Six-Month Outcomes of a Theory- and Technology-Enhanced Physical Activity Intervention for Latina Women (Pasos Hacia La Salud II): Randomized Controlled Trial.

BACKGROUND: More than half (55%) of Latina women do not meet aerobic physical activity (PA) guidelines, and frequently cite time, childcare, and transportation as barriers to PA. In addition to linguistic adaptations for this population, successful PA interventions for Latina women addressed these barriers through remote intervention delivery approaches (eg, mail, phone, or web delivery). OBJECTIVE: We aimed to evaluate 6-month outcomes of a randomized trial comparing a Spanish-language, individually tailored, web-delivered PA intervention (original) to an enhanced version with text messages and additional features (enhanced). Further, we evaluated if increases in PA at 6 months were moderated by baseline activity status. METHODS: In total, 195 Latina women aged 18-65 years participated in a trial comparing the efficacy of the enhanced versus original interventions at initiating PA behavior change. We examined minutes per week of accelerometer-measured PA in the enhanced versus original arms, and the proportion of each arm meeting aerobic PA guidelines (150 min/wk at 6 mo). For moderator analyses, participants were classified as inactive (0 min/wk) or low active (1-90 min/wk) at baseline, measured via the 7 Day Physical Activity Recall interview. RESULTS: PA increased from 19.7 (SD 47.9) minutes per week at baseline to 46.9 (SD 66.2) minutes per week at 6 months in the enhanced arm versus 20.6 (SD 42.7) minutes per week to 42.9 (SD 78.2) minutes per week in the original arm (P=.78). Overall, 30% (31/103) of the enhanced group met aerobic PA guidelines at 6 months, compared to 21% (19/92) of the original group (odds ratio [OR] 1.75, 95% CI 0.87-3.55). Baseline PA (inactive vs low active) moderated treatment effects on PA. For inactive participants, there were no group differences at 6 months (b=7.1; SE 22.8; P=.75), while low-active participants increased more in enhanced than original (b=72.5; SE 27.9; P=.01). For low-active participants, 45% (46/103) of the enhanced group met PA guidelines at 6 months, versus 20% (18/92) of the original arm (OR 3.29, 95% CI 1.05-11.31). For inactive participants, there were no group differences (25/103, 24% vs n=19/92, 21% for enhanced vs original, respectively; OR 1.28, 95% CI 0.54-3.06). CONCLUSIONS: Intervention effects were conditional on baseline PA. For low-active Latina women, the enhanced intervention was more effective at increasing PA. Additional tailored intervention enhancements may be necessary to increase PA for inactive Latina women. TRIAL REGISTRATION: ClinicalTrials.gov NCT03491592; https://www.clinicaltrials.gov/study/NCT03491592. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-022-06575-4.

A randomized controlled trial examining general parenting training and family-based behavioral treatment for childhood obesity: The ReFRESH study design.

Family-based behavioral treatment (FBT) is one of the most effective treatments for childhood obesity. These programs include behavior change strategies and basic parenting training to help parents make healthy diet and physical activity changes for their children. While effective, not all families respond to this program. Additional training on how to effectively deliver these behavior change strategies may improve outcomes. The authoritative parenting style is associated with many positive academic and socio-emotional outcomes in children, and is characterized by displays of warmth and support while also being consistent with setting limits and boundaries. This parenting style has also been associated with normal weight status. Furthermore, parenting training programs that promote this parenting style for children with behavioral issues have shown unintended effects on decreasing child weight status. Therefore, our goal was to examine the effect of adding more intensive parenting training to FBT on child weight status. We randomized 140 children and their parent to either FBT or FBT + Parenting Training (FBT + PT). Assessments were conducted at baseline, mid-treatment (month 3), post-treatment (month 6), 6-month follow-up (month 12), and 12-month follow-up (month 18). Primary outcome was change in child weight status. Secondary outcomes were rates of drop-out, treatment adherence, and acceptability. If effective, this program may provide another alternative for families to help improve outcomes in childhood obesity management.

Pasos Hacia La Salud II: A Superiority RCT Utilizing Technology to Promote Physical Activity in Latinas.

INTRODUCTION: Latinas face an increased risk for chronic diseases associated with insufficient physical activity (PA). The researchers previously showed that a website-based intervention could increase PA among insufficiently active Latinas, yet rates of meeting national PA guidelines were low. The original intervention was enhanced by adding additional features, content, and points of contact, including via text messaging. This study tests the efficacy of the enhanced intervention compared with the original, aimed at maximizing and sustaining PA gains across 24 months. It also examines if increases in PA differed by baseline PA. STUDY DESIGN: The researchers conducted a superiority randomized controlled trial (data collected 2018-2022, analyzed 2023). SETTING/PARTICIPANTS: Participants were 195 Spanish-speaking Latinas ages 18-65 in the Providence, RI area. INTERVENTION: The original intervention is an empirically supported Spanish-language, individually-tailored, website-delivered PA intervention. The enhanced intervention includes text messaging and additional data-driven content and interactive features. MAIN OUTCOME MEASURES: Total weekly minutes of moderate to vigorous PA (MVPA) was measured via accelerometry and self-report at 6, 12, 18, and 24 months. RESULTS: Participants in both groups increased their MVPA over 24 months. There were no significant between-group differences at 6 or 12 months; at 18 months the enhanced intervention group had higher levels of self-reported (mean (sd): 90.35 (43.55) vs 70.18 [9.99]) and accelerometer-measured (66.21 [18.26] vs 60.27 [16.00]) MVPA compared to the original intervention group. They also had higher levels of self-reported (111.17 [23.35] vs 81.44 [1.82]) and accelerometer-measured (63.76 [15.12] vs 54.86 [14.59]) MVPA at 24 months. Baseline PA moderated the intervention effect. CONCLUSIONS: This study demonstrates the potential to enhance the efficacy of website-based PA interventions by utilizing text messaging, and adding more interactive features, content, and phone support. These enhancements may be particularly beneficial in supporting long-term PA maintenance. TRIAL REGISTRATION: This study is registered at www. CLINICALTRIAL: gov (NCT03491592).

Body image and physical activity in Latinas.

Women with negative body image engage in less physical activity. The purpose of this study is to examine the relationship between body image and physical activity in Latinas participating in a lifestyle program. Participants (age 43.8 ± 10.1 years and BMI 30.4 ± 5.2 kg/m2) were enrolled in a 12-month culturally and linguistically adapted, individually tailored, intervention focused on increasing moderate-to-vigorous intensity physical activity (MVPA). Longitudinal assessments were conducted on body image dissatisfaction (BID) using the Figure Rating Scale, MVPA using the 7-day PAR interview, and objectively measured body weight. Pre-intervention BID did not significantly predict MVPA change. Participants experienced considerable reduction in BID. Greater MVPA engagement and weight loss were independently related to BID reduction. Acculturation did not moderate these relationships. Body image improved in Latinas participating in a cognitive and behavioral physical activity intervention regardless of weight loss and acculturation level.

The impact of a lifestyle intervention on postpartum weight retention among US Hispanic women with overweight and obesity.

Introduction: To evaluate the effect of a culturally-modified, motivationally-targeted, individually-tailored lifestyle intervention on postpartum weight retention among Hispanic women with overweight/obesity. Materials and methods: Proyecto Mamá was a randomized controlled trial conducted in western Massachusetts (2014-2020). Hispanic women with overweight/obese pre-pregnancy BMI (n = 148) were randomized in early pregnancy to a Lifestyle Intervention (LI) or a Health & Wellness (HW) comparison arm. The LI was based upon theoretical concepts, used a low-cost, high-reach strategy, and focused on healthy exercise and diet with follow-up through 12-months postpartum. The primary outcome of change in weight was calculated as the difference between pre-pregnancy weight and 6-week, 6-month, and 12-month postpartum weight. The secondary outcome was achievement of 5 % weight reduction from pre-pregnancy weight. Retention was 68.2 % in the overall postpartum period and 31.0 % at 12-months. Results: In intent-to-treat analyses, compared to the HW arm, there was no difference in postpartum weight retention at 6-weeks (0.0 kg, 95 % CI: -3.4, 3.5), 6-months (-1.8 kg, 95 % CI: -5.6, 2.0), or 12-months (-2.0 kg, 95 % CI: -7.0, 3.1). In a secondary complete case analysis, compared to the HW arm, the LI arm had 5.5 times higher odds of meeting the postpartum weight reduction goal (aOR = 5.5, 95 % CI: 1.7, 17.9) adjusting for pre-pregnancy weight. Conclusions: A lifestyle intervention among at-risk Hispanic women with overweight/obesity had no overall impact on postpartum weight, but a beneficial impact among those who completed the trial. Future studies should focus on increasing the feasibility and acceptability of the intervention in this at-risk population.

Improvements in stress among Latinas participating in a randomized controlled trial of technology-supported physical activity interventions.

High levels of stress and inactivity likely contribute to chronic disease disparities among Latinas in the U.S. and call for intervention. To inform such efforts, the current study examined the relationships among changes (over time) in physical activity, stress, and related cardiometabolic biomarkers among sedentary (mostly) first generation Latinas. Data are taken from a randomized controlled trial (N = 199 Latinas) of two home-based physical activity interventions (Original vs. theory- and technology- Enhanced versions). Physical activity and perceived stress were assessed at baseline and 6 and 12 months. Blood draws occurred at baseline and 6 months in a random subsample (N = 153). The participants were underactive (<60/min week of moderate-to-vigorous physical activity) Mexican American (89%) women with moderate perceived stress scores (M = 21.49, SD = 8.55, range = 0-40) and excess weight (M BMI = 30.6) at baseline. Overall, participants reported decreases in stress after 6 months enroled in the physical activity programs. The odds of a reduction in perceived stress were 11% higher among Enhanced versus Original Intervention participants (OR = 1.11, 95% CI: 1.05-2.27). Those who met physical activity guidelines were significantly more likely to report reductions in perceived stress over 6 months (OR = 1.92, 95% CI: 1.08-4.16). Furthermore, those who reported reductions in perceived stress over 6 months reported significantly more moderate-to-vigorous physical activity at 12 months (+69 min/week, SE = 27.98, p = 0.01) compared to those who did not. Greater reductions in perceived stress over 6 months were associated with greater improvements in cardiometabolic biomarkers (HbA1c, triglycerides, p's < 0.05). These results support a bidirectional relationship between improvements in stress and physical activity among Latinas. Future implications include using physical activity to address stress management and health disparities in this community.

Barriers and Facilitators to Muscle-Strengthening Activity Among Latinas in the U.S.: Results From Formative Research Assessments.

BACKGROUND: Latinas are disproportionately affected by low physical activity (PA) levels and related health conditions (e.g., diabetes, obesity). Few Latinas in the U.S. (17%) meet the National PA Guidelines for both aerobic PA and muscle-strengthening activity (MSA), yet, research to date in this population has focused almost exclusively on aerobic PA. Performing regular MSA is linked with numerous health improvements and reduced mortality; thus, may be key to addressing health disparities in this community. This study examined perspectives on engaging in MSA among Latinas enrolled in two aerobic PA RCTs. METHODS: Brief quantitative surveys were conducted to assess interest in MSA among Latinas (N = 81), along with 19 follow-up in-depth semi-structured interviews on knowledge, barriers, and facilitators for engaging in regular MSA. Interview transcripts were analyzed by two independent bilingual researchers using a directed content analysis approach. RESULTS: Eighty-one Latinas (18-65 years) completed the survey. Most (91%) expressed interest in learning more about MSA and 60% reported not knowing how to do MSA as a substantial MSA barrier. Interview results indicated Latinas were aware of health benefits of MSA and motivated to engage in MSA but reported barriers (e.g., perception that MSA is for men, a taboo topic, and lack of knowledge on how to do MSA). CONCLUSION: This study contributes to a critical gap in PA research among Latinas. Findings will inform future culturally appropriate MSA interventions in this at-risk population. Addressing MSA and aerobic PA together in future interventions will provide a more comprehensive approach to reducing PA-related health disparities in Latinas than aerobic PA alone.

The Impact of a Lifestyle Intervention on Postpartum Cardiometabolic Risk Factors Among Hispanic Women With Abnormal Glucose Tolerance During Pregnancy: Secondary Analysis of a Randomized Trial.

BACKGROUND: Women with abnormal glucose tolerance during pregnancy are at risk for cardiovascular disease (CVD), with higher rates among Hispanics. However, studies on the impact of lifestyle interventions on postpartum CVD profiles are sparse. METHODS: This is a secondary analysis of a controlled trial among a subsample of Hispanic women with abnormal glucose tolerance participating in Estudió PARTO (Project Aiming to Reduce Type twO diabetes; mean age = 28.2 y, SD: 5.8) who were randomized to a culturally modified Lifestyle intervention (n = 45) or a comparison Health and Wellness intervention (n = 55). Primary endpoints were biomarkers of cardiovascular risk (lipids, C-reactive protein, fetuin-A, and albumin-to-creatinine ratio) and insulin resistance (fasting insulin, glucose, HbA1c, homeostasis model assessment, leptin, tumor necrosis factor-alpha, and adiponectin) measured at baseline (6-wk postpartum) and 6 and 12 months. RESULTS: In intent-to-treat analyses, there were no significant differences in changes in biomarkers of CVD risk or insulin resistance over the postpartum year. In prespecified sensitivity analyses, women adherent with the Lifestyle Intervention had more favorable improvements in insulin (intervention effect = -4.87, SE: 1.93, P = .01) and HOMA-IR (intervention effect = -1.15, SE: 0.53, P = .03) compared with the Health and Wellness arm. In pooled analyses, regardless of intervention arm, women with higher postpartum sports/exercise had greater increase in HDL-cholesterol (intervention effect = 6.99, SE: 1.72, P = .0001). CONCLUSIONS: In this randomized controlled trial among Hispanic women with abnormal glucose tolerance, we did not observe a significant effect on postpartum biomarkers of CVD risk or insulin resistance. Women adherent to the intervention had more favorable changes in insulin and HOMA-IR.

The Hombres Saludables Physical Activity Web-Based and Mobile Phone Intervention: Pilot Randomized Controlled Trial With Latino Men.

BACKGROUND: Owing to structural-level, interpersonal-level, and individual-level barriers, Latino men have disproportionately high rates of physical inactivity and experience related chronic diseases. Despite these disparities, few physical activity (PA) interventions are culturally targeted for Latino men. OBJECTIVE: This study reported the feasibility and acceptability of Hombres Saludables PA intervention for Latino men. We also reported the preliminary efficacy of the intervention on PA change and provided the results of the exploratory moderator and mediator analysis. METHODS: We completed a 6-month, single-blind, pilot randomized controlled trial of Hombres Saludables with Latino men aged between 18 and 65 years. Men were randomized to either (1) a theory-driven, individually tailored, internet-based and SMS text message-based, Spanish-language PA intervention arm or (2) a nutrition and wellness attention contact control arm that was also delivered via the web and SMS text message. We assessed the primary study outcomes of feasibility using participant retention and acceptability using postintervention survey and open-ended interview questions. We measured the preliminary efficacy via change in minutes of moderate to vigorous PA per week using ActiGraph wGT3X-BT accelerometry (primary measure) and self-reported minutes per week using 7-day Physical Activity Recall. Participants completed the assessments at study enrollment and after 6 months. RESULTS: The 38 participants were predominantly Dominican (n=8, 21%) or Guatemalan (n=5, 13%), and the mean age was 38.6 (SD 12.43) years. Retention rates were 91% (21/23) for the PA intervention arm and 100% (15/15) for the control arm. Overall, 95% (19/20) of the intervention arm participants reported that the Hombres study was somewhat to very helpful in getting them to be more physically active. Accelerometry results indicated that participants in the intervention group increased their PA from a median of 13 minutes per week at study enrollment to 34 minutes per week at 6 months, whereas the control group participants showed no increases. On the basis of self-reports, the intervention group was more likely to meet the US PA guidelines of 150 minutes per week of moderate to vigorous PA at 6-month follow-up, with 42% (8/19) of the intervention participants meeting the PA guidelines versus 27% (4/15) of the control participants (odds ratio 3.22, 95% CI 0.95-13.69). Exploratory analyses suggested conditional effects on PA outcomes based on baseline stage of motivational readiness, employment, and neighborhood safety. CONCLUSIONS: The PA intervention demonstrated feasibility and acceptability. Results of this pilot study indicate that the Hombres Saludables intervention is promising for increasing PA in Latino men and suggest that a fully powered trial is warranted. Our technology-based PA intervention provides a potentially scalable approach that can improve health in a population that is disproportionately affected by low PA and related chronic disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT03196570; https://classic.clinicaltrials.gov/ct2/show/NCT03196570. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/23690.

Cost effectiveness of a technology-enhanced physical activity intervention for Latinas.

Latinas report low levels of physical activity (PA) and disproportionate risk of lifestyle-related diseases. Enhancements to evidence-based PA interventions may increase efficacy; however, uptake of interventions will likely depend on costs. To describe costs and examine the cost-effectiveness of two interventions for helping Latinas reach national aerobic PA guidelines. Adult Latinas (N = 199) were randomly assigned to an Original theory-based mail-delivered intervention or an Enhanced version with texting and additional calls and materials. Meeting PA guidelines was measured by the 7-Day PA Recall interview at baseline, 6 and 12 months. Intervention costs were estimated from a payer perspective. Incremental cost-effectiveness ratios (ICERs) were calculated as the additional cost per participant meeting guidelines in the Enhanced versus Original intervention. At baseline, no participants met guidelines. After 6 months, 57% and 44% in the Enhanced and Original arms met guidelines, respectively; at 12 months, rates fell to 46% and 36%. Cost per person of the Enhanced and Original interventions were $184 and $173 at 6 months, respectively, and $234 and $203 at 12 months. The primary additional expense in the Enhanced arm was staff time. ICERs were $87 per additional person meeting guidelines at 6 months (per sensitivity analysis, $26 if delivered by volunteers and $114 by medical assistants), and $317 at 12 months (sensitivity analysis: $57 and $434). Incremental costs per person meeting guidelines in the Enhanced arm were modest and could be warranted given the potential health benefits of meeting PA guidelines.

Latinas report low levels of physical activity (PA) and high rates of related diseases. Existing evidence-based interventions for Latinas may need additional enhancements to help this population meet national PA guidelines. Enhancements could both increase the effectiveness and the costs of PA interventions. It is thus important to consider the costs and benefits of the different versions of these interventions, as these may influence whether the interventions are adopted and sustained on a larger scale in the future. This study describes the costs of two versions of a PA intervention (an original and a technology-enhanced version) and examines their cost effectiveness in helping sedentary Latina participants reach national PA guidelines. At the beginning of the study, none of the participants were meeting PA guidelines. More participants in the Enhanced intervention, compared to the Original intervention, were meeting guidelines both at 6 months (57% vs. 44%) and 12 months (46% vs. 36%). Costs were also higher for the Enhanced Intervention both at 6 and 12 months. Each additional person meeting guidelines in the Enhanced (vs. Original) group cost $87 at 6 months and $317 at 12 months. Given potential cost savings in medical care associated with meeting PA guidelines, these interventions could ultimately save money in addition to promoting health.

Comparing a recommendation for self-paced versus moderate intensity physical activity for midlife adults: Rationale and design.

Current U.S. guidelines recommend that adults obtain 150 min per week of moderate intensity physical activity (PA), 75 min of vigorous intensity PA, or some equivalent combination. However, less than half of U.S. adults reach this goal, with the proportion even smaller among adults with overweight or obesity. Moreover, regular PA declines after age 45-50. Previous research suggests a shift in national guidelines to emphasize PA of a self-selected intensity (i.e., self-paced), instead of prescribed moderate intensity PA, may result in better adherence to PA programs, particularly among midlife adults with overweight or obesity. The present paper presents the protocol for a field-based RCT testing the hypothesis that adherence to PA programs is improved when PA is explicitly recommended to be self-paced rather than prescribed at moderate intensity among midlife (ages 50-64) adults (N = 240) with overweight or obesity. All participants receive a 12-month intervention designed to help them overcome barriers to regular PA and are randomly assigned to either self-paced or prescribed moderate intensity PA. The primary outcome is total volume of PA (minutes by intensity) as measured by accelerometry. Secondary outcomes include self-reported min/week of PA and changes in bodyweight. Additionally, using ecological momentary assessment, we examine putative mediators of treatment effects. We hypothesize self-paced PA will lead to a more positive affective response to PA, more perceived autonomy, and lower perceived exertion during PA, and thus greater increases in PA behavior. Findings will have direct implications for PA intensity recommendations among midlife adults with overweight or obesity.

Clinical Predictors of Adherence to Exercise Training Among Individuals With Heart Failure: THE HF-ACTION STUDY.

PURPOSE: Suboptimal adherence is a major limitation to achieving the benefits of exercise interventions, and our ability to predict and improve adherence is limited. The purpose of this analysis was to identify baseline clinical and demographic characteristics predicting exercise training adherence in the HF-ACTION study cohort. METHODS: Adherence to exercise training, defined by the total duration of exercise performed (min/wk), was evaluated in 1159 participants randomized to the HF-ACTION exercise intervention. More than 50 clinical, demographic, and exercise testing variables were considered in developing a model of the min/wk end point for 1-3 mo (supervised training) and 10-12 mo (home-based training). RESULTS: In the multivariable model for 1-3 mo, younger age, lower income, more severe mitral regurgitation, shorter 6-min walk test distance, lower exercise capacity, and Black or African American race were associated with poorer exercise intervention adherence. No variable accounted for >2% of the variance and the adjusted R2 for the final model was 0.14. Prediction of adherence was similarly limited for 10-12 mo. CONCLUSIONS: Clinical and demographic variables available at the initiation of exercise training provide very limited information for identifying patients with heart failure who are at risk for poor adherence to exercise interventions.

Design of the FRESH-DOSE study: A randomized controlled noninferiority trial evaluating a guided self-help family-based treatment program for children with overweight or obesity.

Overweight and obesity affect 45% of children and increases the risk for several negative health sequelae. Family-Based Behavioral Treatment (FBT) is the most efficacious treatment for child weight management and consists of nutrition and physical activity education, behavior change skills and parenting skills training. FBT is time and staff intensive and can include 20, 60-min separate groups for parents and children, as well as 20-min behavior coaching sessions to help problem solve barriers to implementing the skills learned and individualize the program. Guided self-help (GSH) therapies involve providing families a manual to review independently and brief coaching sessions by an interventionist to facilitate adherence. We developed a GSH version of FBT (gshFBT) which provides a manual to both parents and children and includes 14, 20-min coaching sessions over 6-months. The current study randomized 150 children (mean age = 10.1 years (SD = 1.38); mean BMI% = 97.3% (SD = 2.84); mean BMIz = 2.09 (SD = 0.40); 49% female; 43% Hispanic) and one of their parents (mean age = 41.8 years (SD = 6.52); mean BMI = 32.0 (SD = 7.24); 87.3% female; 43% Hispanic) to either a group-based FBT program or a gshFBT program. Assessments are conducted at baseline, post-treatment (6 months), 6-month follow-up (12 months) and 12-month follow-up (18 months). Primary outcomes are child weight change (BMIz) and cost effectiveness. Recruitment occurred between May 2017 and October 2021 and follow-up assessments are underway. Given the public health concern for children with obesity and the low level of access to FBT, gshFBT could prove extremely useful to provide intervention to a greater proportion of the population.

Pasos Hacia La Salud II: study protocol for a randomized controlled trial of a theory- and technology-enhanced physical activity intervention for Latina women, compared to the original intervention.

BACKGROUND: Latinas are at increased risk for many lifestyle-related chronic diseases and are one of the least physically active populations in the US Innovative strategies are needed to help Latinas achieve the health benefits associated with physical activity (PA). This manuscript describes the study protocol of the Pasos Hacia La Salud II Study, which builds upon our previous research to test an enhanced individually-tailored, text-message and website-delivered, Spanish-language intervention (enhanced intervention), in comparison to the original web-based Pasos Hacia La Salud Intervention (original intervention). METHODS: Sedentary Latinas between the ages of 18-65 will be recruited and will complete an orientation and baseline assessments. Participants will be subsequently randomized to the original intervention, or the Enhanced Intervention, which has greater targeting of theoretical constructs such as self-efficacy, enjoyment, and social support, and which uses text messages and more dynamic and refined website features to encourage increased website use. Using a linear mixed effects regression model, we will simultaneously estimate the intervention effects on mean accelerometer-measured hours/week of moderate-to-vigorous PA (MVPA) at 6, 12, 18, and 24 months, with a subject-specific intercept (intent-to-treat sample). Change in self-reported MVPA, measured via the 7-day Physical Activity Recall, will be assessed as a secondary outcome using a similar model. We will investigate potential mediators of the intervention effect using a multiple mediation approach, and potential moderators by evaluating potential interactions. As an exploratory outcome, we will study the differences (among both study arms) in cost, in US dollars, per minute increases in weekly mean MVPA. DISCUSSION: The original Pasos PA intervention showed efficacy in helping Latinas increase PA; we expect the Enhanced Intervention to help a larger proportion of participants to increase and maintain their PA long term. This web- and text-based enhanced intervention could have great reach and dissemination potential, which could be capitalized on in the future to help to advance health equity. Adaptations made in response to the COVID-19 pandemic are also described in this manuscript. TRIAL REGISTRATION: Clinical Trial Number: NCT03491592 . First posted April 9, 2018.

Regular and App-enhanced Maintenance of Physical Activity among Latinas: A Feasibility Study.

Introduction: Few studies have focused on physical activity (PA) maintenance, particularly among minority populations; smartphone apps could provide valuable tools. This study aimed to 1) assess and understand PA maintenance among Latinas who completed a PA intervention; and 2) evaluate the feasibility, acceptability and preliminary efficacy of commercial smartphone apps as tools for PA maintenance. Methods: For this feasibility study, 27 Latinas who completed a PA intervention and increased their PA were randomly assigned to enhanced maintenance (i.e., taught to use commercial smartphone apps, N=14), or regular maintenance (i.e., no additional treatment, N=13). After 3-months, the feasibility and acceptability of using apps for PA maintenance was assessed via survey questions, analyzed using descriptive statistics. PA was reassessed via the 7-day PA Recall and analyzed using longitudinal mixed effects regression models. Qualitative data were collected via open-ended interview questions and analyzed using thematic analysis. Results: 43% of enhanced maintenance participants reported using study apps at least "a little" and 21% using them "a lot." Although not statistically significant, enhanced maintenance participants reported a smaller drop in PA from post-intervention to post-maintenance, compared to regular maintenance participants. Several participants expressed approval of the apps, while others reported on factors that kept them from using the apps for PA maintenance. Conclusion: Incorporating lessons learned from this study, larger randomized trials are warranted to evaluate the efficacy of using smartphone apps to support PA maintenance. The widespread use of apps could make them ideal tools to support PA maintenance after interventions in different settings.

Effect of a Novel Intervention Targeting Appetitive Traits on Body Mass Index Among Adults With Overweight or Obesity: A Randomized Clinical Trial.

Importance: Behavioral weight loss (BWL) programs result in weight loss for some, but most individuals regain the weight. The behavioral susceptibility theory proposes that genetically determined appetitive traits, such as food responsiveness (FR) and satiety responsiveness (SR), interact with the environment and lead to overeating and weight gain; the regulation of cues (ROC) intervention was developed specifically to target FR and SR. Objective: To evaluate the efficacy of ROC, ROC combined with BWL (ROC+), BWL, and an active comparator (AC) over 12 months of treatment and 12 months of follow-up. Design, Setting, and Participants: This randomized clinical trial was conducted from December 2015 to December 2019 in a university clinic. A total of 1488 volunteers from the community inquired about the study; 1217 were excluded or declined to participate. Eligibility criteria included body mass index (BMI) of 25 to 45, age 18 to 65 years, and lack of comorbidities or other exclusionary criteria that would interfere with participation. Data were analyzed from September 2021 to January 2022. Interventions: ROC uniquely targeted FR and SR. BWL included energy restriction, increasing physical activity, and behavior therapy techniques. ROC+ combined ROC with BWL. AC included mindfulness, social support, and nutrition education. Main Outcomes and Measures: Change in body weight as measured by BMI. Results: A total of 271 adults (mean [SD] age, 46.97 [11.80] years; 81.6% female [221 participants]; mean [SD] BMI, 34.59 [5.28]; 61.9% White [167 participants]) were assessed at baseline, midtreatment, posttreatment, and 6-month and 12-month follow-up. Sixty-six participants were randomized to AC, 69 to ROC, 67 to ROC+, and 69 to BWL. Results showed that ROC, ROC+, and BWL interventions resulted in significantly lower BMI at the end of treatment (BMI ROC, -1.18; 95% CI, -2.10 to -0.35; BMI ROC+, -1.56; 95% CI, -2.43 to -0.67; BMI BWL, -1.58; 95% CI, -2.45 to -0.71). Compared with BWL, BMI at the end of treatment was not significantly different from ROC or ROC+ (BMI ROC, 0.40; 95% CI, -0.55 to 1.36; BMI ROC+, 0.03; 95% CI, -0.88 to 0.93); however, the BMI of the AC group was substantially higher (BMI AC, 1.58; 95% CI, 0.72 to 2.45). BMI reductions at 24 months after randomization were similar for ROC, ROC+, and BWL. Importantly, FR was a moderator of treatment effects with more weight loss for participants who scored higher in FR in the ROC and ROC+ groups. Conclusions and Relevance: These findings suggest that ROC and ROC+ provide alternative weight loss approaches for adults. These models could be particularly effective for individuals who struggle with FR and could be used as a precision approach for weight loss. Trial Registration: ClinicalTrials.gov Identifier: NCT02516839.

Factors Associated with Risk of Perinatal Depressive Symptoms Among Puerto Rican Women with Hyperglycemia.

OBJECTIVES: Rates of perinatal depression and pregnancy hyperglycemia are higher in Hispanic women as compared to non-Hispanic white women. In turn, depressive symptoms may reduce a woman's ability to engage in lifestyle changes that could reduce their subsequent diabetes risk. METHODS: We conducted a secondary analysis using data from Estudio Parto to evaluate sociodemographic, behavioral, psychosocial, and medical factors associated with perinatal depressive symptoms. Estudio Parto was a randomized controlled trial conducted in Western Massachusetts from 2013 to 17. Eligible participants had pregnancy hyperglycemia. The Edinburgh Postnatal Depression Scale (EPDS) was administered at 24-28 weeks gestation and at 6 weeks, 6 months, and 12 months postpartum. An EPDS cutpoint of 10 or greater defined the presence of depressive symptoms. RESULTS: In this sample of Puerto Rican women with pregnancy hyperglycemia, 32% and 27% showed prenatal and postpartum depressive symptoms, respectively. Among participants, 35.5% were diagnosed with GDM, 44.3% with isolated hyperglycemia, and 20.2% with impaired glucose tolerance. In multivariable models, being unmarried (OR 3.87; 95% CI 1.51-9.94), prenatal substance use (smoking or alcohol consumption; OR 2.96; 95% CI 1.41-6.18), and maternal age (1.11 for each year; 95% CI 1.04-1.18) were associated with higher odds of prenatal depressive symptoms. None of the risk factors were associated with subsequent postpartum depression in adjusted analyses. CONCLUSIONS: Identifying factors associated with prenatal and postpartum depression in Puerto Rican women with pregnancy hyperglycemia can inform targeted lifestyle interventions in this at-risk group, increase the likely adoption of healthy lifestyle behaviors, and thereby work to address health disparities. CLINICALTRIALS: gov NCT01679210; date of registration 08/07/2012.

Increases in Muscle-Strengthening Activities Among Latinas in Seamos Saludables.

BACKGROUND: Only 17% of Latinas meet national physical activity (PA) guidelines for both moderate-to-vigorous aerobic and muscle-strengthening PA. Additional health benefits are derived from the combination of aerobic and muscle-strengthening PA (vs. aerobic alone), yet there is paucity in research on muscle-strengthening activity in Latinas. The aim of this study was to examine changes in muscle-strengthening activity from baseline to 6 and 12 months in Seamos Saludables, a 12-month PA randomized controlled trial for Latinas. METHODS: A secondary data analysis was conducted among 131 Latinas ages 18-65 years, who were randomized to either a PA Intervention or a Wellness Control. Self-reported muscle-strengthening exercise was measured at baseline, 6 months, and 12 months via adapted muscle-strengthening questions from the Behavioral Risk Factor Surveillance System. RESULTS: There was a 16-minute/week difference in median minute/week of muscle-strengthening activity between Intervention and Wellness at 6 months (SE = 7.91, p = .04) and 45-minute/week difference at 12 months (SE = 25.80, p = .06) adjusting for baseline. Significantly more PA Intervention participants met muscle-strengthening guidelines of 2 or more days/week at 6 months versus Wellness Control participants (odds ratio [OR] = 4.29, 95% confidence interval [CI] = [1.03, 17.84]). CONCLUSION: Results from the current study showed that Latinas engaged in muscle-strengthening activity in an intervention that emphasized primarily aerobic PA outcomes, suggesting they may be interested in engaging in muscle-strengthening activities. Future interventions targeting both aerobic and muscle-strengthening activity could achieve greater health improvements and help more Latinas reach the full national PA guidelines.ClinicalTrials.gov Identifier. NCT01583140.

A multiple technology-based physical activity intervention for Latina adolescents in the USA: randomized controlled trial study protocol for Chicas Fuertes.

BACKGROUND: Latina adolescents in the USA report some of the lowest rates of physical activity of any demographic subgroup; this is paralleled by a markedly higher lifetime risk of obesity, type 2 diabetes, and other conditions related to inactivity. Despite this, to date, no fully powered clinical trials have tested physical activity interventions specifically for this population. High use of mobile technologies (including text messages, smartphone apps, and social media) suggests this could be an appropriate intervention channel, while also having potential for broad reach. This paper describes the protocol for Chicas Fuertes, a fully powered randomized trial of a mobile technology-based physical activity intervention for Latina adolescents. METHODS: We plan to recruit 200 Latina teens (age 13-18) in San Diego, CA, currently engaging in ≤ 150 min/week of moderate-to-vigorous physical activity (MVPA) to be assigned 1:1 to the intervention or control groups. Those randomly assigned to the intervention group receive a one-on-one goal setting session followed by 6 months of mobile technology-based intervention, including a personalized website, Fitbit activity tracker and app, individually tailored text messages based on Fitbit data, and daily intervention content on Instagram. Those randomized to the control group receive only a Fitbit activity tracker. The main outcome is change in weekly minutes of MVPA from baseline to 6 months, measured both objectively (ActiGraph accelerometers and Fitbit Inspire HR) and subjectively (7-Day Physical Activity Recall Interview). Additional outcomes are maintenance of activity change at 12 months and changes in psychosocial constructs, including social support and self-efficacy, engagement with mobile technology channels, and costs of intervention delivery. We are also examining the potential mediators and moderators of the intervention. The efficacy of the intervention is analyzed using a mixed effects regression model, adjusting for any potential confounders not balanced by randomization. All analyses of accelerometer measured MVPA are also adjusted for wear time. DISCUSSION: The Chicas Fuertes trial uses widely available mobile technologies to target critical health behavior, physical activity, in Latina teens, a population with a high lifetime risk of lifestyle-related diseases. The results will speak to the efficacy and acceptability of the intervention, which has the potential for broad dissemination. TRIAL REGISTRATION: ClinicalTrials.gov NCT04190225 . Registered on November 20, 2019.

Psychosocial Correlates of Meeting National Guidelines for Muscle-Strengthening Activities in Latinas.

BACKGROUND: Performing regular muscle-strengthening activity has numerous health benefits, including improvements in blood pressure, hemoglobin A1c, and lean body mass. Despite the disproportionate prevalence of lifestyle-related chronic disease in Latinas (diabetes, hypertension, obesity), most do not report meeting the national guidelines for muscle-strengthening activity. Existing physical activity (PA) research in Latinas has focused almost exclusively on aerobic PA. Our study examined Latinas' sociodemographic and psychosocial correlates of meeting muscle-strengthening PA guidelines that can inform future PA interventions. METHOD: A cross-sectional study of participants (N = 436) enrolled in a randomized controlled trial promoting PA and cancer screening in Latinas was conducted, and t tests examined the associations between sociodemographic and psychosocial factors with self-reported muscle-strengthening activities. Hierarchical regression was conducted in separate blocks guided by the socioecological model (sociodemographic, individual, and interpersonal factors) to examine the independent contribution of each block to the outcome of meeting national guidelines for muscle-strengthening PA. RESULTS: Participants who met the national PA guidelines of ≥2 days/week of muscle-strengthening activities reported significantly higher social support for PA (p < .001), greater use of behavioral strategies for PA (p < .001), and lower barriers to PA (p < .03) than those who did not meet the guidelines. Hierarchical binary logistic regression indicated behavioral strategies for PA was the only significant correlate of meeting the national guidelines for muscle-strengthening PA (odds ratio = 1.39, 95% confidence interval [1.18, 1.65], p < .001). DISCUSSION/CONCLUSION: Results support a hypothesis that instructing Latinas to use behavior change strategies could help them increase muscle-strengthening PA.