Weight Loss in Underserved Patients - A Cluster-Randomized Trial.

BACKGROUND: Evidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking. METHODS: We conducted a cluster-randomized trial to test the effectiveness of a high-intensity, lifestyle-based program for obesity treatment delivered in primary care clinics in which a high percentage of the patients were from low-income populations. We randomly assigned 18 clinics to provide patients with either an intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care. Patients in the intensive-lifestyle group participated in a high-intensity program delivered by health coaches embedded in the clinics. The program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the remaining 18 months. Patients in the usual-care group received standard care from their primary care team. The primary outcome was the percent change from baseline in body weight at 24 months. RESULTS: All 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic. A total of 803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000. Of the enrolled patients, 83.4% completed the 24-month trial. The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001). There were no significant between-group differences in serious adverse events. CONCLUSIONS: A high-intensity, lifestyle-based treatment program for obesity delivered in an underserved primary care population resulted in clinically significant weight loss at 24 months. (Funded by the Patient-Centered Outcomes Research Institute and others; PROPEL ClinicalTrials.gov number, NCT02561221.).

Physical activity and weight loss in a pragmatic weight loss trial.

The purpose of this study was to determine the association between changes in physical activity and changes in body weight in a cluster-randomized weight loss trial conducted in an underserved population in Louisiana. This study reports analyses conducted in the intervention group only, which was a 24-month multi-component weight loss program delivered by health coaches embedded in primary care clinics. Physical activity was assessed at baseline and at 6, 12, and 24 months of follow-up and changes in body weight were expressed as percent weight change from baseline. Among the sample of 402 patients, percent changes in body weight (mean ± SE) across increasing tertiles of changes in walking between baseline and 24 months were -3.2 ± 1.0%, -5.5 ± 0.9%, and -7.3 ± 0.9%, respectively (p = 0.001). Changes in body weight across increasing tertiles of changes in moderate-to-vigorous-intensity activity between baseline and 24 months were -4.3 ± 1.0%, -5.0 ± 0.9%, and -7.0 ± 0.9%, respectively (p = 0.04). In conclusion, this multi-component intervention resulted in clinically significant weight loss, and greater increases in physical activity over the intervention period were associated with greater percent reductions in body weight. These results are consistent with those from other studies conducted primarily in non-underserved populations.

Dietary intake during a pragmatic cluster-randomized weight loss trial in an underserved population in primary care.

BACKGROUND: Currently there are limited data as to whether dietary intake can be improved during pragmatic weight loss interventions in primary care in underserved individuals. METHODS: Patients with obesity were recruited into the PROPEL trial, which randomized 18 clinics to either an intensive lifestyle intervention (ILI) or usual care (UC). At baseline and months 6, 12, and 24, fruit and vegetable (F/V) intake and fat intake was determined. Outcomes were analyzed by repeated-measures linear mixed-effects multilevel models and regression models, which included random cluster (clinic) effects. Secondary analyses examined the effects of race, sex, age, and food security status. RESULTS: A total of 803 patients were recruited. 84.4% were female, 67.2% African American, 26.1% received Medicaid, and 65.5% made less than $40,000. No differences in F/V intake were seen between the ILI and UC groups at months 6, 12, or 24. The ILI group reduced percent fat at months 6, 12, and 24 compared to UC. Change in F/V intake was negatively correlated with weight change at month 6 whereas change in fat intake was positively associated with weight change at months 6, 12, and 24 for the ILI group. CONCLUSIONS: The pragmatic weight loss intervention in primary care did not increase F/V intake but did reduce fat intake in an underserved population with obesity. F/V intake was negatively associated with weight loss at month 6 whereas percent fat was positively correlated with weight loss throughout the intervention. Future efforts better targeting both increasing F/V intake and reducing fat intake may promote greater weight loss in similar populations. TRIAL REGISTRATION: NCT Registration: NCT02561221.

Effects of a 2-Year Primary Care Lifestyle Intervention on Cardiometabolic Risk Factors: A Cluster-Randomized Trial.

BACKGROUND: Intensive lifestyle interventions (ILIs) are the first-line approach to effectively treat obesity and manage associated cardiometabolic risk factors. Because few people have access to ILIs in academic health centers, primary care must implement similar approaches for a meaningful effect on obesity and cardiometabolic disease prevalence. To date, however, effective lifestyle-based obesity treatment in primary care is limited. We examined the effectiveness of a pragmatic ILI for weight loss delivered in primary care among a racially diverse, low-income population with obesity for improving cardiometabolic risk factors over 24 months. METHODS: The PROPEL trial (Promoting Successful Weight Loss in Primary Care in Louisiana) randomly allocated 18 clinics equally to usual care or an ILI and subsequently enrolled 803 (351 usual care, 452 ILI) adults (67% Black, 84% female) with obesity from participating clinics. The usual care group continued to receive their normal primary care. The ILI group received a 24-month high-intensity lifestyle-based obesity treatment program, embedded in the clinic setting and delivered by health coaches in weekly sessions initially and monthly sessions in months 7 through 24. RESULTS: As recently demonstrated, participants receiving the PROPEL ILI lost significantly more weight over 24 months than those receiving usual care (mean difference, -4.51% [95% CI, -5.93 to -3.10]; P<0.01). Fasting glucose decreased more in the ILI group compared with the usual care group at 12 months (mean difference, -7.1 mg/dL [95% CI, -12.0 to -2.1]; P<0.01) but not 24 months (mean difference, -0.8 mg/dL [95% CI, -6.2 to 4.6]; P=0.76). Increases in high-density lipoprotein cholesterol were greater in the ILI than in the usual care group at both time points (mean difference at 24 months, 4.6 mg/dL [95% CI, 2.9-6.3]; P<0.01). Total:high-density lipoprotein cholesterol ratio and metabolic syndrome severity (z score) decreased more in the ILI group than in the usual care group at both time points, with significant mean differences of the change of -0.31 (95% CI, -0.47 to -0.14; P<0.01) and -0.21 (95% CI, -0.36 to -0.06; P=0.01) at 24 months, respectively. Changes in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and blood pressure did not differ significantly between groups at any time point. CONCLUSIONS: A pragmatic ILI consistent with national guidelines and delivered by trained health coaches in primary care produced clinically relevant improvements in cardiometabolic health in an underserved population over 24 months. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02561221.

Comparison of weight loss data collected by research technicians versus electronic medical records: the PROPEL trial.

BACKGROUND/OBJECTIVES: Pragmatic trials are increasingly used to study the implementation of weight loss interventions in real-world settings. This study compared researcher-measured body weights versus electronic medical record (EMR)-derived body weights from a pragmatic trial conducted in an underserved patient population. SUBJECTS/METHODS: The PROPEL trial randomly allocated 18 clinics to usual care (UC) or to an intensive lifestyle intervention (ILI) designed to promote weight loss. Weight was measured by trained technicians at baseline and at 6, 12, 18, and 24 months. A total of 11 clinics (6 UC/5 ILI) with 577 enrolled patients also provided EMR data (n = 561), which included available body weights over the period of the trial. RESULTS: The total number of assessments were 2638 and 2048 for the researcher-measured and EMR-derived body weight values, respectively. The correlation between researcher-measured and EMR-derived body weights was 0.988 (n = 1 939; p < 0.0001). The mean difference between the EMR and researcher weights (EMR-researcher) was 0.63 (2.65 SD) kg, and a Bland-Altman graph showed good agreement between the two data collection methods; the upper and lower boundaries of the 95% limits of agreement are -4.65 kg and +5.91 kg, and 71 (3.7%) of the values were outside the limits of agreement. However, at 6 months, percent weight loss in the ILI compared to the UC group was 7.3% using researcher-measured data versus 5.5% using EMR-derived data. At 24 months, the weight loss maintenance was 4.6% using the technician-measured data versus 3.5% using EMR-derived data. CONCLUSION: At the group level, body weight data derived from researcher assessments and an EMR showed good agreement; however, the weight loss difference between ILI and UC was blunted when using EMR data. This suggests that weight loss studies that rely on EMR data may require larger sample sizes to detect significant effects. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number NCT02561221.

A Randomized Controlled Trial to Address Consumer Food Waste with a Technology-aided Tailored Sustainability Intervention.

There is growing concern whether pro-environmental behavioral interventions can generate sufficient reductions in carbon emissions to address climate change. While many have suggested enhanced tailoring of interventions to increase effect sizes, and while individual tailoring is common among health interventions, little is known about how individual tailoring may impact effect sizes for pro-environmental behavioral interventions. Using a novel technology-aided delivery and measurement approach, we conduct a randomized controlled trial featuring an individually tailored intervention focused on reducing the amount of food wasted by participants over approximately one week in their normal living conditions. We find large significant effects for the focal area of food wasted during dining (a 79% reduction), a null effect on food wasted over all household stages (preparation, dining and clean outs), and desirable or null effects for critical antecedent (e.g., waste during preparation, continued purchases of fresh produce), concurrent (e.g., food selection and consumption), and attendant behaviors (e.g., waste from storage clean outs, avoiding waste deposits in landfills).

Effect of 2 years of calorie restriction on liver biomarkers: results from the CALERIE phase 2 randomized controlled trial.

PURPOSE: Calorie restriction (CR) is an effective treatment for obesity-related liver and metabolic disease. However, CR studies in individuals without obesity are needed to see if CR could delay disease onset. Liver biomarkers indicate hepatic health and are linked to cardiometabolic disease. Our aim was to examine the effects of a 2-year CR intervention on liver biomarkers in healthy individuals without obesity. METHODS: The Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) study was a 2-year randomized controlled trial. Overall, 218 participants (body mass index: 25.1 ± 1.7 kg/m2) were enrolled into a control group (n = 75) that ate ad libitum (AL), or a CR group (n = 143) that aimed to decrease energy intake by 25%. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and bilirubin were measured during the trial. RESULTS: At month 24, relative to the AL group, ALP (- 7 ± 1 IU/L; P < 0.01) and GGT (- 0.11 ± 0.04 log IU/L; P = 0.02) decreased and bilirubin increased (0.21 ± 0.06 log mg/dL; P < 0.01) in the CR group; no between-group differences in ALT (- 1 ± 1 IU/L; P > 0.99) or AST (2 ± 2 IU/L; P = 0.68) were revealed. However, sex-by-treatment-by-time interactions (P < 0.01) were observed, with CR (vs. control) inducing reduced ALT and GGT and increased AST in men only (P ≤ 0.02). CONCLUSIONS: In metabolically healthy individuals without obesity, 2 years of CR improves several liver biomarkers, with potentially greater improvements in men. These data suggest that sustained CR may improve long-term liver and metabolic disease risk in healthy adults. TRIAL REGISTRATION: Clinicaltrials.gov (NCT00427193). Registered January 2007.

Meal composition during an ad libitum buffet meal and longitudinal predictions of weight and percent body fat change: The role of hyper-palatable, energy dense, and ultra-processed foods.

BACKGROUND: Foods that increase obesity risk are ubiquitous in the US food environment. Such foods may be the target of hedonic eating, which may facilitate weight gain and lead to obesity. The study tested whether meal composition during an ad libitum buffet meal was associated with 1-year weight and percent body fat changes among healthy younger adults without obesity. Hyper-palatable foods (HPF) were the study focus; comparisons were conducted with high energy dense (HED) and ultra-processed foods (UPF). DESIGN: Younger adults without obesity (N = 82; 43% male; mean age 26.8) completed an ad libitum buffet meal and provided body composition measurements at baseline and 1-year follow up. Multiple regression models tested associations between the proportion of the target food consumed (HPF, HED, or UPF) during the ad libitum meal and 1) weight change and 2) percent body fat change. The proportion of HPF was characterized by HPF group, specifically carbohydrate and sodium (CSOD) foods or fat and sodium (FSOD) foods. RESULTS: Participants who consumed a greater proportion of CSOD HPF in their ad libitum buffet meals had significantly greater weight change (b = 0.354, p = .003) and percent body fat change (b = 0.247, p = .036) at 1-year follow up. In contrast, no significant associations were found between the proportion of FSOD HPF, HED, or UPF consumed and anthropometric outcomes (p values = .099-.938). CONCLUSIONS: Eating a greater proportion of hyper-palatable CSOD foods ad libitum appears to be a pattern of hedonic eating, which may increase an individual's risk for weight and body fat gain in early adulthood.

Long-Term Weight Loss With Metformin or Lifestyle Intervention in the Diabetes Prevention Program Outcomes Study.

Background: Identifying reliable predictors of long-term weight loss (LTWL) could lead to improved weight management. Objective: To identify some predictors of LTWL. Design: The DPP (Diabetes Prevention Program) was a randomized controlled trial that compared weight loss with metformin, intensive lifestyle intervention (ILS), or placebo. Its Outcomes Study (DPPOS) observed patients after the masked treatment phase ended. (ClinicalTrials.gov: NCT00004992 and NCT00038727). Setting: 27 DPP and DPPOS clinics. Participants: Of the 3234 randomly assigned participants, 1066 lost at least 5% of baseline weight in the first year and were followed for 15 years. Measurements: Treatment assignment, personal characteristics, and weight. Results: After 1 year, 289 (28.5%) participants in the metformin group, 640 (62.6%) in the ILS group, and 137 (13.4%) in the placebo group had lost at least 5% of their weight. After the masked treatment phase ended, the mean weight loss relative to baseline that was maintained between years 6 and 15 was 6.2% (95% CI, 5.2% to 7.2%) in the metformin group, 3.7% (CI, 3.1% to 4.4%) in the ILS group, and 2.8% (CI, 1.3% to 4.4%) in the placebo group. Independent predictors of LTWL included greater weight loss in the first year in all groups, older age and continued metformin use in the metformin group, older age and absence of either diabetes or a family history of diabetes in the ILS group, and higher fasting plasma glucose levels at baseline in the placebo group. Limitation: Post hoc analysis; examination of nonrandomized subsets of randomized groups after year 1. Conclusion: Among persons with weight loss of at least 5% after 1 year, those originally randomly assigned to metformin had the greatest loss during years 6 to 15. Older age and the amount of weight initially lost were the most consistent predictors of LTWL maintenance. Primary Funding Source: National Institutes of Health.

Unpacking the Decline in Food Waste Measured in Chinese Households from 1991 to 2009.

Food waste reduction is an explicit goal for many countries, yet a paucity of highquality primary measurements of food waste are available to inform policy. We analyze repeated physical measurements of discarded food from more than 37,000 households enrolled in the China Health and Nutrition Survey (CHNS) from 1991 to 2009 and describe relevant food waste patterns and trends within households over a period of dramatic change. Over a period in which average real household incomes tripled, food discarded per person declined by about 20% on a quantity basis and by about 40% on a Calorie basis during the study, with an estimated annual per capita household waste of 14.9 kg in 2009. Comparing across households within narrower periods of the data, we find changing associations between income and food waste, with a weakly negative association during the 1990s and a significant positive association during the 2000s. Carbohydrates, particularly grains and vegetables and fruits, experienced the greatest reduction in waste. Food waste reduction rates over the study period were greatest among small households and rural households. Certain characteristics were associated with higher per person waste levels throughout the study period, including rural residence, intense physical activity levels, and a lack of home refrigeration.

The Validity, Time Burden, and User Satisfaction of the FoodImage™ Smartphone App for Food Waste Measurement Versus Diaries: A Randomized Crossover Trial.

The FoodImage™ smartphone app transmits to researchers users' photographs of food selection and food waste, and includes user-tagged information about waste reasons and destination. Twenty-four participants were trained to record food waste using FoodImage, food waste diaries requiring visual estimation of waste quantities, and diaries requiring scale weights. Participants used each method during three staged food-waste scenarios (food preparation, eating, and clean-out) in a randomized crossover trial. Two participants had extreme values for the weighed diary method; therefore, accuracy results are reported with and without these two participants' data. Error was calculated as waste estimated with the experimental method minus directly weighed waste. Mean absolute error from FoodImage was significantly smaller than or equal to the error from both diary methods in each scenario. Furthermore, the mean values from FoodImage were equivalent to directly weighed values in two out of the three tasks; while weighed diaries were equivalent in two tasks only when the two participants with extreme values were removed. Visually estimated diaries were equivalent for only one task. All 24 participants preferred FoodImage to diaries and all rated FoodImage as less time consuming. Over one week, FoodImage would require ~24 fewer minutes of users' time to record all data. Unlike food waste diaries, FoodImage also transmits data to researchers in real-time and provides detailed data on food selection and intake. ClinicalTrials.gov Identifier: NCT03309306.

A free-choice high-fat, high-sucrose diet induces hyperphagia, obesity, and cardiovascular dysfunction in female cycling and pregnant rats.

The main objective of these studies was to characterize metabolic, body composition, and cardiovascular responses to a free-choice high-fat, high-sucrose diet in female cycling and pregnant rats. In the nonpregnant state, female Sprague-Dawley rats offered a 3-wk free-choice high-fat, high-sucrose diet had greater energy intake, adiposity, serum leptin, and triglyceride concentrations compared with rats fed with standard chow and developed glucose intolerance. In addition, choice-diet-fed rats had larger cardiac ventricular weights, smaller kidney and pancreas weights, and higher blood pressure than chow-fed rats, but they did not exhibit resistance artery endothelial dysfunction. When the free-choice diet continued throughout pregnancy, rats remained hyperphagic, hyperleptinemic, and obese. Choice pregnant rats exhibited uterine artery endothelial dysfunction and had smaller fetuses compared with chow pregnant rats. Pregnancy normalized mean arterial blood pressure and pancreas weights in choice rats. These studies are the first to provide a comprehensive evaluation of free-choice high-fat, high-sucrose diet on metabolic and cardiovascular functions in female rats, extending the previous studies in males to female cycling and pregnant rodents. Free-choice diet may provide a new model of preconceptual maternal obesity to study the role of increased energy intake, individual food components, and preexisting maternal obesity on maternal and offspring physiological responses during pregnancy and after birth.

Effects of Increasing Exercise Intensity and Dose on Multiple Measures of HDL (High-Density Lipoprotein) Function.

OBJECTIVE: Measures of HDL (high-density lipoprotein) function are associated with cardiovascular disease. However, the effects of regular exercise on these measures is largely unknown. Thus, we examined the effects of different doses of exercise on 3 measures of HDL function in 2 randomized clinical exercise trials. APPROACH AND RESULTS: Radiolabeled and boron dipyrromethene difluoride-labeled cholesterol efflux capacity and HDL-apoA-I (apolipoprotein A-I) exchange were assessed before and after 6 months of exercise training in 2 cohorts: STRRIDE-PD (Studies of Targeted Risk Reduction Interventions through Defined Exercise, in individuals with Pre-Diabetes; n=106) and E-MECHANIC (Examination of Mechanisms of exercise-induced weight compensation; n=90). STRRIDE-PD participants completed 1 of 4 exercise interventions differing in amount and intensity. E-MECHANIC participants were randomized into 1 of 2 exercise groups (8 or 20 kcal/kg per week) or a control group. HDL-C significantly increased in the high-amount/vigorous-intensity group (3±5 mg/dL; P=0.02) of STRRIDE-PD, whereas no changes in HDL-C were observed in E-MECHANIC. In STRRIDE-PD, global radiolabeled efflux capacity significantly increased 6.2% (SEM, 0.06) in the high-amount/vigorous-intensity group compared with all other STRRIDE-PD groups (range, -2.4 to -8.4%; SEM, 0.06). In E-MECHANIC, non-ABCA1 (ATP-binding cassette transporter A1) radiolabeled efflux significantly increased 5.7% (95% CI, 1.2-10.2%) in the 20 kcal/kg per week group compared with the control group, with no change in the 8 kcal/kg per week group (2.6%; 95% CI, -1.4 to 6.7%). This association was attenuated when adjusting for change in HDL-C. Exercise training did not affect BODIPY-labeled cholesterol efflux capacity or HDL-apoA-I exchange in either study. CONCLUSIONS: Regular prolonged vigorous exercise improves some but not all measures of HDL function. Future studies are warranted to investigate whether the effects of exercise on cardiovascular disease are mediated in part by improving HDL function. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00962962 and NCT01264406.

Effect of different doses of supervised aerobic exercise on heart rate recovery in inactive adults who are overweight or obese: results from E-MECHANIC.

PURPOSE: Heart rate recovery (HRR) after exercise is an independent risk factor for cardiovascular disease and mortality. Regular aerobic exercise can improve HRR, yet little is known regarding the dose necessary to promote increases. The aim was to assess the impact of different doses of vigorous-intensity aerobic exercise on HRR in individuals with overweight/obesity. METHODS: Data from 137 sedentary adults with overweight/obesity from E-MECHANIC were analyzed. Participants were randomized to either a moderate-dose exercise group (8 kcal/kg body weight/week; KKW), a high-dose exercise group (20 KKW), or a non-exercise control group. HRR was defined as the difference between peak heart rate (HR) during a graded exercise test and the HR after exactly 1 min of active recovery at 1.5 mph and level grade. RESULTS: Change in HRR did not differ significantly by exercise group; therefore, the data from both exercise groups were combined. The combined exercise group showed an improvement in HRR of 2.7 bpm (95% CI 0.1, 5.4; p = 0.04) compared to the control group. Those participants who lost more weight during the intervention (non-compensators) increased HRR by 6.2 bpm (95% CI 2.8, 9.5; p < 0.01) compared to those who lost less weight (compensators). Multiple linear regression models indicated that improvements in HRR are independently associated with increases in VO2peak (ß = 0.4; 95% CI 0.1, 0.7; p = 0.04) but also influenced by concomitant weight loss (ß = 0.6; 95% CI 0.2, 1.1; p = 0.01). CONCLUSION: Exercise-induced improvements in 1-min HRR are likely due to increases in cardiorespiratory fitness as well as concomitant weight loss.

Change in self-efficacy, eating behaviors and food cravings during two years of calorie restriction in humans without obesity.

Calorie restriction (CR) enhances longevity in humans who are normal weight, overweight and obese. While dietary regimens can change self-efficacy, eating behaviors, and food cravings in individuals with obesity, the responses of these measures to prolonged CR in individuals who are exclusively not obese is unknown. The aim of this analysis was to test the effects of a two-year CR intervention on self-efficacy and eating attitudes and behaviors in humans without obesity by analyzing data from the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE 2) study. Participants (n = 218, BMI range = 21.3-29.0 kg/m2) were randomized to a 25% CR group or an ad libitum (AL) group. Eating attitudes and behaviors and self-efficacy were assessed using validated questionnaires at baseline, month 12, and month 24. Dietary restraint and self-efficacy increased in the CR compared to the AL group (ES ≥ 0.32). Increased self-efficacy was negatively related to weight change (ρ < -0.24). In the CR group, males showed a reduction in cravings for carbohydrates and fats at month 24, whereas females did not. The CR group showed elevations in state hunger, which were transient, and disinhibited eating (ES ≥ 0.37). In individuals without obesity, dietary restraint and self-efficacy could be important in promoting long-term CR for individuals looking to use CR as a tool to improve longevity.

Efficacy of a school-based obesity prevention intervention at reducing added sugar and sodium in children's school lunches: the LA Health randomized controlled trial.

BACKGROUND: Decreasing selection and consumption of sodium and added sugars in the school cafeteria setting is important to provide optimal nutrition to children. OBJECTIVE: The ofjective of this study is to determine whether Louisiana (LA) Health, a school-based obesity prevention intervention, could successfully reduce children's selection and consumption of sodium and added sugars during school lunches vs. the control group. DESIGN: Food selection, consumption, and plate waste from student lunches (3 consecutive days) in 33 public schools in rural Louisiana were collected and analyzed using the digital photography of foods method at baseline and after a 28-month obesity prevention intervention (LA Health) beginning in 4th-6th grade (87% of children received free or reduced cost lunch). Selection and consumption of energy, added sugar, and sodium was objectively measured using digital photography of foods. Mixed models, including Race and BMI, were used to determine whether change in selection and consumption differed by group. RESULTS: Sodium decreased for selection (- 233.1 ± 89.4 mg/lunch, p = 0.04) and consumption (- 206.3 ± 65.9, mg/lunch) in the intervention (vs. control) by month 18, and in consumption by month 28 (- 153.5 ± 66.9 mg/lunch, p = 0.03). Change in added sugar consumption decreased in the intervention (vs. control) at month 18 (- 3.7 ± 1.6, p = 0.05) and at month 28 (- 3.5 ± 1.6 tsp/lunch, p = 0.05). CONCLUSIONS: LA Health decreased the amount of added sugar and sodium selected and consumed, but not plate waste, by month 28. Results highlight the importance of long-term interventions and policies targeting provision and selection to improve dietary patterns in children, with less focus on plate waste.

Pharmacotherapy for Patients with Obesity.

BACKGROUND: Although pharmacotherapy is not the cornerstone of obesity treatment, it is a valuable tool that could be considered for patients who have not had adequate benefit from lifestyle interventions or who have difficulty maintaining initial weight loss over longer periods. CONTENT: This review focuses on the role of antiobesity drugs, the mechanisms by which the drugs work, potential pharmacological targets in the neural control of food intake and regulation of body weight, the history of antiobesity drugs, a summary of efficacy and safety data from clinical trials, and the clinical application of pharmacotherapy. Currently, 5 approved drug therapies are available in the US for long-term weight management, with only 2 of these meeting the stronger Food and Drug Administration (FDA) criteria of 5% weight loss relative to a placebo after 1 year and others receiving approval based on the categorical criterion of the proportions of patients achieving 5% weight loss. Interpretation of the results of clinical trials conducted before regulatory agency approval is limited by high dropout rates; thus, the results might not be replicable in clinical practice settings. Many patients who are suitable candidates for pharmacotherapy are not using the new drugs due to lack of insurance coverage and high out-of-pocket costs. SUMMARY: With the availability of 4 new drugs since 2012, clinicians in the US now have more tools for long-term weight management. The quality of pharmacotherapy clinical investigations needs considerable improvement. Future research should focus on examining the mediators and moderators of response.

Video chat technology to remotely quantify dietary, supplement and medication adherence in clinical trials.

We conducted two studies to test the validity, reliability, feasibility and acceptability of using video chat technology to quantify dietary and pill-taking (i.e. supplement and medication) adherence. In study 1, we investigated whether video chat technology can accurately quantify adherence to dietary and pill-taking interventions. Mock study participants ate food items and swallowed pills, while performing randomised scripted 'cheating' behaviours to mimic non-adherence. Monitoring was conducted in a cross-over design, with two monitors watching in-person and two watching remotely by Skype on a smartphone. For study 2, a twenty-two-item online survey was sent to a listserv with more than 20 000 unique email addresses of past and present study participants to assess the feasibility and acceptability of the technology. For the dietary adherence tests, monitors detected 86 % of non-adherent events (sensitivity) in-person v. 78 % of events via video chat monitoring (P=0·12), with comparable inter-rater agreement (0·88 v. 0·85; P=0·62). However, for pill-taking, non-adherence trended towards being more easily detected in-person than by video chat (77 v. 60 %; P=0·08), with non-significantly higher inter-rater agreement (0·85 v. 0·69; P=0·21). Survey results from study 2 (n 1076 respondents; ≥5 % response rate) indicated that 86·4 % of study participants had video chatting hardware, 73·3 % were comfortable using the technology and 79·8 % were willing to use it for clinical research. Given the capability of video chat technology to reduce participant burden and outperform other adherence monitoring methods such as dietary self-report and pill counts, video chatting is a novel and promising platform to quantify dietary and pill-taking adherence.

Examination of the reliability and validity of the Mindful Eating Questionnaire in pregnant women.

OBJECTIVE: Mindfulness is theorized to affect the eating behavior and weight of pregnant women, yet no measure has been validated during pregnancy. METHODS: This study qualitatively and quantitatively evaluated the reliability and validity of the Mindful Eating Questionnaire (MEQ) in overweight and obese pregnant women. Participants completed focus groups and cognitive interviews. The MEQ was administered twice to measure test-retest reliability. The Eating Inventory (EI) and Mindful Attention Awareness Scale (MAAS) were administered to assess convergent validity, and the Neighborhood Environment Walkability Scale (NEWS) assessed discriminant validity. RESULTS: Participants were 20 ± 8 weeks gestation (mean ± SD), 30 ± 2 years old, and 55% were obese. The MEQ total score had good test-retest reliability (r = .85). The total score internal consistency reliability was poor (Cronbach's α = .56). The external cues subscale (ECS) was not internally consistent (α = .31). Other subscales ranged from α = .59-.68. When the ECS was excluded, the MEQ total score internal consistency was acceptable (α = .62). Convergent validity was supported by the MEQ total score (with and without ECS) correlating significantly with the MAAS and the EI disinhibition and hunger subscales. Discriminant validity of the MEQ was supported by the MEQ and NEWS total scores and subscales not being significantly correlated. The quantitative results were supported by the qualitative context and content analysis. CONCLUSION: With the exception of the ECS, the MEQ's reliability and validity was supported in pregnant women, and most of the subscales were more robust in pregnant women than in the original sample of healthy adults. The MEQ's use with overweight and obese pregnant women is supported.