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The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension.
Miller, HN, Berger, MB, Askew, S, Kay, MC, Hopkins, CM, Iragavarapu, MS, de Leon, M, Freed, M, Barnes, CN, Yang, Q, et al
Contemporary clinical trials. 2021;:106539
Abstract
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.
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Prolonged, Controlled Daytime versus Delayed Eating Impacts Weight and Metabolism.
Allison, KC, Hopkins, CM, Ruggieri, M, Spaeth, AM, Ahima, RS, Zhang, Z, Taylor, DM, Goel, N
Current biology : CB. 2021;(3):650-657.e3
Abstract
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.
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Comparing Self-Monitoring Strategies for Weight Loss in a Smartphone App: Randomized Controlled Trial.
Patel, ML, Hopkins, CM, Brooks, TL, Bennett, GG
JMIR mHealth and uHealth. 2019;(2):e12209
Abstract
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).
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Association between weight bias internalization and metabolic syndrome among treatment-seeking individuals with obesity.
Pearl, RL, Wadden, TA, Hopkins, CM, Shaw, JA, Hayes, MR, Bakizada, ZM, Alfaris, N, Chao, AM, Pinkasavage, E, Berkowitz, RI, et al
Obesity (Silver Spring, Md.). 2017;25(2):317-322
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Plain language summary
Weight stigma is a psychosocial consequence in which individuals with obesity experience public discrimination and devaluation. Some individuals apply these negative stereotypes to themselves, which creates a self-directed stigma referred to as weight bias internalization (WBI). While studies have found perceived weight discrimination to be associated with an increased risk of mortality, no study has investigated the relationship between WBI and obesity on the risk of developing metabolic syndrome (MetS). The aim of this study is to examine the relationship between WBI and MetS. The authors hypothesised that among obese individuals, higher levels of WBI would be associated with increased odds of having MetS. Among the 178 obese adults recruited, 159 completed the study. Tests included anthropometric measurements, blood analysis, the Weight Bias Internalization Scale (WBIS) and the Patient Health Questionnaire. This study found that individuals who self-stigmatise may have a heightened risk of dyslipidemia, one component of MetS. Based on these results, the authors conclude that weight stigma is a chronic stressor and may contribute to poor health. Future studies are needed to identify specific pathways in which WBI exacerbates cardiometaoblic risk factors.
Abstract
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.
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Sex/gender differences in neural correlates of food stimuli: a systematic review of functional neuroimaging studies.
Chao, AM, Loughead, J, Bakizada, ZM, Hopkins, CM, Geliebter, A, Gur, RC, Wadden, TA
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2017;(6):687-699
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Sex and gender differences in food perceptions and eating behaviors have been reported in psychological and behavioral studies. The aim of this systematic review was to synthesize studies that examined sex/gender differences in neural correlates of food stimuli, as assessed by functional neuroimaging. Published studies to 2016 were retrieved and included if they used food or eating stimuli, assessed patients with functional magnetic resonance imaging (fMRI) or positron emission tomography (PET), and compared activation between males and females. Fifteen studies were identified. In response to visual food cues, females, compared to males, showed increased activation in the frontal, limbic, and striatal areas of the brain as well as the fusiform gyrus. Differences in neural response to gustatory stimuli were inconsistent. This body of literature suggests that females may be more reactive to visual food stimuli. However, findings are based on a small number of studies and additional research is needed to establish a more definitive explanation and conclusion.
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Binge-eating disorder and the outcome of bariatric surgery in a prospective, observational study: Two-year results.
Chao, AM, Wadden, TA, Faulconbridge, LF, Sarwer, DB, Webb, VL, Shaw, JA, Thomas, JG, Hopkins, CM, Bakizada, ZM, Alamuddin, N, et al
Obesity (Silver Spring, Md.). 2016;24(11):2327-2333
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Binge eating disorder is characterised by the consumption of an objectively large amount of food in a discrete period of time (i.e. 2hrs) with an accompanying loss of control over eating. This study is a follow-up study that examined weight loss over an average of 24 months post bariatric surgery (as most studies are based on a shorter duration i.e. less than 12 months) in 59 patients. Another aim of the study was whether bariatric surgery had any effects on the remission or precipitation of binge eating. Results indicate that patients with a preoperative diagnosis of binge-eating disorder lost significantly less weight 2 years after surgery than those individuals who were free from binge-eating prior surgery. However, those with a diagnosis of binge-eating disorder who received lifestyle modifications lost significantly less than those who had bariatric surgery. Authors conclude that bariatric-surgery may be a useful long-term weight loss strategy for patients with eating disorders. However, they also recommend that these patients may benefit from additional counselling and behavioural support, such as cognitive behaviour therapy.
Abstract
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.
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Combination phentermine and topiramate extended release in the management of obesity.
Alfaris, N, Minnick, AM, Hopkins, CM, Berkowitz, RI, Wadden, TA
Expert opinion on pharmacotherapy. 2015;(8):1263-74
Abstract
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.
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Comparison of high-fat and high-protein diets with a high-carbohydrate diet in insulin-resistant obese women.
McAuley, KA, Hopkins, CM, Smith, KJ, McLay, RT, Williams, SM, Taylor, RW, Mann, JI
Diabetologia. 2005;(1):8-16
Abstract
AIMS/HYPOTHESIS A diet low in saturated fatty acids and rich in wholegrains, vegetables and fruit is recommended in order to reduce the risk of obesity, cardiovascular disease and type 2 diabetes mellitus. However there is widespread interest in high-fat ("Atkins Diet") and high-protein ("Zone Diet") alternatives to the conventional high-carbohydrate, high-fibre approach. We report on a randomised trial that compared these two alternative approaches with a conventional diet in overweight insulin-resistant women. METHODS Ninety-six normoglycaemic, insulin-resistant women (BMI >27 kg/m(2)) were randomised to one of three dietary interventions: a high-carbohydrate, high-fibre (HC) diet, the high-fat (HF) Atkins Diet, or the high-protein (HP) Zone Diet. The experimental approach was designed to mimic what might be achieved in clinical practice: the recommendations involved advice concerning food choices and were not prescriptive in terms of total energy. There were supervised weight loss and weight maintenance phases (8 weeks each), but there was no contact between the research team and the participants during the final 8 weeks of the study. Outcome was assessed in terms of body composition and indicators of cardiovascular and diabetes risk. RESULTS Body weight, waist circumference, triglycerides and insulin levels decreased with all three diets but, apart from insulin, the reductions were significantly greater in the HF and HP groups than in the HC group. These observations suggest that the popular diets reduced insulin resistance to a greater extent than the standard dietary advice did. When compared with the HC diet, the HF and HP diets were shown to produce significantly (p<0.01) greater reductions in several parameters, including weight loss (HF -2.8 kg, HP -2.7 kg), waist circumference (HF -3.5 cm, HP -2.7 cm) and triglycerides (HF -0.30 mmol/l, HP [corrected] -0.22 mmol/l). LDL cholesterol decreased in individuals on the HC and HP diets, but tended to fluctuate in those on the HF diet to the extent that overall levels were significantly lower in the HP group than in the HF group (-0.28 mmol/l, 95% CI 0.04-0.52, p=0.02). Of those on the HF diet, 25% showed a >10% increase in LDL cholesterol, whereas this occurred in only 13% of subjects on the HC diet and 3% of those on the HP diet. CONCLUSIONS/INTERPRETATION In routine practice a reduced-carbohydrate, higher protein diet may be the most appropriate overall approach to reducing the risk of cardiovascular disease and type 2 diabetes. To achieve similar benefits on a HC diet, it may be necessary to increase fibre-rich wholegrains, legumes, vegetables and fruits, and to reduce saturated fatty acids to a greater extent than appears to be achieved by implementing current guidelines. The HF approach appears successful for weight loss in the short term, but lipid levels should be monitored. The potential deleterious effects of the diet in the long term remain a concern.