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Background: For patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina., Methods: Balance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m 2 ) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network., Discussion: For underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care., Trials Registration: NCT03003403 . Registered December 28, 2016.

Introduction: Obesity treatment is less successful for socioeconomically disadvantaged populations, particularly when delivered in primary care. Digital health strategies can extend the reach of clinical obesity treatments to care settings serving patients at highest risk., Methods: Track was an effectiveness RCT of a 12-month digital weight-loss intervention, embedded within a community health center system. Participants were 351 adult patients (aged 21-65 years) with obesity and hypertension, diabetes, and hyperlipidemia. Patients were randomized to usual care (n=175) or an intervention (n=176) comprising app-based self-monitoring of behavior change goals with tailored feedback, a smart scale, dietitian-delivered counseling calls, and clinician counseling informed by app-generated recommendations, delivered via electronic health record. The primary outcome was 12-month weight change. Randomization began on June 18, 2013, final assessments were completed on September 10, 2015. Data analysis was conducted in 2016 and 2017. The trial retained 92% of usual care and 96% of intervention participants at 12 months., Results: The Track intervention produced larger weight losses relative to usual care at 6 months (net effect: -4.4 kg, 95% CI= -5.5, -3.3, p<0.001) and 12 months (net effect: -3.8 kg, 95% CI= -5.0, -2.5, p<0.001). Intervention participants were more likely to lose ≥5% of their baseline weight at 6 months (43% vs 6%, p<0.001) and 12 months (40% vs 17%, p<0.001). Intervention participants completing ≥80% of expected self-monitoring episodes (-3.5 kg); counseling calls (-3.0 kg); or self-weighing days (-4.4 kg) lost significantly more weight than less engaged intervention participants (all p<0.01)., Conclusions: A digital obesity treatment, integrated with health system resources, can produce clinically meaningful weight-loss outcomes among socioeconomically disadvantaged primary care patients with elevated cardiovascular disease risk., Trial Registration: This study is registered at www.clinicaltrials.gov NCT01827800., (Copyright © 2018 American Journal of Preventive Medicine. All rights reserved.)

Background: Few evaluations of the Veterans Health Administration Motivating Overweight/Obese Veterans Everywhere (MOVE!) weight management program have assessed 6-month weight change or factors associated with weight change by gender., Materials and Methods: Analysis of administrative data from a national sample of veterans in the VA MOVE!, Results: A total of 62,882 participants were included, 14.6% were women. Compared with men, women were younger (49.6 years [standard deviation, SD, 10.8] vs. 59.3 years [SD, 9.8], p < 0.0001), less likely to be married (34.1% vs. 56.0%, p < 0.0001), and had higher rates of post-traumatic stress disorder (26.0% vs. 22.4%, p < 0.0001) and depression (49.3% vs. 32.9%, p < 0.001). The mean number of MOVE! visits attended by women was lower than men (5.6 [SD, 5.3] vs. 6.0 [SD, 5.9], p < 0.0001). Women, compared with men, reported lower rates of being able to rely on family or friends (35.7% vs. 40.8%, p < 0.0001). Observed mean percent change in weight for women was -1.5% (SD, 5.2) and for men was -1.9% (SD, 4.8, p < 0.0001). The odds of ≥5% weight loss were no different for women (body-mass index [BMI] >25 kg/m 2 ) compared with men (BMI >25 kg/m 2 ; odds ratio, 1.05 [95% confidence interval, 0.99-1.11; p = 0.13])., Conclusions: Women veterans lost less weight overall compared with men. There was no difference in the odds of achieving clinically significant weight loss by gender. The majority of women and men enrolled lost <5% weight despite being enrolled in a lifestyle intervention. Future studies should focus on identifying program- and participant-level barriers to weight loss.

Background: Obesity and poor sleep are highly prevalent among Black women., Purpose: We examined whether a weight gain prevention intervention improved sleep among Black women., Methods: We conducted a randomized trial comparing a 12-month weight gain prevention intervention that included self-monitoring through mobile technologies and phone coaching to usual care in community health centers. We measured sleep using the Medical Outcomes Study Sleep Scale at baseline, 12 months, and 18 months. The scale examines quantity of sleep, sleep disturbance, sleep adequacy, daytime somnolence, snoring, shortness of breath, and global sleep problems (sleep problem indices I and II)., Results: Participants (n = 184) were on average 35.4 years and obese (BMI 30.2 kg/m 2 ); 74% made <$30,000/year. At baseline, average sleep duration was 6.4 (1.5) hours. Controlling for weight change and sleep medication, the intervention group reported greater improvements in sleep disturbance [-8.35 (-16.24, -0.45)] and sleep problems at 12 months: sleep problem index I [-8.35 (-16.24, -0.45)]; sleep problem index II [-8.35 (-16.24, -0.45)]. However, these findings did not persist at 18 months., Conclusions: Preventing weight gain may afford clinical benefit on improving sleep quality., Trial Registration Number: The trial was registered with the ClinicalTrials.gov database (NCT00938535).

Introduction: Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings., Methods: Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24months., Results: Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2). Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression., Conclusions: Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment., (Copyright © 2016 Elsevier Inc. All rights reserved.)

In overweight/obese individuals, cardiometabolic risk factors differ by race and sex categories. Small-molecule metabolites and metabolic hormone levels might also differ across these categories and contribute to risk factor heterogeneity. To explore this possibility, we performed a cross-sectional analysis of fasting plasma levels of 69 small-molecule metabolites and 13 metabolic hormones in 500 overweight/obese adults who participated in the Weight Loss Maintenance trial. Principal-components analysis (PCA) was used for reduction of metabolite data. Race and sex-stratified comparisons of metabolite factors and metabolic hormones were performed. African Americans represented 37.4% of the study participants, and females 63.0%. Of thirteen metabolite factors identified, three differed by race and sex: levels of factor 3 (branched-chain amino acids and related metabolites, p<0.0001), factor 6 (long-chain acylcarnitines, p<0.01), and factor 2 (medium-chain dicarboxylated acylcarnitines, p<0.0001) were higher in males vs. females; factor 6 levels were higher in Caucasians vs. African Americans (p<0.0001). Significant differences were also observed in hormones regulating body weight homeostasis. Among overweight/obese adults, there are significant race and sex differences in small-molecule metabolites and metabolic hormones; these differences may contribute to risk factor heterogeneity across race and sex subgroups and should be considered in future investigations with circulating metabolites and metabolic hormones.

Objective: To identify novel biomarkers through metabolomic profiles that distinguish metabolically well (MW) from metabolically unwell (MUW) individuals, independent of body mass index (BMI)., Materials/methods: This study was conducted as part of the Measurement to Understand the Reclassification of Disease of Cabarrus/Kannapolis (MURDOCK) project. Individuals from 3 cohorts were classified as lean (BMI<25kg/m²), overweight (BMI≥25kg/m², BMI<30kg/m²) or obese (BMI≥30kg/m²). Cardiometabolic abnormalities were defined as: (1) impaired fasting glucose (≥100mg/dL and ≤126mg/dL); (2) hypertension; (3) triglycerides ≥150mg/dL; (4) HDL-C <40mg/dL in men, <50mg/dL in women; and (5) insulin resistance (calculated Homeostatic Model Assessment (HOMA-IR) index of >5.13). MW individuals were defined as having <2 cardiometabolic abnormalities and MUW individuals had≥two cardiometabolic abnormalities. Targeted profiling of 55 metabolites used mass-spectroscopy-based methods. Principal components analysis (PCA) was used to reduce the large number of correlated metabolites into clusters of fewer uncorrelated factors., Results: Of 1872 individuals, 410 were lean, 610 were overweight, and 852 were obese. Of lean individuals, 67% were categorized as MUW, whereas 80% of overweight and 87% of obese individuals were MUW. PCA-derived factors with levels that differed the most between MW and MUW groups were factors 4 (branched chain amino acids [BCAA]) [p<.0001], 8 (various metabolites) [p<.0001], 9 (C4/Ci4, C3, C5 acylcarnitines) [p<.0001] and 10 (amino acids) [p<.0002]. Further, Factor 4, distinguishes MW from MUW individuals independent of BMI., Conclusion: BCAA and related metabolites are promising biomarkers that may aid in understanding cardiometabolic health independent of BMI category., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Obesity has spread to all segments of the U.S. population. Young adults, aged 18-35 years, are rarely represented in clinical weight loss trials. We conducted a qualitative study to identify factors that may facilitate recruitment of young adults into a weight loss intervention trial. Participants were 33 adults aged 18-35 years with BMI ≥25 kg/m(2). Six group discussions were conducted using the nominal group technique. Health, social image, and "self" factors such as emotions, self-esteem, and confidence were reported as reasons to pursue weight loss. Physical activity, dietary intake, social support, medical intervention, and taking control (e.g. being motivated) were perceived as the best weight loss strategies. Incentives, positive outcomes, education, convenience, and social support were endorsed as reasons young adults would consider participating in a weight loss study. Incentives, advertisement, emphasizing benefits, and convenience were endorsed as ways to recruit young adults. These results informed the Cellphone Intervention for You (CITY) marketing and advertising, including message framing and advertising avenues. Implications for recruitment methods are discussed., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objective: To pilot test a culturally adapted behavioral weight loss intervention in obese and overweight Latino adults., Design: Pilot study., Setting: Latino community organization in Durham, North Carolina., Participants: Overweight and obese, self-identified Latinos > or =18 years old., Intervention: Intervention consisted of 20 weekly group sessions (90-120 minutes each) incorporating motivational interviewing techniques. The intervention goal was weight loss by adopting the Dietary Approach to Stop Hypertension (DASH) dietary pattern, increasing physical activity, and reducing caloric intake. The cultural adaptation included foods and physical activities commonly used in the Latino culture, using a Spanish-speaking interventionist, and conducting the intervention at a local Latino community organization., Main Outcome Measures: Weight, body mass index (BMI), blood pressure, dietary pattern, and physical activity were measured at baseline and at 20 weeks., Results: A total of 56 participants are included in the final analysis. The average weight loss was 5.1 lbs (95% CI -8.7 to -1.5; P = .006); and there was a reduction in BMI of 1.3 kg/m2 (95% CI -2.2 to -0.5; P =.002) at 20 weeks. Systolic blood pressure decreased by 2.6 mm Hg (95% CI -4.7 to -0.6; P = .013)., Conclusion: A culturally adapted behavioral intervention for the treatment of overweight and obesity is potentially effective in a diverse group of Latino adults.

Introduction: Changes in sex hormones with weight loss might have implications for breast cancer prevention but have not been examined extensively, particularly in African-American (AA) women., Methods: We conducted a prospective study of 278 overweight/obese postmenopausal women (38% AA) not taking hormone therapy within the Weight Loss Maintenance Trial. All participants lost at least 4 kg after a 6-month weight-loss phase and attempted to maintain weight loss during the subsequent 12 months. We evaluated the percentage changes in estrone, estradiol, free estradiol, testosterone, free testosterone, androstenedione, dehydroepiandrosterone sulfate and sex hormone-binding globulin (SHBG) using generalized estimating equations., Results: In all study phases, AA women had higher levels of estrogen and testosterone concentrations, independent of adiposity. On average, participants lost 7.7 kg during the weight-loss phase, and concentrations of estrone (-5.7%, P = 0.006), estradiol (-9.9%, P <0.001), free estradiol (-13.4%, P <0.0001), and free testosterone (-9.9%, P <0.0001) decreased, while the SHBG concentration (16.2%, P <0.001) increased. Weight change did not significantly affect total testosterone or other androgen concentrations. Compared with non-AA women, AA women experienced less change in estrogens per kilogram of weight change (that is, per 1 kg weight loss: estrone, -0.6% vs. -1.2%, P-interaction = 0.10; estradiol, -1.1% vs. -1.9%, P-interaction = 0.04; SHBG, 0.9% vs. 1.6%, P-interaction = 0.006; free estradiol, -1.4% vs. -2.1%, P-interaction = 0.01)., Conclusion: To the best of our knowledge this is the first study to examine and compare the effects of intentional weight loss and maintenance on a panel of sex hormones in AA women and non-AA women. Although speculative, these data suggest hormonal differences may contribute to different racial patterns of breast cancer incidence and mortality and encourage further investigations to understand the long-term effects of weight loss on sex hormones in obese postmenopausal women., Trial Registration: ClinicalTrials.gov: NCT00054925.

Effective weight management interventions could reduce race-sex disparities in cardiovascular disease (CVD), yet little is known about factors associated with successful weight loss maintenance in race-sex subgroups. In the Weight Loss Maintenance trial (WLM), overweight/obese (BMI 25-45 kg/m(2)) adults who lost ≥4 kg in a 6-month behavioral weight loss intervention (phase I) were randomized into one of three 30-month maintenance interventions (phase II). To investigate predictors in subgroups, randomized groups were combined for this analysis. Of 1,685 phase I participants, 1,032 (61%) entered phase II, including 12% black men (BM), 26% black women (BW), 25% white men (WM), and 37% white women (WW). Weight change over the 36-month study ranged from -2.3% (95% confidence interval = -3.1 to -1.5%) in BW to -4.5% (95% confidence interval = -5.7 to -4.0%) in WM, the result of differential weight loss during phase I. Within race, men lost significantly more weight than women, but within sex group, weight loss did not differ significantly between races. Although participants regained weight during phase II, regain did not differ by race-sex group, and mean weight at the end of the study was significantly lower than phase I entry weight for each subgroup. In regression models, phase I weight loss predicted overall 36-month weight loss in all race-sex groups. Healthy dietary pattern at entry, improvement in dietary pattern, or both were predictive in three of four race-sex groups. Few other variables other than initial weight loss and dietary pattern were predictive. Future research should identify additional modifiable influences on long-term maintenance after a modest weight loss.

Background: Dietary components effective in weight maintenance efforts have not been adequately identified., Objective: To determine the effects of changes in dietary consumption on weight loss and maintenance during the Weight Loss Maintenance clinical trial., Design: Weight Loss Maintenance was a randomized controlled trial. Successful weight loss participants who completed Phase I of the trial and lost 4 kg were randomized to one of three maintenance intervention arms in Phase II and followed for an additional 30 months., Participants/setting: The multicenter trial was conducted from 2003 through 2007. This substudy included 828 successful weight loss participants., Methods: The Block Food Frequency Questionnaire (FFQ) was used to assess nutrient intake levels and food group servings. Carbohydrates, proteins, fats, dietary fiber, fruit/vegetable, and dairy servings were utilized as predictor variables. The FFQ was collected on all participants at study entry (beginning of Phase I). Those randomized to Phase II completed the FFQ at three additional time points: randomization (beginning of Phase II), 12 months, and 30 months., Intervention: The main intervention focused on long-term maintenance of weight loss using the Dietary Approaches to Hypertension diet. This substudy examined if changes to specific dietary variables were associated with weight loss and maintenance., Statistical Analyses Performed: Linear regression models that adjusted for change in total energy examined the relationship between changes in dietary intake and weight for each time period. Site, age, race, sex, and a race-sex interaction were included as covariates., Results: Participants who substituted protein for fat lost, on average, 0.33 kg per 6 months during Phase I (P<0.0001) and 0.07 kg per 6 months during Phase II (P<0.0001) per 1% increase in protein. Increased intake of fruits and vegetables was associated with weight loss in Phases I and II: 0.29 kg per 6 months (P<0.0001) and 0.04 kg per 6 months (P=0.0062), respectively, per 1-serving increase. Substitution of carbohydrates for fat and protein for carbohydrates were associated with weight loss during both phases. Increasing dairy intake was associated with significant weight loss during Phase II (-0.17 kg per 6 months per 1-serving increase, P=0.0002), but not during Phase I. Dietary fiber revealed no significant findings., Conclusions: Increasing fruits, vegetables, and low-fat dairy may help achieve weight loss and maintenance., (Copyright © 2011 American Dietetic Association. Published by Elsevier Inc. All rights reserved.)

Little is known about the transition in behaviors from short-term weight loss to maintenance of weight loss. We wanted to determine how short-term and long-term weight loss and patterns of weight change were associated with intervention behavioral targets. This analysis includes overweight/obese participants in active treatment (n = 507) from the previously published PREMIER trial, an 18-month, multicomponent lifestyle intervention for blood pressure reduction, including 33 intervention sessions and recommendations to self-monitor food intake and physical activity daily. Associations between behaviors (attendance, recorded days/week of physical activity, food records/week) and weight loss of ≥5% at 6 and 18 months were examined using logistic regression. We characterized the sample using 5 weight change categories (weight gained, weight stable, weight loss then relapse, late weight loss, and weight loss then maintenance) and analyzed adherence to the behaviors for each category, comparing means with ANOVA. Participants lost an average of 5.3 ± 5.6 kg at 6 months and 4.0 ± 6.7 kg (4.96% of body weight) by 18 months. Higher levels of attendance, food record completion, and recorded days/week of physical activity were associated with increasing odds of achieving 5% weight loss. All weight change groups had declines in the behaviors over time; however, compared to the other four groups, the weight loss/maintenance group (n = 154) had statistically less significant decline in number of food records/week (48%), recorded days/week of physical activity (41.7%), and intervention sessions attended (12.8%) through 18 months. Behaviors associated with short-term weight loss continue to be associated with long-term weight loss, albeit at lower frequencies. Minimizing the decline in these behaviors may be important in achieving long-term weight loss.

Background: Consumption of liquid calories from beverages has increased in parallel with the obesity epidemic in the US population, but their causal relation remains unclear., Objective: The objective of this study was to examine how changes in beverage consumption affect weight change among adults., Design: This was a prospective study of 810 adults participating in the PREMIER trial, an 18-mo randomized, controlled, behavioral intervention trial. Measurements (weight, height, and 24-h dietary recall) were made at baseline, 6 mo, and 18 mo., Results: Baseline mean intake of liquid calories was 356 kcal/d (19% of total energy intake). After potential confounders and intervention assignment were controlled for, a reduction in liquid calorie intake of 100 kcal/d was associated with a weight loss of 0.25 kg (95% CI: 0.11, 0.39; P < 0.001) at 6 mo and of 0.24 kg (95% CI: 0.06, 0.41; P = 0.008) at 18 mo. A reduction in liquid calorie intake had a stronger effect than did a reduction in solid calorie intake on weight loss. Of the individual beverages, only intake of sugar-sweetened beverages (SSBs) was significantly associated with weight change. A reduction in SSB intake of 1 serving/d was associated with a weight loss of 0.49 kg (95% CI: 0.11, 0.82; P = 0.006) at 6 mo and of 0.65 kg (95% CI: 0.22, 1.09; P = 0.003) at 18 mo., Conclusions: These data support recommendations to limit liquid calorie intake among adults and to reduce SSB consumption as a means to accomplish weight loss or avoid excess weight gain. This trial was registered at clinicaltrials.gov as NCT00000616.