Traditional Mexican dietary pattern and cancer risk among women of Mexican descent.

PURPOSE: To examine the association of a traditional Mexican diet score with risk of total, breast, and colorectal cancer among women of Mexican ethnic descent in the Women's Health Initiative (WHI). METHODS: Participants were WHI enrollees who self-identified as being of Mexican descent. Data from food frequency questionnaires self-administered at study baseline were used to calculate the MexD score, with higher scores indicating greater adherence to an a priori-defined traditional Mexican diet (high in dietary fiber, vegetables, and legumes). Incident cancers were self-reported by participants from 1993 to 2020 and adjudicated by trained physicians. We used multivariable-adjusted Cox proportional hazards models to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). RESULTS: Among 2,343 Mexican descent women (median baseline age: 59 years), a total of 270 cancers (88 breast, 37 colorectal) occurred during a mean follow-up of 14.4 years. The highest tertile of MexD score was associated with a lower risk of all-cancer incidence (HR: 0.67; 95% CI 0.49-0.91; p-trend: 0.01) and colorectal cancer (HR: 0.38; 95% CI 0.14-0.998; p-trend < 0.05), with each unit increase in the MexD score associated with a 6% lower risk of all-cancer incidence (HR: 0.94; 95% CI 0.88-0.99). There was no statistically significant association with risk of breast cancer. CONCLUSION: Consumption of a traditional Mexican diet was associated with a significantly lower risk of all-cancer incidence and colorectal cancer. Confirmation of these findings in future studies is important, given the prevalence of colorectal cancer and a growing U.S. population of women of Mexican descent.

Emotional dysregulation among English-speaking Hispanic persons who smoke living in the United states.

Hispanic/Latinx (hereafter Hispanic) individuals in the United States (US) experience serious tobacco-related disparities and factors contributing to such disparities need to be adequately identified and clinically addressed. Emotion dysregulation is a key transdiagnostic relevant to smoking. The present cross-sectional investigation sought to test if emotion dysregulation was related to more severe problems during smoking quit attempts (e.g., irritability, weight gain), perceptions of difficulty about quitting, as well as negative and positive beliefs about smoking abstinence in a sample of English-speaking Hispanic adults residing in the US who smoke. Participants included 332 Hispanic adults who engaged in daily cigarette smoking (35.46 years old, 37 % identified as female). Emotion dysregulation was significantly related to more severe problems when quitting and perceived barriers for quitting, as well as negative beliefs about smoking abstinence. Additionally, emotion dysregulation was significantly and negatively related to positive outcomes about smoking abstinence. The amount of change in the various smoking criterion variables accounted for by emotion dysregulation was small (sr2 range: 0.028-0.085), but evident in adjusted models that accounted for a wide range of factors (e.g., depression, drug use severity). Overall, this investigation found consistent empirical evidence that individual differences in emotion dysregulation in Hispanic individuals were associated with several clinically significant smoking processes, suggesting this construct may represent an important factor involved in the maintenance and relapse of smoking among this ethnic population.

Do Smartphone Apps Impact Long-Term Smoking Cessation for Sexual and Gender Minority Adults? Exploratory Results from a 2-Arm Randomized Trial Comparing Acceptance and Commitment Therapy with Standard US Clinical Practice Guidelines.

Sexual and gender minority (SGM) adults face unique challenges in accessing smoking cessation care due to stigma tied to their identities and smoking. While cessation apps show promise in the general population, their efficacy for SGM adults is unclear. This study utilized data from a randomized trial to compare two cessation apps, iCanQuit (Acceptance and Commitment Therapy-based) and QuitGuide (US Clinical Practice Guidelines-based) among 403 SGM adults. The primary outcome was self-reported complete-case 30-day abstinence from cigarette smoking at 12 months. Mediation analyses explored whether interventions operated through acceptance of cues to smoke and app engagement. At 12 months, quit rates did not differ between arms (26% iCanQuit vs. 22% QuitGuide, OR = 1.22; 95% CI: 0.74 to 2.00, p = .43). iCanQuit positively impacted cessation via acceptance of cues to smoke (indirect effect = 0.23; 95% CI: 0.06 to 0.50, p < .001) and demonstrated higher engagement (no. logins, 28.4 vs. 12.1; p < .001) and satisfaction (91% vs. 75%, OR = 4.18; 95% CI: 2.12 to 8.25, p < .001) than QuitGuide. Although quit rates did not differ between arms, acceptance of cues to smoke seemed to play a crucial role in helping SGM adults quit smoking. Future interventions should consider promoting acceptance of cues to smoke in this population.

Do medications increase the efficacy of digital interventions for smoking cessation? Secondary results from the iCanQuit randomized trial.

BACKGROUND AND AIMS: iCanQuit is a smartphone application (app) proven efficacious for smoking cessation in a Phase III randomized controlled trial (RCT). This study aimed to measure whether medications approved by the US Food and Drug Administration (FDA) for smoking cessation would further enhance the efficacy of iCanQuit, relative to its parent trial comparator-the National Cancer Institute's (NCI's) QuitGuide app. DESIGN: Secondary analysis of the entire parent trial sample of a two-group (iCanQuit and QuitGuide), stratified, doubled-blind RCT. SETTING: United States. PARTICIPANTS: Participants who reported using an FDA-approved cessation medication on their own (n = 619) and those who reported no use of cessation medications (n = 1469). INTERVENTIONS: Participants were randomized to receive iCanQuit app or NCI's QuitGuide app. MEASUREMENTS: Use of FDA-approved medications was measured at 3 months post-randomization. Smoking cessation outcomes were measured at 3, 6 and 12 months. The primary outcome was 12-month self-reported 30-day point prevalence abstinence (PPA). FINDINGS: The data retention rate at the 12-month follow-up was 94.0%. Participants were aged 38.5 years, 71.0% female, 36.6% minority race/ethnicity, 40.6% high school or less education, residing in all 50 US States and smoking 19.2 cigarettes/day. The 29.6% of all participants who used medications were more likely to choose nicotine replacement therapy (NRT; 78.8%) than other cessation medications (i.e. varenicline or bupropion; 18.3 and 10.5%, respectively) and use did not differ by app treatment assignment (all P > 0.05). There was a significant (P = 0.049) interaction between medication use and app treatment assignment on PPA. Specifically, 12-month quit rates were 34% for iCanQuit versus 20% for QuitGuide [odds ratio (OR) = 2.36, 95% confidence interval (CI) = 1.59, 3.49] among participants reporting any medication use, whereas among participants reporting no medication use, quit rates were 28% for iCanQuit versus 22% for QuitGuide (OR = 1.41, 95% CI = 1.09, 1.82). Results were stronger for those using only NRT: 40% quit rates for iCanQuit versus 18% quit rates for QuitGuide (OR = 3.57, 95% CI = 2.20, 5.79). CONCLUSIONS: The iCanQuit smartphone app for smoking cessation was more efficacious than the QuitGuide smartphone app, regardless of whether participants used medications to aid cessation. Smoking cessation medications, especially nicotine replacement therapy, might enhance the efficacy of the iCanQuit app.

Relative Efficacy of an Acceptance and Commitment Therapy-Based Smartphone App with a Standard US Clinical Practice Guidelines-Based App for Smoking Cessation in Dual Users of Combustible and Electronic Cigarettes: Secondary Findings from a Randomized Trial.

BACKGROUND: While smartphone apps for smoking cessation have shown promise for combustible cigarette smoking cessation, their efficacy in helping dual users of combustible and electronic cigarettes (e-cigarettes) to quit cigarettes remains unknown. This study utilized data from a randomized trial to determine if an Acceptance and Commitment Therapy (ACT)-based app (iCanQuit) was more efficacious than a US Clinical Practice Guidelines-based app (QuitGuide) for combustible cigarette smoking cessation among 575 dual users. METHODS: The primary cessation outcome was self-reported, complete-case 30-day abstinence from combustible cigarettes at 12 months. Logistic regression assessed the interaction between dual use and treatment arm on the primary outcome in the full trial sample (N = 2,415). We then compared the primary outcome between arms among dual users (iCanQuit: n = 297; QuitGuide: n = 178). Mediation analyses were conducted to explore mechanisms of action of the intervention: acceptance of cues to smoke and app engagement. Results: There was an interaction between dual use of combustible and e-cigarettes and treatment arm on the primary outcome (p = 0.001). Among dual users, 12-month abstinence from cigarettes did not differ between arms (23% for iCanQuit vs. 27% for QuitGuide, p = 0.40). Mediation analysis revealed a significant positive indirect effect of the iCanQuit app on 12-month abstinence from cigarettes through acceptance of emotions that cue smoking (p = 0.004). CONCLUSIONS: Findings from this study of dual users of combustible and e-cigarettes showed no evidence of a difference in quit rates between arms. Acceptance of emotions that cue smoking is a potential mechanism contributing to cigarette smoking abstinence among dual users.

Use of e-Cigarettes in Cigarette Smoking Cessation: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Many adults use e-cigarettes to help them quit cigarette smoking. However, the impact of self-selected use of e-cigarettes on cigarette smoking cessation, particularly when concurrently receiving app-based behavioral interventions, remains unexplored. OBJECTIVE: This study used data from a randomized trial of 2 smartphone apps to compare 12-month cigarette smoking cessation rates between participants who used e-cigarettes on their own (ie, adopters: n=465) versus those who did not (ie, nonadopters: n=1097). METHODS: The study population included all participants who did not use e-cigarettes at baseline. "Adopters" were those who self-reported the use of e-cigarettes at either 3- or 6-month follow-ups. "Nonadopters" were those who self-reported no use of e-cigarettes at either follow-up time point. The primary cessation outcome was self-reported, complete-case, 30-day point prevalence abstinence from cigarette smoking at 12 months. Secondary outcomes were missing-as-smoking and multiple imputation analyses of the primary outcome, prolonged abstinence, and cessation of all nicotine and tobacco products at 12 months. In logistic regression models, we first examined the potential interaction between e-cigarette use and treatment arm (iCanQuit vs QuitGuide) on the primary cessation outcome. Subsequently, we compared 12-month cigarette smoking cessation rates between adopters and nonadopters separately for each app. RESULTS: There was suggestive evidence for an interaction between e-cigarette use and treatment arm on cessation (P=.05). In the iCanQuit arm, 12-month cigarette smoking cessation rates were significantly lower among e-cigarette adopters compared with nonadopters (41/193, 21.2% vs 184/527, 34.9%; P=.003; odds ratio 0.55, 95% CI 0.37-0.81). In contrast, in the QuitGuide arm, 12-month cigarette smoking cessation rates did not differ between adopters and nonadopters (46/246, 18.7% vs 104/522, 19.9%; P=.64; odds ratio 0.91, 95% CI 0.62-1.35). CONCLUSIONS: The use of e-cigarettes while concurrently receiving an app-based smoking cessation intervention was associated with either a lower or an unimproved likelihood of quitting cigarette smoking compared to no use. Future behavioral treatments for cigarette smoking cessation should consider including information on the potential consequences of e-cigarette use. TRIAL REGISTRATION: ClinicalTrials.gov NCT02724462; https://clinicaltrials.gov/study/NCT02724462.

Mi Vida Saludable: Content Validity and Reliability of The Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Questionnaire for Latina Women (PSEDPALW) for Cancer Survivors.

The purpose of this study is to conduct validity and reliability testing of a new instrument, the Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Questionnaire for Latina Women (PSEDPALW), which is for women who identify as Latina and are breast cancer survivors. PSEDPALW measures preferences and self-efficacy for four behaviors: physical activity (PA), fruit and vegetable (FV) intake, dietary fat (DF) intake, and added sugar (AS) intake (eight scales in total). Validity testing was conducted through an expert panel review and a cognitive interviewing focus group (n = 4). Reliability was tested via internal consistency reliability (n = 118) and test-retest reliability (n = 30). Validity testing was used to refine PSEDPALW. Reliability testing was conducted on three versions with 104, 47, and 41 items. PA scales had acceptable Cronbach's α (>0.70) but low ICC (NS). FV and DF scales had acceptable Cronbach's α (>0.70), with preferences for the shorter (47- and 41-item) versions (Cronbach's α < 0.70), and all scales had moderate ICC (p < 0.05, except the FV scale on the 104-item version (p = 0.07)). The AS preferences scale had Cronbach's α < 0.70, with self-efficacy > 0.70 for all versions and ICC moderate for all versions (p ≤ 0.01). PSEDPALW may be useful to assess diet and physical activity preferences and self-efficacy in theory-based diet and physical activity interventions in women who identify as Latina and are breast cancer survivors.

Energy-Adjusted Dietary Inflammatory Index and Diabetes Risk in Postmenopausal Hispanic Women.

BACKGROUND: Type 2 diabetes is a major public health concern in the United States and worldwide. The dietary inflammatory index (DII) and the energy-adjusted DII (E-DII) are tools that assess dietary inflammation. Previous evidence suggests that obesity can modify the association between inflammation and disease. OBJECTIVE: The aim of this study was to evaluate the association between the DII/E-DII and incident diabetes in self-identified Hispanic women from the Women's Health Initiative (WHI). The secondary aim was to evaluate whether obesity modifies the association between the DII/E-DII scores and incident diabetes. DESIGN: Participants were from the WHI Observational Study and the Clinical Trial Components (except women from the treatment arm in the Dietary Modification Trial) conducted among postmenopausal women in the United States. DII/E-DII scores were calculated from a self-administered food frequency questionnaire at baseline that included 122 food items, of which 12 are representative of Hispanic eating patterns. PARTICIPANTS/SETTINGS: Participants included 3,849 postmenopausal women who self-identified as Hispanic that were recruited for the WHI from 1993 to 1998 at 40 US clinical centers. MAIN OUTCOME MEASURES: The outcome was incident diabetes. STATISTICAL ANALYSIS PERFORMED: Cox regression models were used to assess the association between DII/E-DII and incident diabetes. Models were adjusted for age at baseline, lifestyle-related risk factors, known type 2 diabetes mellitus (T2DM) risk factors, and neighborhood socioeconomic status. Interaction was tested between the DII/E-DII scores and obesity. RESULTS: The incidence of diabetes was 13.1% after a median follow-up of 13 years. Higher E-DII scores were associated with a higher risk of incident diabetes (hazard ratio [HR], 1.09; 95% confidence interval [CI], 1.04-1.14). There was no interaction between E-DII scores and obesity (P = 0.73). CONCLUSIONS: Pro-inflammatory diets, as measured by higher E-DII scores, were associated with a higher risk of incident diabetes. Future research is needed for understanding how the inflammatory potential of diets can be decreased.

Efficacy of smartphone applications to help cancer patients quit smoking: Protocol of the Quit2Heal randomized controlled trial.

Cigarette smoking is highly prevalent among cancer patients in the United States (US), with up to half of cancer patients smoking at the time of their initial cancer diagnosis. However, evidence-based cessation programs are rarely implemented in oncology care, and smoking is not consistently treated in cancer treatment settings. Consequently, there is an urgent need for accessible and efficacious cessation treatments that are uniquely tailored to the needs of cancer patients. Here we describe the design and implementation of a randomized controlled trial (RCT) testing the efficacy of a smartphone app (Quit2Heal) versus a US Clinical Practice Guidelines-based app (QuitGuide) for smoking cessation among a planned sample of 422 cancer patients. Quit2Heal is designed to address cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting. Quit2Heal is based on the principles of Acceptance and Commitment Therapy, a behavioral therapy that teaches skills for accepting cravings to smoke without smoking, values-driven motivation to quit, and preventing relapse. The primary aim of the RCT is to determine whether Quit2Heal has significantly higher self-reported 30-day point prevalence abstinence at 12 months relative to QuitGuide. The trial will also determine whether Quit2Heal's effect on cessation is (1) mediated by improvements in cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting; and (2) moderated by baseline factors (e.g., cancer type, stage, time since diagnosis). If successful, Quit2Heal will offer a more efficacious, broadly scalable smoking cessation treatment that could be implemented alongside existing oncology care, thereby improving cancer outcomes.

Role of perceived discrimination and anxiety sensitivity in cigarette smoking among english-speaking latinx adults living in the United States.

OBJECTIVE: The Latinx/Hispanic (hereafter, Latinx) population in the United States (US) experiences significant tobacco-related health disparities. Extant work suggests social determinants of health (SDoH) such as perceived discrimination is an individual differences factor for cigarette smoking behavior among Latinx individuals who smoke cigarettes. Other research has suggested sensitivity to internal cues, referred to as anxiety sensitivity, is related to smoking among Latinx adults, but this work has not explored whether anxiety sensitivity may moderate the association between perceived discrimination and smoking behavior. METHOD: Therefore, the present investigation sought to explore the main and interactive association of perceived discrimination and anxiety sensitivity in relation to cigarettes smoked per day, severity of problems experienced when quitting, and perceived barriers for smoking cessation among 338 English-speaking Latinx individuals living in the US (Mage = 35.5 years; SD = 8.65; age range 18-61; 37.3% female) who smoke cigarettes. RESULTS: Results supported statistically significant main effects for perceived discrimination and anxiety sensitivity in relation to increased severity of problems experienced when quitting and perceived barriers for smoking cessation. These associations were evident after adjusting for a sociodemographic covariates. CONCLUSION: Overall, the present investigation suggests that both perceived discrimination and anxiety sensitivity are important constructs relevant to understanding smoking processes among Latinx adults who smoke cigarettes and should be integrated in theoretical models of smoking among this population.

Telehealth acceptance and commitment therapy for weight loss: Protocol of the WeLNES full scale randomized controlled trial.

Behavioral interventions delivered via one-on-one telephone coaching (hereafter referred to as telehealth) for weight loss have had great population-level reach but to date limited efficacy. Acceptance and Commitment Therapy (ACT) has promise to improve behavioral weight loss treatment efficacy by addressing the fundamental challenges of weight loss and maintenance: overeating in response to internal (e.g., stress) and external (e.g., high calorie foods) cues. Here we describe the Weight Loss, Nutrition, and Exercise Study (WeLNES) randomized controlled trial that is testing the efficacy of an ACT-based telehealth coaching intervention for weight loss in comparison to a Standard Behavioral Therapy (SBT)-based telehealth coaching intervention. A total of 398 adults with overweight or obesity are being recruited and randomized to either ACT or SBT telehealth coaching. Participants in both arms are offered twenty-five telehealth coaching sessions in year one and nine booster sessions in year two. All participants receive a Bluetooth-enabled scale to self-monitor weight and a Fitbit Inspire + Fitbit app for tracking diet and physical activity. The primary aim is to determine whether a greater proportion of ACT participants will achieve a clinically significant weight loss of ≥10% compared with SBT participants at 12-months. Secondary outcomes include change in weight from baseline to 6, 12, and 24-months. Whether the effect of ACT on weight loss is mediated by ACT processes and is moderated by baseline factors will also be examined. If ACT proves efficacious, ACT telehealth coaching will offer an effective, broadly scalable weight loss treatment-thereby making a high public health impact.

Acceptance and Commitment Therapy-Based Smartphone Applications for Cessation of Tobacco Use among Adults with High Nicotine Dependence: Results from the iCanQuit Randomized Trial.

Background: With 1 in 2 adult tobacco users being highly dependent on nicotine, population-based interventions specifically designed for this group are urgently needed. This study used data from a randomized trial to evaluate whether (1) Acceptance and Commitment Therapy (ACT) delivered via a smartphone application (iCanQuit) would be more efficacious for cessation of nicotine-containing tobacco products than the US Clinical Practice Guidelines (USCPG)-based application (QuitGuide) among highly nicotine-dependent adults, (2) the effect of treatment on cessation was mediated by increases in acceptance of cravings to smoke, and (3) treatment utilization and satisfaction differed by arm. Methods: A total of 1452 highly nicotine-dependent adults received the iCanQuit or QuitGuide application for 12-months. Cessation outcomes were self-reported complete-case 30-day abstinence of nicotine-containing tobacco products (e.g., combustible cigarettes, e-cigarettes, chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks) at 3, 6, and 12-month post-randomization timepoints, missing-as-smoking, and multiple imputation analyses. Acceptance of cues to smoke and satisfaction with the applications was also reported. Results: Participants who received iCanQuit were significantly more likely to report 30-day abstinence of nicotine-containing tobacco products than those who received QuitGuide at 12-months (24% vs. 17%; OR = 1.47 95% CI: 1.11, 1.95). iCanQuit participants utilized their application more frequently and reported greater satisfaction than those who received QuitGuide. Increases in participants' acceptance of cues to smoke mediated the intervention effect on cessation of nicotine-containing tobacco products. Conclusions: Among nicotine-dependent adults, an application-delivered ACT-based intervention was more engaging and efficacious than a USCPG-based intervention for cessation of nicotine-containing tobacco products.

Dietary inflammatory index and cardiovascular disease risk in Hispanic women from the Women's Health Initiative.

BACKGROUND: To evaluate the association between the dietary inflammatory index (DII®) and incident cardiovascular disease (CVD) in Hispanic women from the Women's Health Initiative (WHI), and to determine if body mass index (BMI) interacted with the DII scores. METHODS: Secondary analysis of baseline dietary data and long-term CVD outcomes among 3,469 postmenopausal women who self-identified as Hispanic enrolled in WHI. DII scores were calculated from self-administered food frequency questionnaires. The CVD outcomes included coronary heart disease (CHD) and stroke. Stratified Cox regression models were used to assess the relationship between DII scores and CVD in women with and without obesity. Models were adjusted for age, lifestyle risk factors, known risk factors, and neighborhood socioeconomic status. RESULTS: The incidence of CHD was 3.4 and 2.8% for stroke after a median follow-up of 12.9 years. None of the DIIs were associated with CVD risk in this sample of Hispanic women. BMI interacted with the DII (p < 0.20) and stratified models showed that the associations between the DII and CVD were only significant in women with overweight (p < 0.05). In this group, higher DII scores were associated with a higher risk of CHD (HR 1.27; 95% CI: 1.08, 1.51) and a higher risk of stroke (HR 1.32; 95% CI: 1.07, 1.64). CONCLUSION: Among postmenopausal Hispanic women with overweight, greater adherence to pro-inflammatory diets was associated with higher risk of CVD. Additional research is needed to understand how to promote long-term heart-healthy dietary habits to reduce inflammation and prevent CVD in at-risk Hispanic women.

Can a Single Variable Predict Early Dropout From Digital Health Interventions? Comparison of Predictive Models From Two Large Randomized Trials.

BACKGROUND: A single generalizable metric that accurately predicts early dropout from digital health interventions has the potential to readily inform intervention targets and treatment augmentations that could boost retention and intervention outcomes. We recently identified a type of early dropout from digital health interventions for smoking cessation, specifically, users who logged in during the first week of the intervention and had little to no activity thereafter. These users also had a substantially lower smoking cessation rate with our iCanQuit smoking cessation app compared with users who used the app for longer periods. OBJECTIVE: This study aimed to explore whether log-in count data, using standard statistical methods, can precisely predict whether an individual will become an iCanQuit early dropout while validating the approach using other statistical methods and randomized trial data from 3 other digital interventions for smoking cessation (combined randomized N=4529). METHODS: Standard logistic regression models were used to predict early dropouts for individuals receiving the iCanQuit smoking cessation intervention app, the National Cancer Institute QuitGuide smoking cessation intervention app, the WebQuit.org smoking cessation intervention website, and the Smokefree.gov smoking cessation intervention website. The main predictors were the number of times a participant logged in per day during the first 7 days following randomization. The area under the curve (AUC) assessed the performance of the logistic regression models, which were compared with decision trees, support vector machine, and neural network models. We also examined whether 13 baseline variables that included a variety of demographics (eg, race and ethnicity, gender, and age) and smoking characteristics (eg, use of e-cigarettes and confidence in being smoke free) might improve this prediction. RESULTS: The AUC for each logistic regression model using only the first 7 days of log-in count variables was 0.94 (95% CI 0.90-0.97) for iCanQuit, 0.88 (95% CI 0.83-0.93) for QuitGuide, 0.85 (95% CI 0.80-0.88) for WebQuit.org, and 0.60 (95% CI 0.54-0.66) for Smokefree.gov. Replacing logistic regression models with more complex decision trees, support vector machines, or neural network models did not significantly increase the AUC, nor did including additional baseline variables as predictors. The sensitivity and specificity were generally good, and they were excellent for iCanQuit (ie, 0.91 and 0.85, respectively, at the 0.5 classification threshold). CONCLUSIONS: Logistic regression models using only the first 7 days of log-in count data were generally good at predicting early dropouts. These models performed well when using simple, automated, and readily available log-in count data, whereas including self-reported baseline variables did not improve the prediction. The results will inform the early identification of people at risk of early dropout from digital health interventions with the goal of intervening further by providing them with augmented treatments to increase their retention and, ultimately, their intervention outcomes.

Efficacy of Web-Delivered Acceptance and Commitment Therapy (ACT) for Helping Black Adults Quit Smoking.

BACKGROUND: Digital smoking cessation interventions may reduce racial disparities in cessation because they are low cost, scalable, and can provide support at any place or time. Despite their promise, whether Black adults engage with and benefit from these tools is largely unknown. In a secondary analysis of a randomized trial, we explored the efficacy of an acceptance and commitment therapy (ACT)-based website (WebQuit) for smoking cessation compared to a US clinical practice guidelines-based website (Smokefree.gov) among Black adults. METHODS: A total of 316 Black adult smokers were enrolled in the trial between May 2017 and September 2018 and received access to WebQuit or Smokefree for 12 months. Participants self-reported on 30-day and 7-day abstinence from cigarette smoking at 3, 6, and 12-months. Treatment engagement was objectively measured and compared between arms. Participants also reported on their willingness to accept cues to smoke without smoking. RESULTS: WebQuit versus Smokefree participants engaged more with their website (higher number of logins, Incidence Rate Ratio (IRR) = 2.21; 95% CI: 1.70, 2.89). Complete-case 30-day point prevalence abstinence (PPA) at 12-months was 34% for WebQuit vs. 29% for Smokefree (OR = 1.22 95% CI: 0.73, 2.04). Increases in participants' willingness to accept cues to smoke mediated the intervention effect on abstinence from cigarette smoking at 12 months. CONCLUSIONS: This study addressed the lack of research on the utilization and efficacy of digital interventions for helping Black adults quit smoking. WebQuit participants engaged more with their website and quit smoking at a somewhat higher rate relative to Smokefree participants, albeit nonsignificant. Findings suggest high acceptability of ACT-based digital interventions to enable Black adult smokers to engage and sustain behavior changes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01812278.

A digital health intervention to improve nutrition and physical activity in breast cancer survivors: Rationale and design of the Cook and Move for Your Life pilot and feasibility randomized controlled trial.

BACKGROUND: The design of a randomized pilot trial evaluating the feasibility of two doses of a digital health intervention promoting changes in nutrition and physical activity in breast cancer (BC) survivors is described. METHODS: Eligible women were adults with history of early-stage breast cancer and > 60 days post-treatment, consumed <5 servings/day of fruits/vegetables and/or engaged in <150 min/week of aerobic moderate-to-vigorous physical activity, and had internet access. Participants were randomized to 6 months of either a "low" (1 session) or "high" (12 sessions) dose digital health intervention. Zoom-delivered sessions focused on improving diet and physical activity through didactic and experiential classes delivered by a registered dietitian, chef, exercise physiologist, and culinary educator. All study participants received weekly motivational texts, a Fitbit, and study website access. Diet, accelerometry, anthropometric, psychosocial, and biospecimen data were collected remotely at baseline and six months. Primary outcome was feasibility measured via accrual rate, adherence, retention, and acceptability. RESULTS: Recruitment began in December 2019, was suspended in March 2020 due to the COVID-19 pandemic, resumed September 2020, and concluded in January 2021. Women were identified from the local BC registry and flyers posted in the oncology clinic. Of 929 women recruited, 321 completed the screening assessment, and of these, 138 were eligible. A total of 74 women were enrolled and randomized to the study. CONCLUSION: BC survivors were successfully enrolled in a digital health nutrition and physical activity intervention. If feasible, this intervention will be tested in larger and more diverse populations of cancer survivors. TRIAL REGISTRATION: ClinicalTrials.govNCT04200482.

Can a smartphone application help Hispanic/Latinx adults quit smoking? A randomized trial secondary analysis.

Introduction: There are no known efficacious digital smoking cessation interventions for Hispanic/Latinx adults who smoke. This study is a secondary analysis using data from a randomized trial to evaluate whether Acceptance and Commitment Therapy (ACT) delivered via a smartphone app (iCanQuit) would be more efficacious for smoking cessation than the US Clinical Practice (USCPG)-based app (QuitGuide) in a sample of Hispanic/Latinx participants. Methods: A total of 210 Hispanic/Latinx adults who smoke were randomized to receive the iCanQuit or QuitGuide app for 12-months. Participants self-reported on 30-day abstinence from cigarette smoking at the 3-month, 6-month, and 12-month follow-ups; 7-day abstinence at all follow-ups; abstinence from other nicotine/tobacco products at 12-months; and continuous prolonged abstinence from 3 to 12-months. Participants also reported on their willingness to accept cues to smoke without smoking and satisfaction with their apps. Results: A total of 176 (84%) participants reported on study outcomes at the 12-month follow-up. Compared to QuitGuide participants, iCanQuit participants were significantly more likely to report 30-day abstinence from cigarette smoking at 12-months (34% iCanQuit, 20% QuitGuide; p=0.026). iCanQuit participants utilized their app more frequently and reported greater satisfaction with their assigned app than those who received the QuitGuide app. Increases in participants' willingness to accept cues to smoke mediated the intervention effect on abstinence from cigarette smoking at 12-months. Conclusions: Acceptance and Commitment Therapy-delivered via a smartphone app may be efficacious for helping Hispanic/Latinx adults abstain from cigarette smoking. Replication in a fully powered randomized trial that focuses on an independent sample of Hispanic/Latinx adults is now needed.

Web-delivered Acceptance and Commitment Therapy (ACT) for smoking cessation: Is it engaging and efficacious for US Hispanic/Latinx adult smokers?

Hispanic/Latinx adult smokers in the United States (US) face barriers to receiving and utilizing evidenced-based cessation treatments compared with other racial/ethnic groups. The lack of efficacious and accessible smoking cessation treatments for this population further contributes to such smoking disparities. In a secondary analysis, we explored the efficacy of an Acceptance and Commitment Therapy (ACT)-based website (WebQuit.org) versus a US Clinical Practice Guidelines (USCPG)-based website (Smokefree.gov) for smoking cessation in a subset of Hispanic/Latinx adult participants enrolled in the WebQuit trial. Of the 2,637 participants who were randomized in the parent trial, 222 were Hispanic/Latinx (n = 101 in WebQuit, n = 121 in Smokefree). Smoking cessation outcomes were measured at 3, 6, and 12-months. The primary outcome was self-reported complete-case 30-day point prevalence abstinence (PPA) at 12-months. Treatment engagement and satisfaction, change in acceptance of urges to smoke, and commitment to quitting smoking were compared across conditions. Retention rate was 88% at 12-months. WebQuit participants had higher odds of smoking cessation compared to Smokefree participants at 12-months (40% vs. 25%; OR = 1.93 95% CI: 1.04, 3.59). Findings were similar using multiple imputation. WebQuit participants engaged more with the website than Smokefree participants through multiple indicators of engagement, including spending more time using the website (IRR = 2.32; 95% CI: 1.68, 3.20). Although WebQuit participants engaged more with the website than Smokefree participants, there was no evidence that differences in quit rates were mediated by engagement level. This study provides initial empirical evidence that digital interventions may be efficacious for helping Hispanic/Latinx adults quit smoking.

Smoking Cessation Smartphone App Use Over Time: Predicting 12-Month Cessation Outcomes in a 2-Arm Randomized Trial.

BACKGROUND: Little is known about how individuals engage over time with smartphone app interventions and whether this engagement predicts health outcomes. OBJECTIVE: In the context of a randomized trial comparing 2 smartphone apps for smoking cessation, this study aimed to determine distinct groups of smartphone app log-in trajectories over a 6-month period, their association with smoking cessation outcomes at 12 months, and baseline user characteristics that predict data-driven trajectory group membership. METHODS: Functional clustering of 182 consecutive days of smoothed log-in data from both arms of a large (N=2415) randomized trial of 2 smartphone apps for smoking cessation (iCanQuit and QuitGuide) was used to identify distinct trajectory groups. Logistic regression was used to determine the association of group membership with the primary outcome of 30-day point prevalence of smoking abstinence at 12 months. Finally, the baseline characteristics associated with group membership were examined using logistic and multinomial logistic regression. The analyses were conducted separately for each app. RESULTS: For iCanQuit, participants were clustered into 3 groups: "1-week users" (610/1069, 57.06%), "4-week users" (303/1069, 28.34%), and "26-week users" (156/1069, 14.59%). For smoking cessation rates at the 12-month follow-up, compared with 1-week users, 4-week users had 50% higher odds of cessation (30% vs 23%; odds ratio [OR] 1.50, 95% CI 1.05-2.14; P=.03), whereas 26-week users had 397% higher odds (56% vs 23%; OR 4.97, 95% CI 3.31-7.52; P<.001). For QuitGuide, participants were clustered into 2 groups: "1-week users" (695/1064, 65.32%) and "3-week users" (369/1064, 34.68%). The difference in the odds of being abstinent at 12 months for 3-week users versus 1-week users was minimal (23% vs 21%; OR 1.16, 95% CI 0.84-1.62; P=.37). Different baseline characteristics predicted the trajectory group membership for each app. CONCLUSIONS: Patterns of 1-, 3-, and 4-week smartphone app use for smoking cessation may be common in how people engage in digital health interventions. There were significantly higher odds of quitting smoking among 4-week users and especially among 26-week users of the iCanQuit app. To improve study outcomes, strategies for detecting users who disengage early from these interventions (1-week users) and proactively offering them a more intensive intervention could be fruitful.

Efficacy of smartphone applications for smoking cessation in heavy-drinking adults: Secondary analysis of the iCanQuit randomized trial.

INTRODUCTION: Efficacious smoking cessation treatments are needed for heavy-drinking adults who often have difficulty quitting smoking. In a secondary analysis of a parent randomized controlled trial, we explored the efficacy of an Acceptance and Commitment Therapy (ACT)-based smartphone application (iCanQuit) versus a US Clinical Practice Guidelines (USCPG)-based smartphone application (QuitGuide) for smoking cessation among heavy-drinking participants (4 + drinks/day for women; 5 + drinks/day for men). METHODS: Participants were randomized to receive iCanQuit (n = 188) or QuitGuide (n = 160) for 12-months. Smoking cessation outcomes were measured at 3, 6 and 12-months. The primary outcome was self-reported complete-case 30-day point prevalence abstinence (PPA) at 12-months. Secondary outcomes were 7-day PPA at all timepoints; prolonged abstinence; and cessation of all nicotine-containing products at 12-months. Multiple imputation and missing-as-smoking analyses were also conducted. Exploratory outcomes were cessation of both smoking and heavy drinking and change in alcohol use (drinks/day) at 12-months. Treatment engagement and satisfaction and change in ACT-based processes were compared between arms. RESULTS: Retention rate was 85% at 12-months and did not differ by arm. At 12-months, iCanQuit participants had nearly double the odds of smoking cessation compared to QuitGuide (complete-case 30-day PPA = 24% vs. 15%; OR = 1.87 95% CI: 1.03, 3.42). Findings were similar for the multiple imputation and missing-as-smoking outcomes at 12-months. Combined cessation of smoking and heavy drinking, and alcohol use at 12-months did not differ by arm. iCanQuit was significantly more engaging and satisfying than QuitGuide. Increased acceptance of thoughts about smoking mediated the effect of treatment on cessation of heavy drinking at 12-months. CONCLUSIONS: The iCanQuit smartphone application was more efficacious and engaging for smoking cessation among heavy-drinking adults than a USCPG-based smartphone application.