Feasibility of a family-oriented mHealth intervention for Chinese Americans with type 2 diabetes: A pilot randomized control trial.

OBJECTIVES: To test the feasibility, acceptability, and potential efficacy of a mHealth intervention tailored for Chinese immigrant families with type 2 diabetes (T2D). METHODS: We conducted a pilot randomized controlled trial (RCT) with baseline, 3-, and 6-month measurements. Participating dyads, T2D patients and families/friends from NYC, were randomized into the intervention group (n = 11) or the wait-list control group (n = 12). Intervention includes 24 videos covering T2D self-management, behavioral techniques, and family-oriented sessions. Feasibility and acceptability were measured respectively by the retention rate and video watch rate, and a satisfaction survey. Patients' HbA1c, weight, and self-management were also assessed to test potential efficacy. RESULTS: Most T2D patients (n = 23; mean age 56.2±9.4 years; 52.2% male) and families/friends (n = 23, mean age 54.6±11.2 years; 52.2% female) had high school education or less (69.6% and 69.6%), annual household income < $25,000 (65.2% and 52.2%), and limited English proficiency (95.7% and 95.7%). The retention rates were not significantly different between the intervention and the control groups for both the patients (90.91% vs 83.3%, p = 0.589); and their families/friends (3-month: 90.9% vs 75%, p = 0.313; 6-month: 90.9% vs 83.3%, p = 0.589). The mean video watch rate was 76.8% (7%). T2D patients and families/friends rated satisfaction as 9.4 and 10 out of 10, respectively. Despite no between-group differences, the intervention group had significantly lower HbA1c (p = 0.014) and better self-management (p = 0.009), and lost 12 lbs. on average at 6 months (p = 0.079), compared to their baseline levels. CONCLUSIONS: A culturally-tailored, family-based mHealth intervention is feasible and acceptable among low-income, limited English-proficient Chinese families with T2D in NYC. Significant changes in HbA1c and self-management within the intervention group indicate this intervention may have potential efficacy. Given the small sample size of this study, a future RCT with adequate power is needed to test efficacy.

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.

Adapting the Diabetes Prevention Program for Older Adults: Descriptive Study.

BACKGROUND: Prediabetes affects 26.4 million people aged 65 years or older (48.8%) in the United States. Although older adults respond well to the evidence-based Diabetes Prevention Program, they are a heterogeneous group with differing physiological, biomedical, and psychosocial needs who can benefit from additional support to accommodate age-related changes in sensory and motor function. OBJECTIVE: The purpose of this paper is to describe adaptations of the Centers for Disease Control and Prevention's Diabetes Prevention Program aimed at preventing diabetes among older adults (ages ≥65 years) and findings from a pilot of 2 virtual sessions of the adapted program that evaluated the acceptability of the content. METHODS: The research team adapted the program by incorporating additional resources necessary for older adults. A certified lifestyle coach delivered 2 sessions of the adapted content via videoconference to 189 older adults. RESULTS: The first session had a 34.9% (38/109) response rate to the survey, and the second had a 34% (30/88) response rate. Over three-quarters (50/59, 85%) of respondents agreed that they liked the virtual program, with 82% (45/55) agreeing that they would recommend it to a family member or a friend. CONCLUSIONS: This data will be used to inform intervention delivery in a randomized controlled trial comparing in-person versus virtual delivery of the adapted program.

Study protocol: BRInging the Diabetes prevention program to GEriatric Populations.

In the Diabetes Prevention Program (DPP) randomized, controlled clinical trial, participants who were ≥ 60 years of age in the intensive lifestyle (diet and physical activity) intervention had a 71% reduction in incident diabetes over the 3-year trial. However, few of the 26.4 million American adults age ≥65 years with prediabetes are participating in the National DPP. The BRInging the Diabetes prevention program to GEriatric Populations (BRIDGE) randomized trial compares an in-person DPP program Tailored for Older AdulTs (DPP-TOAT) to a DPP-TOAT delivered via group virtual sessions (V-DPP-TOAT) in a randomized, controlled trial design (N = 230). Eligible patients are recruited through electronic health records (EHRs) and randomized to the DPP-TOAT or V-DPP-TOAT arm. The primary effectiveness outcome is 6-month weight loss and the primary implementation outcome is intervention session attendance with a non-inferiority design. Findings will inform best practices in the delivery of an evidence-based intervention.

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.

Obesity and Overweight: Probing Causes, Consequences, and Novel Therapeutic Approaches Through the American Heart Association's Strategically Focused Research Network.

As the worldwide prevalence of overweight and obesity continues to rise, so too does the urgency to fully understand mediating mechanisms, to discover new targets for safe and effective therapeutic intervention, and to identify biomarkers to track obesity and the success of weight loss interventions. In 2016, the American Heart Association sought applications for a Strategically Focused Research Network (SFRN) on Obesity. In 2017, 4 centers were named, including Johns Hopkins University School of Medicine, New York University Grossman School of Medicine, University of Alabama at Birmingham, and Vanderbilt University Medical Center. These 4 centers were convened to study mechanisms and therapeutic targets in obesity, to train a talented cadre of American Heart Association SFRN-designated fellows, and to initiate and sustain effective and enduring collaborations within the individual centers and throughout the SFRN networks. This review summarizes the central themes, major findings, successful training of highly motivated and productive fellows, and the innovative collaborations and studies forged through this SFRN on Obesity. Leveraging expertise in in vitro and cellular model assays, animal models, and humans, the work of these 4 centers has made a significant impact in the field of obesity, opening doors to important discoveries, and the identification of a future generation of obesity-focused investigators and next-step clinical trials. The creation of the SFRN on Obesity for these 4 centers is but the beginning of innovative science and, importantly, the birth of new collaborations and research partnerships to propel the field forward.

An Evaluation of Alternative Technology-Supported Counseling Approaches to Promote Multiple Lifestyle Behavior Changes in Patients With Type 2 Diabetes and Chronic Kidney Disease.

OBJECTIVES: Although technology-supported interventions are effective for reducing chronic disease risk, little is known about the relative and combined efficacy of mobile health strategies aimed at multiple lifestyle factors. The purpose of this clinical trial is to evaluate the efficacy of technology-supported behavioral intervention strategies for managing multiple lifestyle-related health outcomes in overweight adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). DESIGN AND METHODS: Using a 2 × 2 factorial design, adults with excess body weight (body mass index ≥27 kg/m2, age ≥40 years), T2D, and CKD stages 2-4 were randomized to an advice control group, or remotely delivered programs consisting of synchronous group-based education (all groups), plus (1) Social Cognitive Theory-based behavioral counseling and/or (2) mobile self-monitoring of diet and physical activity. All programs targeted weight loss, greater physical activity, and lower intakes of sodium and phosphorus-containing food additives. RESULTS: Of 256 randomized participants, 186 (73%) completed 6-month assessments. Compared to the ADVICE group, mHealth interventions did not result in significant changes in weight loss, or urinary sodium and phosphorus excretion. In aggregate analyses, groups receiving mobile self-monitoring had greater weight loss at 3 months (P = .02), but between 3 and 6 months, weight losses plateaued, and by 6 months, the differences were no longer statistically significant. CONCLUSIONS: When engaging patients with T2D and CKD in multiple behavior changes, self-monitoring diet and physical activity demonstrated significantly larger short-term weight losses. Theory-based behavioral counseling alone was no better than baseline advice and demonstrated no interaction effect with self-monitoring.

The RAGE/DIAPH1 axis: mediator of obesity and proposed biomarker of human cardiometabolic disease.

Overweight and obesity are leading causes of cardiometabolic dysfunction. Despite extensive investigation, the mechanisms mediating the increase in these conditions are yet to be fully understood. Beyond endogenous formation of advanced glycation end products (AGEs) in overweight and obesity, exogenous sources of AGEs accrue through the heating, production and consumption of highly-processed foods. Evidence from cellular and mouse model systems indicates that the interaction of AGEs with their central cell surface receptor for AGE (RAGE) in adipocytes suppresses energy expenditure and that AGE/RAGE contributes to increased adipose inflammation and processes linked to insulin resistance. In human subjects, the circulating soluble forms of RAGE, which are mutable, may serve as biomarkers of obesity and weight loss. Antagonists of RAGE signaling, through blockade of the interaction of the RAGE cytoplasmic domain with the formin, Diaphanous-1 (DIAPH1), target aberrant RAGE activities in metabolic tissues. This review focuses on the potential roles for AGEs and other RAGE ligands and RAGE/DIAPH1 in the pathogenesis of overweight and obesity and their metabolic consequences.

Leveraging Social Media to Increase Access to an Evidence-Based Diabetes Intervention Among Low-Income Chinese Immigrants: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes (T2D) in Chinese Americans is a rising public health concern for the US health care system. The majority of Chinese Americans with T2D are foreign-born older immigrants and report limited English proficiency and health literacy. Multiple social determinants of health limit access to evidence-based diabetes interventions for underserved Chinese immigrants. A social media-based diabetes intervention may be feasible to reach this community. OBJECTIVE: The purpose of the Chinese American Research and Education (CARE) study was to examine the potential efficacy of a social media-based intervention on glycemic control in Chinese Americans with T2D. Additionally, the study aimed to explore the potential effects of the intervention on psychosocial and behavioral factors involved in successful T2D management. In this report, we describe the design and protocol of the CARE trial. METHODS: CARE was a pilot randomized controlled trial (RCT; n=60) of a 3-month intervention. Participants were randomized to one of two arms (n=30 each): wait-list control or CARE intervention. Each week, CARE intervention participants received two culturally and linguistically tailored diabetes self-management videos for a total of 12 weeks. Video links were delivered to participants via WeChat, a free and popular social media app among Chinese immigrants. In addition, CARE intervention participants received biweekly phone calls from the study's community health workers to set goals related to T2D self-management and work on addressing goal-achievement barriers. Hemoglobin A1c (HbA1c), self-efficacy, diabetes self-management behaviors, dietary intake, and physical activity were measured at baseline, 3 months, and 6 months. Piecewise linear mixed-effects modeling will be performed to examine intergroup differences in HbA1c and psychosocial and behavioral outcomes. RESULTS: This pilot RCT study was approved by the Institutional Review Board at NYU Grossman School of Medicine in March 2021. The first participant was enrolled in March 2021, and the recruitment goal (n=60) was met in March 2022. All data collection is expected to conclude by November 2022, with data analysis and study results ready for reporting by December 2023. Findings from this pilot RCT will further guide the team in planning a future large-scale study. CONCLUSIONS: This study will serve as an important first step in exploring scalable interventions to increase access to evidence-based diabetes interventions among underserved, low-income, immigrant populations. This has significant implications for chronic care in other high-risk immigrant groups, such as low-income Hispanic immigrants, who also bear a high T2D burden, face similar barriers to accessing diabetes programs, and report frequent social media use (eg, WhatsApp). TRIAL REGISTRATION: ClinicalTrials.gov NCT03557697; https://clinicaltrials.gov/ct2/show/NCT03557697. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42554.

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.

Research gaps and opportunities in precision nutrition: an NIH workshop report.

Precision nutrition is an emerging concept that aims to develop nutrition recommendations tailored to different people's circumstances and biological characteristics. Responses to dietary change and the resulting health outcomes from consuming different diets may vary significantly between people based on interactions between their genetic backgrounds, physiology, microbiome, underlying health status, behaviors, social influences, and environmental exposures. On 11-12 January 2021, the National Institutes of Health convened a workshop entitled "Precision Nutrition: Research Gaps and Opportunities" to bring together experts to discuss the issues involved in better understanding and addressing precision nutrition. The workshop proceeded in 3 parts: part I covered many aspects of genetics and physiology that mediate the links between nutrient intake and health conditions such as cardiovascular disease, Alzheimer disease, and cancer; part II reviewed potential contributors to interindividual variability in dietary exposures and responses such as baseline nutritional status, circadian rhythm/sleep, environmental exposures, sensory properties of food, stress, inflammation, and the social determinants of health; part III presented the need for systems approaches, with new methods and technologies that can facilitate the study and implementation of precision nutrition, and workforce development needed to create a new generation of researchers. The workshop concluded that much research will be needed before more precise nutrition recommendations can be achieved. This includes better understanding and accounting for variables such as age, sex, ethnicity, medical history, genetics, and social and environmental factors. The advent of new methods and technologies and the availability of considerably more data bring tremendous opportunity. However, the field must proceed with appropriate levels of caution and make sure the factors listed above are all considered, and systems approaches and methods are incorporated. It will be important to develop and train an expanded workforce with the goal of reducing health disparities and improving precision nutritional advice for all Americans.

A Social Media-Based Diabetes Intervention for Low-Income Mandarin-Speaking Chinese Immigrants in the United States: Feasibility Study.

BACKGROUND: Chinese immigrants bear a high diabetes burden and face significant barriers to accessing diabetes self-management education (DSME) and counseling programs. OBJECTIVE: The goal of this study was to examine the feasibility and acceptability and to pilot test the potential efficacy of a social media-based DSME intervention among low-income Chinese immigrants with type 2 diabetes (T2D) in New York City. METHODS: This was a single group pretest and posttest study in 30 Chinese immigrants with T2D. The intervention included 24 culturally and linguistically tailored DSME videos, focusing on diabetes education and behavioral counseling techniques. Over 12 weeks, participants received 2 brief videos each week via WeChat, a free social media app popular among Chinese immigrants. Primary outcomes included the feasibility and acceptability of the intervention. Feasibility was evaluated by recruitment processes, retention rates, and the video watch rate. Acceptability was assessed via a satisfaction survey at 3 months. Secondary outcomes, that is, hemoglobin A1c (HbA1c), self-efficacy, dietary intake, and physical activity, were measured at baseline, 3 months, and 6 months. Descriptive statistics and paired 2-sided t tests were used to summarize the baseline characteristics and changes before and after the intervention. RESULTS: The sample population (N=30) consisted of mostly females (21/30, 70%) who were married (19/30, 63%), with limited English proficiency (30/30, 100%), and the mean age was 61 (SD 7) years. Most reported an annual household income of

Mobile Device Ownership, Current Use, and Interest in Mobile Health Interventions Among Low-Income Older Chinese Immigrants With Type 2 Diabetes: Cross-sectional Survey Study.

BACKGROUND: Chinese immigrants suffer a disproportionately high type 2 diabetes (T2D) burden and tend to have poorly controlled disease. Mobile health (mHealth) interventions have been shown to increase access to care and improve chronic disease management in minority populations. However, such interventions have not been developed for or tested in Chinese immigrants with T2D. OBJECTIVE: This study aims to examine mobile device ownership, current use, and interest in mHealth interventions among Chinese immigrants with T2D. METHODS: In a cross-sectional survey, Chinese immigrants with T2D were recruited from Chinese community centers in New York City. Sociodemographic characteristics, mobile device ownership, current use of social media software applications, current use of technology for health-related purposes, and interest in using mHealth for T2D management were assessed. Surveys were administered face-to-face by bilingual study staff in the participant's preferred language. Descriptive statistics were used to characterize the study sample and summarize technology use. RESULTS: The sample (N=91) was predominantly female (n=57, 63%), married (n=68, 75%), and had a high school education or less (n=58, 64%); most participants had an annual household income of less than US $25,000 (n=63, 69%) and had limited English proficiency (n=78, 86%). The sample had a mean age of 70 (SD 11) years. Almost all (90/91, 99%) participants had a mobile device (eg, basic cell phones, smart devices), and the majority (n=83, 91%) reported owning a smart device (eg, smartphone or tablet). WeChat was the most commonly used social media platform (65/91, 71%). When asked about their top source for diabetes-related information, 63 of the 91 participants (69%) reported health care providers, followed by 13 who reported the internet (14%), and 10 who reported family, friends, and coworkers (11%). Less than one-quarter (21/91, 23%) of the sample reported using the internet to search for diabetes-related information in the past 12 months. About one-third of the sample (34/91, 37%) reported that they had watched a health-related video on their cell phone or computer in the past 12 months. The majority (69/91, 76%) of participants reported interest in receiving an mHealth intervention in the future to help with T2D management. CONCLUSIONS: Despite high mobile device ownership, the current use of technology for health-related issues remained low in older Chinese immigrants with T2D. Given the strong interest in future mHealth interventions and high levels of social media use (eg, WeChat), future studies should consider how to leverage these existing low-cost platforms and deliver tailored mHealth interventions to this fast-growing minority group.

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.

Feasibility and Acceptability of mHealth Interventions for Managing Hyperphosphatemia in Patients Undergoing Hemodialysis.

OBJECTIVE: The objective of the study was to evaluate the feasibility and acceptability of mobile health (mHealth) phosphorus management programs in hemodialysis (HD) patients. METHODS: Patients receiving thrice-weekly HD who had 3-month average serum phosphorus of >5.5 mg/dL were randomized to one of the three self-directed phosphorus management programs delivered using tablet PCs: (1) educational videos and handouts (Education), (2) education intervention plus mobile self-monitoring with email feedback (Monitoring), or (3) education and monitoring interventions plus social cognitive theory-based behavioral videos (Combined). Feasibility and acceptability were assessed based on enrollment and retention and training needs (feasibility) and adherence to self-monitoring and reported satisfaction (acceptability). RESULTS: Of 312 patients, 56 expressed interest, and 40 were enrolled. The majority of participants (80%) completed the 6-month study; none withdrew for intervention-related reasons. The Monitoring and Combined groups received 44 ± 15 minutes of technology training, which was considered adequate by most (75%). Self-monitoring rates were initially high, with 78% and 71% of the participants recording at least one meal and phosphate binder in week 1, respectively, but decreased over time to 15% and 9% in the final week. Most participants reported that self-monitoring helped them stay motivated (64%), track nutrients (80%), and understand how to change diet (76%), and nearly two-thirds of participants (64%) stated that they would like to continue using the tablet PC to manage their health. However, few participants (16%) indicated that self-monitoring was worth the effort. The Monitoring and Combined groups did not differ from the Education group in study outcomes. CONCLUSION: Although the mHealth programs were generally well received, self-monitoring rates decreased substantially over time and were unaffected by social cognitive theory-based videos. Self-directed mHealth programs may be a useful adjunct to standard care but should be compared to more resource intensive programs (e.g., involving more "live" contact with a dietitian) to determine overall cost-effectiveness and role in HD care.

Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Protocol: A Randomized Clinical Trial.

Fire Department of New York (FDNY) rescue and recovery workers exposed to World Trade Center (WTC) particulates suffered loss of forced expiratory volume in 1 s (FEV1). Metabolic Syndrome increased the risk of developing WTC-lung injury (WTC-LI). We aim to attenuate the deleterious effects of WTC exposure through a dietary intervention targeting these clinically relevant disease modifiers. We hypothesize that a calorie-restricted Mediterranean dietary intervention will improve metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function in firefighters with WTC-LI. To assess our hypothesis, we developed the Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE), a randomized controlled clinical trial (RCT). Male firefighters with WTC-LI and a BMI > 27 kg/m2 will be included. We will randomize subjects (1:1) to either: (1) Low Calorie Mediterranean (LoCalMed)-an integrative multifactorial, technology-supported approach focused on behavioral modification, nutritional education that will include a self-monitored diet with feedback, physical activity recommendations, and social cognitive theory-based group counseling sessions; or (2) Usual Care. Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV1, fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary). By implementing a technology-supported LoCalMed diet our FIREHOUSE RCT may help further the treatment of WTC associated pulmonary disease.