to 5 ml (range 1.2-40 ml) after three years (p < 0.001). The percentage of patients who discontinued methimazole therapy was reduced by increasing the initial volume of the toxic nodule. In nodules with a volume less than 5 ml, all patients were able to suspend methimazole; this percentage was reduced to 90.2% in nodules with a volume between 5 and 15 ml, 61.1% in those with volume 15-25 ml and only 28.5% in nodules larger than 25 ml. We had no major complications but only moderate pain and fever in the evening, a few hours after ablation therapy in 10% of treated patients. CONCLUSIONS: Single session of LA of toxic thyroid nodules is effective and safe, especially in nodules with a volume under 15 ml.

An intensive lifestyle intervention reduces circulating oxidised low-density lipoprotein and increases human paraoxonase activity in obese subjects.

OBJECTIVE: Obesity has a great impact on cardiovascular morbidity and mortality, the treatment of this pathological state is important given the significant health consequences. Lifestyle and behaviour changes play a significant role in weight management. The purpose of this study was to investigate the impact of an intensive multidisciplinary lifestyle intervention on well-known atherogenic factors in a group of overweight and obese subjects. METHODS: A total of 44 people with overweight/obesity underwent a lifestyle intervention based on nutritional education, psychological support and a 3-month exercise training program with a frequency of twice a week. Several anthropometric and biochemical parameters were measured before and after the lifestyle intervention. RESULTS: Lifestyle intervention led to a significant reduction in metabolic profile including body mass index (BMI), waist circumference, systolic and diastolic blood pressure, plasma glucose, and plasma triglycerides. These reductions were also accompanied by a significant increase in maximal oxygen consumption and muscle strength. Furthermore, paraoxonase and lactonase activities and the concentration of Apoliproteins A1 (APO A1) were significantly increased and the serum levels of oxLDL reduced without any changes in the circulating levels of LDL and HDL. CONCLUSION: In conclusion, our study suggests that an intensive lifestyle intervention in obese subjects promotes a series of beneficial antiatherogenic changes which included increased enzyme activites of paraoxonase and lactonase, concentration of Apoliproteins A1 and decreased circulating levels of oxLDL.

A comparison of laser with radiofrequency ablation for the treatment of benign thyroid nodules: a propensity score matching analysis.

PURPOSE: To compare technique efficacy and safety of laser ablation (LA) and radiofrequency ablation (RFA) in treatment of benign thyroid nodules. MATERIALS AND METHODS: Institutional review board approval was obtained, and patients' consent was waived. 601 nodules were treated from May 2009 to December 2014 at eight centres, 449 (309 females, age 57 ± 14 years) with LA and 152 (107 females, age 57 ± 14 years) with RFA. A matched cohort composed of 138 patients from each group was selected after adjustment with propensity score matching. Factors influencing volume reduction at 6 and 12 months and complications were evaluated. RESULTS: No significant differences were observed in the baseline characteristics between groups after propensity score matching adjustment. Mean nodule reduction at 6 and 12 months was -67 ± 19% vs. -57 ± 21% (p < 0.001) - 70 ± 19% vs. -62 ± 22% (p = 0.001) in LA group and in RFA group, respectively. Nodules with volume >30 mL had significantly higher percentage volume reduction at 6 and 12 months (-69 ± 19 vs. -50 ± 21, p = 0.001) and (-73 ± 18 vs. -54 ± 23 8, p = 0.001) in the LA group than in the RFA group, respectively. In both groups, operator's skills affected the results. Major complications occurred in 4 cases in each group (p = 0.116) Conclusions: LA and RFA showed nearly similar outcome but LA was slightly more effective than RFA in large nodules. Operator's skills could be crucial in determining the extent of nodule volume reduction regardless of the used technique.

Effects of an Intensive Lifestyle Intervention to Treat Overweight/Obese Children and Adolescents.

OBJECTIVE: The purpose of the present study is to examine the effects of a multidisciplinary lifestyle intervention to treat overweight/obese children and adolescents. The main outcome was cardiometabolic risk based on the waist-to-height ratio (WHTR) measurement. Secondary outcomes were (1) changes in body composition; (2) adherence to a Mediterranean diet; and (3) physical performance. METHOD: The study involved 74 overweight/obese children or adolescents. The intervention was multidisciplinary including nutrition, exercise, and psychological aspects based on a family-based approach; it was delivered for six months for children and three months for adolescents. Before and after the intervention, several anthropometric measures (height, body weight, body mass index or BMI, waist circumference, and body composition), cardiometabolic risk index (waist-to-height ratio or WHTR), and nutrition habits of the participants and their families were evaluated. In addition, a set of functional motor fitness tests was performed to evaluate physical performance measures. RESULTS: After the intervention both children and adolescents showed a significant reduction in body weight, BMI, waist circumference, fat mass, and WHTR index and an improvement of fat-free mass, adherence to the Mediterranean diet, and physical fitness performance. CONCLUSION: A family-based multidisciplinary approach is effective in the short term in ameliorating the health status, the nutrition habits, and physical performance in children and adolescents.

True Precocious Puberty Following Treatment of a Leydig Cell Tumor: Two Case Reports and Literature Review.

Leydig cell testicular tumors are a rare cause of precocious pseudopuberty in boys. Surgery is the main therapy and shows good overall prognosis. The physical signs of precocious puberty are expected to disappear shortly after surgical removal of the mass. We report two children, 7.5 and 7.7 year-old boys, who underwent testis-sparing surgery for a Leydig cell testicular tumor causing precocious pseudopuberty. During follow-up, after an immediate clinical and laboratory regression, both boys presented signs of precocious puberty and ultimately developed central precocious puberty. They were successfully treated with gonadotropin-releasing hormone (GnRH) analogs. Only six other cases have been described regarding the development of central precocious puberty after successful treatment of a Leydig cell tumor causing precocious pseudopuberty. Gonadotropin-dependent precocious puberty should be considered in children treated for a Leydig cell tumor presenting persistent or recurrent physical signs of puberty activation. In such cases, therapy with GnRH analogs appears to be the most effective medical treatment.

Thyroid nodule morphology affects the efficacy of ultrasound-guided interstitial laser ablation: a nested case-control study.

PURPOSE: The literature reports a wide range of percentages of ablation in the treatment of thyroid nodules. The aim of this nested case-control study was to evaluate whether the different morphological (well-defined vs. agglomerate) characteristics of nodules affect the success rate. MATERIALS AND METHODS: We selected 20 patients with a single and /or dominant well-defined nodule (group 1) and 20 with a nodular formation resulting from the fusion of multiple nodules (group 2). All the nodules were treated by the laser method receiving the same energy. RESULTS: At 6 months, patients in group 1 showed a greater decrease in volume than those in group 2. These differences were more evident after 12 months. CONCLUSIONS: Our study demonstrates that the efficacy of laser treatment can be predicted by nodule morphology and contributes to explaining the wide differences in the percentages of ablation reported in literature.

The impact of strenuous group physical activity on mood states, personal views, body composition, and markers of myocardial damage in overweight/obese adults: the "Step-by-step Italy's coast to coast" trek.

It is clinically relevant to understand whether it is safe to recommend to trained overweight/obese people long-distance treks and whether these experiences could have a negative psychological impact or become even dangerous exposing the trekkers to the risk of clinically silent myocardial damage. To answer these questions we have performed a quantitative/qualitative study comparing the changes in mood profiles, personal views, body composition, and plasma troponin levels of 40 overweight/obese subjects with those of 36 healthy normal weight subjects after the participation in a trek of 388 km from the Adriatic to the Tyrrhenian seas trek: the "Step by step…Italy's coast to coast". The results of this study demonstrate that long-distance treks are a safe activity for trained overweight/obese people which should be recommended because they improve mood, health status, and the relationship of participants with themselves and with the regular practice of exercise with effects similar to those obtained by healthy normal weight subjects.

Description of the EUROBIS program: a combination of an Epode community-based and a clinical care intervention to improve the lifestyles of children and adolescents with overweight or obesity.

The present paper describes the Epode Umbria Region Obesity Prevention Study (EUROBIS) and aims to implement the C.U.R.I.A.MO. model through the EPODE methodology. The main goal of the EUROBIS is to change the pendency of slope of the actual trend towards the increase in the yearly rates of childhood overweight and obesity in Umbria and to improve healthy lifestyles of children and their parents. The project is the first EPODE program to be performed in Italy. The aims of the Italian EUROBIS study are: (1) a community-based intervention program (CBP) carrying out activities in all primary schools of the Umbria Region and family settings as first step, to reverse the current obesity trend on a long-term basis, and (2) a clinical care program for childhood and adolescent by C.U.R.I.A.MO. model. C.U.R.I.A.MO. model is a multidisciplinary approach to improve three key aspects of healthy lifestyles: nutrition, exercise, and psychological aspects with the strategy of a family-based approach. The community-based intervention and clinical trial provide an innovative valuable model to address the childhood obesity prevention and treatment in Italy.

The role of both parents' attachment pattern in understanding childhood obesity.

Within the research area on the determinants of childhood obesity, a relatively new approach is the use of attachment theory to explore the mechanisms underlying children's obesity risk, especially considered as emotion regulation strategies in parent-child relationship. Few are the empirical researches that have addressed this issue. The empirical investigations have used self-report measures to assess adult attachment. In attachment studies, the use of interview methods and/or performance-based instruments is advised to evaluate the entire range of possible adult attachment patterns and comprehensively explain the emotional strategies, correlates, and consequences of individual differences in attachment system functioning. The aim of this study was to explore the extent to which both parents' attachment patterns serve as self-regulative mechanisms related to childhood overweight/obesity by the Adult Attachment Projective Picture System (AAP) in a sample of 44 mothers and fathers of children referred for obesity. Insecure attachment was found as a risk factor both for mothers and fathers. Also unresolved/disorganization was found to play a significant role in childhood obesity. The role of father's attachment was explored and findings suggested considering it in etiology and treatment of childhood obesity.

A time-lagged, actor-partner interdependence analysis of alliance to the group as a whole and group member outcome in overweight and obesity treatment groups.

A time-lagged design was used to examine how the perceptions of alliance to the group as a whole by the other group members at an earlier point in the group were related to an individual group member's perceptions of alliance to the group as a whole at a later point in the group. We also examined how treatment outcome moderated this relationship. Seventy-three patients diagnosed as overweight or obese participating in 10 short-term therapy groups provided data for analyses. Group members completed measures of cohesion to the group and alliance to the group as a whole at the third, sixth, and last session of 12-session groups as well as pre- and posttest ratings on Obesity-Related Well-Being and the Outcome Questionnaire-45. As hypothesized, earlier ratings of alliance to the group as a whole by the other group members were related to later ratings of alliance to the group as a whole by the group member. Also as hypothesized, when group members had a better outcome, there was a significant positive relationship between perceptions of alliance to the group as a whole by the other group members at an earlier point in the group and an individual group member's perceptions of alliance to the group as a whole at a later point in time. When members had a worse outcome, there was no relationship between perceptions of alliance to the group as a whole by the other group members at an earlier point in the group and an individual group member's perceptions of alliance to the group as a whole at a later point in the group.

Parental alliance and family functioning in pediatric obesity from both parents' perspectives.

OBJECTIVE: The aim of the present study was to investigate the maternal and paternal specific contributions on the associations between family socioeconomic status, parental anthropometric factors, parental alliance, and family functioning. These were assessed separately for mothers and fathers, by means of a case-control study with families of Italian youths with and without overweight/obesity. METHODS: Ninety families with children aged 11 to 16 years (mean = 13.27 years; SD = 1.5) participated in the study. Half of the families included children with overweight/obesity (n = 45). The body mass indices (BMIs) of youths and parents were measured and the former transformed in BMI z-scores. The parents completed the Parenting Alliance Measure and the Family Assessment Measure Version III, General Scale. RESULTS: Higher levels of dysfunction in parental alliance and family functioning of the mothers and fathers of the overweight/obese group were found. Socioeconomic status did not contribute significantly to the prediction of overweight and obesity in youth. Both maternal and paternal BMIs were positively associated with youth overweight/obesity. The degrees of parental alliance perceived by both mothers (odds ratio [OR], 81; 95% confidence interval [CI], 0.72-0.90) and fathers (OR, 89; 95% CI, 0.81-0.98) predicted child's weight status. The perception of poor parental and familial functioning by both parents contributed to the prediction of overweight and obesity in youth (mother: OR, 1.06; 95% CI, 1.02-1.10; father: OR, 1.06; 95% CI, 1.01-1.11). CONCLUSION: The results support a strong effect of parental and family functioning on a youth's overweight/obesity also from the father's perspective. The importance of considering the father's perspective is discussed.

Feasibility and effectiveness in clinical practice of a multifactorial intervention for the reduction of cardiovascular risk in patients with type 2 diabetes: the 2-year interim analysis of the MIND.IT study: a cluster randomized trial.

OBJECTIVE: To evaluate the feasibility and effectiveness of an intensive, multifactorial cardiovascular risk reduction intervention in a clinic-based setting. RESEARCH DESIGN AND METHODS: The study was a pragmatic, cluster randomized trial, with the diabetes clinic as the unit of randomization. Clinics were randomly assigned to either continue their usual care (n = 5) or to apply an intensive intervention aimed at the optimal control of cardiovascular disease (CVD) risk factors and hyperglycemia (n = 4). To account for clustering, mixed model regression techniques were used to compare differences in CVD risk factors and HbA1c. Analyses were performed both by intent to treat and as treated per protocol. RESULTS: Nine clinics completed the study; 1,461 patients with type 2 diabetes and no previous cardiovascular events were enrolled. After 2 years, participants in the interventional group had significantly lower BMI, HbA1c, LDL cholesterol, and triglyceride levels and significantly higher HDL cholesterol level than did the usual care group. The proportion of patients reaching the treatment goals was systematically higher in the interventional clinics (35% vs. 24% for LDL cholesterol, P = 0.1299; 93% vs. 82% for HDL cholesterol, P = 0.0005; 80% vs. 64% for triglycerides, P = 0.0002; 39% vs. 22% for HbA1c, P = 0.0259; 13% vs. 5% for blood pressure, P = 0.1638). The analysis as treated per protocol confirmed these findings, showing larger and always significant differences between the study arms for all targets. CONCLUSIONS: A multifactorial intensive intervention in type 2 diabetes is feasible and effective in clinical practice and it is associated with significant and durable improvement in HbA1c and CVD risk profile.