Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity.

Previously in the SCALE Obesity and Prediabetes trial, at 1 year, participants with obesity (or overweight with comorbidities) and prediabetes receiving liraglutide 3.0 mg experienced greater improvements in health-related quality of life (HRQoL) than those receiving placebo. The current study extends these findings by examining 3-year changes in HRQoL. HRQoL was assessed using the obesity-specific Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, as well as the Short-Form 36 v2 (SF-36) health survey. At 3 years, mean change (±standard deviation) in IWQOL-Lite total score from baseline for liraglutide (n = 1472) was 11.0 ± 14.2, vs. 8.1 ± 14.7 for placebo (n = 738) (estimated treatment difference [ETD] 3.4 [95% confidence interval (CI): 2.0, 4.7], P < 0.0001). Mean change in SF-36 physical component summary (PCS) score from baseline for liraglutide was 3.1 ± 7.3, vs. 2.6 ± 7.6 for placebo (ETD 0.87 [95% CI: 0.17, 1.6], P = 0.0156). Mean change in SF-36 mental component summary score did not significantly differ between groups. Both IWQOL-Lite total score and PCS score demonstrated an association between greater HRQoL improvement with higher weight loss. Liraglutide 3.0 mg was also associated with improved health utility (Short-Form-6D and EuroQol-5D, mapped from IWQOL-Lite and/or SF-36) vs. placebo. Liraglutide 3.0 mg, plus diet and exercise, is associated with long-term improvements in HRQoL with obesity or overweight with comorbidity vs. placebo.

Health-related quality of life in randomized controlled trials of lorcaserin for obesity management: what mediates improvement?

Lorcaserin, plus diet and exercise, has demonstrated significant weight loss and improved cardiometabolic parameters vs. placebo in patients with overweight/obesity in three randomized, placebo-controlled trials. We examined whether lorcaserin is also associated with greater improvements in health-related quality of life (HRQOL) and whether these improvements are wholly attributable to weight loss. Pooled data from Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM), Behavioral Modification and Lorcaserin Second Study for Obesity Management (BLOSSOM) and BLOOM-Diabetes Mellitus (BLOOM-DM) trials were analysed (n = 5624). HRQOL was assessed at baseline and 52 weeks using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire. Multiple mediation analyses were conducted to evaluate the mechanisms underlying improved HRQOL. Greater HRQOL improvements were observed at 52 weeks in lorcaserin vs. placebo (P < 0.0001). A greater percentage of lorcaserin patients (54.1%) experienced meaningful improvements in IWQOL-Lite total score than placebo patients (48.2%) (P < 0.001). Body mass index (BMI) reduction was the primary driver of improved HRQOL (P < 0.0001), with depressive symptoms and total cholesterol also playing a role (P < 0.05). Improved HRQOL varied by gender, age, race and presence of diabetes and other comorbidities. Lorcaserin treatment significantly improves HRQOL compared with placebo. Although BMI reduction accounts for the majority of these improvements, improvement in depressive symptoms and total cholesterol are contributing factors.

A systematic review of reviews: exploring the relationship between obesity, weight loss and health-related quality of life.

This is the first systematic review of reviews to assess the effect of obesity and weight loss on health-related quality of life (HRQoL). We identified 12 meta-analyses/systematic reviews published between January 2001 and July 2016. They addressed the following themes: (i) the relationship between weight/body mass index and HRQoL (baseline/pre-intervention; n = 2). (ii) HRQoL after weight loss (varied interventions and/or study design; n = 2). (iii) HRQoL after weight loss (randomized controlled trials only; n = 2). (iv) HRQoL after bariatric surgery (n = 6). We found that in all populations, obesity was associated with significantly lower generic and obesity-specific HRQoL. The relationship between weight loss and improved HRQoL was consistently demonstrated after bariatric surgery, perhaps due to a greater than average weight loss compared with other treatments. Improved HRQoL was evident after non-surgical weight loss, but was not consistently demonstrated, even in randomized controlled trials. This inconsistency may be attributed to variation in quality of reporting, assessment measures, study populations and weight-loss interventions. We recommend longer-term studies, using both generic and obesity-specific measures, which go beyond HRQoL in isolation to exploring mediators of HRQoL changes and interactions with other variables, such as comorbidities, fitness level and body image.

Development of a clinical trials version of the Impact of Weight on Quality of Life-Lite questionnaire (IWQOL-Lite Clinical Trials Version): results from two qualitative studies.

Existing 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.

Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management.

Obesity has a negative impact on health-related quality of life (HRQoL). The SCALE Obesity and Prediabetes study investigated the effect of liraglutide 3.0 mg, as adjunct to diet and exercise, on HRQoL in patients with obesity [body mass index (BMI) ≥ 30 kg m(-2) ] or overweight (BMI ≥ 27 kg m(-2) ) with comorbidity. Participants were advised on a 500 kcal d(-1) deficit diet and a 150-min week(-1) exercise programme and were randomised 2:1 to once-daily subcutaneous liraglutide 3.0 mg or placebo. HRQoL was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) and Short-Form 36 (SF-36) v2 health questionnaires. Individuals on liraglutide 3.0 mg (n = 2046) had significantly greater improvements in IWQOL-Lite total score (10.6 ± 13.3) vs. placebo (n = 1020) (7.7 ± 12.8) and SF-36 physical (PCS) and mental (MCS) component summary scores (PCS, 3.6 ± 6.8; MCS, 0.2 ± 8.1) vs. placebo (PCS, 2.2 ± 7.7; MCS, -0.9 ± 9.1). The estimated treatment differences were IWQOL-Lite total score 3.1 (95% CI: 2.2; 4.0), P < 0.0001; SF-36 PCS 1.7 (95% CI: 1.2; 2.2), P < 0.0001 and MCS 0.9 (95% CI: 0.3; 1.5), P = 0.003. All subscales of the IWQOL-Lite and SF-36 were significantly improved with liraglutide 3.0 mg vs. placebo. More patients on liraglutide 3.0 mg experienced meaningful improvement on the IWQOL-Lite total (P < 0.0001) and the SF-36 PCS (P < 0.0001) scores.

Patient-reported quality of life in a randomized placebo-controlled trial of naltrexone/bupropion for obesity.

Weight loss is associated with improved quality of life in some, but not all, weight loss trials. We evaluated changes at 56 weeks in quality of life, measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, in a pooled analysis of patient-level data from four randomized controlled Phase 3 studies of naltrexone/bupropion (NB32 or Contrave®). The total number of subjects was 3362 (NB32 = 2043; placebo = 1319; mean body mass index = 36.3 kg m(2); mean age = 46). Improvements in IWQOL-Lite Total Score were greater in subjects treated with NB32 (11.9 points [SE 0.3]) vs. placebo (8.2 points [SE 0.3]; P < 0.001), corresponding to weight reductions of 7.0% (SE 0.2) and 2.3% (SE 0.2), respectively. Greater improvements were also observed for NB32 vs. placebo on all five subscale scores of the IWQOL-Lite. Fifty per cent of NB32-treated subjects achieved clinically meaningful improvements in IWQOL-Lite Total Score vs. 32.3% of placebo-treated subjects (odds ratio, 95% confidence interval; 2.09, 1.79-2.44). Subjects losing the most weight (≥ 15% of baseline weight) experienced the greatest improvement in IWQOL-Lite Total Score (19.3 points [SE 0.7] for NB32 and 18.7 points [SE 1.3] for placebo; P = 0.624). Improved quality of life was associated with weight reduction and was achieved in more subjects treated with NB32 than placebo.

The effects of weight loss after bariatric surgery on health-related quality of life and depression.

BACKGROUND: In severe obesity, impairments in health-related quality of life (HRQoL) and dysphoric mood are reported. This is a post-surgery analysis of the relationship between HRQoL and depressive symptoms, and weight change after four different types of bariatric procedures. METHODS: A total of 105 consented patients completed the Short-Form-36 Health Survey (SF-36), the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) and the Beck Depression Inventory (BDI) before and 25 months after surgery. Analysis of variance or Kruskal-Wallis test evaluated changes. RESULTS: Patients with Roux-en Y gastric bypass (46 patients), decreased body mass indexes (BMIs; kg m(-)(2)) 47-31 kg m(-)(2) (P<0.0001); biliopancreatic diversion with duodenal switch (18 patients), decreased BMIs 57-30 kg m(-)(2) (P<0.0001); adjustable gastric banding (18 patients), decreased BMIs 45-38 kg m(-)(2) (P<0.0001); and sleeve gastrectomies (23 patients), decreased BMIs 58 42 kg m(-)(2) (P<0.0001). The excess percentage BMI loss was 69, 89, 36 and 53 kg m(-)(2), respectively (P<0.0001). Before surgery, the SF-36 differences were significant regarding bodily pain (P=0.008) and social functioning (P=0.01). After surgery, physical function (P=0.03), general health (P=0.05) and physical component (P=0.03) were different. IWQOL-Lite recorded no differences until after surgery: physical function (P=0.003), sexual life (P=0.04) and public distress (P=0.003). BDI scores were not different for the four groups at baseline. All improved with surgery, 10.6-4.4 (P=0.0001). CONCLUSIONS: HRQoL and depressive symptoms significantly improvement after surgery. These improvements do not have a differential effect over the wide range of weight change.Nutrition & Diabetes (2014) 4, e132; doi:10.1038/nutd.2014.29; published online 1 September 2014.

Psychometric evaluation of the German version of the impact of weight on Quality of Life-Lite (IWQOL-Lite) questionnaire.

OBJECTIVE: To evaluate the psychometric properties of a German version of the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire. METHOD: IWQOL-Lite scores were obtained from 351 overweight/obese individuals and 127 lean adult volunteers. In addition, a subgroup of 126 obese subjects completed also the German versions of the 36-item short-form health survey (SF-36), the Beck Depression Inventory (BDI), the Eating Disorder Examination-Questionnaire (EDE-Q), and the German validated version of the Three-Factor Eating Questionnaire (TFEQ). RESULTS: The German version of the IWQOL-Lite has psychometric properties comparable to those found for the original version and demonstrates high internal consistency and excellent construct validity. Furthermore, the German IWQOL-Lite clearly discriminates between groups based on BMI on all subscales and the total score. CONCLUSION: The results of the present study suggest that the German IWQOL-Lite is a psychometrically validated instrument with which to measure weight-specific health related quality of life.

Psychometric evaluation of a Brazilian version of the impact of weight on quality of life (IWQOL-Lite) instrument.

PURPOSE: The impact of weight on quality of life (IWQOL-Lite) is a self-administered instrument that assesses quality of life in obesity. It is composed of 31 items and five domains (physical function, self-esteem, sexual life, public distress, and work). The aim of the present study was to evaluate reliability (test-retest), internal structure, construct validity and discriminant validity. METHODS: IWQOL-Lite scores were obtained from 89 people in a Weight Watchers institution (clinical sample) and 156 community volunteers (community sample). The participants were selected based on the same criteria: gender (female) and age (> 24 years), except for BMI. The community sample also completed the SF-36, a generic measure of health-related quality of life. RESULTS: The Brazilian IWQOL-Lite demonstrated good test-retest reliability, internal consistency, discriminative validity and convergent validity. CONCLUSIONS: The IWQOL-Lite is the first specific instrument validated in Brazil for assessing quality of life in obesity. The results reveal that IWQOL-Lite is an instrument with good psychometric properties. Nevertheless, in some cases results were dissimilar to those reported in earlier studies using the original American English.

Improvements in sexual quality of life after moderate weight loss.

We evaluated changes in sexual quality of life as they relate to weight loss over a 2-year period in individuals undergoing weight loss treatment. Six dimensions of sexual quality of life were measured using items from the Impact of Weight on Quality of Life questionnaire (feeling sexually unattractive, lacking sexual desire, reluctance to be seen undressed, difficulty with sexual performance, avoidance of sexual encounters and lack of enjoyment of sexual activity). At baseline women were more likely than men to report lack of sexual enjoyment and reluctance to be seen undressed in spite of lower body mass index (BMI). Weight loss averaged 13.1% and was significantly associated with improvements in all sexual quality of life dimensions. A 3-4% regain did not appear to negatively affect sexual quality of life. The greatest improvements for women had occurred by 3 months and were observed in all dimensions, whereas for men only 'not feeling sexually attractive' showed marked improvement in this short time frame.

Effect of moderate weight loss on health-related quality of life: an analysis of combined data from 4 randomized trials of sibutramine vs placebo.

OBJECTIVES: To determine whether (1) patients who experience greater weight loss also experience correspondingly greater improvements in health-related quality of life (HRQOL); (2) the improvement in HRQOL is noticeable for patients achieving moderate (5%-10%) weight reduction; and (3) the relationship between weight reduction and HRQOL is similar for patients receiving sibutramine hydrochloride vs placebo. STUDY DESIGN: We combined data from 4 double-blind, randomized, controlled trials of administration of sibutramine (20 mg/d) vs placebo. PATIENTS AND METHODS: Patients (n = 555) were mildly to moderately obese and had type 2 diabetes mellitus, dyslipidemia, or hypertension that was well controlled with an angiotensin-converting enzyme inhibitor or calcium channel blocker. The HRQOL was operationalized using the Impact of Weight on Quality of Life (IWQOL) and the Medical Outcomes Study 36-Question Short-Form (SF-36) instruments. The main statistical technique was a patient-level analysis of variance predicting change in HRQOL from study, treatment, and weight change. RESULTS: Moderate weight loss was associated with a statistically significant improvement in HRQOL for approximately half of the subscales evaluated (P < .05). The greatest sensitivity to change was shown by the SF-36 general health perception and change in health since last year subscales and the IWQOL overall health, mobility, and total subscales. Greater weight loss was associated with the most improvement in HRQOL. Weight losses of 5.01% to 10.00% were associated with 2-unit changes in the SF-36 general health perception subscale and 10-unit changes in the IWQOL total subscale. Results were similar across study and treatment. CONCLUSIONS: Moderate weight loss is associated with noticeably improved HRQOL. Improvements in HRQOL are achievable by patients receiving sibutramine.

The relationship between health-related quality of life and weight loss.

OBJECTIVE: This is a report of health-related quality of life (HRQOL) changes in obese patients completing at least 1 year of outpatient treatment in a weight reduction program combining phentermine-fenfluramine and dietary counseling. RESEARCH METHODS AND PROCEDURES: Participants were 141 women (87.6%) and 20 men (12.4%) who had an average body mass index at intake of 41.1 kg/m(2) (SD = 7.0, range = 29.5 to 67.0 kg/m(2)) and an average age of 44.9 years (SD = 9.3, range = 23 to 65 years). HRQOL was assessed at intake and at 1-year follow-up using the Impact of Weight on Quality of Life (IWQOL)-Lite questionnaire. The relationship between HRQOL changes and weight loss was examined using Pearson correlations. Clinically meaningful change in HRQOL was defined as a 1.96 SEM reduction in IWQOL-Lite total score. RESULTS: On average, participants lost 20.2 kg or 17.6% of their weight over the 1-year period. Of the participants, 15.5% lost <10% of their weight, 24.2% lost 10% to 14.9%, 23.6% lost 15% to 19.9%, and 36.6% lost 20% or more. All five IWQOL-Lite scales and total score showed statistically significant improvement over the 1-year period. Changes in IWQOL-Lite scores from intake to 1 year showed statistically significant correlations with percentage of weight loss for all subscales and total score. Subscale correlations with weight loss ranged from 0.166 (Public Distress) to 0.396 (Physical Function) and was 0.370 for the total score. Forty-four percent of participants losing <10% met the criterion of clinically meaningful change, compared with 51.3% losing 10% to 14.9%, 55.3% losing 15% to 19.95%, and 76.3% losing >20%. For total score and for three of the five IWQOL-Lite scales (Physical Function, Self-Esteem, and Sexual Life), the relationship between weight loss and clinically meaningful change was linear and was significant at p < 0.05. Physical Function and Self-Esteem were most strongly affected by weight loss. DISCUSSION: HRQOL changes, as measured by an obesity-specific instrument (IWQOL-Lite), are strongly related to weight reduction.

Development of a brief measure to assess quality of life in obesity.

OBJECTIVE: Obesity researchers have a growing interest in measuring the impact of weight and weight reduction on quality of life. The Impact of Weight on Quality of Life questionnaire (IWQOL) was the first self-report instrument specifically developed to assess the effect of obesity on quality of life. Although the IWQOL has demonstrated excellent psychometric properties, its length (74 items) makes it somewhat cumbersome as an outcome measure in clinical research. This report describes the development of a 31-item version of the IWQOL (IWQOL-Lite). RESEARCH METHODS AND PROCEDURES: IWQOLs from 996 obese patients and controls were used to develop the IWQOL-Lite. Psychometric properties of the IWQOL-Lite were examined in a separate cross-validation sample of 991 patients and controls. RESULTS: Confirmatory factor analysis provided strong support for the adequacy of the scale structure. The five identified scales of the IWQOL-Lite (Physical Function, Self-Esteem, Sexual Life, Public Distress, and Work) and the total IWQOL-Lite score demonstrated excellent psychometric properties. The reliability of the IWQOL-Lite scales ranged from 0.90 to 0.94 and was 0.96 for the total score. Correlations between the IWQOL-Lite and collateral measures supported the construct validity of the IWQOL-Lite. Changes in IWQOL-Lite scales over time correlated significantly with changes in weight, supporting its sensitivity to change. Significant differences in IWQOL-Lite scale and total scores were found among groups differing in body mass index, supporting the utility of the IWQOL-Lite across the body mass index spectrum. DISCUSSION: The IWQOL-Lite appears to be a psychometrically sound and clinically sensitive brief measure of quality of life in obese persons.

Quality of life and obesity.

Interest in the quality of life of patients with different diseases continues to grow. Recent years have witnessed a dramatic rise in the prevalence of obesity worldwide, stimulating interest in the health and quality of life consequences of this phenomenon. The body of research on the quality of life of obese individuals has grown to a point that a review of this literature is warranted. Numerous studies have demonstrated that obese persons experience significant impairments in quality of life as a result of their obesity, with greater impairments associated with greater degrees of obesity. Weight loss has been shown to improve quality of life in obese persons undergoing a variety of treatments. Further research is needed to clarify whether quality of life differs among subsets of obese persons. Until recently, there has been little standardization of quality of life measures in obesity. The SF-36 has been used in a number of studies of obese persons. Several obesity-specific instruments have also been developed and have shown great promise. The quality of life of obese individuals is an important issue that should be included in weight management treatment and research.

Construct validity of the Impact of Weight on Quality of Life Questionnaire.

The Impact of Weight on Quality of Life questionnaire (IWQOL) is a 74-item self-report, condition-specific instrument that (1) assesses the effect of weight on quality of life in eight key areas, and (2) may be used as a treatment outcome measure and/or an evaluation tool for healthcare policy makers and third-party payers. This study explores IWQOL construct validity and provides new information on internal consistency, treatment effects, and differences between men and women. IWQOL total scores correlated highly with other measures of overall quality of life, and subscale scores correlated well with counterparts in the assessment battery. Internal consistency estimates for the IWQOL scales generally were high. For the women, 4-week participants, and the total sample, pretreatment-posttreatment differences were significant for all IWQOL scales and total score. For men, treatment differences were significant for the total score and all subscales except for Work and Mobility. Treatment differences for 2-week participants were significant for all scales except for Work. Consistent with previous IWQOL study results, the Comfort With Food scale scores reflected more discomfort at posttreatment as compared with pretreatment. The IWQOL, already translated into French and Italian, currently is demonstrating clinical and research utility as a quality-of-life outcome measure for clinical trials of antiobesity drugs and surgical treatments for patients with obesity.

Assessing Impact of Weight on Quality of Life.

This paper is a preliminary report on the development of a new instrument, the Impact of Weight on Quality of Life (IWQOL) questionnaire, that assesses the effects of weight on various areas of life. We conducted two studies utilizing subjects in treatment for obesity at Duke University Diet and Fitness Center. The first study describes item development, assesses reliability, and compares pre- and post-treatment scores on the IWQOL. In the second study we examined the effects of body mass index (BMI), gender, and age on subjects' perceptions of impact of weight on quality of life. Results indicate adequate psychometric properties with test-retest reliabilities averaging .75 for single items, and .89 for scales. Scale internal consistency averaged .87. Post-treatment scores differed significantly from pre-treatment scores on all scales, indicating that treatment produced positive changes in impact of weight on quality of life. The results of the second study indicate that the impact of weight generally worsened as the patients' size increased. However for women there was no association between BMI and impact of weight on Self-Esteem and Sexual Life. Even at the lowest BMI tertile studied, women reported that weight had a substantial impact in these areas. There were also significant gender differences, with women showing greater impact of weight on Self-Esteem and Sexual Life compared with men. The impact of age was a bit surprising, with some areas showing positive changes and others showing no change.