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BackgroundAdults with type 2 diabetes may experience health benefits, including glycemic control and weight loss, from following a very low–carbohydrate, ketogenic (VLC) diet. However, it is unclear which ancillary strategies may enhance these effects. ObjectiveThis pilot study aims to estimate the effect sizes of 3 intervention enhancement strategies (text messages, gifts, and breath vs urine ketone self-monitoring) that may improve outcomes of a 12-month web-based ad libitum VLC diet and lifestyle intervention for adults with type 2 diabetes. The primary intervention also included other components to improve adherence and well-being, including positive affect and mindfulness as well as coaching. MethodsOverweight or obese adults (n=44; BMI 25-45 kg/m2) with type 2 diabetes (glycated hemoglobin [HbA1c] ≥6.5%), who had been prescribed either no glucose-lowering medications or metformin alone, participated in a 12-month web-based intervention. Using a 2×2×2 randomized factorial design, we compared 3 enhancement strategies: (1) near-daily text messages about the intervention’s recommended behaviors (texts n=22 vs no texts n=22), (2) mailed gifts of diet-relevant foods and cookbooks (6 rounds of mailed gifts n=21 vs no gifts n=23), and (3) urine- or breath-based ketone self-monitoring (urine n=21 vs breath n=23). We assessed HbA1c and weight at baseline and at 4, 8, and 12 months. We evaluated whether each strategy exerted a differential impact on HbA1c and weight at 12 months against an a priori threshold of Cohen d of 0.5 or greater. ResultsWe retained 73% (32/44) of the participants at 12 months. The intervention, across all conditions, led to improvements in glucose control and reductions in body weight at the 12-month follow-up. In intent-to-treat (ITT) analyses, the mean HbA1c reduction was 1.0% (SD 1.6) and the mean weight reduction was 5.3% (SD 6.0), whereas among study completers, these reductions were 1.2% (SD 1.7) and 6.3% (SD 6.4), respectively, all with a P value of less than .001. In ITT analyses, no enhancement strategy met the effect size threshold. Considering only study completers, 2 strategies showed a differential effect size of at least a d value of 0.5 or greater ConclusionsText messages, gifts of food and cookbooks, and urine-based ketone self-monitoring may potentially enhance the glycemic or weight loss benefits of a web-based VLC diet and lifestyle intervention for individuals with type 2 diabetes. Future research could investigate other enhancement strategies to help create even more effective solutions for the treatment of type 2 diabetes. Trial RegistrationClinicalTrials.gov NCT02676648; http://clinicaltrials.gov/ct2/show/NCT02676648

BackgroundPolycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. Diet and lifestyle programs improve health, but women’s preferences for these programs have not been formally explored. ObjectiveThe aim of our study was to examine diet and lifestyle program preferences among women with PCOS. MethodsWe conducted a cross-sectional online survey of women with PCOS. ResultsAt least half of the 197 respondents expressed strong interest in programs addressing energy level, anxiety, depression, weight, diabetes prevention, menstrual period regulation, and hirsutism. Similarly, at least half reported willingness to modify their sleep, stress, and physical activity; and slightly less than half reported willingness to adopt a very low-carbohydrate, paleo, or low–glycemic index diet. At least half reported interest in online or mobile programs and email-based mentoring. Younger age was associated with interest in help with acne and fertility; higher body mass index was associated with wanting help with weight loss, energy, and anxiety; and greater stress eating was associated with wanting help with depression, anxiety, and menstrual period regulation. ConclusionsTo our knowledge, this is the first study to examine attitudes and preferences of women with PCOS toward such programs. Future online and mobile diet and lifestyle programs may be able to capitalize on this information to better target this population’s expressed preferences.

BackgroundDespite evidence that Diabetes Prevention Programs (DPPs) can delay or prevent progression to type 2 diabetes mellitus (T2DM), few individuals with prediabetes enroll in offered programs. This may be in part because many individuals with prediabetes have low levels of autonomous motivation (ie, motivation that arises from internal sources) to prevent T2DM. ObjectiveThis study aims to examine the feasibility and acceptability of a mobile health (mHealth) intervention designed to increase autonomous motivation and healthy behaviors among adults with prediabetes who previously declined participation free DPPs. In addition, the study aims to examine changes in autonomous motivation among adults offered 2 versions of the mHealth program compared with an information-only control group. MethodsIn this 12-week, parallel, 3-arm, mixed-methods pilot randomized controlled trial, participants were randomized to (1) a group that received information about prediabetes and strategies to prevent T2DM (control); (2) a group that received a mHealth app that aims to increase autonomous motivation among users (app-only); or (3) a group that received the app plus a physical activity tracker and wireless-enabled digital scale for self-monitoring (app-plus). Primary outcome measures included rates of intervention uptake (number of individuals enrolled/number of individuals assessed for eligibility), retention (number of 12-week survey completers/number of participants), and adherence (number of device-usage days). The secondary outcome measure was change in autonomous motivation (measured using the Treatment Self-Regulation Questionnaire), which was examined using difference-in-difference analysis. Furthermore, we conducted postintervention qualitative interviews with participants. ResultsOverall, 28% (69/244) of eligible individuals were randomized; of these, 80% (55/69) completed the 12-week survey. Retention rates were significantly higher among app-plus participants than participants in the other 2 study arms combined (P=.004, χ2). No significant differences were observed in adherence rates between app-only and app-plus participants (43 days vs 37 days; P=.34). Among all participants, mean autonomous motivation measures were relatively high at baseline (6.0 of 7.0 scale), with no statistically significant within- or between-group differences in follow-up scores. In qualitative interviews (n=15), participants identified reasons that they enjoyed using the app (eg, encouraged self-reflection), reasons that they did not enjoy using the app (eg, did not consider personal circumstances), and strategies to improve the intervention (eg, increased interpersonal contact). ConclusionsAmong individuals with prediabetes who did not engage in free DPPs, this mHealth intervention was feasible and acceptable. Future work should (1) examine the effectiveness of a refined intervention on clinically relevant outcomes (eg, weight loss) among a larger population of DPP nonenrollees with low baseline autonomous motivation and (2) identify other factors associated with DPP nonenrollment, which may serve as additional potential targets for interventions. Trial RegistrationClinicalTrials.gov NCT03025607; https://clinicaltrials.gov/ct2/show/NCT03025607 (Archived by WebCite at http://www.webcitation.org/73cvaSAie)

BackgroundA very low-carbohydrate (VLC) nutritional strategy may improve glycemic control and weight loss in adults with type 2 diabetes (T2D). However, the supplementary behavioral strategies that might be able to improve outcomes using this nutritional strategy are uncertain.ObjectiveThis study aims to compare the impact of adding 3 different supplementary behavioral strategies to a web-based VLC diet intervention. To our knowledge, this is the first trial to randomize participants to different frequencies of dietary self-monitoring.MethodsThe study included 112 overweight adults with T2D (hemoglobin A1c ≥6.5%) taking no antiglycemic medications or only metformin. They received a remotely delivered 12-month VLC diet intervention. Participants were randomly assigned through a full factorial 2×2×2 design to supplementary strategies: either daily or monthly dietary self-monitoring, either mindful eating training or not, and either positive affect skills training or not. Our research goal was to determine whether 3 different supplemental strategies had at least a medium effect size (Cohen d=0.5).ResultsOverall, the VLC intervention led to statistically significant improvements in glycemic control (-0.70%, 95% CI -1.04% to -0.35%; P

BackgroundOptimal carbohydrate intake is an important and controversial area in the nutritional management of type 2 diabetes. Some evidence indicates that reducing overall carbohydrate intake with a low- or very low-carbohydrate eating plan can improve glycemic control compared to following eating plans that involve greater carbohydrate intake. However, critical knowledge gaps currently prevent clear recommendations about carbohydrate intake levels.MethodsThe LEGEND (Lifestyle Education about Nutrition for Diabetes) Trial aims to compare a very low-carbohydrate diet to a moderate-carbohydrate plate-method diet for glycemic control in adults with type 2 diabetes. This two-site trial plans to recruit 180 adults with type 2 diabetes. We will randomize participants to either a 20-session group-based diet and lifestyle intervention that teaches either a very low-carbohydrate diet or a moderate-carbohydrate plate-method diet. We will assess participants at study entry and 4 and 12 months later. The primary outcome is HbA1c, and secondary outcomes include inflammation (high sensitivity C-reactive protein), body weight, changes in diabetes medications, lipids (small particle LDL, HDL, triglycerides), skeletal metabolism (bone mineral density from dual-energy x-ray absorptiometry and bone turnover markers serum procollagen type I N propeptide and serum C-terminal telopeptide of type I collagen), and body composition (percent body fat, percent lean body mass).DiscussionThe LEGEND trial is a randomized controlled trial to assess optimal carbohydrate intake in type 2 diabetes by evaluating the effects of a very low-carbohydrate diet vs. a moderate-carbohydrate plate-method diet over a year-long period. The research addresses important gaps in the evidence base for the nutritional management of type 2 diabetes by providing data on potential benefits and adverse effects of different levels of carbohydrate intake.Trial registrationClinicalTrials.gov NCT05237128. Registered on February 11, 2022.

The decades-long dietary experiment embodied in the Dietary Guidelines for Americans (DGA) focused on limiting fat, especially saturated fat, and higher carbohydrate intake has coincided with rapidly escalating epidemics of obesity and type 2 diabetes (T2D) that are contributing to the progression of cardiovascular disease (CVD) and other diet-related chronic diseases. Moreover, the lack of flexibility in the DGA as it pertains to low carbohydrate approaches does not align with the contemporary trend toward precision nutrition. We argue that personalizing the level of dietary carbohydrate should be a high priority based on evidence that Americans have a wide spectrum of metabolic variability in their tolerance to high carbohydrate loads. Obesity, metabolic syndrome, and T2D are conditions strongly associated with insulin resistance, a condition exacerbated by increased dietary carbohydrate and improved by restricting carbohydrate. Low-carbohydrate diets are grounded across the time-span of human evolution, have well-established biochemical principles, and are now supported by multiple clinical trials in humans that demonstrate consistent improvements in multiple established risk factors associated with insulin resistance and cardiovascular disease. The American Diabetes Association (ADA) recently recognized a low carbohydrate eating pattern as an effective approach for patients with diabetes. Despite this evidence base, low-carbohydrate diets are not reflected in the DGA. As the DGA Dietary Patterns have not been demonstrated to be universally effective in addressing the needs of many Americans and recognizing the lack of widely available treatments for obesity, metabolic syndrome, and T2D that are safe, effective, and sustainable, the argument for an alternative, low-carbohydrate Dietary Pattern is all the more compelling.

PURPOSE Adults with a triple multimorbidity (hypertension, prediabetes or type 2 diabetes, and overweight or obesity), are at increased risk of serious health complications, but experts disagree on which dietary patterns and support strategies should be recommended. METHODS We randomized 94 adults from southeast Michigan with this triple multimorbidity using a 2 * 2 diet-by-support factorial design, comparing a very low-carbohydrate (VLC) diet vs a Dietary Approaches to Stop Hypertension (DASH) diet, as well as comparing results with and without multicomponent extra support (mindful eating, positive emotion regulation, social support, and cooking). RESULTS Using intention-to-treat analyses, compared with the DASH diet, the VLC diet led to greater improvement in estimated mean systolic blood pressure (-9.77 mm Hg vs -5.18 mm Hg; P = .046), greater improvement in glycated hemoglobin (-0.35% vs -0.14%; P = .034), and greater improvement in weight (-19.14 lb vs -10.34 lb; P = .0003). The addition of extra support did not have a statistically significant effect on outcomes. CONCLUSIONS For adults with hypertension, prediabetes or type 2 diabetes, and overweight or obesity, the VLC diet resulted in greater improvements in systolic blood pressure, glycemic control, and weight over a 4-month period compared with the DASH diet. These findings suggest that larger trials with longer follow-up are warranted to determine whether the VLC diet might be more beneficial for disease management than the DASH diet for these high-risk adults. Key words: type 2 diabetes; hypertension; obesity; diet; very low-carbohydrate diet; DASH diet https://doi.org/10.1370/afm.2968, INTRODUCTION Adults with hypertension, prediabetes or type 2 diabetes, and overweight or obesity are at increased risk of health complications, including stroke, end-stage renal disease, myocardial infarction, premature death, and [...]

BackgroundA carbohydrate-restricted (CR) diet can improve glycemic control in people with type 2 diabetes mellitus (T2DM). There are concerns, however, that the high dietary fat content of CR diets can increase low-density lipoprotein cholesterol (LDL-C), thus increasing cardiovascular disease (CVD) risk. Quantifying CVD risk associated with changes in LDL-C in the context of CR diets is complicated by the fact that LDL-C reflects heterogeneous lipids. For example, small LDL particle number (sLDL-P) is more closely associated with CVD risk than is total LDL-C, and CR diets tend to decrease the proportion of sLDL-C in LDL-C, which standard lipid measures do not indicate. Advanced lipoprotein assays, such as nuclear magnetic resonance (NMR) testing, can subfractionate lipoproteins by size and density and may better depict the effects of CR diets on CVD risk.MethodsAdults (N = 58) with T2DM (n = 37 women; baseline HbA1c ≥ 6.5%) completed a 6-month group-based CR diet intervention. We obtained a standard lipid panel, advanced lipoprotein assays (NMR testing), and two 24-h diet recalls at baseline and post-intervention (6 months). Participants also completed home-based blood ketone testing (a biological index of dietary adherence) during the final five weeks of the intervention.ResultsFrom baseline to post-intervention, participants had increased mean HDL-C, decreased triglycerides and triglyceride/HDL ratio, decreased mean sLDL-P, and increased LDL size, which reflect reductions in CVD risk (ps

BackgroundThis manuscript describes the first two phases of pilot testing MARIGOLD, an online self-guided positive emotion skills intervention for adults with elevated depressive symptoms, along with enhancements to overcome retention and adherence problems reported in previous research.MethodsAdults with elevated depressive symptoms were recruited online and assessed at baseline, post-intervention, 1- and 3-month follow-up. Phase 1 participants (n = 58) were randomized to MARIGOLD, daily emotion reporting, or waitlist. Phase 2 participants (n = 79) were randomized to MARIGOLD plus one enhancement: online discussion board (ODB), virtual badges (VB), or facilitator contact (FC). Post-intervention interviews assessed acceptability. Intention-to-treat analyses examined retention, adherence, and preliminary efficacy.ResultsIn both phases, retention and adherence did not differ between groups. MARIGOLD skills were highly acceptable, but qualitative results indicate web-based features (e.g., log-in, ODB, VB) require refinement prior to larger testing. Neither phase demonstrated between-group differences in preliminary efficacy. In Phase 1 within-group analyses, MARIGOLD and emotion reporting control demonstrated a similar pattern of findings (stable depressive symptoms, increased positive emotion, decreased negative emotion and stress), whereas the waitlist group significantly increased in depressive mood. Most Phase 2 within-group analyses demonstrated the expected pattern of results (i.e., decreases in PHQ-8 and negative emotion, increases in positive emotion). However, CES-D scores were stable in FC; perceived stress was stable in FC and ODB.LimitationsThis pilot study is not powered to evaluate efficacy.ConclusionPositive emotion skills, plus enhancements for web-based, self-guided delivery, warrant additional study in people with elevated depressive symptoms.

[This corrects the article DOI: 10.1186/s12986-019-0383-2.].

Dietary treatment is important in management of type 2 diabetes or prediabetes, but uncertainty exists about the optimal diet. We randomized adults (n = 34) with glycated hemoglobin (HbA1c) > 6.0% and elevated body weight (BMI > 25) to a very low-carbohydrate ketogenic (LCK) diet (n = 16) or a moderate-carbohydrate, calorie-restricted, low-fat (MCCR) diet (n = 18). All participants were encouraged to be physically active, get sufficient sleep, and practice behavioral adherence strategies based on positive affect and mindful eating. At 12 months, participants in the LCK group had greater reductions in HbA1c levels (estimated marginal mean (EMM) at baseline = 6.6%, at 12 mos = 6.1%) than participants in MCCR group (EMM at baseline = 6.9%, at 12 mos = 6.7%), p = .007. Participants in the LCK group lost more weight (EMM at baseline = 99.9 kg, at 12 mos = 92.0 kg) than participants in the MCCR group (EMM at baseline = 97.5 kg, at 12 mos = 95.8 kg), p

The present research examined the effect of the 5-HTTLPR polymorphism in the serotonin transporter gene on objectively coded positive emotional expressions (i.e., laughing and smiling behavior objectively coded using the Facial Action Coding System). Three studies with independent samples of participants were conducted. Study 1 examined young adults watching still cartoons. Study 2 examined young, middle-aged, and older adults watching a thematically ambiguous yet subtly amusing film clip. Study 3 examined middle-aged and older spouses discussing an area of marital conflict (that typically produces both positive and negative emotion). Aggregating data across studies, results showed that the short allele of 5-HTTLPR predicted heightened positive emotional expressions. Results remained stable when controlling for age, gender, ethnicity, and depressive symptoms. These findings are consistent with the notion that the short allele of 5-HTTLPR functions as an emotion amplifier, which may confer heightened susceptibility to environmental conditions.

What can a speech reveal about someone's state? We tested the idea that greater stress reactivity would relate to lower linguistic cognitive complexity while speaking. In Study 1, we tested whether heart rate and emotional stress reactivity to a stressful discussion would relate to lower linguistic complexity. In Studies 2 and 3, we tested whether a greater cortisol response to a standardized stressful task including a speech (Trier Social Stress Test) would be linked to speaking with less linguistic complexity during the task. We found evidence that measures of stress responsivity (emotional and physiological) and chronic stress are tied to variability in the cognitive complexity of speech. Taken together, these results provide evidence that our individual experiences of stress or "stress signatures"-how our body and mind react to stress both in the moment and over the longer term-are linked to how complex our speech under stress.

Why do some individuals become dissatisfied with their marriages when levels of negative emotion are high and levels of positive emotions are low, whereas others remain unaffected? Using data from a 13-year longitudinal study of middle-aged and older adults in long-term marriages, we examined whether the 5-HTTLPR polymorphism in the serotonin transporter gene moderates the association between negative and positive emotional behavior (objectively measured during marital conflict) and changes in marital satisfaction over time. For individuals with two short alleles of 5-HTTLPR, higher negative and lower positive emotional behavior at Time 1 predicted declines in marital satisfaction over time (even after controlling for depression and other covariates). For individuals with one or two long alleles, emotional behavior did not predict changes in marital satisfaction. We also found evidence for a crossover interaction (individuals with two short alleles of 5-HTTLPR and low levels of negative or high levels of positive emotion had the highest levels of marital satisfaction). These findings provide the first evidence of a specific genetic polymorphism that moderates the association between emotional behavior and changes in marital satisfaction over time and are consistent with increasing evidence that the short allele of this polymorphism serves as a susceptibility factor that amplifies sensitivity to both negative and positive emotional influences.

Adults with type 2 diabetes need to master illness self-management to meaningfully sustain behavior change and mindfulness practice may facilitate this process. This study investigated the effectiveness of the Mindfulness-Based Diabetes Self- and Family Management Support Program to improve glycated hemoglobin among Thai adults with uncontrolled diabetes. This program was developed from a literature review, and in-depth interviews with 15 participants who had poorly controlled diabetes and their family members. The Information-Motivation-Behavioral Skills Model and mindfulness approach was used as a framework to develop study intervention. We conducted a randomized controlled trial from September 2018 to March 2019. Eighty adults with uncontrolled type 2 diabetes were randomized to 12 weeks of either the control group who received only usual care (n = 40) or the experimental group (n = 40) who received an intervention in addition to usual care. Glycated hemoglobin, fasting blood glucose, mindful-eating, self-efficacy, dietary consumption, physical activity, and medication adherence were assessed at baseline, week 12 and week 16. Data were analyzed using descriptive statistics, ANCOVA, Repeated Measures ANOVA, and Independent t-test. The findings showed that participants receiving the intervention improved more between baseline and both weeks 12 and 16 in fasting blood glucose and HbA1c, appropriate dietary consumption, amount of physical activity, medication adherence, mindful eating, and self-efficacy than those in the control group. Nurses can be trained to implement this intervention program in adults with uncontrolled diabetes. However, more studies with a larger number of community participants are recommended with the application of advanced technology such as mobile health. [ABSTRACT FROM AUTHOR]