Effects of liraglutide on appetite, food preoccupation, and food liking: results of a randomized controlled trial.

BACKGROUND: Some weight loss medications, including liraglutide 3.0 mg, are thought to facilitate weight loss by improving appetite control. However, no studies have evaluated their long-term appetitive effects. SUBJECTS/METHODS: This study examined changes in appetite in a subsample of 113 adults with obesity (76.1% female, 55.8% white, BMI = 38.8 ± 4.8 kg/m2) who participated in a 52-week trial. Participants were randomized to intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0 mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component). Participants rated their hunger, fullness after meals, liking of meals, and food preoccupation (all as experienced over the past week) using visual analogue scales (0-100 mm). Ratings were completed at baseline and eight subsequent visits over the year. RESULTS: At week 52, participants treated by IBT-alone lost 6.2 ± 1.6% of baseline weight, compared with 11.8 ± 1.6% and 12.1 ± 1.5% in the IBT-liraglutide and Multi-component groups, respectively. Compared to IBT-alone, IBT-liraglutide participants reported larger reductions at week 6 in hunger (-0.3 ± 4.2 vs -16.8 ± 4.0 mm, p = .005) and food preoccupation (+0.2 ± 3.7 vs -16.3 ± 3.6 mm, p = .002) and larger increases in fullness (-5.1 ± 3.2 vs +9.8 ± 3.0 mm, p = .001). These significant differences persisted at all assessments through week 24. There were no differences between IBT-alone and IBT-liraglutide in meal liking. IBT-alone and Multi-component participants differed in hunger at week 6, and in food preoccupation at all assessments through week 24. Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively. There were no other differences among any groups at week 52. CONCLUSIONS: Consistent with short-term studies, IBT-liraglutide participants reported greater improvements in hunger, fullness, and food preoccupation than those assigned to IBT-alone. Differences in appetite persisted for 24 weeks but were not maintained at week 52, despite the relatively greater weight losses in the liraglutide-treated participants at the trial's end.

Intensive Behavioral Therapy for Obesity Combined with Liraglutide 3.0 mg: A Randomized Controlled Trial.

OBJECTIVE: The Centers for Medicare and Medicaid Services (CMS) covers intensive behavioral therapy (IBT) for obesity. The efficacy, however, of the specific approach has never been evaluated in a randomized trial, as described here. The 1-year trial also assessed whether the addition to IBT of liraglutide 3.0 mg would significantly increase weight loss and whether the provision of meal replacements would add further benefit. METHODS: A total of 150 adults with obesity were randomly assigned to: IBT (IBT-alone), providing 21 counseling visits; IBT combined with liraglutide (IBT-liraglutide); or IBT-liraglutide combined for 12 weeks with a 1,000- to 1,200-kcal/d meal-replacement diet (Multicomponent). All participants received weekly IBT visits in month 1, every-other-week visits in months 2 to 6, and monthly sessions thereafter. RESULTS: Ninety-one percent of participants completed 1 year, at which time mean (± SEM) losses for IBT-alone, IBT-liraglutide, and Muticomponent participants were 6.1 ± 1.3%, 11.5 ± 1.3%, and 11.8 ± 1.3% of baseline weight, respectively. Fully 44.0%, 70.0%, and 74.0% of these participants lost ≥ 5% of weight, respectively. The liraglutide-treated groups were superior to IBT-alone on both outcomes. Weight loss in all three groups was associated with clinically meaningful improvements in cardiometabolic risk factors. CONCLUSIONS: The findings demonstrate the efficacy of IBT for obesity and the potential benefit of adding pharmacotherapy to this approach.

Effects of addictive-like eating behaviors on weight loss with behavioral obesity treatment.

To examine the relationship between food cravings and food addiction as defined by the Yale Food Addiction Scale (YFAS) and to assess the effects of these variables on weight loss during a 14-week group lifestyle modification program. Data were from 178 participants who were prescribed a 1000-1200 kcal/day portion-controlled diet and provided with weekly group lifestyle modification sessions. Participants completed the Food Craving Inventory and YFAS pre- and post-treatment. Weight was measured weekly. Participants with YFAS-defined food addiction (6.7%) reported more frequent overall food cravings relative to those without food addiction. More frequent food cravings at baseline were associated with less weight loss over the 14 weeks. Analyzed categorically, participants in the highest tertile of baseline food cravings lost 7.6 ± 0.5% of initial weight, which was significantly less compared to those in the lowest tertile who lost 9.1 ± 0.5%. Percent weight loss did not differ significantly between participants with YFAS-defined food addiction (6.5 ± 1.2%) and those who did not meet criteria (8.6 ± 0.3%). Addictive-like eating behaviors significantly declined from pre- to post-treatment. Participants with frequent food cravings lost less weight than their peers. Targeted interventions for food cravings could improve weight loss in these individuals. Few participants met YFAS-defined criteria for food addiction. Addictive-like eating behaviors tended to decline during behavioral weight loss, but neither baseline nor change in YFAS scores predicted weight loss.

Short- and Long-Term Changes in Health-Related Quality of Life with Weight Loss: Results from a Randomized Controlled Trial.

OBJECTIVE: The objective of this study was to determine the effects of weight loss and weight loss maintenance (WLM) on weight-specific health-related quality of life in a 66-week trial. METHODS: Adults with obesity (N = 137, 86.1% female, 68.6% black, mean age = 46.1 years) who had lost ≥ 5% of initial weight in a 14-week intensive lifestyle intervention/low-calorie diet (LCD) program were randomly assigned to lorcaserin or placebo for an additional 52-week WLM program. The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) scale (including five subscales), Patient Health Questionnaire-9 (depression), and Perceived Stress Scale were administered at the start of the 14-week LCD program, randomization, and week 52 of the randomized controlled trial (i.e., 66 weeks total). RESULTS: Significant improvements in all outcomes, except weight-related public distress, were found following the 14-week LCD program (P values < 0.05). Improvements were largely maintained during the 52-week randomized controlled trial, despite weight regain of 2.0 to 2.5 kg across treatment groups. Participants who lost ≥ 10% of initial weight achieved greater improvements in physical function, self-esteem, sexual life, and the IWQOL-Lite total score than those who lost < 5% and did not differ from those who lost 5% to 9.9%. CONCLUSIONS: Improvements in weight-specific health-related quality of life were achieved with moderate weight loss and were sustained during WLM.

Sociocultural and Familial Factors Associated with Weight Bias Internalization.

BACKGROUND/AIMS: Sociocultural and familial factors associated with weight bias internalization (WBI) are currently unknown. The present study explored the relationship between interpersonal sources of weight stigma, family weight history, and WBI. METHODS: Participants with obesity (N = 178, 87.6% female, 71.3% black) completed questionnaires that assessed the frequency with which they experienced weight stigma from various interpersonal sources. Participants also reported the weight status of their family members and completed measures of WBI, depression, and demographics. Participant height and weight were measured to calculate body mass index (BMI). RESULTS: Linear regression results (controlling for demographics, BMI, and depression) showed that stigmatizing experiences from family and work predicted greater WBI. Experiencing weight stigma at work was associated with WBI above and beyond the effects of other sources of stigma. Participants who reported higher BMIs for their mothers had lower levels of WBI. CONCLUSION: Experiencing weight stigma from family and at work may heighten WBI, while having a mother with a higher BMI may be a protective factor against WBI. Prospective research is needed to understand WBI's developmental course and identify mechanisms that increase or mitigate its risk.

A Randomized Trial of Lorcaserin and Lifestyle Counseling for Maintaining Weight Loss Achieved with a Low-Calorie Diet.

OBJECTIVE: Improving the maintenance of lost weight remains a critical challenge, which can be addressed by long-term behavioral and/or pharmacological interventions. METHODS: This study investigated the efficacy of combined behavioral and pharmacological treatment in facilitating weight loss maintenance (WLM) in 137 adults (86.1% female; 68.6% black; BMI = 37.0 ± 5.6 kg/m2 ) who had lost ≥ 5% of initial weight during a 14-week low-calorie diet (LCD) program (mean = 9.3 ± 2.9%). Participants were randomly assigned to lorcaserin (10 mg twice a day) or placebo and were provided 16 group WLM counseling sessions over 52 weeks. RESULTS: At 24 weeks post randomization, more lorcaserin-treated than placebo-treated participants maintained a ≥ 5% loss (73.9% vs. 57.4%; P = 0.033), and the lorcaserin-treated participants lost an additional 2.4 ± 0.8 kg versus a 0.6 ± 0.8 kg gain for placebo (P = 0.010). However, at week 52, groups did not differ on either co-primary outcome; 55.1% and 42.6%, respectively, maintained ≥ 5% loss (P = 0.110), with gains from randomization of 2.0 ± 0.8 kg and 2.5 ± 0.8 kg (P = 0.630), respectively. From the start of the LCD, groups maintained reductions of 7.8% and 6.6%, respectively (P = 0.318). CONCLUSIONS: Combined behavioral and pharmacological treatment produced clinically meaningful long-term weight loss in this group of predominantly black participants. Lorcaserin initially improved upon weight loss achieved with WLM counseling, but this advantage was not maintained at 1 year.

Binge Eating and Weight Loss Outcomes in Individuals with Type 2 Diabetes: 4-Year Results from the Look AHEAD Study.

OBJECTIVE: This study aims to assess whether an intensive lifestyle intervention (ILI) for weight reduction precipitates binge eating (BE) and whether BE attenuates 4-year weight loss among participants with type 2 diabetes and overweight or obesity. METHODS: Participants (N = 4,901) were from Look AHEAD, a randomized controlled trial that compared ILI to diabetes support and education (DSE). Annual assessments of measured weight and self-reported BE were used. By using the yearly time points when a person endorsed BE, participants were classified as no BE, remitted BE, incident BE, inconsistent BE (2-3 years, including baseline), and consistent BE (≥ 4 years, including baseline). Cox regression and mixed-effects models were used for analyses. RESULTS: ILI participants were marginally more likely to report incident BE at year 4 than those in DSE (P = 0.06). At year 4, ILI participants with remitted BE lost more weight (4.7 ± 0.8%) than those with consistent BE (1.9 ± 1.0%; P = 0.03). ILI participants with no BE lost more weight (4.6 ± 0.2%) than those with incident BE (3.1 ± 0.6%; P = 0.02) and consistent BE (P = 0.01). DSE participants with remitted BE lost more weight than those with incident and consistent BE. CONCLUSIONS: Preexisting BE did not seem to be a contraindication for ILI, although persistent BE attenuated weight loss. Patients who report new or ongoing BE may need additional treatment.

Lorcaserin plus lifestyle modification for weight loss maintenance: Rationale and design for a randomized controlled trial.

BACKGROUND/AIMS: Few studies have examined the efficacy of recently approved medications for chronic weight management in facilitating the maintenance of lost weight. This paper provides an overview of the design and rationale for a trial investigating whether lorcaserin, when combined with behavioral weight loss maintenance sessions (WLM), will facilitate the maintenance of losses of ≥5% of initial weight. METHODS: In this two-phase trial, participants with obesity will enroll in a 14-week run-in diet program consisting of weekly group lifestyle modification sessions and a 1000-1200kcal/d meal replacement diet. Participants who complete this weight induction phase and lose at least 5% of initial weight will then be randomized to 52weeks of WLM plus lorcaserin or WLM plus placebo. We hypothesize that at 52weeks post randomization, participants assigned to WLM plus lorcaserin will achieve significantly better maintenance of the prior 5% weight loss. RESULTS: We will recruit 182 adults with obesity to participate in the diet run-in, 136 of whom (75%) are expected to become eligible for the randomized controlled trial. Co-primary outcomes include the percentage of participants who maintain a loss of at least 5% of initial weight at week 52 and change in weight (kg) from randomization to week 52. CONCLUSIONS: This two-phase design will allow us to determine the potential efficacy of chronic weight management using lorcaserin for maintaining initial losses of at least 5% body weight, induced by the use of a structured meal-replacement diet. This combined approach holds promise of achieving larger long-term weight losses. CLINICAL TRIAL REGISTRATION: NCT02388568 on ClinicalTrials.gov.

Association between weight bias internalization and metabolic syndrome among treatment-seeking individuals with obesity.

OBJECTIVE: Weight stigma is a chronic stressor that may increase cardiometabolic risk. Some individuals with obesity self-stigmatize (i.e., weight bias internalization, WBI). No study to date has examined whether WBI is associated with metabolic syndrome. METHODS: Blood pressure, waist circumference, and fasting glucose, triglycerides, and high-density lipoprotein cholesterol were measured at baseline in 178 adults with obesity enrolled in a weight-loss trial. Medication use for hypertension, dyslipidemia, and prediabetes was included in criteria for metabolic syndrome. One hundred fifty-nine participants (88.1% female, 67.3% black, mean BMI = 41.1 kg/m2 ) completed the Weight Bias Internalization Scale and Patient Health Questionnaire (PHQ-9, to assess depressive symptoms). Odds ratios and partial correlations were calculated adjusting for demographics, BMI, and PHQ-9 scores. RESULTS: Fifty-one participants (32.1%) met criteria for metabolic syndrome. Odds of meeting criteria for metabolic syndrome were greater among participants with higher WBI, but not when controlling for all covariates (OR = 1.46, 95% CI = 1.00-2.13, P = 0.052). Higher WBI predicted greater odds of having high triglycerides (OR = 1.88, 95% CI = 1.14-3.09, P = 0.043). Analyzed categorically, high (vs. low) WBI predicted greater odds of metabolic syndrome and high triglycerides (Ps < 0.05). CONCLUSIONS: Individuals with obesity who self-stigmatize may have heightened cardiometabolic risk. Biological and behavioral pathways linking WBI and metabolic syndrome require further exploration.

Prevalence and psychosocial correlates of food addiction in persons with obesity seeking weight reduction.

INTRODUCTION: Food addiction is a controversial concept. The potential influence of food addiction on patients' psychosocial functioning and well-being has not been well established. The purpose of this study was to examine the relationships between psychosocial functioning (depressive symptoms and health-related quality of life [HRQOL]) and food addiction as measured by the Yale Food Addiction Scale (YFAS). We also explored whether food addiction contributed additional variance in explaining psychosocial functioning, beyond demographic and clinical factors (e.g., binge eating). METHODS: The sample included 178 participants (mean age=44.2±11.2years; BMI=40.9±5.9kg/m2; 88.2% female; 70.8% Black) with obesity seeking treatment for weight loss. Participants completed the Medical Outcomes Study 36-Item Short-Form Health Survey, Impact of Weight on Quality of Life-Lite, Patient Health Questionnaire, YFAS, and Questionnaire on Eating and Weight Patterns-5. RESULTS: Twelve (6.7%) participants met criteria for food addiction, with 4 (33.3%) of these participants having co-occurring binge eating disorder. After adjusting for covariates, the number of food addiction symptoms accounted for 6.5% to 16.3% of additional variance in general HRQOL, 5.0% to 21.5% in weight-related HRQOL, and 19.1% in symptoms of depression. CONCLUSIONS: In this treatment-seeking sample of participants, we found a low prevalence of food addiction, suggesting that addictive-like eating is unlikely to be a causal mechanism for most people with obesity. However, individuals who met criteria for food addiction had reduced psychosocial functioning compared to those who did not meet criteria. Individuals with addictive-like eating may require additional psychosocial support.

Management of Obesity.

This review examines weight loss and accompanying improvements in obesity-related comorbidities produced by intensive lifestyle intervention, pharmacotherapy, and bariatric surgery. Obese individuals lose approximately 6 to 8 kg (approximately 6% to 8% of initial weight) with 6 months of participation in a high-intensity lifestyle intervention (≥ 14 treatment visits) consisting of diet, physical activity, and behavior therapy. Such losses reduce progression to type 2 diabetes in at-risk people and decrease blood pressure and triglyceride levels. All diets, regardless of macronutrient composition, can produce clinically meaningful weight loss (> 5%) if they induce a deficit ≥ 500 kcal/d. Physical activity of 150 to 180 min/wk yields modest short-term weight loss compared with diet but contributes to improvements in obesity-related conditions. Gradual weight regain is common after lifestyle intervention but can be prevented by continued participation in monthly weight loss maintenance sessions, as well as by high levels of physical activity (ie, 200 to 300 min/wk). Patients unable to reduce satisfactorily with lifestyle intervention may be candidates for pharmacotherapy, recommended as an adjunct. Five medications have been approved by the US Food and Drug Administration for chronic weight management, and each has its own risk/benefit profile. The addition of these medications to lifestyle intervention increases mean weight loss by 2.5 to 8.9 kg compared with placebo. Patients with severe obesity who are unable to reduce successfully with lifestyle intervention and pharmacotherapy are eligible for bariatric surgery, including Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding. The first two procedures yield long-term (≥ 3 years) reductions of ≥ 20% of initial weight that are associated with decreases in morbidity and potentially mortality. Greater resources and dissemination efforts are needed to increase the availability of these three approaches for the millions of Americans who would benefit from them.

Binge-eating disorder and the outcome of bariatric surgery in a prospective, observational study: Two-year results.

OBJECTIVE: A previous study reported that preoperative binge-eating disorder (BED) did not attenuate weight loss at 12 months after bariatric surgery. This report extends the authors' prior study by examining weight loss at 24 months. METHODS: A modified intention-to-treat population was used to compare 24-month changes in weight among 59 participants treated with bariatric surgery, determined preoperatively to be free of a current eating disorder, with changes in 33 surgically treated participants with BED. Changes were also compared with 49 individuals with obesity and BED who sought lifestyle modification for weight loss. Analyses included all available data points and were adjusted for covariates. RESULTS: At month 24, surgically treated patients with BED preoperatively lost 18.6% of initial weight, compared with 23.9% for those without BED (P = 0.049). (Mean losses at month 12 had been 21.5% and 24.2%, respectively; P = 0.23.) Participants with BED who received lifestyle modification lost 5.6% at 24 months, significantly less than both groups of surgically treated patients (P < 0.001). CONCLUSIONS: These results suggest that preoperative BED attenuates long-term weight loss after bariatric surgery. We recommend that patients with this condition, as well as other eating disturbances, receive adjunctive behavioral support, the timing of which remains to be determined.