Massimo Cuzzolaro

BioEnterics® Intragastric Balloon (BIB®) : a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

Background:The BioEnterics® Intragastric Balloon (BIB®) System in association with restricted diet has been used for the short-term treatment of morbid obesity. Aim of this study was to evaluate the real, short term, efficacy of the BIB for weight reduction in morbidly obese patients by using a prospective, double-blind, randomised, sham-controlled, crossover study.Methods:Patients were recruited from January 2003 to December 2003. After selection, they were randomly allocated into two groups: BIB followed by sham procedure after 3 months (Group A), and sham procedure followed by BIB after 3 months (Group B). All endoscopic procedures were performed under unconscious intravenous sedation. The BioEnterics Intragastric Balloon (Inamed Health; Santa Barbara, CA, USA) was filled by using saline (500 ml) and methylene blue (10 ml). Patients were discharged with omeprazole therapy and diet (1000 kcal). Patients were followed up weekly by a physician blinded to randomisation. In both groups mortality, complications, BMI, BMI reduction and %EWL were considered. Data were expressed as mean±s.d., except as otherwise indicated. Statistical analysis was performed by means of Students t-test, Fishers exact test or χ 2 with Yates correction; P<0.05 was considered significant.Results:A total of 32 patients were selected and entered the study (8M/24F; mean age: 36.2±5.6 years, range 25–50 years; mean BMI 43.7±1.5 kg/m2, range 40–45 kg/m2; mean %EW: 43.1±13.1, range: 35–65). All patients completed the study. Mortality was absent. Complications related to endoscopy, balloon placement and removal were absent. Mean time of BIB positioning was 15±2 min, range 10–20 min. After the first 3 months of the study, in Group A patients the mean BMI significantly (P<0.001) lowered from 43.5±1.1 to 38.0±2.6 kg/m2, while in Group B patients the decrease was not significant (from 43.6±1.8 to 43.1±2.8 kg/m2). The mean %EWL was significantly higher in Group A than in Group B (34.0±4.8 vs 2.1±1%; P<0.001). After crossover, at the end of the following 3 months, the BMI lowered from 38.0±2.6 to 37.1±3.4 kg/m2 and from 43.1±2.8 to 38.8±3.1 kg/m2 in Groups A and B, respectively.Conclusions:The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon is a safe and effective procedure. In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet. The BIB® procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients.

The Body Uneasiness Test (BUT): Development and validation of a new body image assessment scale

Objective: To investigate the psychometric properties of the Body Uneasiness Test (BUT), a 71-item self-report questionnaire that consists of two parts: BUT·A which measures weight phobia, body image concerns, avoidance, compulsive self-monitoring, detachment and estrangement feelings towards one’s own body (depersonalization); and BUT·B which looks at specific worries about particular body parts or functions. Methods: We recruited a clinical sample of 531 subjects (491 females) suffering from eating disorders and a general population sample of 3273 subjects (2016 females) with BMI <25 and Eating Attitudes Test-26 scores under the cut-off 20. Results: The exploratory and confirmatory analyses confirmed a structural five-factor model for BUT·A and an eight-factor model for BUT·B. Internal consistency was satisfactory. The test-retest correlation coefficients were highly significant. Concurrent validity with other tests (Eating Disorder Inventory, EDI-2; Eating Attitudes Test, EAT-26; Symptom Check List, SCL-90R and Coopersmith Self-Esteem Inventory, SEI) was evaluated. Normative values for BUT scores in non-clinical samples of normal-weight non eating disordered subjects, from adolescence to old age, males and females, were calculated. The differences between males and females were highly significant, above all in the 18–39-age range. As for the comparison between women with eating disorders and controls, the results demonstrated a good predictive validity for anorexia nervosa and bulimia nervosa. Conclusions: The BUT is psychometrically sound. It can be a valuable tool for the screening and the clinical assessment of abnormal body image attitudes and eating disorders.

Early separation anxiety and adult attachment style in women with eating disorders.

OBJECTIVE To ascertain whether women with eating disorders have a higher frequency of separation anxiety symptoms in childhood, and a higher prevalence of insecure styles of adult attachment, compared with healthy women. METHODS The Separation Anxiety Symptom Inventory (SASI) and the Attachment Style Questionnaire (ASQ) were administered to 78 women with eating disorders and 64 healthy women. RESULTS Compared with control women, women with eating disorders reported more severe symptoms of separation anxiety during childhood, and scored higher on the ASQ scales, reflecting insecure styles of adult attachment. Early separation anxiety and insecure attachment were not correlated with age of onset or illness duration. The diagnostic subgroup was not associated with a specific style of insecure attachment: compared with control women, both anorexic and bulimic women scored higher on the ASQ scales reflecting anxious attachment, but not on the scales reflecting avoidant attachment. CONCLUSIONS The results confirm the link between eating disorders and insecure attachment that has been found in previous studies, and extend it to childhood symptoms of separation anxiety.

Complexity of attrition in the treatment of obesity: clues from a structured telephone interview

Objectives:To investigate the causes of attrition reported by obese patients treated by medical centres.Design:Observational study.Setting:Obese patients enrolled in a long-term study involving 18 Italian medical centres.Participants:A total of 940 obese patients (727 female; mean age, 49 years; mean BMI, 38.6 kg/m2).Measurements:Causes of attrition reported by dropouts during a structured telephone interview.Results:After a median observation period of 41 months (range, 25–50), 766 of 940 patients (81.5%) discontinued treatment. Sixty-two per cent of total dropout occurred in the first year of follow-up. Seventy-four per cent of dropouts reported a single primary reasons for treatment interruption. Two primary reasons were reported by 22.4% of patients, and three reasons by 3.4%. Practical difficulties, alone or in combination, were reported by more than half of dropouts (55%), and were the leading cause of attrition followed by perceived failure of treatment. Among practical difficulties, family problems or problems at work and logistics, coupled with health problems other than obesity, were the most frequent reasons of attrition, but also a perceived sense of abandonment or a bad interaction with therapists were frequently reported.Conclusion:Practical difficulties and psychological problems are the most important reasons of attrition reported by patients. A therapeutic alliance addressing these issues has a large potential to reduce treatment interruption and to improve outcome in obesity.

Weight cycling in treatment-seeking obese persons: data from the QUOVADIS study

OBJECTIVE: To determine parameters of weight history useful for the assessment of weight cycling and their association with psychological distress and binge eating.DESIGN: Cross-sectional.SUBJECTS: A total of 1889 treatment-seeking obese subjects, enrolled by 25 Italian centers (78% female subject), aged 20–65 y (median 45); 1691 reported previous efforts to lose weight (median age of first dieting, 30 y).MEASUREMENTS: The number of yearly attempts to lose weight, weight gain since age 20 y, cumulative weight loss and gain were checked by a predefined structured interview. Psychological distress was tested by means of Symptom Check-List 90 (SCL-90), Binge Eating Scale (BES) and Three Factor Eating Questionnaire (TFEQ).RESULTS: Differences in anthropometric, clinical and psychological parameters were observed in relation to previous attempts to lose weight. Patients in the upper quartile of parameters of weight history were considered weight cyclers. In multivariate logistic regression analysis, after correction for age, sex and BMI, a high BES score was the only factor systematically associated with a high frequency of dieting (OR, 1.70; 95% confidence interval, 1.22–2.36; P=0.022), with higher cumulative weight loss (1.42; 1.12–1.80; P=0.003) and cumulative weight gain (1.38; 1.06–1.79; P=0.017). However, the sensitivity, specificity and positive predictive value of a high BES score were very low to detect cyclers. Weight cycling did not carry a higher risk of complicating diseases.CONCLUSIONS: Weight cycling is associated with psychological distress, and binge eating independently increases the risk, but cannot be used to predict cycling. Also, obese patients who do not experience overeating as a loss of control discontinue treatment or regain weight following therapy.

Metabolic or bariatric surgery? Long-term effects of malabsorptive vs restrictive bariatric techniques on body composition and cardiometabolic risk factors

Background:Obesity is an increasing health problem and surgery seems to be the only treatment effective in achieving weight loss without relapse. Among bariatric techniques, many differences exist in terms of weight loss and resolution of comorbidities. Up to now, there are no prospective studies comparing long-term effects of malabsorptive vs restrictive techniques.Objective:In this study, cardiometabolic risk factors and body composition changes after malabsorptive biliointestinal bypass (BIBP) and restrictive laparoscopic adjustable gastric banding (LAGB) were compared during a 4-year follow-up.Design:Prospective, case–control and cohort study.Patients:In all, 80 obese subjects, matched for weight and age. Altogether, 40 patients underwent BIBP and 40 underwent LAGB.Measurements:Weight, body composition, fasting and post-loading plasma glucose and insulin, homeostatic model assessment index (HOMA-I), lipid profile, blood pressure (BP), erythrocyte sedimentation rate and fibrinogen were monitored at baseline, 12 and 48 months.Results:At 12 months after surgery, a significant reduction in body mass index, total fat mass (FM), trunk FM (trFM), trFM/legs FM (lFM) ratio (trFM/lFM), triglycerides, BP and inflammation markers was observed in both groups. BIBP patients showed a significant reduction in total cholesterol (Tot-C), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C), whereas the LAGB group showed a significant increase of HDL-C. A further improvement of all the parameters evaluated was seen in the BIBP group at 48 months after surgery.Conclusions:Both bariatric procedures exerted positive effects on cardiometabolic risk factors and on weight loss in the population studied, but on the long-term period, HOMA-I, Tot-C/HDL-C ratio and body composition improvements were more evident after BIBP. We conclude that malabsorptive BIBP seems to be more effective than LAGB in treating visceral obesity and its metabolic complications

Assessing disability in morbidly obese individuals: the Italian Society of Obesity test for obesity-related disabilities.

Purpose. To validate a new obesity-specific disability assessment test: the Obesity-related Disability test (Test SIO Disabilità Obesità Correlata, TSD-OC). Methods. Adult obese individuals were assessed with the TSD-OC, 36-Item Short-Form Health Survey (SF-36), 6-min walking test (6MWT) and grip strength. The TSD-OC is composed of 36 items divided into seven sections (pain, stiffness, activities of daily living and indoor mobility, housework, outdoor activities, occupational activities and social life). Statistical correlations between the TSD-OC, functional assessment (6MWT and grip strength) and quality of life parameters (SF-36) were analysed. Internal consistency was assessed with Cronbachs α test. Test–retest reliability was evaluated in a subgroup of 30 individuals. A linking exercise between TSD-OC items and categories of the International Classification of Functioning, Disability and Health was performed. Results. Test–retest showed excellent stability (r  ==  0.90) and excellent internal consistency was reported (Cronbachs α  >  0.90). Significant low to moderate correlations between TSD-OC, SF-36 scores, 6MWT and grip strength were observed. A total of 26 ICF categories were linked, mostly related to the area of mobility. Conclusions. The TSD-OC is a reliable and valid instrument for measuring self-reported disability in obese subjects. It may represent an important tool for establishing rehabilitation needs in individuals with obesity-related disability, for planning appropriate rehabilitation programmes and for evaluating their effectiveness.

Validating the Body Uneasiness Test (BUT) in obese patients

OBJECTIVE: To investigate the psychometric properties of the Body Uneasiness Test (BUT) in a large sample of subjects with obesity seeking treatment. BUT is a 71-item self-report questionnaire in two parts: BUT-A which measures weight phobia, body image concerns, avoidance, compulsive self-monitoring, detachment and estrangement feelings towards one’s own body (depersonalization); and BUT-B, which looks at specific worries about particular body parts or functions. METHODS: We recruited a clinical sample of 1,812 adult subjects (age range 18–65 years, females 1,411, males 401) with obesity (Body Mass Index, BMI ≧30 kg/m2) and a normal weight (BMI value between 18.5 and 25 kg/m2) non-clinical sample of 457 adult subjects (females 248, males 209) with an Eating Attitudes Test-26 (EAT-26) score under the cut-off point 20 (scores ≧20 indicate possible cases of eating disorders). RESULTS: The exploratory and confirmatory analyses confirmed a structural five-factor model for BUT-A and an eight-factor model for BUT-B. Internal consistency was satisfactory. Concurrent validity with Binge Eating Scale (BES) and Three-Factor Eating Questionnaire (TFEQ) was evaluated. The authors calculated mean values for BUT scores in adult (18–65 years) patients with obesity, and evaluated the influence of gender, age and BMI. Females obtained statistically significant higher scores than males in all age groups and in all classes of obesity; patients with obesity, compared with normal weight subjects, generally obtained statistically significant higher scores, but few differences could be attributed to the influence of BMI. CONCLUSION: The BUT can be a valuable multidimensional tool for the clinical assessment of body uneasiness in obesity; the scores of its sub-scales do not show a linear correlation with BMI values.

The Effect of Obesity Management on Body Image in Patients Seeking Treatment at Medical Centers

Objective: Body image dissatisfaction is common in treatment‐seeking patients with obesity. We aimed to investigate the effects of obesity management on body image in patients with obesity attending Italian medical centers for weight loss programs.

Family functioning in adolescent anorexia nervosa: A comparison of family members’ perceptions

Abnormal patterns of family functioning have often been reported in anorexia nervosa. Moreover, members of families with an adult with eating disorders have different family functioning perspectives. This study investigated whether differences in family members’ perspectives, similar to the ones found in families of adults with eating disorders, can be found in families of adolescents with anorexia nervosa. Perceived family functioning, measured with the Family Assessment Device, was compared between 49 control and 34 clinical families, and across family members. Differences were found between the two groups on a number of aspects of family functioning, with the clinical families showing most disturbances. There was a general agreement across family members in their perceptions of family functioning, with one notable exception. Clinical daughters disagreed with both their parents about the family level of communication, whereas control daughters disagreed only with their fathers. Disagreements between clinical adolescents and their mothers about the family communication style appear to be important in anorexia nervosa in this age group, although it is not possible to reach conclusions about the direction of causality. These findings support the use of family-oriented therapies that aim to identify and work with difficulties in communication within the family.