The development of scientific evidence for health policies for obesity: why and how?

Potential obesity-related policy approaches have recently been receiving more attention. Although some have been implemented and others only proposed, few have been formally evaluated. We discuss the relevance, and in some cases irrelevance, of some of the types of evidence that are often brought to bear in considering obesity-related policy decisions. We discuss major methods used to generate such evidence, emphasizing study design and the varying quality of the evidence obtained. Third, we consider what the standards of evidence should be in various contexts, who ought to set those standards, as well as the inherent subjectivity involved in making policy decisions. Finally, we suggest greater transparency from both academics and policymakers in the acknowledgment of subjectivities so they can distinguish and communicate the roles of empirical evidence and subjective values in the formulation of policy.

Hope thinking and past trauma mediate the relationships of body mass index with perceived mental health treatment need and mental health treatment use.

UNLABELLED: Greater body mass is associated with a greater risk of mental health conditions and more frequent mental health treatment use. However, factors that might influence perceived mental health treatment need and mental health treatment use among those of greater weight, including hope thinking, trauma history and perceived mental health treatment stigma, are not well understood. OBJECTIVE: The objective of this study was to determine if hope thinking, trauma history and/or perceived mental health treatment stigma mediate the relationships of body mass index [BMI] with perceived mental health treatment need and mental health treatment use. METHOD: Primary care clinic patients in the Midwest United States (N = 196; BMI range = 18.5 to 47.0, mean = 29.26 ± 6.61, median = 27.90) were recruited to complete a battery of self-report measures that assessed perceived mental health treatment need, mental health treatment use, hope thinking (Trait Hope Scale), trauma history (a single-item traumatic event history screen from the posttraumatic stress disorder module of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), and perceived mental health treatment stigma (Stigma Scale for Receiving Psychological Help). RESULTS: Reduced hope thinking and a greater incidence of past trauma accounted for greater perceived mental health treatment need and greater mental health treatment use among those of greater BMI. BMI was not related to perceived unmet mental health treatment need. CONCLUSION: Increased perceived mental health treatment need and mental health treatment use among those of greater BMI may be explained by lower hope thinking and a greater incidence of trauma in this population. Heavier patients may benefit from interventions designed to augment hope and address traumatic histories.

Randomized controlled trial examining expectancy effects on the accuracy of weight measurement.

BACKGROUND: Researchers and participants' expectations can influence treatment response. Less is known about the effects of researchers' expectations on the accuracy of data collection in the context of a weight loss trial. METHODS: Student raters (N = 58; age = 20.1 ± 2.3 years) were recruited to weigh individuals who they thought were completing a 12-month weight loss trial, although these 'participants' were actually standardized patients (SPs) playing these roles. Prior to data collection, student raters were provided information suggesting that the tested treatment had been effective. Each student rater received a list of 9-10 'participants' to weigh. While the list identified each person as 'treatment' or 'control', this assignment was at random, which allowed us to examine the effects of non-blinding and expectancy manipulation on weight measurement accuracy. We hypothesized that raters would record the weights of 'treatment participants' as lower than those of 'control participants'. RESULTS: Contrary to our hypothesis, raters recorded weights that were 0.293 kg heavier when weighing 'treatment' vs. 'control' SPs, although this difference was not significant (P = 0.175). CONCLUSIONS: This pilot study found no evidence that manipulating expectancies about treatment efficacy or not blinding raters biased measurements. Future work should examine other biases which may be created by not blinding research staff who implement weight loss trials as well as the participants in those trials.

Obesity and mortality: are the risks declining? Evidence from multiple prospective studies in the United States.

We evaluated whether the obesity-associated years of life lost (YLL) have decreased over calendar time. We implemented a meta-analysis including only studies with two or more serial body mass index (BMI) assessments at different calendar years. For each BMI category (normal weight: BMI 18.5 to <25 [reference]; overweight: BMI 25 to <30; grade 1 obesity: BMI 30 to <35; and grade 2-3 obesity: BMI ≥ 35), we estimated the YLL change between 1970 and 1990. Because of low sample sizes for African-American, results are reported on Caucasian. Among men aged ≤60 years YLL for grade 1 obesity increased by 0.72 years (P < 0.001) and by 1.02 years (P = 0.01) for grade 2-3 obesity. For men aged >60, YLL for grade 1 obesity decreased by 1.02 years (P < 0.001) and increased by 0.63 years for grade 2-3 obesity (P = 0.63). Among women aged ≤60, YLL for grade 1 obesity decreased by 4.21 years (P < 0.001) and by 4.97 years (P < 0.001) for grade 2-3 obesity. In women aged >60, YLL for grade 1 obesity decreased by 3.98 years (P < 0.001) and by 2.64 years (P = 0.001) for grade 2-3 obesity. Grade 1 obesity's association with decreased longevity has reduced for older Caucasian men. For Caucasian women, there is evidence of a decline in the obesity YLL association across all ages.

Body mass index and mortality rate among Hispanic adults: a pooled analysis of multiple epidemiologic data sets.

OBJECTIVE: To evaluate the association between body mass index (BMI, kg m⁻²) and mortality rate among Hispanic adults. METHODS AND PROCEDURES: Analysis of five data sets (total N=16,798) identified after searching for publicly available, prospective cohort data sets containing relevant information for at least 500 Hispanic respondents (≥18 years at baseline), at least 5 years of mortality follow-up, and measured height and weight. Data sets included the third National Health and Nutrition Examination Survey, the Puerto Rico Heart Health Program (PRHHP), the Hispanic Established Population for Epidemiologic Studies of the Elderly (HEPESE), the San Antonio Heart Study (SAHS) and the Sacramento Area Latino Study on Aging. RESULTS: Cox proportional hazards regression models, adjusting for sex and smoking, were fit within three attained-age strata (18 to younger than 60 years, 60 to younger than 70 years, and 70 years and older). We found that underweight was associated with elevated mortality rate for all age groups in the PRHHP (hazard ratios [HRs]=1.38-1.60) and the SAHS (HRs=1.88-2.51). Overweight (HRs=0.38 and 0.84) and obesity grade 2-3 (HRs=0.75 and 0.60) associated with reduced mortality rate in the HEPESE dataset for those in the 60 to younger than 70 years, and 70 years and older attained-age strata. Weighted estimates combining the HRs across the data sets revealed a similar pattern. CONCLUSION: Among Hispanic adults, there was no clear evidence that overweight and obesity associate with elevated mortality rate.

Is funding source related to study reporting quality in obesity or nutrition randomized control trials in top-tier medical journals?

BACKGROUND: Faithful and complete reporting of trial results is essential to the validity of the scientific literature. An earlier systematic study of randomized controlled trials (RCTs) found that industry-funded RCTs appeared to be reported with greater quality than non-industry-funded RCTs. The aim of this study was to examine the association between systematic differences in reporting quality and funding status (that is, industry funding vs non-industry funding) among recent obesity and nutrition RCTs published in top-tier medical journals. METHODS: Thirty-eight obesity or nutrition intervention RCT articles were selected from high-profile, general medical journals (The Lancet, Annals of Internal Medicine, JAMA and the British Medical Journal) published between 2000 and 2007. Paired papers were selected from the same journal published in the same year, one with and the other without industry funding. The following identifying information was redacted: journal, title, authors, funding source and institution(s). Then three raters independently and blindly rated each paper according to the Chalmers method, and total reporting quality scores were calculated. FINDINGS: The inter-rater reliability (Cronbach's alpha) was 0.82 (95% confidence interval = 0.80-0.84). The total mean (M) and s.d. of Chalmers Index quality score (out of a possible 100) for industry-funded studies were M = 84.5, s.d. = 7.04 and for non-industry-funded studies they were M = 79.4, s.d. = 13.00. A Wilcoxon matched-pairs signed-ranks test indicates no significant rank difference in the distributions of total quality scores between funding sources, Z = -0.966, P = 0.334 (two tailed). INTERPRETATION: Recently published RCTs on nutrition and obesity that appear in top-tier journals seem to be equivalent in quality of reporting, regardless of funding source. This may be a result of recent reporting of quality statements and efforts of journal editors to raise all papers to a common standard.

Use of self-reported height and weight biases the body mass index-mortality association.

BACKGROUND: Many large-scale epidemiological data sources used to evaluate the body mass index (BMI: kg/m(2)) mortality association have relied on BMI derived from self-reported height and weight. Although measured BMI (BMI(M)) and self-reported BMI (BMI(SR)) correlate highly, self-reports are systematically biased. OBJECTIVE: To rigorously examine how self-reporting bias influences the association between BMI and mortality rate. SUBJECTS: Samples representing the US non-institutionalized civilian population. DESIGN AND METHODS: National Health and Nutrition Examination Survey data (NHANES II: 1976-80; NHANES III: 1988-94) contain BMI(M) and BMI(SR). We applied Cox regression to estimate mortality hazard ratios (HRs) for BMI(M) and BMI(SR) categories, respectively, and compared results. We similarly analyzed subgroups of ostensibly healthy never-smokers. RESULTS: Misclassification by BMI(SR) among the underweight and obesity ranged from 30-40% despite high correlations between BMI(M) and BMI(SR) (r>0.9). The reporting bias was moderately correlated with BMI(M) (r>0.35), but not BMI(SR) (r<0.15). Analyses using BMI(SR) failed to detect six of eight significant mortality HRs detected by BMI(M). Significantly biased HRs were detected in the NHANES II full data set (χ(2)=12.49; P=0.01) and healthy subgroup (χ(2)=9.93; P=0.04), but not in the NHANES III full data set (χ(2)=5.63; P=0.23) or healthy subgroup (χ(2)=1.52; P=0.82). CONCLUSIONS: BMI(SR) should not be treated as interchangeable with BMI(M) in BMI mortality analyses. Bias and inconsistency introduced by using BMI(SR) in place of BMI(M) in BMI mortality estimation and hypothesis tests may account for important discrepancies in published findings.

Putative contributors to the secular increase in obesity: exploring the roads less traveled.

OBJECTIVE: To investigate plausible contributors to the obesity epidemic beyond the two most commonly suggested factors, reduced physical activity and food marketing practices. DESIGN: A narrative review of data and published materials that provide evidence of the role of additional putative factors in contributing to the increasing prevalence of obesity. DATA: Information was drawn from ecological and epidemiological studies of humans, animal studies and studies addressing physiological mechanisms, when available. RESULTS: For at least 10 putative additional explanations for the increased prevalence of obesity over the recent decades, we found supportive (although not conclusive) evidence that in many cases is as compelling as the evidence for more commonly discussed putative explanations. CONCLUSION: Undue attention has been devoted to reduced physical activity and food marketing practices as postulated causes for increases in the prevalence of obesity, leading to neglect of other plausible mechanisms and well-intentioned, but potentially ill-founded proposals for reducing obesity rates.

Citrus aurantium and synephrine alkaloids in the treatment of overweight and obesity: an update.

Obesity is a major health problem facing the developed and developing world. Efforts by individuals, health professionals, educators, and policy makers to combat the escalating trend of growing obesity prevalence have been multifaceted and mixed in outcome. Various dietary supplements have been marketed to reduce obesity. These products have been suggested to accomplish this by decreasing energy intake and energy absorption, and/or increasing metabolic rate. Ephedra, one such supplement, was banned from sale in the US market because of concerns about adverse events. Another substance, Citrus aurantium, which contains several compounds including synephrine alkaloids, has been suggested as a safe alternative. This review examines the evidence for safety and efficacy of C. aurantium and synephrine alkaloids as examined in animal studies, clinical weight loss trials, acute physiologic studies and case reports. Although at least three reviews of C. aurantium have been published, our review expands upon these by: (i) distinguishing and evaluating the efficacy of C. aurantium and related compounds; (ii) including results from previously unreviewed research; (iii) incorporating recent case reports that serve to highlight, in an anecdotal way, potential adverse events related to the use of C. aurantium and related compounds; and (iv) offering recommendations to guide the design of future trials to evaluate the safety and efficacy of C. aurantium. While some evidence is promising, we conclude that larger and more rigorous clinical trials are necessary to draw adequate conclusions regarding the safety and efficacy of C. aurantium and synephrine alkaloids for promoting weight loss.

Depressive mood and obesity in US adults: comparison and moderation by sex, age, and race.

OBJECTIVE: Sustained depressive mood is a gateway symptom for a major depressive disorder. This paper investigated whether the association between depressive mood and obesity differs as function of sex, age, and race in US adults after controlling for socio-economic variables of martial status, employment status, income level and education level. METHODS: A total of 44,800 nationally representative respondents from the 2001 Behavioral Risk Factor Surveillance Survey were studied. Respondents were classified as having experienced a depressive mood if they felt sad, blue, or depressed at least for 1 week in the previous month. The depressive mood was operationalized in terms of duration and sustenance, both defined based on number of days with depressive mood: 7+ and 14+ days. Age groups were classified as young (18-64 years) and old (65+ years). Obesity status was classified as: not overweight/obese (BMI<25); overweight (25or=30). RESULTS: Prevalence of prior-month depressive mood was 14.3 and 7.8% for 7+ and 14+ days, respectively. Controlling for race and socio-economic variables, both young overweight and obese women were significantly more likely to have experienced depressive mood than nonoverweight/nonobese women. Young overweight, but not obese, men were significantly more likely to have experienced depressive mood than nonoverweight/nonobese men. Young obese women were also significantly more likely to have a sustained depressive mood than nonoverweight/nonobese women. For old respondents, depressive mood and its sustenance were not associated with obesity in either sex. DISCUSSION: The relationship between the depressive mood and obesity is dependent upon gender, age, and race. Young obese women, Hispanics in particular, are much more prone to depressive mood than nonobese women. Future studies testing associations between depression and obesity should be sensitive to the influence of these demographic and socio-economic variables.

Obesity and prostate cancer screening in the USA.

OBJECTIVE: To estimate the association between body mass index (BMI: kg/m2) and prostate-specific antigen (PSA) cancer screening in a nationally representative sample of US men aged 50 years and older using data from the 2001 Behavioral Risk Factor Surveillance Survey. RESPONDENTS: Men aged 50 years or older classified by BMI as healthy weight range (18.5-24.9), overweight (25-29.9), obese class I (30-34.9), obese class II (35-39.9), and obese class III (> or =40). OUTCOME MEASURES: Interval since most recent screening for PSA. RESULTS: Adjusting for age, race, smoking, education, employment, income and health insurance status, we found that, compared with men in the healthy weight range, men in the overweight [odds ratio (OR)=1.13; 95% confidence interval (95% CI)=1.04-1.35], obese class I (OR=1.26; 95% CI=1.06-1.36) and obese class II (OR=1.14, 95% CI=1.02-1.26) categories were significantly more likely to have obtained a PSA test within the previous year. A similar pattern was observed when we examined other screening intervals (e.g. within past 2 years, within past 3 years, etc.). CONCLUSIONS: Among men aged 50 years and older, overweight and obesity is associated with obtaining a PSA test.

A novel soy-based meal replacement formula for weight loss among obese individuals: a randomized controlled clinical trial.

OBJECTIVE: To assess the efficacy and safety of a low calorie soy-based meal replacement program for the treatment of obesity. DESIGN: A 12-week prospective randomized controlled clinical trial. SETTING: Outpatient weight control research unit. SUBJECTS: One hundred obese (28

Weight loss causes increased mortality: cons.

Short-term studies indicate that intentional weight loss (IWL) among obese persons significantly improves health variables that are often precursors or markers of chronic diseases (e.g. heart diseases, type-2 diabetes). Hence, it is logical to assume that IWL among obese persons would lead to increased longevity. On the whole, epidemiological studies, including recent ones that use conservative analytic approaches such as distinguishing between apparently IWL and unintentional weight loss (UWL), adjusting for potential confounders and excluding apparently unhealthy subjects, indicate that apparently IWL appears to neither increase nor decrease mortality rate. However, it is important to note that none of the existing studies were designed specifically to test the hypothesis that IWL reduces mortality rate, and given methodological problems, these studies do not provide a satisfactory way to address the body mass index (BMI)-mortality question. Several controlled clinical trials suggest that IWL may reduce mortality rate. However, even in these studies, it is important to acknowledge that subjects are randomized to conditions that produce more or less weight loss and not to distinct levels of weight loss per se. Nevertheless, while we await additional data from better designed studies, given our incomplete knowledge, we conclude that it seems more likely than not that IWL achieved by medically recommended methods does not increase and probably decreases mortality rate.

A meta-analytic investigation of linkage and association of common leptin receptor (LEPR) polymorphisms with body mass index and waist circumference.

METHODS: We analyzed data pooled from nine studies on the human leptin receptor (LEPR) gene for the association of three alleles (K109R, Q223R and K656N) of LEPR with body mass index (BMI; kg/m(2)) and waist circumference (WC). A total of 3263 related and unrelated subjects from diverse ethnic backgrounds including African-American, Caucasian, Danish, Finnish, French Canadian and Nigerian were studied. We tested effects of individual alleles, joint effects of alleles at multiple loci, epistatic effects among alleles at different loci, effect modification by age, sex, diabetes and ethnicity, and pleiotropic genotype effects on BMI and WC. RESULTS: We found that none of the effects were significant at the 0.05 level. Heterogeneity tests showed that the variations of the non-significant effects are within the range of sampling variation. CONCLUSIONS: We conclude that, although certain genotypic effects could be population-specific, there was no statistically compelling evidence that any of the three LEPR alleles is associated with BMI or WC in the overall population.

Body weight and cancer screening among women.

Obesity increases cancer risk, yet small-scale surveys indicate that obese women delay or avoid cancer screening even more so than do nonobese women. We sought to estimate the association between body mass index (BMI) (kg/m(2)) and delayed cancer screening among adult women in a population-based survey. Subjects were women classified by BMI as underweight (<18.5), desirable weight (18.5-24.9), overweight (25-29.9), obese class I (30-34.9), obese class II (35-39.9), and obese class III (> or =40). Outcome measures were intervals (0 for < or =2 years versus 1 for >2 years) since most recent screening for Papanicolaou (Pap) smear, mammography, and clinical breast examination (CBE). Adjusting for age, race, smoking, and health insurance, we observed J-shaped associations between BMI and screening. Compared with desirable weight women, underweight women (odds ratios [OR] = 1.21, 95% confidence interval [95% CI] 1.09-1.34), overweight women (OR = 1.13, 95% CI 1.07-1.18), and obese women (OR range 1.22-1.69) were significantly more likely to delay Pap smear testing for >2 years. Underweight (OR = 1.32, 95% CI 1.13-1.54), obesity class I (OR = 1.12, 95% CI 1.02-1.23), and obesity class III women (OR = 1.32, 95% CI 1.10-1.54) were more likely to delay mammography, and overweight (OR = 1.10, 95% CI 1.01-1.19), obesity class I (OR = 1.18, 95% CI 1.08-1.30), and obesity class III women (OR = 1.47, 95% CI 1.23-1.75) were more likely to delay CBE. White women were more likely to delay CBE as a function of BMI than were non-white women. Weight may be an important correlate of cancer screening behavior, particularly for white women.

Metabolic disharmony and mortality.

The concept of 'metabolic harmony' is introduced and conceptualized as the state in which indices of metabolic activity (i.e., serum glucose, cholesterol, systolic and diastolic blood pressure, body mass index) within an individual attain their expected values given the individual values on related variables. Its complement, 'metabolic disharmony' (i.e., the extent to which an individual's 'profile' of metabolic variables is jointly unusual in relation to their expected values) is operationalized via Mahalanbis' D(2 )statistic calculated on these indices of metabolic activity (plus age and sex). Analysis of a large (N = 5209) longitudinal (32 years) cohort study shows that, independent of the linear and quadratic effects of the aforementioned metabolic variables, the disharmony index (DI) significantly and strongly predicted hazard of death (chi(2)(1) = 20.05, P < 0.00005). That is, each 10 percentile increase in DI was associated with a 6.9% increase in the hazard rate. The association of DI to hazard rate was not materially altered when potential confounders (e.g., smoking status) were added to the model or when all subjects were included by imputing missing data. These results demonstrate that metabolic disharmony is associated with, and may cause, an increased hazard of death.

Estimating the consequences of anti-psychotic induced weight gain on health and mortality rate.

Many anti-psychotic medications produce marked weight gain. In this study, we estimate the expected impact of degrees of antipsychotic-induced weight gain on selected mortality rate and incidence rates of impaired glucose tolerance (IGT) and hypertension (HTN) among US adults. Using raw data from 5209 respondents from the Framingham Heart Study's public use data set and national statistics on population demographics, we estimated the expected effect of weight gain on number of deaths and incident cases of IGT and HTN for a 10-year period commencing in 1999. Results indicated that the estimated deleterious effects of weight gain were greater for people with higher BMIs at baseline, for greater degrees of weight gain, for men than women, and for older than younger persons. Because there is a 'U-shaped' relation between BMI and mortality rate, small to moderate weight gains among people with baseline BMIs less than 23 were predicted to decrease mortality rates, whereas weight gains among people with baseline BMIs above that level were expected to increase mortality rates. However, the relations of IGT and HTN with BMI are monotonically increasing. Thus, the anticipated effect of weight gain on IGT and HTN is deleterious regardless of baseline BMI. Because it is unclear whether the beneficial effects of the atypical agents on, for example, reducing suicide mortality, outweigh the putative increase in mortality due to weight gain, we estimate the beneficial effects due to decreased death from suicide with the potential deleterious effects due to a 10-kg weight gain. We found that 492 suicide deaths per 100,000 schizophrenic patients would be prevented over 10 years with the use of clozapine compared to 416 additional deaths due to antipsychotic induced weight gain. Although this estimate is rather crude and should be seen only as offering a sense of the likely situation, results suggest that the lives saved via clozapine may essentially be offset by the deaths due to weight gain. As we discuss, it is not possible to provide definitive estimates of the effect of antipsychotic-induced weight gain on health and mortality, but our findings suggest that the magnitude of weight gains induced by many antipsychotic agents is likely to have important deleterious effects on mortality and health.

Alternative treatments for weight loss: a critical review.

"Nontraditional" or "alternative" treatments are extremely popular, especially with respect to obesity and body composition. Although such treatments are widely used, it is not clear that these are supported by the existing data in the peer-reviewed literature. Herein, we review the data on 18 methods/products advocated as potential anti-obesity/fat-reducing agents. We have found that none have been convincingly demonstrated to be safe and effective in two or more peer-reviewed publications of randomized double-blind placebo-controlled trials conducted by at least two independent laboratories. Nevertheless, some have plausible mechanisms of action and encouraging preliminary data that are sufficiently provocative to merit further research.

Weight loss and exercise walking reduce pain and improve physical functioning in overweight postmenopausal women with knee osteoarthritis.

We conducted an uncontrolled pilot study to determine the effects of a weight loss and walking program on knee pain and physical function in overweight and obese (body mass index; BMI [kg/m] 25-29.9 and BMI > or = 30, respectively) postmenopausal women with knee osteoarthritis (OA). Forty-eight such women completed self-report (Western Ontario and McMaster University Osteoarthritis Index (WOMAC)) and performance-based measures of physical function ("up and go" test, 6-min walk) and enrolled in a 6-month intervention that included weekly nutrition classes and an exercise-walking program. The intervention produced an average weight loss of 5.6 +/- 4.0 kg in the 30 women who completed the program. There also were significant improvements in the 6-min walk and on VO(2max). Improvements in the timed up and go test and on the WOMAC pain and function scores, however, were restricted only to women who were classified as obese at baseline. These findings suggest that a 6-month weight loss and walking program improves measures of physical functioning and pain in overweight and obese postmenopausal women with knee OA. Among obese women, functional improvement correlated with weight loss, encouraging continued emphasis on weight loss for managing knee OA.