A pilot, randomized, placebo-controlled study of mindfulness meditation in treating insomnia in multiple sclerosis.

OBJECTIVE: Mindfulness is an established approach to reduce distress and stress reactivity by improving awareness and tolerability of thoughts and emotions. This study compares mindfulness training to sleep hygiene in persons with multiple sclerosis (PWMS) who report chronic insomnia, examining sleep efficiency (SE), self-reported sleep quality and quality of life. METHODS: Fifty-three PWMS were randomized (1:1) in a single-blinded, parallel group design to ten, two-hour weekly sessions of Mindfulness Based Stress Intervention for Insomnia (MBSI-I) over a span of ten weeks or a single, one hour sleep hygiene (SH) session over one day. The primary outcome measure was SE, measured by the Fitbit™ Charge 2 wrist device, at 10 and 16 weeks from the start of study interventions. Self-report outcomes included the Pittsburg Sleep Quality Rating Scale (PSQI), Insomnia Severity Index (ISI) and the Multiple Sclerosis Quality of Life Inventory (MSQLI). Nineteen participants in the MBSI-I group and 24 in the SH group completed the primary study. Subsequently, ten participants in the original SH group participated in the 10-week MSBI-I course and their data was added to the MBSI-I cohort (eMSBI-I). RESULTS: While neither SE nor the PSQI showed significant differences between MBSI-I, eMBSI-I and SH groups, ISI improved in both the MSBI-I and eMBSI-I vs SH at 10 weeks (p = 0.0014 and p = 0.0275) but not 16 weeks. However, pre and post assessments within the MBSI-I and eMBSI-I cohorts did show significant improvement in the PSQI and ISI at 10 and 16 weeks, while SH was significant in the ISI only at 16 weeks. Several quality of life measurements, including fatigue, mental health and cognitive function favored the mindfulness cohorts. CONCLUSION: This pilot study demonstrates beneficial effects of MBSR on insomnia, sleep quality and quality of life in PWMS. TRIAL REGISTRATION: NCT03949296. 14 May 2019.

Egg Consumption in the Context of Plant-Based Diets and Cardiometabolic Risk Factors in Adults at Risk of Type 2 Diabetes.

BACKGROUND: Plant-based diets (PBDs) are typically recommended to those at risk of type 2 diabetes mellitus (T2DM). OBJECTIVES: We examined how including eggs, compared with excluding them from PBDs, affected cardiometabolic risk factors in adults at risk of T2DM. METHODS: This was a randomized, controlled, single-blind, crossover trial of 35 adults (mean age: 60.7 y; 25 women, 10 men) at risk of T2DM assigned to 1 of 2 sequence permutations of 2 dietary treatments (plant-based plus eggs, and exclusively plant-based), with a 4-wk washout period. A dietitian counseled participants to exclude or include 2 eggs daily in the context of PBDs for a 6-wk interval. Our primary outcome measure was endothelial function (EF) measured as flow-mediated dilatation. Secondary outcome measures included lipid profile, blood pressure, insulin sensitivity, anthropometry, and dietary intake. Data were analyzed using generalized linear models. RESULTS: Compared with egg exclusion, egg inclusion in the context of PBDs did not adversely affect EF (-1.7% ± 6.5% compared with -1.8% ± 7.5%; P = 0.9805). Likewise, egg inclusion, compared with egg exclusion, did not adversely affect (P = 0.1096-0.9781) lipid profile, blood pressure, insulin sensitivity, or anthropometry. Egg inclusion, compared with egg exclusion, improved reported intakes of selenium (23.1 ± 30.3 µg/d compared with 2.3 ± 34.9 µg/d; P = 0.0124) and choline (172.0 ± 96.0 mg/d compared with -3.4 ± 68.1 mg/d; P < 0.0001). CONCLUSIONS: Consuming 2 eggs daily in the context of PBDs does not adversely affect cardiometabolic risk factors among adults at risk of T2DM. Eggs could be used as an adjuvant to enhance PBDs that are typically recommended for those at risk of T2DM.This trial was registered at clinicaltrials.gov as NCT04316429.

Efficacy and Safety of Massage for Osteoarthritis of the Knee: a Randomized Clinical Trial.

BACKGROUND: Current treatment options for knee osteoarthritis have limited effectiveness and potentially adverse side effects. Massage may offer a safe and effective complement to the management of knee osteoarthritis. OBJECTIVE: Examine effects of whole-body massage on knee osteoarthritis, compared to active control (light-touch) and usual care. DESIGN: Multisite RCT assessing the efficacy of massage compared to light-touch and usual care in adults with knee osteoarthritis, with assessments at baseline and weeks 8, 16, 24, 36, and 52. Subjects in massage or light-touch groups received eight weekly treatments, then were randomized to biweekly intervention or usual care to week 52. The original usual care group continued to week 24. Analysis was performed on an intention-to-treat basis. PARTICIPANTS: Five hundred fifty-one screened for eligibility, 222 adults with knee osteoarthritis enrolled, 200 completed 8-week assessments, and 175 completed 52-week assessments. INTERVENTION: Sixty minutes of protocolized full-body massage or light-touch. MAIN MEASURES: Primary: Western Ontario and McMaster Universities Arthritis Index. Secondary: visual analog pain scale, PROMIS Pain Interference, knee range of motion, and timed 50-ft walk. KEY RESULTS: At 8 weeks, massage significantly improved WOMAC Global scores compared to light-touch (- 8.16, 95% CI = - 13.50 to - 2.81) and usual care (- 9.55, 95% CI = - 14.66 to - 4.45). Additionally, massage improved pain, stiffness, and physical function WOMAC subscale scores compared to light-touch (p < 0.001; p = 0.04; p = 0.02, respectively) and usual care (p < 0.001; p = 0.002; p = 0.002; respectively). At 52 weeks, the omnibus test of any group difference in the change in WOMAC Global from baseline to 52 weeks was not significant (p = 0.707, df = 3), indicating no significant difference in change across groups. Adverse events were minimal. CONCLUSIONS: Efficacy of symptom relief and safety of weekly massage make it an attractive short-term treatment option for knee osteoarthritis. Longer-term biweekly dose maintained improvement, but did not provide additional benefit beyond usual care post 8-week treatment. TRIAL REGISTRATION: clinicaltrials.gov NCT01537484.

Safety of pacemaker implantation in nonagenarians: an analysis of the healthcare cost and utilization project-nationwide inpatient sample.

BACKGROUND: Data are scarce on outcomes of pacemaker implantation in nonagenarians (age≥90 years). METHODS AND RESULTS: We identified patients >70 years of age (n=115 683) who underwent initial pacemaker implantation in the 2004 to 2008 Healthcare Cost and Utilization Project-Nationwide Inpatient Sample. Outcomes included in-hospital mortality, complications, length of stay, and charges. Unadjusted outcomes were compared using χ(2) and Mantel-Haenszel tests. Multivariate hierarchical logistic models and stepwise linear regression models adjusted for case-mix variation and clustering. Eleven percent (12 917) were >90 years of age. Relative to patients aged 70 to 79 years, patients >90 years of age were more likely to have moderate/severe comorbidity (Charlson score >1; 43.2% versus 40.1%) and less likely to be admitted electively (17.5% versus 29.9%), all P<0.001. The unadjusted mortality and complication rates in patients aged 70 to 79 years were 0.60% (confidence interval [CI], 0.53-0.67%) and 5.61% (CI, 5.40-5.82%), respectively, and in patients aged >90 years were 1.87% (CI, 1.63-2.11%) and 6.31% (CI, 5.89-6.72%). Length of stay and charges in patients aged 70 to 79 years were 3.22 days (CI, 3.20-3.24 days) and $38 871 (CI, $38 700-$39 043), and in patients aged >90 years, 4.27 days (CI, 4.25-4.30 days) and $41 373 (CI, $41 190-$41 556). Multivariable analysis revealed severe comorbidity (odds ratio, 5.00; 95% CI, 4.05-6.17) was a greater predictor of mortality than increasing age (odds ratio, 2.81 per decade; CI, 2.35-3.35), all P<0.001. Similarly, severe comorbidity (Charlson score >5) was more strongly associated with complications, length of stay, and charges than age. CONCLUSIONS: Although increasing age predicts worsening outcomes in the elderly, the absolute rates are modest, even in nonagenarians, and comorbidity is a stronger predictor.

The mortality toll of estrogen avoidance: an analysis of excess deaths among hysterectomized women aged 50 to 59 years.

OBJECTIVES: We examined the effect of estrogen avoidance on mortality rates among hysterectomized women aged 50 to 59 years. METHODS: We derived a formula to relate the excess mortality among hysterectomized women aged 50 to 59 years assigned to placebo in the Women's Health Initiative randomized controlled trial to the entire population of comparable women in the United States, incorporating the decline in estrogen use observed between 2002 and 2011. RESULTS: Over a 10-year span, starting in 2002, a minimum of 18 601 and as many as 91 610 postmenopausal women died prematurely because of the avoidance of estrogen therapy (ET). CONCLUSIONS: ET in younger postmenopausal women is associated with a decisive reduction in all-cause mortality, but estrogen use in this population is low and continuing to fall. Our data indicate an associated annual mortality toll in the thousands of women aged 50 to 59 years. Informed discussion between these women and their health care providers about the effects of ET is a matter of considerable urgency.

Dietary Assessment by Pattern Recognition: a Comparative Analysis.

Background: Diet quality photo navigation (DQPN) is a novel dietary intake assessment tool that was developed to help address limitations of traditional tools and to easily integrate into health care delivery systems. Prevailing practice is to validate new tools against approaches that are in wide use. Objective: This study aimed to assess 1) the validity of Diet ID in measuring diet quality, food group and nutrient intake against 2 traditional dietary assessment methods (i.e., food record [FR], food frequency questionnaire) and 2) the test reproducibility/reliability of Diet ID to obtain similar results with repeat assessments. Methods: Using a participant-sourcing platform for online research, we recruited 90 participants, 58 of whom completed DQPN, a 3-d FR (via the Automated Self-Administered 24-hour Dietary Assessment Tool), and a food frequency questionnaire (FFQ, via the Dietary History Questionnaire III). We estimated mean nutrient and food group intake with all 3 instruments and generated Pearson correlations between them. Results: Mean age (SD) of participants was 38 (11) y, and more than half were male (64%). The strongest correlations for DQPN when compared with the other 2 instruments were for diet quality, as measured by the Healthy Eating Index 2015; between DQPN and the FFQ, the correlation was 0.58 (P < 0.001), and between DQPN and the FR, the correlation was 0.56 (P < 0.001). Selected nutrients and food groups also showed moderate strength correlations. Test-retest reproducibility for measuring diet quality was evaluated for DQPN and showed a correlation of 0.70 (P < 0.0001). Conclusions: The current study offers evidence that DQPN is comparable to traditional dietary assessment tools for estimating overall diet quality. This performance, plus DQPN's ease-of-use and scalability, may recommend it in efforts to make dietary assessment a universal part of clinical care.

Egg Consumption in the Context of Plant-Based Diets and Diet Quality in Adults at Risk for Type 2 Diabetes: A Randomized Single Blind Cross-over Controlled Trial.

Lifestyle changes that emphasis on plant-based diets (PBD) are typically recommended for those at risk for type 2 diabetes mellitus (T2DM) to mitigate their cardo-metabolic risk. We examined the impact of the inclusion of eggs compared with their exclusion from PBD on diet quality among adults at risk for T2DM.This was a randomized, controlled, single-blind, crossover trial of 35 adults (mean age 60.7 years; 25 women, 10 men; 34 Caucasians, 1 African-American) at risk for T2DM (i.e., pre- diabetes or metabolic syndrome) assigned to one of two possible sequence permutations of two treatments (PBD with eggs and exclusively PBD), with a 4-week washout period. Participants received dietary counseling from a dietitian to exclude or to include 2 eggs daily in the context of PBD for a 6-week period. Diet quality was assessed using the Healthy Eating Index 2015 (HEI-2015) at baseline and 6 weeks.Compared with the exclusion of eggs, the inclusion of eggs in the context of PBD improved the diet quality score for intake of total protein foods (1.0 ± 1.1 vs. -0.4 ± 1.0; p <.0001); seafood and plant proteins (0.2 ± 1.2 vs. -0.4 ± 1.1; p = 0.0338); and fatty acids (0.8 ± 2.5 vs. -0.7 ± 2.7; p = 0.0260). Overall diet quality score depreciated with the adoption of exclusively PBD without eggs (-3.1 ± 8.3; p = 0.0411), while it was unaffected with the adoption of a PBD with the inclusion of eggs (-0.6 ± 7.9; p = 0.6892).Eggs could be used as an adjuvant to enhance the diet quality among those at risk for T2DM who adopt plant-based dietary patterns.

Effect of fruit and vegetable concentrates on endothelial function in metabolic syndrome: a randomized controlled trial.

BACKGROUND AND OBJECTIVE: Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient supplementation that may offer cardioprotective effects. This study assessed the effects of two blends of encapsulated juice powder concentrates (with and without added berry powders) on endothelial function in persons with metabolic syndrome, a risk factor for type 2 diabetes and cardiovascular disease. METHODS: Randomized, double blind, placebo controlled crossover clinical trial with three treatment arms. 64 adults with metabolic syndrome were enrolled and received 8-week sequences of each blend of the concentrates and placebo. The primary outcome measure was change in endothelial function (assessed as flow-mediated dilatation of the brachial artery) 2 hr after consuming a 75 g glucose load, after 8-weeks of daily consumption (sustained) or 2 hr after consumption of a single dose (acute). Secondary outcome measures included plasma glucose, serum insulin, serum lipids, and body weight. RESULTS: No significant between-group differences in endothelial function with daily treatment for 8 weeks were seen. No other significant treatment effects were discerned in glucose, insulin, lipids, and weight. CONCLUSION: Encapsulated fruit and vegetable juice powder concentrates did not alter insulin or glucose measures in this sample of adults with metabolic syndrome. TRIAL REGISTRATION: clinicaltrials.gov NCT01224743.

Post-prandial effects of high-polyphenolic extra virgin olive oil on endothelial function in adults at risk for type 2 diabetes: A randomized controlled crossover trial.

BACKGROUND: Effects of olive oil on cardiovascular risk have been controversial. We compared the effects of high-polyphenolic extra virgin olive oil (EVOO) and refined olive oil without polyphenols on endothelial function (EF) in adults at risk for Type 2 diabetes mellitus (T2DM). METHODS: Randomized, controlled, double-blind, crossover trial of 20 adults (mean age 56.1 years; 10 women, 10 men) at risk for T2DM (i.e., as defined by either prediabetes or metabolic syndrome) assigned to one of two possible sequence permutations of two different single dose treatments (50 mL of high-polyphenolic EVOO or 50 mL of refined olive oil without polyphenols), with 1-week washout. Participants received their olive oils in a smoothie consisting of ½ cup frozen blueberries and 1 cup (8 oz) low-fat vanilla yogurt blended together. Primary outcome measure was EF measured as flow-mediated dilatation. Participants were evaluated before and 2 h after ingestion of their assigned olive oil treatment. RESULTS: EVOO acutely improved EF as compared to refined olive oil (1.2 ± 6.5% versus -3.6 ± 3.8%; p = 0.0086). No significant effects on systolic or diastolic blood pressure were observed. CONCLUSIONS: High-polyphenolic EVOO acutely enhanced EF in the study cohort, whereas refined olive oil did not. Blood pressure effects were not observed. Reports on the vascular effects of olive oil ingestion should specify the characteristics of the oil. CLINICAL TRIAL REGISTRATION NUMBER: NCT04025281.

The stratification of foods on the basis of overall nutritional quality: the overall nutritional quality index.

PURPOSE: Consumer understanding of nutrition information is key to making dietary choices consistent with guidelines. The development of an objective, science-based, and universally applicable system of nutrition guidance would be of considerable potential value to the public health. DESIGN: A multidisciplinary expert panel was convened to develop the Overall Nutritional Quality Index (ONQI). Dietary guidelines, existing nutritional scoring systems, and other pertinent scientific literature were reviewed. An algorithm based on the overall nutritional quality of food was developed and subjected to consumer research and validation testing. RESULTS: The ONQI algorithm incorporates over 30 entries representing both micronutrient and macronutrient properties of foods, as well as weighting coefficients representing epidemiologic associations between nutrients and health outcomes. The basic entry in the algorithm is a weighted trajectory score, which compares nutrient concentration in a food to the recommended concentration of a given nutrient in a healthful diet. In content validity testing, ONQI rankings and expert panel rankings correlated highly (R = .92; p < .001). In regression analysis, aggregated ONQI scores for total diet corresponded well with the Healthy Eating Index (p < .001) in the National Health and Nutrient Examination Survey 2003-2006 cohort (n = 15,900). Consumer research indicated strong appeal to consumers of the ONQI system in general, and the scores on a 1 to 100 scale specifically. A system for acquiring nutrient data, meeting U.S. Food and Drug Administration and U.S. Department of Agriculture standards, has been established so that virtually any food, beverage, meal, or recipe can be scored. CONCLUSIONS: The ONQI is a sophisticated nutrition guidance system developed by a multidisciplinary group independently of all food industry interests with excellent initial performance in both consumer research and validation testing. Combined with a consumer education program, the ONQI has considerable potential to improve dietary patterns, and consequently the public health. Prospective study of effects on dietary patterns and health outcomes is warranted.

Promoting healthy people 2010 through small grants.

The Department of Health and Human Services initiated a pilot "microgrant" or small grants program in 2001 to promote Healthy People 2010 (HP 2010) implemented by the Yale-Griffin Prevention Research Center. This article describes the 103 agencies funded under this initiative and 67 control group agencies. It evaluates the HP 2010 focus areas targeted and the effectiveness of promoting HP 2010 objectives through microgrants. Forty-four percent of the grant recipients and 79% of the control group agencies indicated low levels of familiarity with HP 2010 goals. Changes in knowledge of HP 2010 goals for the microgrant group increased significantly from 5.24 +/- 3.67 to 7.83 +/- 1.86 (p < .05). The results suggest that microgrants can be a useful mechanism to plant the seeds for developing community and organizational capacity to define local health priorities, practice and test new initiatives or expand existing programs and promote knowledge about HP 2010.

The Resulting Variation in Nutrient Intake With the Inclusion of Walnuts in the Diets of Adults at Risk for Type 2 Diabetes: A Randomized, Controlled, Crossover Trial.

PURPOSE: We previously demonstrated that including walnuts in the diets of adults at risk for type 2 diabetes mellitus (T2DM) led to improved overall diet quality. This report examines the specific changes in their nutrient intake. DESIGN: This was a randomized, controlled, modified Latin square parallel design trial with 2 treatment arms. Participants were randomized to walnut intake with, or without, dietary advice to regulate caloric intake. Within each treatment arm, they were further randomized to one of 2 sequence permutations (walnut-included/walnut-excluded or walnut-excluded/walnut-included diet), with a 3-month washout between treatment phases. SETTING: Community hospital in Lower Naugatuck Valley in Connecticut. PARTICIPANTS: Cohort of 112 participants (31 men and 81 women) at risk for T2DM. INTERVENTION: Participants included 56 g (366 kcal) of walnuts in their daily diets for 6 months. MEASURES: Nutrient intake was assessed using web-based Automated Self-Administered 24-Hour Dietary Assessment. ANALYSIS: Data were analyzed using generalized linear models. RESULTS: Walnut inclusion led to increased intake of total fat, calcium, magnesium, thiamin, total saturated fatty acids, and monounsaturated and polyunsaturated fatty acids (379.0 ± 90.3 g vs -136.5 ± 92.7 g, P < .01; 230.7 ± 114.2 mg vs -95.2 ± 117.4 mg, P = .05; 111.0 ± 33.9 mg vs -32.3 ± 34.9 mg, P < .01; 0.28 ± 0.2 mg vs -0.47 ± 0.2 mg, P = .02; 8.6 ± 3.4 g vs -1.1 ± 3.5 g, P =.05; 6.3 ± 3.9 g vs -6.3 ± 4.0 g, P = .03; and 25.4 ± 4.0 vs -6.6 ± 4.2 g, P < .01, respectively). Vitamin C intake decreased (-65.3 ± 55.3 mg vs 98.9 ± 56.8 mg, P = .04). Protein intake increased from baseline with the inclusion of walnuts (20.0 ± 8.8 g, P < .05). Walnut inclusion led to an increase in total calories consumed when caloric intake is not regulated. CONCLUSION: Including walnuts in the diets of these adults led to increased dietary intake of some nutrients associated with lower risk of developing T2DM and other cardiometabolic risk factors.

Change in Glycemic Control With Use of a Digital Therapeutic in Adults With Type 2 Diabetes: Cohort Study.

BACKGROUND: Intensive lifestyle change can treat and even reverse type 2 diabetes. Digital therapeutics have the potential to deliver lifestyle as medicine for diabetes at scale. OBJECTIVE: This 12-week study investigates the effects of a novel digital therapeutic, FareWell, on hemoglobin A1c (HbA1c) and diabetes medication use. METHODS: Adults with type 2 diabetes and a mobile phone were recruited throughout the United States using Facebook advertisements. The intervention aim was to effect a sustainable shift to a plant-based dietary pattern and regular exercise by advancing culinary literacy and lifestyle skill acquisition. The intervention was delivered by an app paired with specialized human support, also delivered digitally. Health coaching was provided every 2 weeks by telephone, and a clinical team was available for participants requiring additional support. Participants self-reported current medications and HbA1c at the beginning and end of the 12-week program. Self-efficacy related to managing diabetes and maintaining dietary changes was assessed via survey. Engagement was recorded automatically through the app. RESULTS: We enrolled 118 participants with a baseline HbA1c >6.5%. Participants were 81.4% female (96/118) and resided in 38 US states with a mean age of 50.7 (SD 9.4) years, baseline body mass index of 38.1 (SD 8.8) kg/m2, and baseline HbA1c of 8.1% (SD 1.6). At 12 weeks, 86.2% (94/109) of participants were still using the app. Mean change in HbA1c was -0.8% (97/101, SD 1.3, P<.001) for those reporting end-study data. For participants with a baseline HbA1c >7.0% who did not change medications midstudy, HbA1c change was -1.1% (67/69, SD 1.4, P<.001). The proportion of participants with an end-study HbA1c <6.5% was 28% (22/97). After completion of the intervention, 17% (16/97) of participants reported a decrease in diabetic medication while 8% (8/97) reported an increase. A total of 57% (55/97) of participants achieved a composite outcome of reducing HbA1c, reducing diabetic medication use, or both; 92% (90/98) reported greater confidence in their ability to manage their diabetes compared to before the program, and 91% (89/98) reported greater confidence in their ability to maintain a healthy dietary pattern. Participants engaged with the app an average of 4.3 times per day. We observed a significantly greater decrease in HbA1c among participants in the highest tertile of app engagement compared to those in the lowest tertile of app engagement (P=.03). CONCLUSIONS: Clinically meaningful reductions in HbA1c were observed with use of the FareWell digital therapeutic. Greater glycemic control was observed with increasing app engagement. Engagement and retention were both high in this widely distributed sample.

Information given to postmenopausal women on coronary computed tomography may influence cardiac risk reduction efforts.

OBJECTIVE: Cardiovascular disease (CVD) is largely preventable through appropriate risk-factor modification. We sought to compare effects of comprehensive cardiac risk factor screening with and without computed tomography (CT) imaging of the coronary arteries on behavior change related to cardiac risk in postmenopausal women. STUDY DESIGN AND SETTING: 56 postmenopausal women were randomized to alternative screening programs and followed for 1 year. RESULTS: Subjects randomized (n=26) to the CT imaging group were shown images of their coronary arteries and received an interpretation from a radiologist. Most subjects in the CT group had a very low-risk (73.1%) coronary calcification score at baseline. Systolic blood pressure, total cholesterol, triglyceride, LDL, and cholesterol/HDL ratio declined significantly in the conventional screening group, but not in the CT imaging group (P<0.05). As compared to baseline values, study participation lead to significant reductions in total cholesterol, HDL, LDL, and blood pressure at 6 months (P<0.05) and triglyceride (P<0.05) at 12 months. CONCLUSIONS: CVD risk-screening programs can facilitate cardiac risk reduction in women, but these data do not support an independent benefit of coronary CT imaging in a low-to-moderate risk group. The possibility of a deleterious effect of imaging on patient commitment to lifestyle changes is suggested.

Advancing School and Community Engagement Now for Disease Prevention (ASCEND).

PURPOSE: To compare two intensity levels (standard vs. enhanced) of a nutrition and physical activity intervention vs. a control (usual programs) on nutrition knowledge, body mass index, fitness, academic performance, behavior, and medication use among elementary school students. DESIGN: Quasi-experimental with three arms. SETTING: Elementary schools, students' homes, and a supermarket. SUBJECTS: A total of 1487 third-grade students. INTERVENTION: The standard intervention (SI) provided daily physical activity in classrooms and a program on making healthful foods, using food labels. The enhanced intervention (EI) provided these plus additional components for students and their families. MEASURES: Body mass index (zBMI), food label literacy, physical fitness, academic performance, behavior, and medication use for asthma or attention-deficit hyperactivity disorder (ADHD). ANALYSIS: Multivariable generalized linear model and logistic regression to assess change in outcome measures. RESULTS: Both the SI and EI groups gained less weight than the control (p < .001), but zBMI did not differ between groups (p = 1.00). There were no apparent effects on physical fitness or academic performance. Both intervention groups improved significantly but similarly in food label literacy (p = .36). Asthma medication use was reduced significantly in the SI group, and nonsignificantly (p = .10) in the EI group. Use of ADHD medication remained unchanged (p = .34). CONCLUSION: The standard intervention may improve food label literacy and reduce asthma medication use in elementary school children, but an enhanced version provides no further benefit.

Which foods are displaced in the diets of adults with type 2 diabetes with the inclusion of eggs in their diets? A randomized, controlled, crossover trial.

BACKGROUND: The inclusion or exclusion of specific foods from the overall diet inevitably affects other food choices, and this matter is routinely neglected in dietary guidance and nutritional epidemiology. We examined how the inclusion of eggs in the diets of type 2 diabetics affected dietary pattern. METHODS: Randomized, controlled, single-blind, crossover trial of 34 adults (mean age 64.5 years; 14 women, 20 men) with type 2 diabetes assigned to one of two possible sequence permutations of two different 12-week treatments (two eggs/day or egg exclusion), with 6-week washout periods. For the egg inclusion phase, participants received advice from a dietitian on how to preserve an isocaloric condition relative to the egg exclusion phase. To assess changes in dietary pattern in the diets of our study participants, we analyzed the 12 components of the 2010 Healthy Eating Index. RESULTS: The inclusion of eggs was associated with reduced consumption of refined grains nearing statistical significance (-0.7±3.4 vs 0.7±2.2; p=0.0530). The consumption of total protein foods significantly increased from baseline (0.3±0.7; p=0.0153) with the inclusion of eggs for 12 weeks, while the consumption of dairy products significantly decreased with the exclusion of eggs from their diets (-1.3±2.9; p=0.0188). CONCLUSIONS: Eggs in the diets of type 2 diabetics may lead to increased consumption of some healthful foods and reduced consumption of some less healthful foods. TRIAL REGISTRATION NUMBER: NCT02052037; Post-results.

Egg ingestion in adults with type 2 diabetes: effects on glycemic control, anthropometry, and diet quality-a randomized, controlled, crossover trial.

BACKGROUND: The inclusion of eggs as part of a healthful diet for adults with diabetes is controversial. We examined the effects of including eggs in the diet of adults with type 2 diabetes on cardiometabolic risk factors. METHODS: Randomized, controlled, single-blind, crossover trial of 34 adults (mean age 64.5 years; 14 postmenopausal women, 20 men) with type 2 diabetes assigned to one of two possible sequence permutations of two different 12-week treatments (two eggs/day inclusion or egg exclusion), with 6-week washout periods. For the egg inclusion phase, participants received advice from a dietitian on how to preserve an isocaloric condition relative to the egg exclusion phase. The primary outcome was glycemic control as measured by glycated hemoglobin. Secondary measures included anthropometry, blood pressure, and diet quality. RESULTS: Compared with the exclusion of eggs in the habitual diet, the inclusion of eggs did not measurably affect glycated hemoglobin (0.01±0.5% vs -0.24±0.7%; p=0.115) and systolic blood pressure (-0.8±13.0 vs -3.0±10.0 mm Hg; p=0.438); and significantly reduced body mass index (0.06±0.8 vs -0.4±0.8 kg/m²; p=0.013) and visceral fat rating (0.2±1.1 vs -0.4±1.0; p=0.016). The inclusion of eggs in the habitual diet of diabetics significantly reduced waist circumference (-0.4±1.2 cm; p=0.004) and percent body fat (-0.7±1.8; p=0.033) from baseline. CONCLUSIONS: Short-term daily inclusion of eggs in the habitual diet of adults with type 2 diabetes does not improve glycemic control but can improve anthropometric measures. TRIAL REGISTRATION NUMBER: NCT02052037; results.