The change in eating behaviors in a Web-based weight loss program: a longitudinal analysis of study completers.

BACKGROUND: Eating behaviors are essential components in weight loss programs, but limited research has explored eating behaviors in Web-based weight loss programs. OBJECTIVES: The aim was to evaluate an interactive Web-based weight loss program on eating behaviors using the 18-item Three-Factor Eating Questionnaire Revised (TFEQ-R18) which measures uncontrolled eating, emotional eating, and cognitive restrained eating. Our Web-based weight loss program is comprised of information about healthy lifestyle choices, weekly chats with experts, social networking features, databases for recipe searches, and features allowing members to self-report and track their weight, physical activity, and dietary intake on the website. METHODS: On registering for the weight loss program, 23,333 members agreed to take part in the research study. The participants were then asked to complete the TFEQ-R18 questionnaire at baseline and after 3 and 6 months of participation. All data collection was conducted online, with no face-to-face contact. To study changes in TFEQ-R18 eating behaviors we restricted our study to those members who completed all 3 TFEQ-R18 questionnaires. These participants were defined as "completers" and the remaining as "noncompleters." The relationships between sex, change in eating behaviors, and total weight loss were studied using repeated measures ANOVA and Pearson correlation coefficient. RESULTS: In total, 22,800 individuals participated (females: 19,065/22,800, 83.62%; mean age 39.6, SD 11.4 years; BMI 29.0 kg/m(2); males: 3735/22,800, 16.38%; mean age 43.2, SD 11.7 years; BMI 30.8 kg/m(2)). Noncompleters (n=22,180) were younger and reported a lower score of uncontrolled eating and a higher score of cognitive restrained eating. Over time, completers (n=620) decreased their uncontrolled eating score (from 56.3 to 32.0; P<.001) and increased their cognitive restrained eating (from 50.6 to 62.9; P<.001). Males decreased their emotional eating (from 57.2 to 35.9; P<.001), but no significant change was found among females. The baseline cognitive restrained eating score was significantly and positively associated with weight loss for completers in both men (P=.02) and women (P=.002). CONCLUSIONS: To our knowledge, this is the largest TFEQ sample that has been documented. This Web-based weight loss intervention suggests that eating behaviors (cognitive restrained eating, uncontrolled eating, and emotional eating) measured by TFEQ-R18 were significantly changed during 6 months of participation. Our findings indicate differences in eating behaviors with respect to sex, but should be interpreted with caution because attrition was high.

Using hypnotic suggestion in the rehabilitation of working memory capacity after acquired brain injury: study protocol for a randomized controlled trial.

OBJECTIVES: Establishment of effective evidence-based interventions in rehabilitation of working memory (WM) deficits after acquired brain injury (ABI) is sorely needed. Despite robust evidence for the efficiency of clinical hypnosis in a wide range of clinical conditions, and improved understanding of mechanisms underlying its effects, the potential of clinical hypnosis in cognitive rehabilitation is underexplored. A recent study has shown large effects of hypnotic suggestion on WM capacity following ABI. This randomized controlled trial aims to evaluate and explore the replicability of these findings and examine the generalization of treatment effects. The study will also explore possible mechanisms of change. METHODS: Ninety patients will be recruited from the Sunnaas Rehabilitation Hospital. Inclusion criteria are nonprogressive ABI, minimum 12-month post-injury, ongoing WM deficits, and age between 18 and 67 years. Patients will be randomized to either (a) an intervention group receiving four weekly 1-h sessions with induction and hypnosis, (b) an active control group receiving four weekly 1-h sessions of induction and mindfulness, or (c) a passive control group without intervention. The targeted procedure consists of suggestions about enhancing WM functions, for example through the instantiation of preinjury WM capacity in the present using age regression or through visualizations of brain plasticity. The non-targeted suggestions contain no explicit mention of ABI- or WM-related abilities. Each participant will be assessed at baseline, immediately after intervention, and 6 months after baseline. The primary outcome is the WM index from WAIS-IV and self- and informant-reported WM subscale from BRIEF-A, a questionnaire exploring executive functioning in everyday life. Secondary outcomes include a cognitive composite score derived from tests measuring processing speed, executive functions, learning capacity and memory, and self-reported measures of emotional distress, quality of life, and community integration. Exploratory measures include self-rated ABI and WM-related self-efficacy. DISCUSSION: Rehabilitation of impaired WM after ABI has hitherto yielded limited transfer effects beyond the training material, i.e., improvement effects on everyday WM capacity, and clinical trials of new interventions are thus warranted. Long-standing empirical evidence demonstrates that hypnosis is an effective therapeutic technique in a wide range of conditions, and recent exploratory research has suggested a high efficacy of hypnosis in improving WM capacity in patients with ABI. However, these extraordinary findings need replication in studies applying scientifically rigorous designs. If successful, our ambition is to provide recommendations and materials to implement hypnotic suggestion as an adjunct treatment following ABI. Study findings may inform future studies exploring the use of clinical hypnosis in other areas of rehabilitation, such as mild TBI, and in other neurological conditions where WM deficit is prominent. TRIAL REGISTRATION: ClinicalTrials.gov NCT05287542. Registered on March 2022 PROTOCOL VERSION: Protocol version 2.0, December 2023.

Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study.

BACKGROUND: The frequency of obesity has risen dramatically in recent years but only few safe and effective drugs are currently available. We assessed the effect of liraglutide on bodyweight and tolerability in obese individuals without type 2 diabetes. METHODS: We did a double-blind, placebo-controlled 20-week trial, with open-label orlistat comparator in 19 sites in Europe. 564 individuals (18-65 years of age, body-mass index 30-40 kg/m2) were randomly assigned, with a telephone or web-based system, to one of four liraglutide doses (1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg, n=90-95) or to placebo (n=98) administered once a day subcutaneously, or orlistat (120 mg, n=95) three times a day orally. All individuals had a 500 kcal per day energy-deficit diet and increased their physical activity throughout the trial, including the 2-week run-in. Weight change analysed by intention to treat was the primary endpoint. An 84-week open-label extension followed. This study is registered with ClinicalTrials.gov, number NCT00422058. FINDINGS: Participants on liraglutide lost significantly more weight than did those on placebo (p=0.003 for liraglutide 1.2 mg and p<0.0001 for liraglutide 1.8-3.0 mg) and orlistat (p=0.003 for liraglutide 2.4 mg and p<0.0001 for liraglutide 3.0 mg). Mean weight loss with liraglutide 1.2-3.0 mg was 4.8 kg, 5.5 kg, 6.3 kg, and 7.2 kg compared with 2.8 kg with placebo and 4.1 kg with orlistat, and was 2.1 kg (95% CI 0.6-3.6) to 4.4 kg (2.9-6.0) greater than that with placebo. More individuals (76%, n=70) lost more than 5% weight with liraglutide 3.0 mg that with placebo (30%, n=29) or orlistat (44%, n=42). Liraglutide reduced blood pressure at all doses, and reduced the prevalence of prediabetes (84-96% reduction) with 1.8-3.0 mg per day. Nausea and vomiting occurred more often in individuals on liraglutide than in those on placebo, but adverse events were mainly transient and rarely led to discontinuation of treatment. INTERPRETATION: Liraglutide treatment over 20 weeks is well tolerated, induces weight loss, improves certain obesity-related risk factors, and reduces prediabetes. FUNDING: Novo Nordisk A/S, Bagsvaerd, Denmark.

Oral intake of mesoporous silica is safe and well tolerated in male humans.

BACKGROUND: Precisely engineered mesoporous silica has been shown to induce weight loss in mice, but whether it is safe to use in humans have not investigated. OBJECTIVE: The aim was to determine whether oral dosing, up to 9 grams/day, of precisely engineered mesoporous silica as a food additive can be used safely in male humans. DESIGN: This single blinded safety study consisted of two study arms including 10 males each (18-35 years). One arm consisted of participants with normal weight and one with obesity. After a placebo run-in period, all subjects were given porous silica three times daily, with increasing dose up to 9 grams/day (Phase 1). Subjects with obesity continued the study with highest dose for additional 10 weeks (Phase 2). RESULTS: All participants completed Phase 1 and 90% completed Phase 2, with approximately 1% missed doses. Participants reported no abdominal discomfort, and changes in bowel habits were minor and inconsistent. The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred. CONCLUSION: Mesoporous silica intake of up to 9 grams/day can be consumed by males without any major adverse events or safety concerns.

Long-term effect of CB1 blockade with rimonabant on cardiometabolic risk factors: two year results from the RIO-Europe Study.

AIMS: Rimonabant, the first selective cannabinoid type 1 receptor blocker, has been shown to produce weight loss and improvements in several cardiometabolic risk factors over 1 year. We report the 2 year efficacy and tolerability data of rimonabant. METHODS AND RESULTS: Patients with a body mass index > or =30 or >27 kg/m(2) with treated/untreated hypertension, dyslipidaemia, or both, were randomized to double-blind treatment with placebo, rimonabant 5 or 20 mg once daily plus a calorie-restricted diet for 2 years. Weight loss from baseline to 2 years in the intention-to-treat population was significantly greater with rimonabant 20 mg (mean +/- SD: -5.5 +/- 7.7 kg; P < 0.001) and 5 mg (-2.9 +/- 6.5 kg; P = 0.002) than placebo (-1.2 +/- 6.8 kg). Rimonabant 20 mg produced significantly greater improvements than placebo in waist circumference, high-density lipoprotein cholesterol, triglycerides, fasting glucose and insulin levels, insulin resistance, and metabolic syndrome prevalence. Rimonabant 20 mg produced clinically meaningful improvements in all Impact of Weight on Quality of Life-Lite questionnaire domain scores at 2 years. Rimonabant was generally well tolerated and rates of adverse events, including depressed mood disorders and disturbances were similar to placebo during year 2. Proportions of patients with clinically significant depression (Hospital Anxiety and Depression Scale score >11) were similar in all treatment groups. CONCLUSION: Rimonabant 20 mg over 2 years promoted clinically relevant and durable weight loss and improvements in cardiometabolic risk factors.

Effect of orlistat on weight regain and cardiovascular risk factors following a very-low-energy diet in abdominally obese patients: a 3-year randomized, placebo-controlled study.

OBJECTIVE: To investigate the efficacy of orlistat on the maintenance of weight loss over 3 years following a major weight loss induced by very-low-energy diet (VLED) in obese patients with metabolic risk factors such as dyslipidemia, impaired fasting glucose, and diet-treated type 2 diabetes. RESEARCH DESIGN AND METHODS: Initially, weight loss was induced by an 8-week VLED (600-800 kcal/day) in 383 patients with a mean BMI of 37.5 kg/m(2) (range 30.0-45.2). Those who lost > or = 5% of their body weight (309 of 383 patients) were then randomized to receive lifestyle counseling for 3 years together with either orlistat 120 mg t.i.d. or matching placebo capsules. Primary end points were the maintenance of > or = 5% weight loss after 3 years. Additionally, differences in the development of type 2 diabetes between orlistat and placebo were analyzed. RESULTS: The VLED induced a mean weight loss of 14.4 +/- 2.0 kg among the subsequently randomized patients. The mean weight gain after 3 years was lower with orlistat than with placebo (4.6 +/- 8.6 vs. 7.0 +/- 7.1 kg; P < 0.02). The number of participants who achieved > or =5% weight loss also favored orlistat (67 vs. 56%; P = 0.037). Waist circumference was significantly more reduced in the orlistat group (P < 0.05), but no other differences in the risk factors were observed between the two groups. The incidences of new cases of type 2 diabetes were significantly reduced in the orlistat group (8 cases out of 153 subjects) versus placebo (17 cases out of 156 subjects) (P = 0.041). CONCLUSIONS: The addition of orlistat to lifestyle intervention was associated with maintenance of an extra 2.4 kg weight loss after VLED for up to 3 years in obese subjects. The combination of orlistat and lifestyle intervention was associated with a reduced occurrence of type 2 diabetes.

Association of weight gain in infancy and early childhood with metabolic risk in young adults.

CONTEXT: Early postnatal life has been suggested as an important window during which risks for long-term health may be influenced. OBJECTIVE: The aim of this study was to examine the independent associations between weight gain during infancy (0-6 months) and early childhood (3-6 yr) with components of the metabolic syndrome in young adults. DESIGN: This was a prospective cohort study (The Stockholm Weight Development Study). SETTING: The study was conducted in a general community. PARTICIPANTS: Subjects included 128 (54 males) singletons, followed from birth to 17 yr. MAIN OUTCOME MEASURE: None of these young adults met the full criteria for the metabolic syndrome. We therefore calculated a continuous clustered metabolic risk score by averaging the standardized values of the following components: waist circumference, blood pressure, fasting triglycerides, high-density lipoprotein cholesterol, glucose, and insulin level. RESULTS: Clustered metabolic risk at age 17 yr was predicted by weight gain during infancy (standardized beta = 0.16; P < 0.0001) but not during early childhood (standardized beta = 0.10; P = 0.23), adjusted for birth weight, gestational age, current height, maternal fat mass, and socioeconomic status at age 17 yr. Further adjustment for current fat mass and weight gain during childhood did not alter the significant association between infancy weight gain with the metabolic risk score (standardized beta = 0.20; P = 0.007). CONCLUSIONS: Rapid weight gain during infancy (0-6 months) but not during early childhood (3-6 yr) predicted clustered metabolic risk at age 17 yr. Early interventions to moderate rapid weight gain even at very young ages may help to reduce adult cardiovascular disease risks.

Upward weight percentile crossing in infancy and early childhood independently predicts fat mass in young adults: the Stockholm Weight Development Study (SWEDES).

BACKGROUND: Rapid early postnatal weight gain predicts increased subsequent obesity and related disease risks. However, the exact timing of adverse rapid postnatal weight gain is unclear. OBJECTIVE: The objective was to examine the associations between rapid weight gain in infancy and in early childhood in relation to body composition at age 17 y. DESIGN: This prospective cohort study was conducted in 248 (103 males) singletons and their mothers. Height and weight were measured at birth, 6 mo, and 3 and 6 y. The rates of weight gain during infancy (0-6 mo) and early childhood (3-6 y) were calculated as changes in sex- and age-adjusted weight SD scores during these time periods. At 17 y, body composition was measured by air-displacement plethysmography. RESULTS: Increasing weight gain during infancy and early childhood were both independently associated with larger body mass index, fat mass, relative fat mass, fat-free mass, and waist circumference at 17 y (P < 0.005 for all; adjusted for sex, birth weight, gestational age, current height, maternal socioeconomic status, and maternal fat mass). Rapid weight gain in infancy, but not in early childhood, also predicted taller height at 17 y (P < 0.001). CONCLUSIONS: Rapid weight gain in both infancy and early childhood is a risk factor for adult adiposity and obesity. Rapid weight gain in infancy also predicted taller adult height. We hypothesize that rapid weight gains in infancy and early childhood are different processes and may allow separate opportunities for early intervention against obesity risk later in life.

Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study.

BACKGROUND: In animal models, cannabinoid-1 receptor (CB1) blockade produces a lean phenotype, with resistance to diet-induced obesity and associated dyslipidaemia. We assessed the effect of rimonabant, a selective CB1 blocker, on bodyweight and cardiovascular risk factors in overweight or obese patients. METHODS: patients with body-mass index 30 kg/m2 or greater, or body-mass index greater than 27 kg/m2 with treated or untreated dyslipidaemia, hypertension, or both, were randomised to receive double-blind treatment with placebo, 5 mg rimonabant, or 20 mg rimonabant once daily in addition to a mild hypocaloric diet (600 kcal/day deficit). The primary efficacy endpoint was weight change from baseline after 1 year of treatment in the intention-to-treat population. FINDINGS: Weight loss at 1 year was significantly greater in patients treated with rimonabant 5 mg (mean -3.4 kg [SD 5.7]; p=0.002 vs placebo) and 20 mg (-6.6 kg [7.2]; p<0.001 vs placebo) compared with placebo (-1.8 kg [6.4]). Significantly more patients treated with rimonabant 20 mg than placebo achieved weight loss of 5% or greater (p<0.001) and 10% or greater (p<0.001). Rimonabant 20 mg produced significantly greater improvements than placebo in waist circumference, HDL-cholesterol, triglycerides, and insulin resistance, and prevalence of the metabolic syndrome. The effects of rimonabant 5 mg were of less clinical significance. Rimonabant was generally well tolerated with mild and transient side effects. INTERPRETATION: CB1 blockade with rimonabant 20 mg, combined with a hypocaloric diet over 1 year, promoted significant decrease of bodyweight and waist circumference, and improvement in cardiovascular risk factors.

[Autotransfusion in prosthetic hip surgery]. / Autotransfusjon ved hofteprotesekirurgi.

BACKGROUND: Homologous transfusion implies a risk for transmission of infectious diseases and transfusion reactions. The aim of the present study was to compare homologue transfusion with mechanical autotransfusion perioperatively in prosthetic hip surgery. METHODS: 111 patients were included in the study; group 1: 29 patients operated between June 2001 and June 2002 (before using autotransfusion); group 2: 35 patients operated between September 2002 and March 2003 (using common autotransfusion); group 3: 47 patients operated after March 2003 (using common autotransfusion and salvaging of rinsing fluid). RESULTS: Postoperative hemoglobin was significantly higher in group 3 (10,9 +/- 0.3 g/dl) than in group 2 (9,6 +/- 0.3 g/dl; p < 0.01) and group 1 (9,5 +/- 0,4 g/dl; p < 0.01). Amount of autologous erythrocyte concentrate in group 3 was significant higher than in group 2 (440 +/- 51 ml vs. 238 31 ml; p < 0.01). There were fewer patients in group 3 (9%) than in group 2 (29%; p < 0.04) and in group 1 (76%; < 0.01) who required homologous blood. CONCLUSION: The use of perioperative blood collection and retransfusion significantly reduces homologue blood transfusion in prosthetic hip surgery.