ABSTRACT
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.
Subject(s)
Diabetes Mellitus, Type 2 , Renal Insufficiency, Chronic , Adult , Humans , Diabetes Mellitus, Type 2/complications , Life Style , Renal Insufficiency, Chronic/therapy , Counseling , Weight Gain , Weight Loss , Phosphorus , SodiumABSTRACT
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.
Subject(s)
Hyperphosphatemia , Telemedicine , Diet , Feasibility Studies , Humans , Renal DialysisABSTRACT
OBJECTIVE: Scalable nonpharmacologic treatment options are needed for chronic pain conditions. Migraine is an ideal condition to test smartphone-based mind-body interventions (MBIs) because it is a very prevalent, costly, disabling condition. Progressive muscle relaxation (PMR) is a standardized, evidence-based MBI previously adapted for smartphone applications for other conditions. We sought to examine the usability of the RELAXaHEAD application (app), which has a headache diary and PMR capability. METHODS: Using the "Think Aloud" approach, we iteratively beta-tested RELAXaHEAD in people with migraine. Individual interviews were conducted, audio-recorded, and transcribed. Using Grounded Theory, we conducted thematic analysis. Participants also were asked Likert scale questions about satisfaction with the app and the PMR. RESULTS: Twelve subjects participated in the study. The mean duration of the interviews (SD, range) was 36 (11, 19-53) minutes. From the interviews, four main themes emerged. People were most interested in app utility/practicality, user interface, app functionality, and the potential utility of the PMR. Participants reported that the daily diary was easy to use (75%), was relevant for tracking headaches (75%), maintained their interest and attention (75%), and was easy to understand (83%). Ninety-two percent of the participants would be happy to use the app again. Participants reported that PMR maintained their interest and attention (75%) and improved their stress and low mood (75%). CONCLUSIONS: The RELAXaHEAD app may be acceptable and useful to migraine participants. Future studies will examine the use of the RELAXaHEAD app to deliver PMR to people with migraine in a low-cost, scalable manner.
Subject(s)
Migraine Disorders/therapy , Mobile Applications , Relaxation Therapy/methods , Smartphone , Adult , Aged , Female , Humans , Male , Medical Records , Middle Aged , Relaxation Therapy/instrumentation , Young AdultABSTRACT
OBJECTIVE: This study was to assess the impact of baseline dietary self-efficacy on the effect of a dietary intervention to reduce sodium intake in patients undergoing hemodialysis (HD) and to identify determinants of low dietary self-efficacy. METHODS: This is a post hoc analysis of the BalanceWise study, a randomized controlled trial that aimed to reduce dietary sodium intake in HD patients recruited from 17 dialysis centers in Pennsylvania. The main outcome measures include dietary self-efficacy and reported dietary sodium density. Analysis of variance with post hoc group-wise comparison was used to examine the effect of baseline dietary self-efficacy on changes in reported sodium density in the intervention and control groups at 8 and 16 weeks. Chi-square test, independent t tests, or Wilcoxon rank-sum tests were used to identify determinants of low dietary self-efficacy. RESULTS: The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively). Younger age and perceived income inadequacy were significantly associated with low self-efficacy in patients undergoing HD. CONCLUSION: The benefits of dietary interventions designed to improve self-efficacy may differ by the baseline self-efficacy status. This may be particularly important for HD patients who are younger and report inadequate income as they had lower dietary self-efficacy.
Subject(s)
Diet/methods , Health Behavior , Renal Dialysis , Renal Insufficiency, Chronic/therapy , Self Efficacy , Sodium, Dietary/administration & dosage , Age Factors , Female , Humans , Income , Male , Middle Aged , Nutritional Status , Poverty/statistics & numerical dataABSTRACT
BACKGROUND: The Mobile Insulin Titration Intervention (MITI) program helps patients with type 2 diabetes find their correct basal insulin dose without in-person care. Requiring only basic cell phone technology (text messages and phone calls), MITI is highly accessible to patients receiving care in safety-net settings. MITI was shown in a randomized controlled trial (RCT) to be efficacious at a New York City (NYC) safety-net clinic where patients often have challenges coming for in-person care. In 2016, MITI was implemented as usual care at Bellevue Hospital (the site of the original RCT) and at Gouverneur Health (a second NYC safety-net clinic) under 2 different staffing models. OBJECTIVE: This implementation study examined MITI's transition into real-world settings. To understand MITI's flexibility, generalizability, and acceptability among patients and providers, we evaluated whether MITI continued to produce positive outcomes in expanded underserved populations, outside of an RCT setting. METHODS: Patients enrolled in MITI received weekday text messages asking for their fasting blood glucose (FBG) values and a weekly titration call. The goal was for patients to reach their optimal insulin dose (OID), defined either as the dose of once-daily basal insulin required to achieve either an FBG of 80-130 mg/dL (4.4-7.2 mmol/L) or as the reaching of the maximum dose of 50 units. After 12 weeks, if OID was not reached, the patients were asked to return to the clinic for in-person care and titration. MITI program outcomes, clinical outcomes, process outcomes, and patient satisfaction were assessed. RESULTS: MITI was successful at both sites, each with a different staffing model. Providers referred 170 patients to the program-129 of whom (75.9%, 129/170) were eligible. Of these, 113 (87.6%, 113/129) enrolled. Moreover, 84.1% (95/113) of patients reached their OID, and they did so in an average of 24 days. Clinical outcomes show that mean FBG levels fell from 209 mg/dL (11.6 mmol/L) to 141 mg/dL (7.8 mmol/L), P<.001. HbA1c levels fell from 11.4% (101 mmol/mol) to 10.0% (86 mmol/mol), P<.001. Process outcomes show that 90.1% of MITI's text message prompts received a response, nurses connected with patients 81.9% of weeks to provide titration instructions, and 85% of attending physicians made at least one referral to the MITI program. Satisfaction surveys showed that most patients felt comfortable sharing information over text and felt the texts reminded them to take their insulin, check their sugar, and make healthy food choices. CONCLUSIONS: This implementation study showed MITI to have continued success after transitioning from an RCT program into real-world settings. MITI showed itself to be flexible and generalizable as it easily fits into a second site staffed by general medical clinic-registered nurses and remained acceptable to patients and staff who had high levels of engagement with the program.
Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Health Plan Implementation/methods , Healthcare Disparities/standards , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Telemedicine/methods , Text Messaging/instrumentation , Adolescent , Adult , Aged , Female , Humans , Hypoglycemic Agents/pharmacology , Insulin/pharmacology , Male , Middle Aged , Young AdultABSTRACT
Phosphorus bioavailability is an emerging topic of interest in the field of renal nutrition that has important research and clinical implications. Estimates of phosphorus bioavailability, based on digestibility, indicate that bioavailability of phosphorus increases from plants to animals to food additives. In this commentary, we examined the proportion of dietary phosphorus from plants, animals, and food additives excreted in urine from four controlled-feeding studies conducted in healthy adults and patients with chronic kidney disease. As expected, a smaller proportion of phosphorus from plant foods was excreted in urine compared to animal foods. However, contrary to expectations, phosphorus from food additives appeared to be incompletely absorbed. The apparent discrepancy between digestibility of phosphorus additives and the proportion excreted in urine suggests a need for human balance studies to determine the bioavailability of different sources of phosphorus.
Subject(s)
Cheese/analysis , Diet , Meat/analysis , Phosphorus, Dietary/urine , Plants, Edible/chemistry , Food Additives/administration & dosage , Humans , Phosphorus, Dietary/pharmacokinetics , Renal Insufficiency, Chronic/urineABSTRACT
IN BRIEF Dietary guidelines for patients with diabetes extend beyond glycemic management to include recommendations for mitigating chronic disease risk. This review summarizes the literature suggesting that excess dietary phosphorus intake may increase the risk of skeletal and cardiovascular disease in patients who are in the early stages of chronic kidney disease (CKD) despite having normal serum phosphorus concentrations. It explores strategies for limiting dietary phosphorus, emphasizing that food additives, as a major source of highly bioavailable dietary phosphorus, may be a suitable target. Although the evidence for restricting phosphorus-based food additives in early CKD is limited, diabetes clinicians should monitor ongoing research aimed at assessing its efficacy.
ABSTRACT
BACKGROUND: The objective was to study the ability of the 30-min plasma glucose (30-min PG) during an oral glucose tolerance test to predict the future risk of type 2 diabetes among Asian Indians with impaired glucose tolerance. METHODS: For the present analyses, we utilized data from 753 participants from two diabetes primary prevention studies, having complete data at the end of the study periods, including 236 from Indian Diabetes Prevention Programme-1 and 517 from the 2013 study. Baseline 30-min PG values were divided into tertiles: T1 < 9.1 mmol/L (<163.0 mg/dL); T2 9.2-10.4 mmol/L (164.0-187.0 mg/dL) and T3 ≥ 10.4 mmol/L (≥188 mg/dL). The predictive values of tertiles of 30-min PG for incident diabetes were assessed using Cox regression analyses RESULTS: At the end of the studies, 230 (30.5%) participants developed diabetes. Participants with higher levels of 30-min PG were more likely to have increased fasting, 2-h PG and HbA1c levels, increased prevalence of impaired fasting glucose and decreased beta cell function. The progression rate of diabetes increased with increasing tertiles of 30-min PG. Cox's regression analysis showed that 30-min PG was an independent predictor of incident diabetes after adjustment for an array of covariates [Hazard Ratio (HR):1.44 (1.01-2.06)] CONCLUSIONS: This prospective analysis demonstrates, for the first time, an independent association between an elevated 30-min PG level and incident diabetes among Asian Indians with impaired glucose tolerance. Predictive utility of glycemic thresholds at various time points other than the traditional fasting and 2-h PG values should therefore merit further consideration. Copyright © 2016 John Wiley & Sons, Ltd.
Subject(s)
Biomarkers/blood , Diabetes Mellitus/epidemiology , Fasting/blood , Glucose Intolerance/epidemiology , Prediabetic State/epidemiology , Adult , Blood Glucose/metabolism , Case-Control Studies , Diabetes Mellitus/blood , Diabetes Mellitus/prevention & control , Female , Follow-Up Studies , Glucose Intolerance/blood , Glucose Intolerance/prevention & control , Glucose Tolerance Test , Glycated Hemoglobin/analysis , Humans , India/epidemiology , Male , Middle Aged , Prediabetic State/blood , Prediabetic State/prevention & control , Predictive Value of Tests , Prevalence , Prospective Studies , Risk Factors , Time FactorsABSTRACT
Hemodialysis patients are often advised to limit their intake of high-potassium foods to help manage hyperkalemia. However, the benefits of this practice are entirely theoretical and not supported by rigorous randomized controlled trials. The hypothesis that potassium restriction is useful is based on the assumption that different sources of dietary potassium are therapeutically equivalent. In fact, animal and plant sources of potassium may differ in their potential to contribute to hyperkalemia. In this commentary, we summarize the historical research basis for limiting high-potassium foods. Ultimately, we conclude that this approach is not evidence-based and may actually present harm to patients. However, given the uncertainty arising from the paucity of conclusive data, we agree that until the appropriate intervention studies are conducted, practitioners should continue to advise restriction of high-potassium foods.
Subject(s)
Hyperkalemia/prevention & control , Potassium, Dietary , Renal Dialysis , Food , Humans , Potassium , Randomized Controlled Trials as TopicABSTRACT
OBJECTIVE: To identify the problems experienced by hemodialysis (HD) patients in attempting to follow the HD diet and their relation to energy and nutrient intakes. DESIGN: Cross-sectional analysis of baseline data from the BalanceWise Study. SUBJECTS: Participants included community-dwelling adults recruited from outpatient HD centers. After excluding participants with incomplete dietary analyses (n = 50), 140 African American and white (40/60%) men and women (52/48%) on chronic intermittent HD for at least 3 months (median 3 years) were included. INTERVENTION: Participant responses, on a 5-point Likert scale ranging from "not at all a problem" to "a very important problem for me," to 34 questions pertaining to potential barriers to following the HD diet in the previous 2 months were classified as either a problem (1) or not a problem (2-5). MAIN OUTCOME MEASURE: Energy and nutrient intakes determined using the Nutrition Data System for Research® based on 3, non-consecutive, unscheduled, 2-pass 24-hour dietary recalls collected on 1 dialysis and 1 non-dialysis weekday, and 1 non-dialysis weekend day. RESULTS: More than half of participants reported having problems related to specific behavioral factors (e.g., feeling deprived), technical difficulties (e.g., tracking nutrients), and physical condition (e.g., appetite), but issues of time and food preparation and behavioral factors tended to be most deterministic of reported dietary intakes. Longer duration of HD was associated with lower intakes of protein, potassium, and phosphorus (P < .05). CONCLUSION: Registered dietitian nutritionists should consider issues of time and food preparation, and behavioral factors in their nutrition assessment of HD patients and should continually monitor HD patients for changes in protein intake that may occur over time.
Subject(s)
Energy Intake , Nutrition Assessment , Renal Dialysis/adverse effects , Black or African American , Aged , Body Mass Index , Cross-Sectional Studies , Dietary Proteins/administration & dosage , Female , Humans , Linear Models , Male , Mental Recall , Middle Aged , Multivariate Analysis , Phosphorus, Dietary/administration & dosage , Potassium, Dietary/administration & dosage , Protein-Energy Malnutrition/diagnosis , Socioeconomic Factors , Sodium, Dietary/administration & dosage , Surveys and Questionnaires , Wasting Syndrome/diagnosis , White PeopleABSTRACT
Dietary phosphorus restriction is recommended to help control hyperphosphatemia in hemodialysis patients, but many high-phosphorus foods are important sources of protein. In this review, we examine whether restricting dietary phosphorus compromises protein status in hemodialysis patients. Although dietary phosphorus and protein are highly correlated, phosphorus intakes can range up to 600 mg/day for a given energy and protein intake level. Furthermore, the collinearity of phosphorus and protein may be biased because the phosphorus burden of food depends on: (1) the presence of phosphate additives, (2) food preparation method, and (3) bioavailability of phosphorus, which are often unaccounted for in nutrition assessments. Ultimately, we argue that clinically relevant reductions in phosphorus intake can be made without limiting protein intake by avoiding phosphate additives in processed foods, using wet cooking methods such as boiling, and if needed, substituting high-phosphorus foods for nutritionally equivalent foods that are lower in bioavailable phosphorus.
Subject(s)
Dietary Proteins/administration & dosage , Hyperphosphatemia/prevention & control , Phosphorus, Dietary/administration & dosage , Phosphorus, Dietary/adverse effects , Renal Dialysis , Renal Insufficiency, Chronic/therapy , Biological Availability , Cooking/methods , Food Additives , Humans , Nutrition Assessment , Nutritional Requirements , Phosphates , Phosphorus, Dietary/pharmacokineticsABSTRACT
OBJECTIVE: To evaluate the efficacy of behavioral counseling combined with technology-based self-monitoring for sodium restriction in hemodialysis (HD) patients. DESIGN: Randomized clinical trial. SUBJECTS: English literate adults undergoing outpatient, in-center intermittent HD for at least 3 months. INTERVENTIONS: Over a 16-week period, both the intervention and the attention control groups were shown 6 educational modules on the HD diet. The intervention group also received social cognitive theory-based behavioral counseling and monitored their diets daily using handheld computers. MAIN OUTCOME MEASURES: Average daily interdialytic weight gain (IDWGA) was calculated for every week of HD treatment over the observation period by subtracting the post-dialysis weight at the previous treatment time (t-1) from the pre-dialysis weight at the current treatment time (t), dividing by the number of days between treatments. Three 24-hour dietary recalls were obtained at baseline, 8 weeks, and 16 weeks and evaluated using the Nutrient Data System for Research. RESULTS: A total of 179 participants were randomized, and 160 (89.4%) completed final measurements. IDWGA did not differ significantly by treatment group at any time point considered (P > .79 for each). A significant differential change in dietary sodium intake observed at 8 weeks (-372 mg/day; P = .05) was not sustained at 16 weeks (-191 mg/day; P = .32). CONCLUSION: The BalanceWise Study intervention appeared to be feasible and acceptable to HD patients although IDWGA was unchanged and the desired behavioral changes observed at 8 weeks were not sustained. Unmeasured factors may have contributed to the mixed findings, and further research is needed to identify the appropriate patients for such interventions.
Subject(s)
Behavior Therapy/methods , Renal Dialysis , Sodium, Dietary/administration & dosage , Weight Gain , Aged , Ethnicity , Female , Humans , Male , Middle Aged , Nutritional Status , Renal Dialysis/adverse effects , Treatment Outcome , United StatesABSTRACT
BACKGROUND: There is increasing interest in using electronic behavioral interventions as well as mobile technologies such as smartphones for improving the care of chronic disabling diseases such as migraines. However, less is known about the current clinical evidence for the feasibility and effectiveness of such behavioral interventions. OBJECTIVE: To review the published literature of behavioral interventions for primary headache disorders delivered by electronic means suitable for use outside of the clinician's office. METHODS: An electronic database search of PubMed, PsycINFO, and Embase was conducted through December 11, 2015. All eligible studies were systematically reviewed to examine the modality in which treatment was delivered (computer, smartphone, watch and other), types of behavioral intervention delivered (cognitive behavioral therapy [CBT], biofeedback, relaxation, other), the headache type being treated, duration of treatment, adherence, and outcomes obtained by the trials to examine the overall feasibility of electronic behavioral interventions for headache. RESULTS: Our search produced 291 results from which 23 eligible articles were identified. Fourteen studies used the internet via the computer, 2 used Personal Digital Assistants, 2 used CD ROM and 5 used other types of devices. None used smartphones or wearable devices. Four were pilot studies (N ≤ 10) which assessed feasibility. For the behavioral intervention, CBT was used in 11 (48 %) of the studies, relaxation was used in 8 (35 %) of the studies, and biofeedback was used in 5 (22 %) of the studies. The majority of studies (14/23, 61 %) used more than one type of behavioral modality. The duration of therapy ranged from 4-8 weeks for CBT with a mean of 5.9 weeks. The duration of other behavioral interventions ranged from 4 days to 60 months. Outcomes measured varied widely across the individual studies. CONCLUSIONS: Despite the move toward individualized medicine and mHealth, the current literature shows that most studies using electronic behavioral intervention for the treatment of headache did not use mobile devices. The studies examining mobile devices showed that the behavioral interventions that employed them were acceptable to patients. Data are limited on the dose required, long term efficacy, and issues related to the security and privacy of this health data. This study was registered at the PROSPERO International Prospective Register of Systematic Reviews (CRD42015032284) (Prospero, 2015).
Subject(s)
Cognitive Behavioral Therapy/instrumentation , Computers, Handheld/statistics & numerical data , Headache/prevention & control , Adult , Cognitive Behavioral Therapy/methods , Feasibility Studies , Female , Headache/physiopathology , Humans , Internet , Male , Prospective StudiesABSTRACT
BACKGROUND: Evidence supports the role of feedback in reinforcing motivation for behavior change. Feedback that provides reinforcement has the potential to increase dietary self-monitoring and enhance attainment of recommended dietary intake. OBJECTIVE: The aim of this study was to examine the impact of daily feedback (DFB) messages, delivered remotely, on changes in dietary intake. METHODS: This was a secondary analysis of the Self- Monitoring And Recording using Technology (SMART) Trial, a single-center, 24-month randomized clinical trial of behavioral treatment for weight loss. Participants included 210 obese adults (mean body mass index, 34.0 kg/m²) who were randomized to either a paper diary (PD), personal digital assistant (PDA), or PDA plus daily tailored feedback messages (PDA + FB). To determine the role of daily tailored feedback in dietary intake, we compared the self-monitoring with DFB group (DFB group; n = 70) with the self-monitoring without DFB group (no-DFB group, n = 140). All participants received a standard behavioral intervention for weight loss. Self-reported changes in dietary intake were compared between the DFB and no-DFB groups and were measured at baseline and at 6, 12, 18, and 24 months. Linear mixed modeling was used to examine percentage changes in dietary intake from baseline. RESULTS: Compared with the no-DFB group, the DFB group achieved a larger reduction in energy (-22.8% vs -14.0%; P = .02) and saturated fat (-11.3% vs -0.5%; P = .03) intake and a trend toward a greater decrease in total fat intake (-10.4% vs -4.7%; P = .09). There were significant improvements over time in carbohydrate intake and total fat intake for both groups (P values < .05). CONCLUSION: Daily tailored feedback messages designed to target energy and fat intake and delivered remotely in real time using mobile devices may play an important role in the reduction of energy and fat intake.
Subject(s)
Computers, Handheld , Dietary Fats/administration & dosage , Energy Intake , Feedback , Health Behavior , Adolescent , Adult , Dietary Carbohydrates/administration & dosage , Female , Humans , Male , Middle Aged , Motivation , Self Care , Weight Loss , Young AdultABSTRACT
OBJECTIVE: To identify characteristics of hemodialysis patients most likely to experience difficulty adhering to sodium restrictions associated with their dietary regimen. DESIGN: Secondary analysis using baseline data from an ongoing randomized clinical trial examining the effects of a technology-supported behavioral intervention on dietary sodium intake in hemodialysis patients. SETTING: Thirteen dialysis centers in southwestern Pennsylvania. SUBJECTS: We included 122 participants (61% women; 48% African American) aged 61 ± 14 years undergoing maintenance, intermittent hemodialysis for end-stage renal disease. MAIN OUTCOME MEASURES: Normalized dietary sodium intake, adjusted interdialytic weight gain, perceived problems, and self-efficacy for restricting dietary sodium. RESULTS: Younger participants were more likely to report problems managing their hemodialysis diet and low self-efficacy for restricting sodium intake. Consistent with these findings, younger participants had a higher median sodium intake and higher average adjusted interdialytic weight gain. Females reported more problems managing their diet. Race, time on dialysis, and perceived income adequacy did not seem to influence outcome measures. CONCLUSION: Our findings suggest that patients who are younger and female encounter more difficulty adhering to the hemodialysis regimen. Hence, there may be a need to individualize counseling and interventions for these individuals. Further investigation is needed to understand the independent effects of age and gender on adherence to hemodialysis dietary recommendations and perceived self-efficacy.
Subject(s)
Patient Compliance , Recommended Dietary Allowances , Renal Dialysis , Sodium, Dietary/administration & dosage , Black or African American , Aged , Diet , Female , Humans , Kidney Failure, Chronic/therapy , Male , Middle Aged , Pennsylvania , Self Efficacy , Socioeconomic Factors , Surveys and Questionnaires , Weight Gain , White PeopleABSTRACT
Patients with type 2 diabetes have an increased risk for cardiovascular and chronic kidney disease. Superimposed hypertension further increases the risk and is associated with increased dietary sodium intake. There are few data available on dietary sodium intake in type 2 diabetes. The aim of this study was to quantify dietary sodium intake in a cohort of self-referred patients with type 2 diabetes and to identify sociodemographic characteristics associated with it. Sodium intake in this cohort was far greater than current recommendations. Increased awareness of sodium intake in this population might lead to target interventions to reduce sodium intake and potentially improve long-term outcomes.
ABSTRACT
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.
Subject(s)
Diabetes Mellitus, Type 2 , Prediabetic State , Adult , Female , Humans , Middle Aged , Aged , Male , Wrist , Self Report , Prediabetic State/diagnosis , Diabetes Mellitus, Type 2/diagnosis , Continuous Glucose Monitoring , Blood Glucose Self-Monitoring , Blood Glucose , Obesity/diagnosisABSTRACT
Purpose: The purpose of this study is to describe diabetes distress and related factors among Chinese Americans with type 2 diabetes in New York City (NYC). Methods: We conducted a secondary data analysis of the baseline data from three research studies conducted among community-dwelling Chinese American adults with type 2 diabetes. Diabetes Distress Scale (DDS) was used to measure sources of diabetes distress including emotional-, regimen-, interpersonal-, and physician-related distress. A score of 2 or greater indicates moderate diabetes distress or higher. Patient Health Questionnaire-2 (PHQ-2) was used to measure depressive symptoms. Participants' sociodemographic information was also collected. Descriptive statistics were used to describe diabetes distress, and logistic least absolute shrinkage and selection operator (LASSO) regression was used to examine factors associated with diabetes distress level. Results: Data from 178 participants (mean age 63.55±13.56 years) were analyzed. Most participants were married (76.40%), had a high school degree or less (65.73%), had a household annual income < $25,000 (70.25%), and reported limited English proficiency (93.22%). About 25.84% reported moderate or higher overall distress. The most common sources of distress were emotional burden (29.78%), followed by regimen- (28.65%), interpersonal- (18.54%), and physician-related distress (14.04%). Participants who were younger, female, limited English proficient, and had elevated depressive symptoms were more likely to have higher diabetes distress. Conclusion: Diabetes distress is prevalent among Chinese immigrants with type 2 diabetes, especially emotional- and regimen-related distress. Given the known link between diabetes distress and poor glycemic control, it is critical to screen for diabetes distress at primary care clinics and incorporate psychological counseling in diabetes care in this underserved population.
ABSTRACT
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 and 80 years of age diagnosed with moderately controlled T2D (HbA1c: 6.0 to 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 macronutrient targets to meet Mediterranean diet guidelines, in addition to 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 educational content as those in the UCC arm, following 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, in addition to real-time feedback on predicted post-prandial glycemic response (PPGR) to meals and snacks logged into the mobile app. DISCUSSION: The DiaTeleMed Study aims to 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: ClinicalTrials.gov NCT05046886. Registered on September 16, 2021.
Subject(s)
Blood Glucose , Diabetes Mellitus, Type 2 , Diet, Mediterranean , Telemedicine , Humans , Diabetes Mellitus, Type 2/diet therapy , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/therapy , Middle Aged , Aged , Adult , Female , Male , Blood Glucose/metabolism , Randomized Controlled Trials as Topic , Aged, 80 and over , Young Adult , Blood Glucose Self-Monitoring , Treatment Outcome , Glycated Hemoglobin/metabolism , Time Factors , Biomarkers/blood , Mobile Applications , Precision Medicine/methods , Diet, Healthy , Counseling/methods , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/administration & dosageABSTRACT
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).