Psychological Support Strategies for Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Randomized Controlled Trial.

BACKGROUND: A 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. OBJECTIVE: This 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. METHODS: The 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). RESULTS: Overall, the VLC intervention led to statistically significant improvements in glycemic control (-0.70%, 95% CI -1.04% to -0.35%; P<.001), weight loss (-6.82%, 95% CI -8.57% to -5.08%; P<.001), and depressive symptom severity (Cohen d -0.67, 95% CI -0.92 to -0.41; P<.001). Furthermore, 30% (25/83) of the participants taking metformin at baseline reduced or discontinued their metformin. Only 1 Cohen d point estimate reached 0.5; daily (vs monthly) dietary self-monitoring had a worse impact on depressive symptoms severity (Cohen d=0.47, 95% CI -0.02 to 0.95; P=.06). None of the strategies had a statistically significant effect on outcomes. For changes in our primary outcome, hemoglobin A1c, the daily (vs monthly) dietary self-monitoring impact was 0.42% (95% CI -0.28% to 1.12%); for mindful eating, it was -0.47% (95% CI -1.15% to 0.22%); and for positive affect, it was 0.12% (95% CI -0.57% to 0.82%). Other results for daily (vs monthly) dietary self-monitoring were mixed, suggesting an increase in weight (0.98%) and depressive symptoms (Cohen d=0.47), less intervention satisfaction (Cohen d=-0.20), more sessions viewed (3.02), and greater dietary adherence (Cohen d=0.24). For mindful eating, the results suggested a benefit for dietary adherence (Cohen d=0.24) and intervention satisfaction (Cohen d=0.30). For positive affect, the results suggested a benefit for depressive symptoms (Cohen d=-0.32), the number of sessions viewed (3.68), dietary adherence (Cohen d=0.16), and intervention satisfaction (Cohen d=0.25). CONCLUSIONS: Overall, our results support the use of a VLC diet intervention in adults with T2D. The addition of monthly (not daily) dietary self-monitoring, mindful eating, and positive affect skills training did not show a definitive benefit, but it is worth further testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT03037528; https://clinicaltrials.gov/ct2/show/NCT03037528.

Comparing Very Low-Carbohydrate vs DASH Diets for Overweight or Obese Adults With Hypertension and Prediabetes or Type 2 Diabetes: A Randomized Trial.

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.

Effects of a Mindfulness-Based Weight Loss Intervention on Long-Term Psychological Well-Being Among Adults with Obesity: Secondary Analyses from the Supporting Health by Integrating Nutrition and Exercise (SHINE) Trial.

Objective: This study tested whether a mindfulness-based intervention for obesity that included components aimed at emotion regulation and mindful eating improved psychological outcomes including stress, anxiety, positive emotion, and depression, during the intervention period and at longer-term follow-up. Methods: Adults with obesity (N=194) were randomized to a 5.5-month diet-exercise weight loss intervention with or without mindfulness training focused on emotion regulation and mindful eating. Participants completed self-report measures of mindfulness and psychological well-being, which were planned secondary outcomes, at baseline, mid-intervention (3 months), and at 6-, 12-, and 18-months post-baseline (maintenance period). Mixed effects models and linear regression were used to test between- and within-group changes in psychological well-being. Finally, this study explored whether changes in mindfulness (from baseline to each 6- and 18-months post-baseline) mediated the effects of intervention arm on changes in psychological outcomes during those respective time periods. This study explored whether changes in mindfulness from baseline to 6 months mediated the effects of intervention arm on changes in psychological outcomes from baseline to 18 months. Results: Participants randomized to the mindfulness arm had significant increases in positive emotions at all follow-up times compared to controls. There were statistically significant increases in mindfulness, psychological flexibility, and reflection, as well as decreases in anxiety and depressive symptoms at 12 months compared to control participants. These changes remained significant for psychological flexibility and reflection at 18 months. There were no significant differences in perceived stress. Among mindfulness participants, greater increases in mindfulness from 6-18 months was associated with greater positive emotions and psychological flexibility as well as lower perceived stress, anxiety, depressive symptoms, and rumination at 18 months, adjusting for 6-month values. Mediation analyses indicated that randomization to the mindfulness intervention arm was associated with 6-month increases in mindfulness, and these increases were in turn associated with improved psychological outcomes at 6 months and 18 months. Changes from baseline to 18 months did not mediate 18-month changes in psychological outcomes. Conclusions: Mindfulness training in emotion regulation and mindful eating may provide greater longer-term psychological well-being benefits in non-clinical populations with obesity compared to conventional diet-exercise interventions.

Impact of an online multicomponent very-low-carbohydrate program in women with polycystic ovary syndrome: a pilot study.

OBJECTIVE: To study the impact of a very-low-carbohydrate (VLC) diet for 16 weeks in overweight or obese women with polycystic ovary syndrome (PCOS). DESIGN: Single-arm prospective pilot study. SETTING: We recruited participants using medical records from an academic medical center. PATIENTS: Twenty-nine overweight or obese women (body mass index, 25-50 kg/m2) with PCOS. INTERVENTIONS: We taught participants to follow a VLC diet and provided information about a variety of behavioral skills including mindfulness and positive affect using an online 16-week intervention. MAIN OUTCOME MEASURES: Changes in body weight, glycated hemoglobin, and PCOS-related quality of life. RESULTS: The intervention led to positive health outcomes including decreases in percent weight (mean difference = -7.67, SD = 6.10) and glycated hemoglobin level (mean difference = -0.21%, SD = 0.27), an increase in sex hormone binding globulin level (mean difference = 9.24 nmol/L, SD = 16.34), and increases in PCOS-related quality of life measures, including menstrual predictability (mean difference = 2.10, SD = 2.76) and body hair (mean difference = 1.14, SD = 1.04). The low-density lipoprotein cholesterol level increased (mean difference = 0.23 mmol/L, SD = 0.49). CONCLUSIONS: The results suggest that a VLC dietary intervention has potential to promote both weight loss and glycemic control in overweight and obese adults with PCOS, two key components in the prevention of type 2 diabetes. TRIAL REGISTRATION NUMBER: NCT03987854.

Methods-Motivational Interviewing Approach for Enhanced Retention and Attendance.

INTRODUCTION: Suboptimal and differential participant engagement in randomized trials-including retention at primary outcome assessments and attendance at intervention sessions-undermines rigor, internal validity, and trial conclusions. METHODS: First, this study describes Methods-Motivational Interviewing approach and strategies for implementation. This approach engages potential participants before randomization through interactive, prerequisite orientation sessions that illustrate the scientific rationale behind trial methods in accessible language and use motivational interviewing to diffuse ambivalence about participation. Then, this study examines the potential improvements in retention (proportion of participants assessed at follow-up visits) and attendance (e.g., mean percentage of intervention sessions attended, percentage of participants who attended 0 sessions) in 3 randomized weight-management trials that quickly added prerequisite orientations to their protocols following early signs of suboptimal or differential participant engagement (Supporting Health by Integrating Nutrition and Exercise [2009-2013, n=194]; Get Social [2016-2020, n=217]; GestationaL Weight Gain and Optimal Wellness [2014-2018, n=389]). Using a pre-post analytical design, adjusted estimates from regression models controlling for condition and assessment timepoint (analyses from 2020) are reported. RESULTS: After adding prerequisite orientations, all 3 trials attained higher participant engagement. Retention at assessments was 11.4% and 17.3% higher (Get Social and Supporting Health by Integrating Nutrition and Exercise, respectively). Mean percentage of attendance at intervention sessions was 8.8% higher (GestationaL Weight Gain and Optimal Wellness), and 10.1% fewer participants attended 0 intervention sessions (Get Social). Descriptively, all the remaining retention and attendance outcomes were consistently higher but were nonsignificant. Across the trials, adding prerequisite orientations did not impact the proportion of eligible participants enrolled or the baseline demographics. CONCLUSIONS: The Methods-Motivational Interviewing approach shows promise for increasing the rigor of randomized trials and is readily adaptable to in-person, webinar, and conference call formats. TRIAL REGISTRATION: All 3 trials are registered at www.clinicaltrials.gov (Supporting Health by Integrating Nutrition and Exercise: NCT00960414; Get Social: NCT02646618; and GestationaL Weight Gain and Optimal Wellness: NCT02130232).

Exploratory Analysis of Racial/Ethnic and Educational Differences in a Randomized Controlled Trial of a Mindfulness-Based Weight Loss Intervention.

OBJECTIVE: People of color and lower socioeconomic groups have higher obesity prevalence, lose less weight compared with Whites and higher socioeconomic groups, and are underrepresented in randomized controlled trials of mindfulness-based interventions. We examined whether mindfulness approaches reduce disparities in weight loss interventions. METHODS: We analyzed data from a randomized controlled trial of 194 participants with obesity (41% participants of color, 36% without college degree) comparing a 5.5-month mindfulness-based weight loss intervention to an active-control with identical diet-exercise guidelines. We assessed attendance, 18-month attrition, and weight change at 6, 12, and 18 months by race/ethnicity and education level using linear mixed models, adjusting for baseline body mass index, age, and education or race/ethnicity, respectively. RESULTS: Participants without versus with a college degree attended fewer sessions and had higher attrition across interventions. Participants of color attended fewer intervention sessions in the mindfulness compared with the control intervention. Overall, participants of color lost significantly less weight at 12 and 18 months compared with Whites. However, during the 6- to 18-month maintenance period, we found an interaction of intervention arm, race/ethnicity, and time (p = .035), indicating that participants of color compared with Whites regained more weight in the control (0.33 kg/mo; p = .005) but not mindfulness intervention (0.06 kg/mo; p = .62). Participants without a college degree had greater initial weight loss in the mindfulness compared to control intervention from 0 to 6 months (-0.46 kg/mo; p = .039). CONCLUSIONS: Although disparities persist, mindfulness approaches may mitigate some racial/ethnic and socioeconomic differences in weight loss compared with conventional diet-exercise programs.Trial Registration: Clinicaltrials.gov registration: NCT00960414.

Intervention Enhancement Strategies Among Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Evaluating the Impact With a Randomized Trial.

BACKGROUND: Adults 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. OBJECTIVE: This 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. METHODS: Overweight 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. RESULTS: We 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. CONCLUSIONS: Text 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 REGISTRATION: ClinicalTrials.gov NCT02676648; http://clinicaltrials.gov/ct2/show/NCT02676648.

Do stress eating or compulsive eating influence metabolic health in a mindfulness-based weight loss intervention?

OBJECTIVE: We aimed to understand the associations of compulsive eating (CE) and stress eating (SE) with metabolic health among adults with obesity and whether mindfulness-based weight loss training may buffer these associations. METHOD: We used data from a trial in which we randomized 194 participants with obesity to a diet-exercise weight loss intervention with either mindful eating training plus mindfulness-based eating awareness and stress management training (n = 100) or active control components (n = 94). We measured CE, SE, weight, and fasting blood glucose (FBG) at baseline, and 6, 12 months, and 18 months. We tested CE and SE as both moderators and mediators of intervention effects on changes in metabolic health. RESULTS: Participants higher (+ 1 SD) in CE at baseline randomized to the mindfulness (vs. control) intervention had greater improvements in FBG at 18 months (p = .05). Twelve-month reductions in CE mediated the effect of the intervention on changes in FBG and weight at 12 and 18 months postbaseline (p ≤ .05). Furthermore, those higher (+ 1 SD) in SE at baseline were nearly 2 BMI points higher than those lower (-1 SD) in SE (p < .01). Decreases in SE (B = 3.42; p < .001; 95% CI [2.55, 4.30]) and CE (B = 0.45; p < .001; 95% CI [0.36, 0.54]) in all participants at 6 months were associated with greater weight loss at 18 months. CONCLUSIONS: Those with greater compulsive eating may reduce risk for metabolic decline by participating in a mindfulness-based weight loss program. Future obesity interventions should consider tailoring treatment toward trait-level characteristics, such as compulsive eating. (PsycINFO Database Record (c) 2020 APA, all rights reserved).

A Randomized Controlled Trial of a Mindfulness-Based Weight Loss Intervention on Cardiovascular Reactivity to Social-Evaluative Threat Among Adults with Obesity.

OBJECTIVE: Mindfulness-based interventions have been found to reduce psychological and physiological stress reactivity. In obesity, however, stress reactivity is complex, with studies showing both exaggerated and blunted physiological responses to stressors. A nuanced view of stress reactivity is the "challenge and threat" framework, which defines adaptive and maladaptive patterns of psychophysiological stress reactivity. We hypothesized that mindfulness training would facilitate increased challenge-related appraisals, emotions, and cardiovascular reactivity, including sympathetic nervous system activation paired with increased cardiac output (CO) and reduced total peripheral resistance (TPR) compared to a control group, which would exhibit an increased threat pattern of psychophysiological reactivity to repeated stressors. METHODS: Adults (N=194) with obesity were randomized to a 5.5-month mindfulness-based weight loss intervention or an active control condition with identical diet-exercise guidelines. Participants were assessed at baseline and 4.5 months later using the Trier Social Stress Task. Electrocardiogram, impedance cardiography, and blood pressure were acquired at rest and during the speech and verbal arithmetic tasks to assess pre-ejection period (PEP), CO, and TPR reactivity. RESULTS: Mindfulness participants showed significantly greater maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR) from pre to post-intervention compared to control participants, but groups did not differ in PEP. Findings were independent of changes in body mass index. CONCLUSIONS: Mindfulness training may increase the ability to maintain a positive outlook and mount adaptive cardiovascular responses to repeated stressors among persons with obesity though findings need to be replicated in other populations and using other forms of mindfulness interventions.

Weight Loss Maintenance and Cellular Aging in the Supporting Health Through Nutrition and Exercise Study.

OBJECTIVE: The aim of the study was to determine, within a weight loss clinical trial for obesity, the impact of intervention arm, weight change, and weight loss maintenance on telomere length (TL). METHODS: Adults (N = 194) with a body mass index between 30 and 45 were randomized to a 5.5-month weight loss program with (n = 100) or without (n = 94) mindfulness training and identical diet-exercise guidelines. We assessed TL at baseline and 3-, 6-, and 12-month postbaseline in immune cell populations (primarily in peripheral blood mononuclear cells [PBMCs], but also in granulocytes and T and B lymphocytes). We defined weight loss maintenance as having lost at least 5% or 10% of body weight (tested in separate models) from preintervention to postintervention, and having maintained this loss at 12 months. We predicted that greater weight loss and weight loss maintenance would be associated with TL lengthening. RESULTS: Neither weight loss intervention significantly predicted TL change nor did amount of weight change, at any time point. Across all participants, weight loss maintenance of at least 10% was associated with longer PBMC TL (b = 239.08, 95% CI = 0.92 to 477.25, p = .049), CD8+ TL (b = 417.26, 95% CI = 58.95 to 775.57, p = .023), and longer granulocyte TL (b = 191.56, 95% CI = -4.23 to 387.35, p = .055) at 12 months after accounting for baseline TL. Weight loss maintenance of 5% or more was associated with longer PBMC TL (b = 163.32, 95% CI = 4.00 to 320.62, p = .045) at 12 months after accounting for baseline TL. These tests should be interpreted in light of corrections for multiple tests. CONCLUSIONS: Among individuals with obesity, losing and maintaining a weight loss of 10% or more may lead to TL lengthening, which may portend improved immune and metabolic function. TL lengthening in this study is of unknown duration beyond 12 months and requires further study. TRIAL REGISTRATION: Clinicaltrials.govidentifierNCT00960414; Open Science Framework (OSF) preregistration: https://osf.io/t3r2g/.

Being aware of the painful body: Validation of the German Body Awareness Questionnaire and Body Responsiveness Questionnaire in patients with chronic pain.

Body awareness is an attentional focus on and awareness of internal body sensations. This study aimed to validate German versions of the Body Awareness Questionnaire (BAQ) and the Body Responsiveness Questionnaire (BRQ) in chronic pain patients and to assess their associations with pain-related variables and to assess their responsiveness to intervention. The instruments were translated to German and administered to 512 chronic pain patients (50.3±11.4 years, 91.6% female) to assess their factor structure and reliability. Cronbach's α for the BAQ total score was 0.86. Factor analysis of the BRQ revealed the two factors Importance of Interoceptive Awareness (Cronbach's α = 0.75) and Perceived Connection (Cronbach's α = 0.75) and the single-item Suppression of Bodily Sensations. The BAQ was independently associated with lower mindfulness, self-esteem, stress, and depression; Importance of Interoceptive Awareness with mindfulness, self-acceptance, self-esteem, and physical contact; Perceived Connection with self-acceptance, vitality, and lower sensory pain; Suppression of Bodily Sensations with lower self-esteem, physical contact, and higher depressive symptoms. After a 10-week multimodal mind-body program (n = 202), the BAQ and Importance of Interoceptive Awareness increased and pain intensity and Suppression of Bodily Sensation decreased. In conclusion, body awareness and body responsiveness are associated with pain-related variables in patients with chronic pain. Mind-body interventions may positively influence both pain and body awareness, hinting at a potential mechanism of action of these interventions to be tested in further research.

Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes.

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 < .001. The LCK participants experienced larger reductions in diabetes-related medication use; of participants who took sulfonylureas or dipeptidyl peptidase-4 inhibitors at baseline, 6/10 in the LCK group discontinued these medications compared with 0/6 in the MCCR group (p = .005). In a 12-month trial, adults with elevated HbA1c and body weight assigned to an LCK diet had greater reductions in HbA1c, lost more weight, and reduced more medications than those instructed to follow an MCCR diet.

An Online Intervention Comparing a Very Low-Carbohydrate Ketogenic Diet and Lifestyle Recommendations Versus a Plate Method Diet in Overweight Individuals With Type 2 Diabetes: A Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes is a prevalent, chronic disease for which diet is an integral aspect of treatment. In our previous trial, we found that recommendations to follow a very low-carbohydrate ketogenic diet and to change lifestyle factors (physical activity, sleep, positive affect, mindfulness) helped overweight people with type 2 diabetes or prediabetes improve glycemic control and lose weight. This was an in-person intervention, which could be a barrier for people without the time, flexibility, transportation, social support, and/or financial resources to attend. OBJECTIVE: The aim was to determine whether an online intervention based on our previous recommendations (an ad libitum very low-carbohydrate ketogenic diet with lifestyle factors; "intervention") or an online diet program based on the American Diabetes Associations' "Create Your Plate" diet ("control") would improve glycemic control and other health outcomes among overweight individuals with type 2 diabetes. METHODS: In this pilot feasibility study, we randomized overweight adults (body mass index ≥25) with type 2 diabetes (glycated hemoglobin [HbA1c] 6.5%-9.0%) to a 32-week online intervention based on our previous recommendations (n=12) or an online diet program based around a plate method diet (n=13) to assess the impact of each intervention on glycemic control and other health outcomes. Primary and secondary outcomes were analyzed by mixed-effects linear regression to compare outcomes by group. RESULTS: At 32 weeks, participants in the intervention group reduced their HbA1c levels more (estimated marginal mean [EMM] -0.8%, 95% CI -1.1% to -0.6%) than participants in the control group (EMM -0.3%, 95% CI -0.6% to 0.0%; P=.002). More than half of the participants in the intervention group (6/11, 55%) lowered their HbA1c to less than 6.5% versus 0% (0/8) in the control group (P=.02). Participants in the intervention group lost more weight (EMM -12.7 kg, 95% CI -16.1 to -9.2 kg) than participants in the control group (EMM -3.0 kg, 95% CI -7.3 to 1.3 kg; P<.001). A greater percentage of participants lost at least 5% of their body weight in the intervention (10/11, 90%) versus the control group (2/8, 29%; P=.01). Participants in the intervention group lowered their triglyceride levels (EMM -60.1 mg/dL, 95% CI -91.3 to -28.9 mg/dL) more than participants in the control group (EMM -6.2 mg/dL, 95% CI -46.0 to 33.6 mg/dL; P=.01). Dropout was 8% (1/12) and 46% (6/13) for the intervention and control groups, respectively (P=.07). CONCLUSIONS: Individuals with type 2 diabetes improved their glycemic control and lost more weight after being randomized to a very low-carbohydrate ketogenic diet and lifestyle online program rather than a conventional, low-fat diabetes diet online program. Thus, the online delivery of these very low-carbohydrate ketogenic diet and lifestyle recommendations may allow them to have a wider reach in the successful self-management of type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT01967992; https://clinicaltrials.gov/ct2/show/NCT01967992 (Archived by WebCite at http://www.webcitation.org/6o0fI9Mkq).

Impact of a Mindfulness-Based Weight-Loss Intervention on Sleep Quality Among Adults with Obesity: Data from the SHINE Randomized Controlled Trial.

BACKGROUND AND OBJECTIVE: Sleep disturbance is a common problem among adults with obesity. Mindfulness interventions have been shown to improve sleep quality in various populations but have not been investigated in adults with obesity. The aim of this study was to compare the effects of a mindfulness-based weight-loss intervention with an active control on self-reported sleep quality among adults with obesity. METHOD: This study was a secondary analysis of a randomized controlled trial and included 194 adults with a body mass index in the range 30-45 kg/m2. The treatment intervention included mindfulness-based eating and stress-management practices, and the active control intervention included training in progressive muscle relaxation (PMR). Both groups received identical diet and exercise guidelines in 17 group sessions conducted over 5.5 months that were matched for time, attention, and social support. The primary outcome of this analysis was between-group change in self-reported sleep quality, which was assessed using the Pittsburgh Sleep Quality Index (PSQI) global score at baseline and at 6, 12, and 18 months. RESULTS: Between-group differences in mean PSQI change scores in the mindfulness group (n = 100) compared to the control group (n = 94) were -0.27 (-0.68, 1.22; p = 0.58) at 6 months, -0.57 (-0.35, 1.50; p = 0.22) at 12 months, and -0.50 (-0.53, 1.53; p = 0.34) at 18 months, all in the direction of more sleep improvement in the mindfulness group but none reaching statistical significance. In the mindfulness group, average weekly minutes of meditation practice time was associated with improved sleep quality from baseline to 6 months. CONCLUSIONS: No statistically significant evidence was found that a weight-loss program that incorporates mindfulness improves self-reported sleep quality compared to a control diet/exercise intervention that included PMR. Within the mindfulness group, average weekly minutes of mindfulness practice was associated with improved sleep quality.

Effects of a mindfulness-based weight loss intervention in adults with obesity: A randomized clinical trial.

OBJECTIVE: To determine whether adding mindfulness-based eating and stress management practices to a diet-exercise program improves weight loss and metabolic syndrome components. METHODS: In this study 194 adults with obesity were randomized to a 5.5-month program with or without mindfulness training and identical diet-exercise guidelines. Intention-to-treat analyses with multiple imputation were used for missing data. The primary outcome was 18-month weight change. RESULTS: Estimated effects comparing the mindfulness to control arm favored the mindfulness arm in (a) weight loss at 12 months, -1.9 kg (95% CI: -4.5, 0.8; P = 0.17), and 18 months, -1.7 kg (95% CI: -4.7, 1.2; P = 0.24), though not statistically significant; (b) changes in fasting glucose at 12 months, -3.1 mg/dl (95% CI: -6.3, 0.1; P = 0.06), and 18 months, -4.1 mg/dl (95% CI: -7.3, -0.9; P = 0.01); and (c) changes in triglyceride/HDL ratio at 12 months, -0.57 (95% CI: -0.95, -0.18; P = 0.004), and 18 months, -0.36 (95% CI: -0.74, 0.03; P = 0.07). Estimates for other metabolic risk factors were not statistically significant, including waist circumference, blood pressure, and C-reactive protein. CONCLUSIONS: Mindfulness enhancements to a diet-exercise program did not show substantial weight loss benefit but may promote long-term improvement in some aspects of metabolic health in obesity that requires further study.

Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial.

Many individuals with obesity report over eating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12- and 18-months post-baseline among 194 adults with obesity (BMI: 30-45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [ß = -0.06, SE(ß) = 0.03, p = .030, 95% CI (-0.12, -0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p = .396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414).

Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial.

We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels. We randomized 194 obese individuals (M age = 47.0 ± 12.7 years; BMI = 35.5 ± 3.6; 78% women) to a 5.5-month diet-exercise program with or without mindfulness training. The mindfulness group, relative to the active control group, evidenced increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment. Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants. Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment. Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels.

Indo-Tibetan Philosophical and Medical Systems: Perspectives on the Biofield.

The word biofield is a term that Western scientists have used to describe various aspects of energy and information fields that guide health processes. Similar concepts and descriptions of energy and information patterns exist in various cultures and have guided whole systems of medicine such as Ayurveda and Tibetan medicine. This article describes Vedic, Jain, and Tibetan philosophical and medical systems' concepts of consciousness and subtle energy and their relationships to health processes in order to foster deeper crosscultural dialogue on the nature of the biofield. Similarities and differences within the 3 traditions are noted, and suggestions for considering these concepts to extend current biofield research are discussed.

Putting the brakes on the "drive to eat": Pilot effects of naltrexone and reward-based eating on food cravings among obese women.

PURPOSE: Obese individuals vary in their experience of food cravings and tendency to engage in reward-driven eating, both of which can be modulated by the neural reward system rather than physiological hunger. We examined two predictions in a sample of obese women: (1) whether opioidergic blockade reduced food-craving intensity, and (2) whether opioidergic blockade reduced an association between food-craving intensity and reward-driven eating, which is a trait-like index of three factors (lack of control over eating, lack of satiation, preoccupation with food). METHODS: Forty-four obese, pre-menopausal women completed the Reward-Based Eating Drive (RED) scale at study start and daily food-craving intensity on 5 days on which they ingested either a pill-placebo (2 days), a 25 mg naltrexone dose (1 day), or a standard 50mg naltrexone dose (2 days). RESULTS: Craving intensity was similar under naltrexone and placebo doses. The association between food-craving intensity and reward-driven eating significantly differed between placebo and 50mg naltrexone doses. Reward-driven eating and craving intensity were significantly positively associated under both placebo doses. As predicted, opioidergic blockade (for both doses 25mg and 50mg naltrexone) reduced the positive association between reward-driven eating and craving intensity to non-significance. CONCLUSIONS: Opioidergic blockade did not reduce craving intensity; however, blockade reduced an association between trait-like reward-driven eating and daily food-craving intensity, and may help identify an important endophenotype within obesity.