Evaluation of a web-based weight loss intervention in overweight cancer survivors aged 50 years and younger.

PURPOSE: Half of adult cancer survivors under age 50 years are obese. Excess body weight is associated with cancer recurrence, and effective weight loss interventions for younger cancer survivors are needed. Commercially available, online weight loss programmes are readily accessible, but few have been studied in this population. This study employed a single-arm, pre-post intervention (baseline-6 month/baseline-12 month comparisons) to preliminarily explore feasibility, efficacy and safety of an online, commercially available weight loss programme in breast (n = 30) and testicular (n = 16) cancer survivors under age 50 years. METHODS: The intervention included three daily components: exercise, nutritional/behavioural modification strategies and health lessons. Intention-to-treat and completers analyses were conducted. Feasibility was measured by participation (number of participants enrolled/number screened), retention (number of participants attending 6/12 month study visit/number of enrolled) and self-reported adherence rates (average of mean percent adherence to each of the three intervention components). Efficacy was assessed by changes in initial weight (percent weight loss). Safety was assessed by adverse events. RESULTS: The mean participation rate was 42%. The retention rate was 59% at 6 and 49% at 12 months. The adherence rate for all participants (completers/dropouts/lost-to-follow-up) was 50.1% at 6 and 44% at 12 months. Completers reported adherence rates of 68% at 12 months. Study participants lost 5.3% body weight at 12 months; completers lost 9%. Only three unexpected adverse events (unrelated to the intervention) were reported. CONCLUSION: Clinically significant weight loss was observed, although retention rates were low. Findings generally support preliminary feasibility, efficacy and safety of this online weight loss programme, and future randomized control trials should be explored.

Romantic, sexual, and sexual risk behaviours of adolescent females with severe obesity.

BACKGROUND: There is an increasing adolescent population with severe obesity with impairments in social and romantic relationships that are seeking clinical weight management, including weight loss surgery (WLS). OBJECTIVE: To document romantic, sexual and sexual risk behaviours in a clinical sample of adolescent females with severe obesity (BMI > 40 kg/m2 ) compared to those of healthy weight (HW). METHODS: This multi-site study-an ancillary to a prospective longitudinal observational study documenting health in adolescents having WLS-presents pre-operative/baseline data from 108 females undergoing WLS, 68 severely obese seeking lifestyle intervention and 118 of HW. Romantic and sexual risk behaviour and birth control information sources were assessed using the Sexual Activities and Attitudes Questionnaire (SAAQ). RESULTS: Severely obese females reported engaging in fewer romantic and sexual behaviours compared to HW. Similar to HW, a subgroup (25%) of severely females were engaging in higher rates of sexual risk behaviours and reported pregnancies and sexually transmitted infections (STIs). A considerable number (28-44%) reported receiving no birth control information from physicians. CONCLUSIONS: Discussion topics with the adolescent patient should extend beyond reproductive health needs (e.g. contraception, unintended pregnancies) to include guidance around navigating romantic and sexual health behaviours that are precursors to these outcomes.

Brimonidine gel 0.33% rapidly improves patient-reported outcomes by controlling facial erythema of rosacea: a randomized, double-blind, vehicle-controlled study.

BACKGROUND: Facial redness contributes to impaired psychosocial functioning in rosacea patients and the only approved treatment for erythema is topical brimonidine gel 0.33%. OBJECTIVES: To evaluate patient-reported outcomes, as well as efficacy and safety, in subjects with self-perceived severe erythema treated with brimonidine gel 0.33% compared to vehicle. METHODS: An 8-day multicenter, randomized study comparing once-daily brimonidine gel 0.33% with vehicle gel using a facial redness questionnaire, subject satisfaction questionnaire and a patient diary of facial redness control to assess patient-reported outcomes. RESULTS: Of the 92 included subjects with self-perceived severe erythema, very few were satisfied with their appearance at baseline (4.2% brimonidine group, 0 vehicle group). On Day 8, significantly more brimonidine group subjects were satisfied with their facial appearance compared to vehicle group (36.9% vs. 21.5%; P < 0.05), with the overall treatment effect (69.6% vs. 40.4%; P < 0.01), and with the improvement in their facial redness (67.4% vs. 33.3%; P < 0.001). More brimonidine group subjects were able to control their facial redness daily (e.g. 83.0% vs. 38.9% on Day 1). On Day 8, significantly more brimonidine group subjects than vehicle group had at least a one-grade improvement from baseline in the Clinician Erythema Assessment score (71.7% vs. 35.7%; P = 0.0011) and Patient Self-Assessment score (76.1% vs. 47.6%; P = 0.004). More subjects in the brimonidine group (29.2%) reported treatment-related adverse events than in the vehicle group (15.9%) but most were mild and transient. CONCLUSIONS: Once-daily brimonidine gel 0.33% allowed patients to rapidly control their facial redness and significantly improved patient-reported outcomes in the treatment of persistent facial erythema of rosacea.

Changes in eating, physical activity and related behaviors in a primary care-based weight loss intervention.

OBJECTIVE: To examine changes in eating behaviors and physical activity, as well as predictors of weight loss success, in obese adults who participated in a 2-year behavioral weight loss intervention conducted in a primary care setting. DESIGN: A longitudinal, randomized controlled, multisite trial. SUBJECTS: Three hundred ninety obese (body mass index, 30-50 kg m(-2)) adults, ≥ 21 years, in the Philadelphia region. METHODS: Participants were assigned to one of three interventions: (1) Usual Care (quarterly primary care provider (PCP) visits that included education on diet and exercise); (2) Brief Lifestyle Counseling (quarterly PCP visits plus monthly lifestyle counseling (LC) sessions about behavioral weight control); or (3) Enhanced Brief LC (the previous intervention with a choice of meal replacements or weight loss medication). RESULTS: At month 24, participants in both Brief LC and Enhanced Brief LC reported significantly greater improvements in mean (± s.e.) dietary restraint than those in Usual Care (4.4 ± 0.5, 4.8 ± 0.5 and 2.8 ± 0.5, respectively; both P-values ≤ 0.016). The percentage of calories from fat, along with fruit and vegetable consumption, did not differ significantly among the three groups. At month 24, both the Brief LC and Enhanced Brief LC groups reported significantly greater increases than usual care in energy expenditure (kcal per week) from moderately vigorous activity (+593.4 ± 175.9, +415.4 ± 179.6 and -70.4 ± 185.5 kcal per week, respectively; both P-values ≤ 0.037). The strongest predictor of weight loss at month 6 (partial R(2)=33.4%, P<0.0001) and at month 24 (partial R(2)=19.3%, P<0.001) was food records completed during the first 6 months. Participants who achieved a 5% weight loss at month 6 had 4.7 times greater odds of maintaining a ≥ 5% weight loss at month 24. CONCLUSIONS: A behavioral weight loss intervention delivered in a primary care setting can result in significant weight loss, with corresponding improvements in eating restraint and energy expenditure. Moreover, completion of food records, along with weight loss at month 6, is a strong predictor of long-term weight loss.

Effect of lifestyle intervention on cardiometabolic risk factors: results of the POWER-UP trial.

OBJECTIVE: To investigate the effects of three weight loss interventions on cardiometabolic risk factors, including blood pressure, lipids, glucose and markers of insulin resistance and inflammation. We also examined whether categories of incremental weight change conferred greater improvements on these parameters. METHODS: This 2-year trial was conducted in a primary care setting and included 390 obese participants who were randomly assigned to one of three interventions: (1) Usual Care (quarterly primary care provider (PCP) visits that included education about weight management); (2) Brief Lifestyle Counseling (quarterly PCP visits plus monthly behavioral counseling provided by a trained auxiliary health-care provider); or (3) Enhanced Brief Lifestyle Counseling (the same care as described for the previous intervention, plus weight loss medications or meal replacements). The primary outcome was change in cardiometabolic risk factors among groups. RESULTS: At month 24, participants in Enhanced Brief Lifestyle Counseling lost significantly more weight than those in Usual Care (4.6 vs 1.7 kg), with no other significant differences between groups. Enhanced Brief Lifestyle Counseling produced significantly greater improvements in high-density lipoprotein (HDL) cholesterol and triglyceride levels at one or more assessments, compared with the other two interventions. Markers of insulin resistance also improved significantly more in this group throughout the 2 years. Collapsing across the three groups, greater weight loss was associated with greater improvements in triglycerides, HDL cholesterol and markers of insulin resistance and inflammation at month 24, but was not significantly associated with reductions in blood pressure, total cholesterol and low-density lipoprotein cholesterol at any time. CONCLUSIONS: Enhanced Brief Lifestyle Counseling, which produced the largest weight loss, was generally associated with the greatest improvements in cardiovascular risk factors. These findings suggest that an intensive weight loss intervention, delivered in a primary care setting, can help obese individuals improve some cardiometabolic risk factors.

The impact of a primary care-based weight loss intervention on the quality of life.

OBJECTIVE: This study investigated changes in the quality of life of men and women who participated in a primary care-based weight loss intervention program. METHODS: Participants were enrolled in a 2-year randomized clinical trial (POWER-UP) conducted at the University of Pennsylvania and in six affiliated primary care practices. Inclusion criteria included the presence of obesity (body mass index of 30-50 kg m(-2)) and at least two components of the metabolic syndrome. MAIN OUTCOME MEASURES: Quality of life was assessed by three measures: the Short Form Health Survey (SF-12); the Impact of Weight on Quality of Life-Lite; and the EuroQol-5D. RESULTS: Six months after the onset of treatment, and with a mean weight loss of 3.9 ± 0.3 kg, participants reported significant improvements on all measures of interest with the exception of the Mental Component Score of the SF-12. These changes remained significantly improved from baseline to month 24, with the exception of the EuroQol-5D. Many of these improvements were correlated with the magnitude of weight loss and, for the most part, were consistent across gender and ethnic group. CONCLUSIONS: Individuals with obesity and components of the metabolic syndrome reported significant improvements in most domains of the quality of life with a modest weight loss of 3.7% of initial weight, which was achieved within the first 6 months of treatment. The majority of these improvements were maintained at month 24, when participants had lost 3.0% of their weight.

Managing obesity in primary care practice: an overview with perspective from the POWER-UP study.

Primary care practitioners (PCPs) have been encouraged to screen all adults for obesity and to offer behavioral weight loss counseling to the affected individuals. However, there is limited research and guidance on how to provide such intervention in primary care settings. This led the National Heart, Lung and Blood Institute in 2005 to issue a request for applications to investigate the management of obesity in routine clinical care. Three institutions were funded under a cooperative agreement to undertake the practice-based opportunities for weight reduction (POWER) trials. The present article reviews selected randomized controlled trials, published before the initiation of POWER, and then provides a detailed overview of the rationale, methods and results of the POWER trial conducted at the University of Pennsylvania (POWER-UP). POWER-UP's findings are briefly compared with those from the two other POWER trials, conducted at Johns Hopkins University and Harvard University/Washington University. The methods of delivering behavioral weight loss counseling differed markedly across the three trials, as captured by an algorithm presented in the article. Delivery methods ranged from having medical assistants and PCPs from the practices provide counseling to using a commercially available call center, coordinated with an interactive website. Evaluation of the efficacy of primary care-based weight loss interventions must be considered in light of costs, as discussed in relation to the recent treatment model proposed by the Centers for Medicare and Medicaid Services.

Cost-effectiveness of a primary care intervention to treat obesity.

BACKGROUND: Data on the cost-effectiveness of the behavioral treatment of obesity are not conclusive. The cost-effectiveness of treatment in primary care settings is particularly relevant. METHODS: We conducted a within-trial cost-effectiveness analysis of a primary care-based obesity intervention. Study participants were randomized to: Usual Care (UC; quarterly visits with their primary care provider); Brief Lifestyle Counseling (BLC; quarterly provider visits plus monthly weight loss counseling visits) or Enhanced Brief Lifestyle Counseling (EBLC; all above interventions, plus choice of meal replacements or weight loss medication). A health-care payer perspective was used. Intervention costs were estimated from tracking data obtained prospectively. Quality-adjusted life years (QALYs) were estimated with the EuroQol-5D. We estimated cost per kilogram-year of weight loss and cost per QALY. RESULTS: Weight losses after 2 years were 1.7, 2.9 and 4.6 kg for UC, BLC and EBLC, respectively (P=0.003 for comparison of EBLC vs UC). The incremental cost per kilogram-year lost was $292 for EBLC compared with UC (95% confidence interval (CI): $219-$437). The short-term incremental cost per QALY was $115,397, but the 95% CI were undefined. Comparison of short-term cost per kg with published estimates of longer-term cost per QALY suggested that the intervention could be cost-effective over the long term (≥ 10 years). CONCLUSIONS: A primary care intervention that includes monthly counseling visits and a choice of meal replacements or weight loss medication could be a cost-effective treatment for obesity over the long term. However, additional studies are needed on the cost-effectiveness of behavioral treatment of obesity.

Gender differences in the relationship between symptoms of depression and high-sensitivity CRP.

BACKGROUND: Depression has been associated with increased risk of cardiovascular disease. The inflammatory marker C-reactive protein (CRP) has also been identified as an independent predictor of short- and long-term cardiovascular disease events. Inflammation may influence the relationship between depression and cardiovascular disease. OBJECTIVE: The objective of this study was to investigate the association between symptoms of depression and high-sensitivity CRP (hs-CRP) in an obese clinical population. We also sought to determine whether this relationship was different in men and women, given prior reports of a gender effect. METHODS: Symptoms of depression and hs-CRP were measured in 390 participants enrolled in a weight loss intervention trial that was delivered in a primary care setting. Symptoms of depression were evaluated with the Patient Health Questionnaire-8 (PHQ-8), in which a score ≥ 10 is consistent with major depression. RESULTS: A total of 58 (15.2%) participants reported a PHQ-8 score ≥ 10. The median (interquartile range) hs-CRP concentration was significantly higher in participants with symptoms consistent with major depression (7.7 (4.2-13) mg l(-1)) compared with those without depression (5.1 (3-9.7) mg l(-1); P<0.01). Symptoms consistent with major depression were significantly associated with log-transformed hs-CRP concentrations in an analysis adjusted for age, gender, obesity class and other metabolic variables (P=0.04). When interaction by gender was examined, this relationship remained significant in men (P<0.01) but not in women (P=0.32). CONCLUSIONS: Symptoms consistent with major depression were significantly associated with hs-CRP in men only, even after adjusting for age, obesity class, metabolic variables and medications known to affect inflammation. This finding suggests that there are biologic differences between men and women that may modify the relationship between hs-CRP and depression. Further studies are needed to elucidate the biologic basis for these findings.

Relation of health-related quality of life to metabolic syndrome, obesity, depression and comorbid illnesses.

BACKGROUND: Metabolic syndrome has been associated with impaired health-related quality of life (HRQoL) in several studies. Many studies used only one HRQoL measure and failed to adjust for important confounding variables, including obesity, depression and comorbid conditions. OBJECTIVE: To investigate the relationship between metabolic syndrome and HRQoL using multiple measures. We also sought to determine whether increasing body mass index or diabetes status further modified this relationship. METHODS: This cross-sectional study included 390 obese participants with elevated waist circumference and at least one other criterion for metabolic syndrome. Of these 390 participants, 269 had metabolic syndrome (that is, they met 3 out of the 5 criteria specified by the NCEP (National Cholesterol Education Program)) and 121 did not. Participants were enrolled in a primary care-based weight-reduction trial. HRQoL was assessed using two generic instruments, the Medical Outcomes Study Short-Form 12 and the EuroQol-5D, as well as an obesity-specific measure, the Impact of Weight on Quality of Life. Differences in HRQoL were compared among participants with and without metabolic syndrome. Multivariable linear regression was used to determine how HRQoL varied according to metabolic syndrome status, and whether factors including weight, depression and burden of comorbid disease modified this relationship. RESULTS: Metabolic syndrome was not associated with HRQoL as assessed by any of the measures. In univariable analysis, depression, disease burden and employment status were significantly associated with worse HRQoL on all instruments. In multivariable models, only depression remained significantly associated with reduced HRQoL on all measures. Increasing obesity and diabetes status did not modify the relationship between metabolic syndrome and HRQoL. CONCLUSION: In contrast to previous studies, metabolic syndrome was not associated with impaired HRQoL as assessed by multiple measures. This suggests that metabolic syndrome in itself is not associated with decreased HRQoL, but other factors such as obesity, depression and greater disease burden may significantly influence the quality of life in this population.

The role of patients' expectations and goals in the behavioral and pharmacological treatment of obesity.

OBJECTIVE: To investigate weight loss expectations and goals among obese treatment seekers and to examine the relationships of these expectations and goals to treatment outcomes. METHOD: Participants were 180 obese men and women (age 43.8+/-10.1 years; body mass index 37.6+/-4.2 kg/m(2)) who received one of four-year-long treatments that combined behavioral and pharmacological methods. Before treatment, they reported the amount of weight they realistically expected to lose after 4, 12, 26 and 52 weeks of treatment, as well as their ultimate weight loss goals. Expectations and goals were compared across treatment groups and examined in relation to previous weight loss efforts, weight loss and regain in treatment, attrition, satisfaction with treatment and mood. RESULTS: Participants in all treatment groups expected reductions at week 52 that were significantly greater than the 5-15% of initial weight they were told was realistic and significantly more than they had ever lost before. Weight loss expectations were unrelated to achieved weight loss in all groups but one, in which greater expectations were associated with greater losses. Failure to meet weight loss expectations for the first 26 weeks of treatment was related to lower satisfaction ratings, but was not related to weight regain or attrition over the next 26 weeks. Symptoms of depression were reduced from baseline, regardless of whether participants achieved or failed to achieve their expected weight losses. CONCLUSION: Across groups, we observed no negative consequences of having (and failing to meet) unrealistic expectations for weight loss.

Impact of weight loss on the metabolic syndrome.

OBJECTIVE: To evaluate the effects of weight loss on the risk of having metabolic syndrome after 1 year of treatment with lifestyle modification alone, pharmacotherapy alone (sibutramine) or the combination of the two. DESIGN: Randomized, controlled, 1-year clinical trial. PATIENTS: One hundred and eighty women and 44 men, 18-65 years of age, with a body mass index of 30-45 kg/m(2), free of uncontrolled hypertension or type 1 or 2 diabetes. INTERVENTION: Fifteen milligrams of sibutramine per day alone, lifestyle modification counseling alone, sibutramine plus lifestyle modification counseling or sibutramine plus brief lifestyle modification counseling. MEASUREMENTS: The metabolic syndrome, as defined by the Adult Treatment Panel III. RESULTS: Before treatment, 34.8% of the participants had the metabolic syndrome. Metabolic syndrome was more prevalent in Caucasians than African Americans (42.5 vs 20.3%; P<0.03), in males than females (65.1 vs 34.9%; P<0.002) and in older (>44 years) than younger (

Childhood sexual abuse and obesity.

The causes of the current obesity epidemic are multifactorial and include genetic, environmental, and individual factors. One potential risk factor may be the experience of childhood sexual abuse. Childhood sexual abuse is remarkably common and is thought to affect up to one-third of women and one-eighth of men. A history of childhood sexual abuse is associated with numerous psychological sequelae including depression, anxiety, substance abuse, somatization, and eating disorders. Relatively few studies have examined the relationship between childhood sexual abuse and adult obesity. These studies suggest at least a modest relationship between the two. Potential explanations for the relationship have focused on the role of disordered eating, particularly binge eating, as well as the possible "adaptive function" of obesity in childhood sexual abuse survivors. Nevertheless, additional research on the relationship between childhood sexual abuse and obesity is clearly needed, not only to address the outstanding empirical issues but also to guide clinical care.

Psychosocial aspects of obesity and obesity surgery.

There is a growing consensus that bariatric surgery is the treatment of choice for extremely obese individuals who have failed to reduce their weight satisfactorily using behavioral or pharmacologic interventions. The gastric bypass in particular is associated with excellent long-term weight loss. Although most extremely obese individuals will have essentially normal psychological functioning, a significant minority suffer from depression, binge eating, trauma, or other emotional complications that may require treatment before or after bariatric surgery. A structured behavioral assessment, conducted by a mental-health professional and a registered dietitian, can readily identify those who are most likely to require adjunct counseling.

Obese patients' perceptions of treatment outcomes and the factors that influence them.

BACKGROUND: Despite considerable professional consensus that modest weight losses of 5% to 10% are successful for reducing the comorbid conditions associated with obesity, obese patients often desire weight losses 2 to 3 times greater than this. Examining ways to reduce the disparities between treatment expectations and subsequent outcomes, this study evaluated the role of physical characteristics, treatment setting, and mood in patients' evaluations of treatment outcomes. METHODS: This study was conducted in a university outpatient weight loss clinic with a sample of 397 obese individuals seeking weight loss by a variety of modalities. Before treatment, participants' heights and weights were measured, and the Beck Depression Inventory and the Goals and Relative Weight Questionnaire were administered. RESULTS: Outcome evaluations ranged from 64.4 +/- 11.1 kg (mean +/- SD) for dream weight to 90.1 +/- 19.1 kg for disappointed weight. Initial body weight was the strongest predictor of disappointed, acceptable, and happy weights (beta =.90,.76, and.57, respectively). Sex (beta = -.37) and height (beta =.37) were the strongest determinants of dream weight. Heavier participants chose higher absolute weights, but the weight loss required to reach each of the outcomes was greater for heavier than for lighter patients. CONCLUSIONS: These data signal a therapeutic dilemma in which the amount of weight loss produced by the best behavioral and/or pharmacologic treatments is viewed as even less than disappointing. Patients with the highest pretreatment weights are likely to have the most unrealistic expectations for success.

Benefits of lifestyle modification in the pharmacologic treatment of obesity: a randomized trial.

BACKGROUND: Weight loss medications are recommended as an adjunct to diet and exercise modification but seem to be prescribed as a monotherapy by many physicians. This practice is likely to be associated with suboptimal weight loss. METHODS: This 1-year, randomized trial compared the effects of sibutramine hydrochloride used alone (ie, the drug-alone group) to sibutramine plus group lifestyle modification, prescribed with either a 5021- to 6276-kJ/d diet (1200-1500-kcal/d diet) (ie, the drug-plus-lifestyle group) or, for the first 4 months, a 4184-kJ/d diet (1000-kcal/d diet (ie, drug-plus-lifestyle with a portion-controlled diet [the combined treatment] group). Participants were 53 women with a mean (+/-SD) age of 47.2 +/- 9.8 years and weight of 101.3 +/- 9.7 kg. At baseline, they reported the number of pounds they expected to lose at the end of treatment. RESULTS: At month 12, patients treated with the drug alone lost (mean +/- SD) 4.1% +/- 6.3% of their initial body weight compared with significantly (P<.05) larger losses in the drug-plus-lifestyle group of 10.8% +/- 10.3% and the combined treatment group of 16.5% +/- 8.0%. Women in the 2 lifestyle groups achieved a significantly (P<.05) greater percentage of their expected weight loss than those in the drug-alone group and were significantly more satisfied with the medication and with changes in weight, health, appearance, and self-esteem (P<.05 for all). Significant reductions were observed at 12 months in triglyceride and low-density lipoprotein cholesterol levels but systolic and diastolic blood pressure both increased significantly (P<.05 for all). CONCLUSION: The addition of group lifestyle modification to the pharmacologic management of obesity significantly improved weight loss and patients' satisfaction with treatment outcome.

Cosmetic breast augmentation surgery: a critical overview.

Despite the ban on silicone gel breast implants in 1992, the last decade witnessed a dramatic increase in the number of cosmetic breast augmentation procedures performed in the United States. According to the American Society of Plastic Surgeons, over 132,000 women in this country underwent the procedure in 1998. This is an underestimate of the actual number of breast augmentations performed annually, as increasing numbers of nonsurgeon physicians are now performing cosmetic surgery. Given the rising number of women who now seek cosmetic breast augmentation surgery, it is likely that women's healthcare providers will be asked by their patients about breast augmentation. This review is designed to provide an overview of the medical and psychological literature on cosmetic breast augmentation. We begin with a history of breast augmentation, including an overview of the controversy of silicone breast implants and the Institute of Medicine's report on their safety published in 1999. We also discuss the psychological characteristics of breast augmentation patients, reviewing both preoperative and postoperative studies. We conclude with suggestions for future research as well as a discussion of the clinical relevance of this area for women's healthcare professionals.