Recruitment of diverse community health center patients in a pragmatic weight gain prevention trial.

Introduction: Pragmatic trials are needed to establish evidence-based obesity treatment in primary care settings, particularly in community health centers (CHCs) that serve populations at heightened risk of obesity. Recruiting a representative trial sample is a critical first step to informing care for diverse communities. We described recruitment strategies utilized in a pragmatic obesity trial and assessed the sociodemographic characteristics and odds of enrollment by recruitment strategy. Methods: We analyzed data from Balance, a pragmatic trial implemented within a network of CHCs. We recruited participants via health center-based and electronic health record (EHR)-informed mail recruitment. We analyzed associations between sociodemographic characteristics and the return rate of patient authorization forms (required for participation) from EHR-informed mail recruitment. We also compared sociodemographic characteristics and randomization odds by recruitment strategy after returning authorization forms. Results: Of the individuals recruited through EHR-informed mail recruitment, females were more likely than males to return authorization forms; however, there were no differences in rates of return by preferred language (English/Spanish) or age. Females; underrepresented racial and ethnic groups; Spanish speakers; younger adults; and those with lower education levels were recruited more successfully in the health center. In contrast, their counterparts were more responsive to mail recruitment. Once authorization forms were returned, the odds of being randomized did not significantly differ by recruitment method. Conclusion: Health center-based recruitment was essential to meeting recruitment targets in a pragmatic weight gain prevention trial, specifically for Hispanic and Spanish-speaking communities. Future pragmatic trials should consider leveraging in-person recruitment for underrepresented groups in research.

Designing Ruby: Protocol for a 2-Arm, Brief, Digital Randomized Controlled Trial for Internalized Weight Bias.

BACKGROUND: Weight bias internalization, also known as weight self-stigma, is a serious health concern for individuals with higher body weight. Weight bias internalization is associated with the greater avoidance of health care and health-promoting activities, disordered eating, social isolation, and weight gain. Elevated weight bias internalization has been associated with low self-compassion, yet few investigations have explored self-compassion as a potential mechanism for reducing internalized weight bias. OBJECTIVE: Ruby is a 2-arm randomized controlled trial that was designed to test the efficacy of a 4-week digital self-compassion intervention to reduce internalized weight bias compared with a wait-list control. METHODS: Adults with elevated internalized weight bias and a BMI of >30 kg/m2 (N=80) were recruited. Ruby is a standalone digital trial that will be delivered entirely via a smartphone and will involve web-based data collection and text messages. The intervention content will include psychoeducation and daily mindfulness practices with a focus on self-compassion and body concerns. We will use intent-to-treat analyses to examine changes in weight bias internalization throughout time by treatment arm. The analyses will be conducted by using one-way analysis of covariance models and linear mixed models. RESULTS: The protocol was designed in May 2020 and approved in December 2020. Data collection is currently underway. CONCLUSIONS: Ruby will be the first digital standalone, self-compassion-based intervention designed to reduce internalized weight bias. Owing to its standalone digital delivery, Ruby may be a highly scalable treatment for internalized weight bias that can be delivered on its own or combined with other treatments. We expect Ruby to be accessible to many, as participants can access the digital intervention at times of the day that are the most convenient in their schedule and are not burdened by in-person time commitments, which can be a barrier for participants with competing demands on their time and resources. If efficacious, Ruby will be poised to expand a burgeoning body of literature related to psychological intervention in this area. TRIAL REGISTRATION: ClinicalTrials.gov NCT04678973; https://clinicaltrials.gov/ct2/show/NCT04678973. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31307.

The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension.

INTRODUCTION: Over 100 million adults in the United States have hypertension. The DASH (Dietary Approaches to Stop Hypertension) eating pattern is an evidence-based first-line treatment option for hypertension; however, adherence to the DASH eating pattern at a population level remains low. To address this gap, we will implement Nourish, a randomized controlled efficacy trial that will leverage a commercially-available smartphone application and evidence-based behavior change principles to improve adherence to the DASH eating pattern among adults with hypertension. METHODS: The Nourish trial is a two-arm, 12-month randomized control trial that will enroll adults (N = 300) with hypertension, defined as a systolic blood pressure of 120-159 mmHg; a diastolic blood pressure of 80-99 mmHg; and/or adults on blood pressure-lowering medication. Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure. Intervention components will include skills training, self-monitoring, personalized feedback, and responsive coaching. The primary outcome of the trial is 6-month changes in adherence to the DASH eating pattern, as measured by 24-h dietary recalls. DISCUSSION: Millions of Americans remain in need of effective behavioral interventions to manage and improve their hypertension and its adverse consequences. The ubiquity of smartphones offers a promising approach to disseminate the DASH eating pattern. By leveraging these widely used smartphone applications, combined with evidence-based behavior change principles and the DASH eating plan, Nourish will demonstrate the effectiveness of a digital health intervention to improve DASH adherence, and ultimately, to reduce blood pressure. Trial Number: NCT03875.

Prolonged, Controlled Daytime versus Delayed Eating Impacts Weight and Metabolism.

A delayed eating schedule is associated with increased risk of obesity and metabolic dysfunction in humans.1-9 However, there are no prolonged, highly controlled experimental studies testing the effects of meal timing on weight and metabolism in adults with a body mass index (BMI) of 19-27 kg/m2.10-18 Twelve healthy adults (age: 26.3 ± 3.4 years; BMI: 21.9 ± 1.7 kg/m2; 5 females) participated in a randomized crossover study in free-living conditions. Three meals and two snacks with comparable energy and macronutrient contents were provided during two, 8-week, counterbalanced conditions separated by a 2-week washout period: (1) daytime (intake limited to 0800 h-1900 h) and (2) delayed (intake limited to 1200 h-2300 h). Sleep-wake cycles and exercise levels were held constant. Weight, adiposity, energy expenditure, and circadian profiles of hormones and metabolites were assessed during four inpatient visits occurring before and after each condition. Body weight, insulin resistance (homeostatic model assessment of insulin resistance [HOMA-IR]), trunk-to-leg fat ratio, resting energy expenditure, respiratory quotient, and fasting glucose, insulin, total and high-density lipoprotein (dHDL) cholesterol, and adiponectin decreased on the daytime compared to the delayed schedule. These measures, as well as triglycerides, increased on the delayed compared to the daytime schedule (effect size range: d = 0.397-1.019). Circadian phase and amplitude of melatonin, cortisol, ghrelin, leptin, and glucose were not differentially altered by the eating schedules. Overall, an 8-week daytime eating schedule, compared to a delayed eating schedule, promotes weight loss and improvements in energy metabolism and insulin in adults with BMI 19-27 kg/m2, underscoring the efficacy and feasibility of daytime eating as a behavioral modification for real-world conditions.

Comparing Self-Monitoring Strategies for Weight Loss in a Smartphone App: Randomized Controlled Trial.

BACKGROUND: Self-monitoring of dietary intake is a valuable component of behavioral weight loss treatment; however, it declines quickly, thereby resulting in suboptimal treatment outcomes. OBJECTIVE: This study aimed to examine a novel behavioral weight loss intervention that aims to attenuate the decline in dietary self-monitoring engagement. METHODS: GoalTracker was an automated randomized controlled trial. Participants were adults with overweight or obesity (n=105; aged 21-65 years; body mass index, BMI, 25-45 kg/m2) and were randomized to a 12-week stand-alone weight loss intervention using the MyFitnessPal smartphone app for daily self-monitoring of either (1) both weight and diet, with weekly lessons, action plans, and feedback (Simultaneous); (2) weight through week 4, then added diet, with the same behavioral components (Sequential); or (3) only diet (App-Only). All groups received a goal to lose 5% of initial weight by 12 weeks, a tailored calorie goal, and automated in-app reminders. Participants were recruited via online and offline methods. Weight was collected in-person at baseline, 1 month, and 3 months using calibrated scales and via self-report at 6 months. We retrieved objective self-monitoring engagement data from MyFitnessPal using an application programming interface. Engagement was defined as the number of days per week in which tracking occurred, with diet entries counted if ≥800 kcal per day. Other assessment data were collected in-person via online self-report questionnaires. RESULTS: At baseline, participants (84/100 female) had a mean age (SD) of 42.7 (11.7) years and a BMI of 31.9 (SD 4.5) kg/m2. One-third (33/100) were from racial or ethnic minority groups. During the trial, 5 participants became ineligible. Of the remaining 100 participants, 84% (84/100) and 76% (76/100) completed the 1-month and 3-month visits, respectively. In intent-to-treat analyses, there was no difference in weight change at 3 months between the Sequential arm (mean -2.7 kg, 95% CI -3.9 to -1.5) and either the App-Only arm (-2.4 kg, -3.7 to -1.2; P=.78) or the Simultaneous arm (-2.8 kg, -4.0 to -1.5; P=.72). The median number of days of self-monitoring diet per week was 1.9 (interquartile range [IQR] 0.3-5.5) in Sequential (once began), 5.3 (IQR 1.8-6.7) in Simultaneous, and 2.9 (IQR 1.2-5.2) in App-Only. Weight was tracked 4.8 (IQR 1.9-6.3) days per week in Sequential and 5.1 (IQR 1.8-6.3) days per week in Simultaneous. Engagement in neither diet nor weight tracking differed between arms. CONCLUSIONS: Regardless of the order in which diet is tracked, using tailored goals and a commercial mobile app can produce clinically significant weight loss. Stand-alone digital health treatments may be a viable option for those looking for a lower intensity approach. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254953; https://clinicaltrials.gov/ct2/show/NCT03254953 (Archived by WebCite at http://www.webcitation.org/72PyQrFjn).

Weight-Related Terms Differentially Affect Self-Efficacy and Perception of Obesity.

OBJECTIVE: Little work has explored the effect of weight-related terms on treatment initiation; only one study has investigated weight-related terms and the psychological constructs associated with treatment uptake. The present study examines the effects of four common weight-related terms on treatment initiation and the moderating effect of weight bias internalization. METHODS: Adult participants with overweight and obesity (n = 436) were recruited online and asked to read three vignettes describing clinical encounters; the weight-related term (i.e., "weight," "BMI," "obesity," or "fat") was varied randomly. Participants then reported self-efficacy, cognitive and emotional illness beliefs about obesity (i.e., illness perception), and interest in a weight loss program. RESULTS: The term "obesity" resulted in the greatest self-efficacy and perceived control over obesity. "Fat" resulted in the least illness coherence (i.e., understanding of obesity). Weight bias internalization did not moderate the effect of term on self-efficacy, nor did it moderate illness perception. No differences in weight loss program enrollment were observed. CONCLUSIONS: Use of the term "obesity" may promote patients' perceived control and self-efficacy. Use of "fat" should be avoided. Results suggest that, despite patient and clinician preference for euphemistic weight terms, use of clinical language such as "obesity" may perform better in provider intervention.

Combined Treatment for Obesity and Depression: A Pilot Study.

OBJECTIVE: Obesity and depression frequently co-occur, and each increases risk for cardiovascular disease (CVD). This study tested whether a combined treatment, targeting obesity and depression simultaneously, would yield greater improvements in weight, mood, and CVD risk factors than treatments that targeted each disease individually. METHODS: Seventy-six participants with obesity and major depression were randomly assigned to (1) behavioral weight control (BWC), (2) cognitive behavioral therapy for depression (CBT-D), or (3) BWC combined with CBT-D. Participants were provided 18 group treatment sessions over 20 weeks. Mood, weight, and CVD risk were assessed at baseline and weeks 8 and 20, with a follow-up visit at week 46. RESULTS: At week 20, participants in combined treatment lost significantly (P < 0.02) more weight (5.2% ± 1.2%) than those assigned to CBT-D (0.8% ± 1.3%) and comparable amounts as those in BWC (3.5% ± 1.3%). Depression scores decreased significantly from baseline levels in each group, with no significant differences between groups. All three groups showed significant improvements in 10-year CVD risk, with no significant differences between groups. Groups did not differ significantly on any of these measures at week 46. CONCLUSIONS: BWC yielded short-term improvements in weight, mood, and CVD risk, comparable to a combined treatment that incorporated CBT-D. Results require replication with a larger sample size.

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.

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.

Sleep and Eating Disorders.

Insomnia is related to an increased risk of eating disorders, while eating disorders are related to more disrupted sleep. Insomnia is also linked to poorer treatment outcomes for eating disorders. However, over the last decade, studies examining sleep and eating disorders have relied on surveys, with no objective measures of sleep for anorexia nervosa or bulimia nervosa, and only actigraphy data for binge eating disorder. Sleep disturbance is better defined for night eating syndrome, where sleep efficiency is reduced and melatonin release is delayed. Studies that include objectively measured sleep and metabolic parameters combined with psychiatric comorbidity data would help identify under what circumstances eating disorders and sleep disturbance produce an additive effect for symptom severity and for whom poor sleep would increase risk for an eating disorder. Cognitive behavior therapy for insomnia may be a helpful addition to treatment of those with both eating disorder and insomnia.

Catastrophizing and anxiety sensitivity mediate the relationship between persistent pain and emotional eating.

Stress-induced or "emotional eating" contributes to increased caloric intake and weight gain, yet models examining psychosocial factors that promote and sustain this behavior are incomplete. There is a need to identify explicit, clinically-relevant mechanisms of emotional eating behavior. Pain is a common stressor associated with increased weight and, potentially, altered eating behaviors. The present study applies the Fear Avoidance Model (FAM) of pain to examine processes that may explain the relationship between pain and increased weight while also providing the opportunity to examine specific mechanisms that may encourage eating during a variety of stressors. Our aim is to better understand the impact of pain on eating behavior and the potential for the FAM to improve our understanding of the psychological mechanisms that promote eating during times of duress. A survey of 312 adults explored the link between pain experience and stress-induced eating, further examining the mediating effects of the psychological aspects of the FAM (e.g., anxiety sensitivity, catastrophizing, and pain-related fear). 24% of respondents reported persistent pain, and had significantly higher BMIs than their pain-free peers. All three FAM components were positively correlated with measures of emotional, external, and restrained eating. Anxiety sensitivity and catastrophizing significantly mediated the relationship between persistent pain and emotional eating behavior, while anxiety sensitivity alone mediated the relationship between persistent pain and external eating. Findings suggest pain may be associated with increased likelihood for emotional eating and that characteristics from FAM, in particular anxiety sensitivity and catastrophizing, may mediate the relationship between the presence of persistent pain and emotional eating behavior. Evidence-based treatments targeting anxiety sensitivity and catastrophizing could be useful to address emotional eating in individuals struggling with both weight and chronic pain.

Combination phentermine and topiramate extended release in the management of obesity.

INTRODUCTION: Losing ≥ 5% of initial weight improves quality of life and risk factors for cardiovascular disease (CVD) in obese individuals. Lifestyle modification, the cornerstone of weight reduction, may be complemented by pharmacotherapy. In 2012, the FDA approved the combination of phentermine and topiramate extended release (ER) for chronic weight management, as an adjunct to lifestyle modification. AREAS COVERED: This review examines the safety and efficacy of phentermine-topiramate ER, as determined by randomized controlled trials (RCTs). A preliminary study confirmed the benefit of combining the two medications for improving weight loss and reducing adverse effects, as compared to using equivalent-dose monotherapy alone. EXPERT OPINION: Across RCTs, groups prescribed phentermine 15 mg/topiramate ER 92 mg lost an average of 10% of initial weight, ∼ 8% more than placebo and 2% more than phentermine 7.5 mg/topiramate 46 mg. Weight loss reduced the risk of developing type 2 diabetes and improved CVD risk factors. Phentermine-topiramate ER, however, was associated with increased heart rate, the clinical significance of which is being investigated in an FDA-required CVD outcomes study. The medication also must be used with caution in women of child-bearing age because of an increased risk to infants of oral cleft.