Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study: study protocol for a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes.

Background The Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study is a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes (T2D). The study aims to test the efficacy of a personalized behavioral approach for dietary management of moderately-controlled T2D, versus a standardized behavioral intervention that uses one-size-fits-all dietary recommendations, versus a usual care control (UCC). The primary outcome will compare the impact of each intervention on the mean amplitude of glycemic excursions (MAGE). Methods Eligible participants are between 21 to 80 years of age diagnosed with moderately-controlled T2D (HbA1c: 6.0-8.0%), and managed on lifestyle alone or lifestyle plus metformin. Participants must be willing and able to attend virtual counseling sessions and log meals into a dietary tracking smartphone application (DayTwo), and wear a continuous glucose monitor (CGM) for up to 12 days. Participants are randomized with equal allocation (n = 255, n = 85 per arm) to one of three arms: 1) Personalized , 2) Standardized , or 3) UCC . Measurements occur at 0 (baseline), 3, and 6 months. All participants receive isocaloric energy and macronutrients targets to meet Mediterranean diet guidelines plus 14 intervention contacts over 6 months (4 weekly then 10 biweekly) to cover diabetes self-management education. The first 4 UCC intervention contacts are delivered via synchronous videoconferences followed by educational video links. Participants in Standardized receive the same education content as UCC on the same schedule. However, all intervention contacts are conducted via synchronous videoconferences, paired with Social Cognitive Theory (SCT)-based behavioral counseling, plus dietary self-monitoring of planned meals using a mobile app that provides real-time feedback on calories and macronutrients. Participants in the Personalized arm receive all elements of the Standardized intervention, plus real-time feedback on predicted post-prandial glycemic response (PPGR) to meals and snacks logged into the mobile app. Discussion The DiaTeleMed study will address an important gap in the current landscape of precision nutrition by determining the contributions of behavioral counseling and personalized nutrition recommendations on glycemic control in individuals with T2D. The fully remote methodology of the study allows for scalability and innovative delivery of personalized dietary recommendations at a population level. Trial registration: The DiaTeleMed Study is registered with ClinicalTrials.gov (Identifier: NCT05046886).

Objective Determination of Eating Occasion Timing: Combining Self-Report, Wrist Motion, and Continuous Glucose Monitoring to Detect Eating Occasions in Adults With Prediabetes and Obesity.

BACKGROUND: Accurately identifying eating patterns, specifically the timing, frequency, and distribution of eating occasions (EOs), is important for assessing eating behaviors, especially for preventing and managing obesity and type 2 diabetes (T2D). However, existing methods to study EOs rely on self-report, which may be prone to misreporting and bias and has a high user burden. Therefore, objective methods are needed. METHODS: We aim to compare EO timing using objective and subjective methods. Participants self-reported EO with a smartphone app (self-report [SR]), wore the ActiGraph GT9X on their dominant wrist, and wore a continuous glucose monitor (CGM, Abbott Libre Pro) for 10 days. EOs were detected from wrist motion (WM) using a motion-based classifier and from CGM using a simulation-based system. We described EO timing and explored how timing identified with WM and CGM compares with SR. RESULTS: Participants (n = 39) were 59 ± 11 years old, mostly female (62%) and White (51%) with a body mass index (BMI) of 34.2 ± 4.7 kg/m2. All had prediabetes or moderately controlled T2D. The median time-of-day first EO (and interquartile range) for SR, WM, and CGM were 08:24 (07:00-09:59), 9:42 (07:46-12:26), and 06:55 (04:23-10:03), respectively. The median last EO for SR, WM, and CGM were 20:20 (16:50-21:42), 20:12 (18:30-21:41), and 21:43 (20:35-22:16), respectively. The overlap between SR and CGM was 55% to 80% of EO detected with tolerance periods of ±30, 60, and 120 minutes. The overlap between SR and WM was 52% to 65% EO detected with tolerance periods of ±30, 60, and 120 minutes. CONCLUSION: The continuous glucose monitor and WM detected overlapping but not identical meals and may provide complementary information to self-reported EO.

A randomized clinical trial comparing low-fat with precision nutrition-based diets for weight loss: impact on glycemic variability and HbA1c.

BACKGROUND: Recent studies have demonstrated considerable interindividual variability in postprandial glucose response (PPGR) to the same foods, suggesting the need for more precise methods for predicting and controlling PPGR. In the Personal Nutrition Project, the investigators tested a precision nutrition algorithm for predicting an individual's PPGR. OBJECTIVE: This study aimed to compare changes in glycemic variability (GV) and HbA1c in 2 calorie-restricted weight loss diets in adults with prediabetes or moderately controlled type 2 diabetes (T2D), which were tertiary outcomes of the Personal Diet Study. METHODS: The Personal Diet Study was a randomized clinical trial to compare a 1-size-fits-all low-fat diet (hereafter, standardized) with a personalized diet (hereafter, personalized). Both groups received behavioral weight loss counseling and were instructed to self-monitor diets using a smartphone application. The personalized arm received personalized feedback through the application to reduce their PPGR. Continuous glucose monitoring (CGM) data were collected at baseline, 3 mo and 6 mo. Changes in mean amplitude of glycemic excursions (MAGEs) and HbA1c at 6 mo were assessed. We performed an intention-to-treat analysis using linear mixed regressions. RESULTS: We included 156 participants [66.5% women, 55.7% White, 24.1% Black, mean age 59.1 y (standard deviation (SD) = 10.7 y)] in these analyses (standardized = 75, personalized = 81). MAGE decreased by 0.83 mg/dL per month for standardized (95% CI: 0.21, 1.46 mg/dL; P = 0.009) and 0.79 mg/dL per month for personalized (95% CI: 0.19, 1.39 mg/dL; P = 0.010) diet, with no between-group differences (P = 0.92). Trends were similar for HbA1c values. CONCLUSIONS: Personalized diet did not result in an increased reduction in GV or HbA1c in patients with prediabetes and moderately controlled T2D, compared with a standardized diet. Additional subgroup analyses may help to identify patients who are more likely to benefit from this personalized intervention. This trial was registered at clinicaltrials.gov as NCT03336411.

Effect of a Personalized Diet to Reduce Postprandial Glycemic Response vs a Low-fat Diet on Weight Loss in Adults With Abnormal Glucose Metabolism and Obesity: A Randomized Clinical Trial.

Importance: Interindividual variability in postprandial glycemic response (PPGR) to the same foods may explain why low glycemic index or load and low-carbohydrate diet interventions have mixed weight loss outcomes. A precision nutrition approach that estimates personalized PPGR to specific foods may be more efficacious for weight loss. Objective: To compare a standardized low-fat vs a personalized diet regarding percentage of weight loss in adults with abnormal glucose metabolism and obesity. Design, Setting, and Participants: The Personal Diet Study was a single-center, population-based, 6-month randomized clinical trial with measurements at baseline (0 months) and 3 and 6 months conducted from February 12, 2018, to October 28, 2021. A total of 269 adults aged 18 to 80 years with a body mass index (calculated as weight in kilograms divided by height in meters squared) ranging from 27 to 50 and a hemoglobin A1c level ranging from 5.7% to 8.0% were recruited. Individuals were excluded if receiving medications other than metformin or with evidence of kidney disease, assessed as an estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration equation, to avoid recruiting patients with advanced type 2 diabetes. Interventions: Participants were randomized to either a low-fat diet (<25% of energy intake; standardized group) or a personalized diet that estimates PPGR to foods using a machine learning algorithm (personalized group). Participants in both groups received a total of 14 behavioral counseling sessions and self-monitored dietary intake. In addition, the participants in the personalized group received color-coded meal scores on estimated PPGR delivered via a mobile app. Main Outcomes and Measures: The primary outcome was the percentage of weight loss from baseline to 6 months. Secondary outcomes included changes in body composition (fat mass, fat-free mass, and percentage of body weight), resting energy expenditure, and adaptive thermogenesis. Data were collected at baseline and 3 and 6 months. Analysis was based on intention to treat using linear mixed modeling. Results: Of a total of 204 adults randomized, 199 (102 in the personalized group vs 97 in the standardized group) contributed data (mean [SD] age, 58 [11] years; 133 women [66.8%]; mean [SD] body mass index, 33.9 [4.8]). Weight change at 6 months was -4.31% (95% CI, -5.37% to -3.24%) for the standardized group and -3.26% (95% CI, -4.25% to -2.26%) for the personalized group, which was not significantly different (difference between groups, 1.05% [95% CI, -0.40% to 2.50%]; P = .16). There were no between-group differences in body composition and adaptive thermogenesis; however, the change in resting energy expenditure was significantly greater in the standardized group from 0 to 6 months (difference between groups, 92.3 [95% CI, 0.9-183.8] kcal/d; P = .05). Conclusions and Relevance: A personalized diet targeting a reduction in PPGR did not result in greater weight loss compared with a low-fat diet at 6 months. Future studies should assess methods of increasing dietary self-monitoring adherence and intervention exposure. Trial Registration: ClinicalTrials.gov Identifier: NCT03336411.

Soluble Receptor for Advanced Glycation End Products (sRAGE) Isoforms Predict Changes in Resting Energy Expenditure in Adults with Obesity during Weight Loss.

Background: Accruing evidence indicates that accumulation of advanced glycation end products (AGEs) and activation of the receptor for AGEs (RAGE) play a significant role in obesity and type 2 diabetes. The concentrations of circulating RAGE isoforms, such as soluble RAGE (sRAGE), cleaved RAGE (cRAGE), and endogenous secretory RAGE (esRAGE), collectively sRAGE isoforms, may be implicit in weight loss and energy compensation resulting from caloric restriction. Objectives: We aimed to evaluate whether baseline concentrations of sRAGE isoforms predicted changes (∆) in body composition [fat mass (FM), fat-free mass (FFM)], resting energy expenditure (REE), and adaptive thermogenesis (AT) during weight loss. Methods: Data were collected during a behavioral weight loss intervention in adults with obesity. At baseline and 3 mo, participants were assessed for body composition (bioelectrical impedance analysis) and REE (indirect calorimetry), and plasma was assayed for concentrations of sRAGE isoforms (sRAGE, esRAGE, cRAGE). AT was calculated using various mathematical models that included measured and predicted REE. A linear regression model that adjusted for age, sex, glycated hemoglobin (HbA1c), and randomization arm was used to test the associations between sRAGE isoforms and metabolic outcomes. Results: Participants (n = 41; 70% female; mean ± SD age: 57 ± 11 y; BMI: 38.7 ± 3.4 kg/m2) experienced modest and variable weight loss over 3 mo. Although baseline sRAGE isoforms did not predict changes in ∆FM or ∆FFM, all baseline sRAGE isoforms were positively associated with ∆REE at 3 mo. Baseline esRAGE was positively associated with AT in some, but not all, AT models. The association between sRAGE isoforms and energy expenditure was independent of HbA1c, suggesting that the relation was unrelated to glycemia. Conclusions: This study demonstrates a novel link between RAGE and energy expenditure in human participants undergoing weight loss.This trial was registered at clinicaltrials.gov as NCT03336411.

Temporal Eating Patterns and Eating Windows among Adults with Overweight or Obesity.

We aim to describe temporal eating patterns in a population of adults with overweight or obesity. In this cross-sectional analysis, data were combined from two separate pilot studies during which participants entered the timing of all eating occasions (>0 kcals) for 10-14 days. Data were aggregated to determine total eating occasions, local time of the first and last eating occasions, eating window, eating midpoint, and within-person variability of eating patterns. Eating patterns were compared between sexes, as well as between weekday and weekends. Participants (n = 85) had a median age of 56 ± 19 years, were mostly female (>70%), white (56.5%), and had a BMI of 31.8 ± 8.0 kg/m2. The median eating window was 14 h 04 min [12 h 57 min-15 h 21 min], which was significantly shorter on the weekend compared to weekdays (p < 0.0001). Only 13.1% of participants had an eating window <12 h/d. Additionally, there was greater irregularity with the first eating occasion during the week when compared to the weekend (p = 0.0002). In conclusion, adults with overweight or obesity have prolonged eating windows (>14 h/d). Future trials should examine the contribution of a prolonged eating window on adiposity independent of energy intake.

Challenges of conducting a remote behavioral weight loss study: Lessons learned and a practical guide.

OBJECTIVES: To describe challenges and lessons learned in conducting a remote behavioral weight loss trial. METHODS: The Personal Diet Study is an ongoing randomized clinical trial which aims to compare two mobile health (mHealth) weight loss approaches, standardized diet vs. personalized feedback, on glycemic response. Over a six-month period, participants attended dietitian-led group meetings via remote videoconferencing and were encouraged to self-monitor dietary intake using a smartphone app. Descriptive statistics were used to report adherence to counseling sessions and self-monitoring. Challenges were tracked during weekly project meetings. RESULTS: Challenges in connecting to and engaging in the videoconferencing sessions were noted. To address these issues, we provided a step-by-step user manual and video tutorials regarding use of WebEx, encouraged alternative means to join sessions, and sent reminder emails/texts about the WebEx sessions and asking participants to join sessions early. Self-monitoring app-related issue included inability to find specific foods in the app database. To overcome this, the study team incorporated commonly consumed foods as "favorites" in the app database, provided a manual and video tutorials regarding use of the app and checked the self-monitoring app dashboard weekly to identify nonadherent participants and intervened as appropriate. Among 135 participants included in the analysis, the median attendance rate for the 14 remote sessions was 85.7% (IQR: 64.3%-92.9%). CONCLUSIONS: Experience and lessons shared in this report may provide critical and timely guidance to other behavioral researchers and interventionists seeking to adapt behavioral counseling programs for remote delivery in the age of COVID-19.

Proxy Finnegan Component Scores for Eat, Sleep, Console in a Cohort of Opioid-Exposed Neonates.

OBJECTIVES: The Finnegan Neonatal Abstinence Score (FNAS) monitors infants with neonatal abstinence syndrome (NAS), but it has been criticized for being time consuming and subjective. Many institutions have transitioned to a more straightforward screening tool, Eat, Sleep, Console (ESC), an assessment based on 3 simple observations with a focus on maximizing nonpharmacologic therapies. We aimed to compare the sensitivity and specificity of the ESC with that of the FNAS to determine if infants who needed pharmacologic therapy could potentially be missed when assessed by using ESC. METHODS: A retrospective cohort study of infants identified by International Classification of Diseases, Ninth Revision and International Classification of Diseases, 10th Revision billing codes for NAS. FNAS scores were recorded every 4 hours for the entire hospitalization. ESC proxy scores were created by using components of the FNAS that referenced eating, sleeping, and consoling. Detailed demographic and clinical data were manually extracted regarding opioid exposures and pharmacologic treatment of NAS. RESULTS: From 2013 to 2016, 423 infants ≥37 weeks' gestation had a total of 33 115 FNAS scores over 921 days of observation. In total, 287 (68%) were exposed to buprenorphine, 100 (23.7%) were exposed to methadone, and 165 (39%) were pharmacologically treated. The FNAS was 94.8% sensitive and 63.5% specific for pharmacologic treatment, and the ESC proxy variables were 99.4% sensitive and 40.2% specific (P < .01). CONCLUSIONS: ESC proxy variables have slightly higher sensitivity compared with FNAS, suggesting that ESC use is unlikely to miss infants requiring treatment who would have been identified by FNAS. Transitioning from FNAS to ESC is not likely to impair the care of infants with NAS.

The rationale and design of the personal diet study, a randomized clinical trial evaluating a personalized approach to weight loss in individuals with pre-diabetes and early-stage type 2 diabetes.

Weight loss reduces the risk of type 2 diabetes mellitus (T2D) in overweight and obese individuals. Although the physiological response to food varies among individuals, standard dietary interventions use a "one-size-fits-all" approach. The Personal Diet Study aims to evaluate two dietary interventions targeting weight loss in people with prediabetes and T2D: (1) a low-fat diet, and (2) a personalized diet using a machine-learning algorithm that predicts glycemic response to meals. Changes in body weight, body composition, and resting energy expenditure will be compared over a 6-month intervention period and a subsequent 6-month observation period intended to assess maintenance effects. The behavioral intervention is delivered via mobile health technology using the Social Cognitive Theory. Here, we describe the design, interventions, and methods used.

Physical attractiveness, issue agreement, and assimilation effects in candidate appraisal.

This study examines the cognitive and affective factors of candidate appraisal by manipulating candidate attractiveness and levels of issue agreement with voters. Drawing upon research in evolutionary psychology and cognitive neuroscience, this analysis proposes that automatic processing of physical appearance predisposes affective disposition toward more attractive candidates, thereby influencing cognitive processing of issue information. An experimental design presented attractive and unattractive candidates who were either liberal or conservative in a mock primary election. The data show strong partial effects for appearance on vote intention, an interaction between appearance and issue agreement, and a tendency for voters to assimilate the dissimilar views of attractive candidates. We argue that physical appearance is important in primary elections when the differences in issue positions and ideology between candidates is small.

Correlates of depression, including overall and gastrointestinal functional status, among patients with systemic sclerosis.

OBJECTIVE: Patients with systemic sclerosis (SSc) may develop psychological problems in addition to physiologic symptoms. We investigated whether demographic and clinical factors are associated with comorbid depression. METHODS: From a university hospital's rheumatology clinic, 72 SSc patients who completed 3 questionnaires [Center for Epidemiologic Studies Depression (CES-D) scale, an abbreviated version of a functional status instrument, the Scleroderma Health Assessment Questionnaire (SHAQ), and the Gastrointestinal Quality of Life Index (GIQLI)] during an examination were recruited into the study. Correlations among scores on the 3 questionnaires [including upper and lower gastrointestinal (GI) tract subscales of the GIQLI] were calculated, and associations between CES-D scores and a variety of demographic and clinical characteristics were examined using stepwise linear regression. RESULTS: Higher CES-D scores (i.e., more depression symptoms) were significantly correlated with upper (r = -0.48, p < 0.0001) and lower (r = -0.41, p < 0.001) GI tract dysfunction and worse overall functional status (r = 0.51, p < 0.0001). Stepwise regression indicated that higher levels of depression were independently associated with lower levels of education (p < 0.01), worse upper GI tract functioning (p = 0.019), worse functional status (p = 0.34), current corticosteroid use (p = 0.061), and cardiac involvement (p = 0.086). CONCLUSION: Decreased functional status and abnormal GI functioning are significantly correlated with depression among patients with SSc. Other demographic and clinical indicators are also associated with depression.

Nutrition labelling: perspectives of a bi-national agency for Australia and New Zealand.

Australia New Zealand Food Authority (ANZFA) is a bi-national government agency forming a partnership between all of Australia's States and Territories and the New Zealand government. Australia New Zealand Food Authority employs scientific, legal policy, communication and administrative staff in our Australia and New Zealand offices. Prior to 1991 each of Australia's States and Territories had their own food standards; however, in 1991 Commonwealth legislation was introduced to consolidate responsibility for developing food standards in one specialist agency and to ensure the uniformity of Standards across all States and Territories in Australia. This was extended to New Zealand in 1995 when we became a bi-national agency following the signing of a Treaty between Australia and New Zealand to develop joint food standards for both countries. Australia New Zealand Food Authority's objectives in setting food standards are to: protect public health and safety; provide adequate information to enable consumers to make informed choices; and prevent misleading or deceptive conduct. Health Ministers have recently approved a new Joint Food Standards Code for Australia and New Zealand. This is the result of over 6 year's work and many rounds of public consultation. The new Code has had extensive input from government agencies, industry and consumers. In drafting the new code our emphasis has been on making decisions based on sound science and the most up-to-date information available. We also recognized the need for Standards to be practical in not imposing unnecessary costs on food manufacturers with an inevitable flow on effect to consumer prices. The Joint Code will replace both the existing Australian Food Standards Code and the New Zealand Food Regulations after a 2-year transition period. During the development of the Joint Code a wide range of matters were considered in relation to labelling. Amongst these were consumer needs, costs to industry, voluntary versus mandatory, enforcement issues, relationship to advertising and exemptions. A number of features of the new Code relate specifically to labelling and include: warning and advisory statements; ingredients lists; date marking; directions for use and storage; nutrition information; legibility requirements; and percentage labelling. One of the key features of the Joint Code is the requirement for most packaged foods to bear a nutrition information panel (NIP). Information must be presented on the amount of fat, saturated fat, protein, energy, carbohydrates, sugars and sodium. For the majority of foods the label is the first and only source of information regarding the nutritional content of food purchased. Mandatory nutrition labelling will ensure that consumers are provided with key nutritional information about foods. Single ingredient produce such as fruit and vegetables, and some other foods such as spices, tea and coffee will be exempt. The new requirements will give consumers more nutritional information to allow product comparison. All products will be required to provide information on these nutrients on both a per 100 g basis and in terms of an average serving. In addition to the mandatory nutrient declarations NIP are also required to carry additional data for any substance for which a nutrition claim is made. During the 2-year transition period to December 2002 ANZFA will be working with industry, enforcement agencies and consumers to help to ensure that there is a smooth transition to the Joint Food Standards Code.