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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)

Background: Insulin resistance and the G allele of rs738409 interact to create a greater risk of metabolic dysfunction-associated steatotic liver disease., Objective: This study aims to confirm that one promising way to reduce insulin resistance is by following a very low-carbohydrate (VLC) dietary pattern., Methods: Adults with rs738409-GG or -CG with liver steatosis and elevated liver function tests, were taught an ad libitum VLC diet, positive affect and mindful eating skills, goal setting, and self-monitoring and given feedback and coaching for 4 months. We measured liver steatosis, anthropometric, serum metabolic diet adherence, and quality of life measures., Results: In this small pilot trial, of the 11 participants enrolled, 9 (82%) participants completed outcomes. All 11 participants viewed at least 1 session of the intervention, and 8 (73%) participants viewed at least half of the sessions. Among the 9 participants who provided 4-month self-report information, intervention satisfaction was high (mean 6.22, 95% CI 5.58-6.85), with 5 (56%) participants rating the intervention the top score, and 4 (44%) participants reporting they did not plan to stop following the VLC diet. Across participants with a 4-month hepatic liver fat percent measurement, the percent change in liver fat was -33.17% (95% CI -86.48 to 20.14), and in only the participants who were adherent to the eating pattern, the percent change in liver fat was -53.12% (95% CI -71.25 to -34.99). Amongst participants with a 4-month hepatic liver fat percent measurement, 6 out of 8 (75%) participants were considered responders, with a relative decline in liver fat ≥30%, and of the 9 participants with a 4-month body weight, 9 (100%) participants lost ≥5% of their body weight. There were no serious adverse events., Conclusions: Results suggest the feasibility, acceptability, and preliminary efficacy of the VLC intervention in adults with higher genetic risk for metabolic dysfunction-associated steatotic liver disease, although there is a need for further studies given the small sample size and the high risk of substantial biases in this small pilot study., (© Laura R Saslow, Jamie Krinock, Alison O'Brien, Kaitlyn Raymond, Hovig Bayandorian, Judith T Moskowitz, Jennifer Daubenmier, Antonio Oliveri, Deanna J Marriott, Dina H Griauzde, Elizabeth K Speliotes. Originally published in JMIR Formative Research (https://formative.jmir.org).)

Background: Type 2 diabetes mellitus (T2DM) is a leading cause of morbidity and mortality globally, with adverse health consequences largely related to hyperglycemia. Despite clinical practice guideline recommendations, effective pharmacotherapy, and interventions to support patients and providers, up to 60% of patients diagnosed with T2DM are estimated to have hemoglobin A 1c (HbA 1c ) levels above the recommended targets owing to multilevel barriers hindering optimal glycemic control., Objective: The aim of this study is to compare changes in HbA 1c levels among patients with suboptimally controlled T2DM who were offered the opportunity to use an intermittently viewed continuous glucose monitor and receive personalized low-carbohydrate nutrition counseling (<100 g/day) versus those who received usual care (UC)., Methods: This was a 12-month, pragmatic, randomized quality improvement program. All adult patients with T2DM who received primary care at a university-affiliated primary care clinic (N=1584) were randomized to either the UC or the enhanced care (EC) group. Within each program arm, we identified individuals with HbA 1c >7.5% (58 mmol/mol) who were medically eligible for tighter glycemic control, and we defined these subgroups as UC-high risk (UC-HR) or EC-HR. UC-HR participants (n=197) received routine primary care. EC-HR participants (n=185) were invited to use an intermittently viewed continuous glucose monitor and receive low-carbohydrate nutrition counseling. The primary outcome was mean change in HbA 1c levels from baseline to 12 months using an intention-to-treat difference-in-differences analysis comparing EC-HR with UC-HR groups. We conducted follow-up semistructured interviews to understand EC-HR participant experiences with the intervention., Results: HbA 1c decreased by 0.41% (4.5 mmol/mol; P=.04) more from baseline to 12 months among participants in the EC-HR group than among those in UC-HR; however, only 61 (32.9%) of 185 EC-HR participants engaged in the program. Among the EC-HR participants who wore continuous glucose monitors (61/185, 32.9%), HbA 1c was 1.1% lower at 12 months compared with baseline (P<.001). Interviews revealed themes related to EC-HR participants' program engagement and continuous glucose monitor use., Conclusions: Among patients with suboptimally controlled T2DM, a combined approach that includes continuous glucose monitoring and low-carbohydrate nutrition counseling can improve glycemic control compared with the standard of care., (©Dina H Griauzde, Grace Ling, Daniel Wray, Melissa DeJonckheere, Kara Mizokami Stout, Laura R Saslow, Jill Fenske, David Serlin, Spring Stonebraker, Tabassum Nisha, Colton Barry, Rodica Pop-Busui, Ananda Sen, Caroline R Richardson. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 02.02.2022.)

Background: Adherence to self-guided interventions tends to be very low, especially in people with depression. Prior studies have demonstrated that enhancements may increase adherence, but little is known about the efficacy of various enhancements in comparison to, or in combination with, one another., Objective: The aim of our study is to test whether 3 enhancements-facilitator contact (FC), an online discussion board, and virtual badges (VB)-alone, or in combination, improve adherence to a self-guided, web-based intervention for depression. We also examined whether age, gender, race, ethnicity, comfort with technology, or baseline depression predicted adherence or moderated the effects that each enhancement had on adherence., Methods: Participants were recruited through web-based sources and, after completing at least 4 out of 7 daily emotion reports, were sequentially assigned to 1 of 9 conditions-the intervention alone; the intervention plus 1, 2, or all 3 enhancements; or an emotion reporting control condition. The intervention was a positive psychological program consisting of 8 skills that specifically targeted positive emotions, and it was delivered over 5 weeks in a self-guided, web-based format. We operationalized adherence as the number of skills accessed., Results: A total of 602 participants were enrolled in this study. Participants accessed, on average, 5.61 (SD 2.76) of 8 skills. The total number of enhancements participants received (0-3) did not predict the number of skills accessed. Participants who were assigned to the VB+FC condition accessed significantly more skills than those in the intervention only conditions. Furthermore, participants in arms that received the combination of both the VB and FC enhancements (VB+FC and VB+FC+online discussion board) accessed a greater number of skills relative to the number of skills accessed by participants who received either VB or FC without the other. Moderation analyses revealed that the receipt of VB (vs no VB) predicted higher adherence among participants with moderately severe depression at baseline., Conclusions: The results suggested that the VB+FC combination significantly increased the number of skills accessed in a self-guided, web-based intervention for elevated depression. We have provided suggestions for refinements to these enhancements, which may further improve adherence., Trial Registration: ClinicalTrials.gov NCT02861755; http://clinicaltrials.gov/ct2/show/NCT02861755., (©Judith Tedlie Moskowitz, Elizabeth L Addington, Eva Shiu, Sarah M Bassett, Stephanie Schuette, Ian Kwok, Melanie E Freedman, Yan Leykin, Laura R Saslow, Michael A Cohn, Elaine O Cheung. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 22.09.2021.)

Background: Diet patterns have a profound influence on glycemic control for individuals with type 2 diabetes mellitus (T2DM), and craving-related eating is an important obstacle to dietary adherence. A growing body of research suggests that carbohydrate-restricted (CR) diets can improve glycemic control and reduce medication dependence in T2DM. However, limited data speak to the effects of long-term adherence to CR diets. Mindful eating training has been shown to reduce craving-related eating in overweight populations but has yet to be examined as a behavioral support for dietary adherence in T2DM. This trial examines behavioral mechanisms, particularly craving-related eating, through which mindful eating training might improve adherence to CR dietary recommendations in T2DM. This will clarify the importance of focusing on craving-related eating in the optimization of dietary adherence interventions., Objective: The aim of this trial is to determine whether providing training in mindful eating increases adherence to a CR dietary recommendation in T2DM., Methods: We are randomizing 60 participants to receive a CR diet with or without mindful eating training (12-week group intervention) and are following participants for 12 weeks after intervention completion. We hypothesize that participants who receive mindful eating training (relative to those who do not) will demonstrate greater adherence to the CR diet., Results: Our primary outcome is change in craving-related eating, as assessed using an ecological momentary assessment mobile phone-based platform. Secondary behavioral pathway outcomes include changes in stress-related eating, impulsivity, glycemic control, weight change, dietary adherence, and resumption of dietary adherence after dietary nonadherence., Conclusions: This theory-driven trial will shed light on the impact of mindfulness training on mechanisms that may impact dietary adherence in T2DM., Trial Registration: ClinicalTrials.gov NCT03207711; https://clinicaltrials.gov/ct2/show/NCT03207711 (Archived by WebCite at http://www.webcitation.org/73pXscwaU)., International Registered Report Identifier (irrid): DERR1-10.2196/11002., (©Ashley E Mason, Laura Saslow, Patricia J Moran, Sarah Kim, Hiba Abousleiman, Alison Hartman, Robert Richler, Samantha Schleicher, Wendy Hartogensis, Elissa S Epel, Frederick Hecht. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 20.02.2019.)

Background: Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion., Objective: The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention., Methods: This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources., Results: The project was funded in August 2014, and data collection was completed in May 2018. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018., Conclusions: Findings from this investigation will enable us to develop an optimal package of intervention content and enhancement strategies for individuals with elevated symptoms of depression. If this intervention proves to be effective, it will provide a cost-effective, anonymous, appealing, and flexible approach for reducing symptoms of depression and improving psychological adjustment through increasing positive emotion., Trial Registration: ClinicalTrials.gov NCT01964820 (Phase 1); https://clinicaltrials.gov/ct2/show/NCT01964820 (Archived by WebCite at http://www.webcitation.org/6zpmKBcyX). ClinicalTrials.gov NCT02861755 (Phase 2); https://clinicaltrials.gov/ct2/show/NCT02861755 (Archived by WebCite at http://www.webcitation.org/6zpmLmy8k)., Registered Report Identifier: RR1-10.2196/10494., (©Elaine O Cheung, Elizabeth L Addington, Sarah M Bassett, Stephanie A Schuette, Eva W Shiu, Michael A Cohn, Yan Leykin, Laura R Saslow, Judith T Moskowitz. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.06.2018.)

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 [HbA 1c ] 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 HbA 1c 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 HbA 1c 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)., (©Laura R Saslow, Ashley E Mason, Sarah Kim, Veronica Goldman, Robert Ploutz-Snyder, Hovig Bayandorian, Jennifer Daubenmier, Frederick M Hecht, Judith T Moskowitz. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 13.02.2017.)