The Impact of Weight on Quality of Life‐Lite (IWQOL‐Lite) is widely used in evaluations of weight‐loss interventions, including pharmaceutical trials. Because this measure was developed using input from individuals undergoing intensive residential treatment, the IWQOL‐Lite may include concepts not relevant to clinical trial populations and may be missing concepts that are relevant to these populations. An alternative version, the IWQOL‐Lite Clinical Trials Version (IWQOL‐Lite‐CT), was developed and validated according to the US Food and Drug Administration's (FDA's) guidance on patient‐reported outcomes. Psychometric analyses were conducted to validate the IWQOL‐Lite‐CT using data from two randomized trials (NCT02453711 and NCT02906930) that included individuals with overweight/obesity, with and without type 2 diabetes. Additional measures included the SF‐36, global items, weight and body mass index. The IWQOL‐Lite‐CT is a 20‐item measure with two primary domains (Physical [seven items] and Psychosocial [13 items]). A five‐item Physical Function composite and Total score were also supported. Cronbach's alpha and intraclass correlation coefficients exceeded 0.77 at each time point; patterns of construct validity correlations were consistent with hypotheses; and scores demonstrated treatment benefit. The IWQOL‐Lite‐CT is appropriate for assessing weight‐related physical and psychosocial functioning in populations commonly targeted for obesity clinical trials. Qualification from the FDA is being sought for use of the IWQOL‐Lite‐CT in clinical trials to support product approval and labelling claims.

ObjectiveThe goal of this study is to investigate obesity and its concomitant effects including the prevalence of comorbidities, its association with patient-reported outcomes and costs, and weight loss strategies in a sample of Mexican adults.MethodsMexican adults (N=2,511) were recruited from a combination of Internet panels and street intercepts using a random-stratified sampling framework, with strata defined by age and sex, so that they represent the population. Participants responded to a survey consisting of a range of topics including sociodemographics, health history, health-related quality of life (HRQoL), work productivity, health care resource use, and weight loss.ResultsThe sample consisted of 50.6% male with a mean age of 40.7 years (SD=14.5); 38.3% were overweight, and 24.4% were obese. Increasing body mass index (BMI) was associated with increased rates of type 2 diabetes, prediabetes, and hypertension, poorer HRQoL, and decreased work productivity. Of the total number of respondents, 62.2% reported taking steps to lose weight with 27.6% and 17.1% having used an over-the-counter/herbal product and a prescription medication, respectively. Treatment discontinuation rates were high.ConclusionFindings indicated that 62% of participants reported, at least, being overweight and that they were experiencing the deleterious effects associated with higher BMI despite the desire to lose weight. Given the rates of obesity, and its impact on humanistic and societal outcomes, improved education, prevention, and management could provide significant benefits.

BACKGROUND: Obesity, a multifactorial disease associated with many severe complications, affects more than 40% of adults in the United States.

SummaryExisting measures of health‐related quality of life and patient functioning in obesity, such as the Impact of Weight on Quality of Life‐Lite (IWQOL‐Lite) questionnaire, lack the developmental rigour required by the Food and Drug Administration (FDA) to support product labelling. Two iterative qualitative studies informed development of a version of the IWQOL‐Lite questionnaire optimized for use in obesity clinical trials: the IWQOL‐Lite Clinical Trials Version. Study 1 included 42 patients with body mass index (BMI) ≥ 30 kg m−2 (obesity); and Study 2 included 29 patients with type 2 diabetes and BMI ≥ 27 kg m−2 (overweight). Candidate items were selected and/or modified from the IWQOL‐Lite or developed de novo based on concept elicitation and cognitive debriefing interviews, as well as input from clinical experts and the FDA. Participants consistently reported that excess weight limited physical activity and comfort, energy/stamina and self‐confidence/self‐esteem. Impacts on emotional, social and sexual functioning, as well as productivity and overall health, were also reported. Each concept addressed in the 22‐item pilot IWQOL‐Lite Clinical Trials Version was consistently reported as salient and likely to change with 10% weight loss. Data from ongoing and planned clinical trials will be used to finalize and conduct psychometric evaluations of the pilot measure in several patient populations.

PurposeThis study investigated the association between body mass index (BMI) and three comorbid conditions (type 2 diabetes [T2D], prediabetes, and hypertension) on humanistic and economic outcomes.Patients and methodsThis retrospective observational study collected data from German (n=14286) and Italian (n=9433) respondents to the 2013 European Union National Health and Wellness Survey, a cross-sectional, nationally representative online survey of the general adult population. Respondents were grouped, based on their self-reported BMI, and stratified into three other comorbid conditions (T2D, prediabetes, and hypertension). Generalized linear models, controlling for demographics and health characteristics, tested the relationship between BMI and health status, work productivity loss, and health care resource utilization. Indirect and direct costs were calculated based on overall work productivity loss and health care resource utilization, respectively. The same generalized linear models were also performed separately for those with T2D, prediabetes, and hypertension.ResultsThe sample of German respondents was 50.16% male, with a mean age of 46.68 years (SD =16.05); 35.24% were classified as overweight and 21.29% were obese. In Italy, the sample was 48.34% male, with a mean age of 49.27 years (SD =15.75); 34.85% were classified as overweight, and 12.89% were obese. Multivariable analyses demonstrated that, in both countries, higher BMI was associated with worse humanistic outcomes and only those from Germany also reported greater direct and indirect costs. Differences in the impact of BMI on outcomes by country were additionally found when the sample was stratified into those with prediabetes, T2D, and hypertension.ConclusionThe high percentage of patients who are overweight or obese in Germany and Italy remains problematic. Better elucidating the impact of overweight or obese BMI, as well as the incremental effects of relevant comorbid conditions, on humanistic and economic outcomes is critical to quantify the multifaceted burden on individuals and society.