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BACKGROUND Hydroxyurea therapy is effective in reducing sickle cell disease (SCD)-related complications and is recommended by NHLBI care guidelines. However, hydroxyurea is underutilized, and adherence is suboptimal. We are testing a multi-level mobile health (mHealth) intervention to increase hydroxyurea adherence among patients and prescribing among providers in a multi-center clinical trial. In the first two study sites, participants were exposed to the early phases of the COVID-19 pandemic, which included disruption to their regular SCD care. The contextual changes that occurred as part of the pandemic response can affect implementation of new interventions. OBJECTIVE We aimed at describing the impact of COVID-19 pandemic on implementation of an mHealth behavioral intervention aimed at improving hydroxyurea adherence among patients with SCD. METHODS The first two sites initiated enrollment three months prior to the start of the pandemic (11/2019-3/2020). During implementation, Site A clinics shut down for 2 months and Site B clinics for 9 months. We used the Reach Effectiveness Adoption Implementation and Maintenance framework to evaluate the implementation and effectiveness of the intervention. mHealth implementation was assessed based on patients’ daily app use. Adherence to hydroxyurea was calculated as Percentage of Days Covered (PDC) from prescription records over the first 12- and 24-weeks after implementation. A linear model examined the relationship between app usage and change in PDC, adjusting for baseline PDC, lock down duration, and site. We also conducted semi-structured interviews with patients, health care providers, administrators and research staff to identify factors associated with mHealth implementation and effectiveness. We used a mixed-methods approach to investigate the convergence of qualitative and quantitative findings. RESULTS The percentage of patients accessing the app decreased after 3/15/2020 (85.9% to 70.3%). The overall mean increase in PDC from baseline to week 12 was 4.5% (p=0.32) and to week 24 was 1.5% (p=0.70). Mean change in PDC was greater at Site A (12 weeks: 20.9%, p=0.0029; 24 weeks: 16.7%, p=0.0139) compared to Site B (12 weeks: -8.2%, p=0.14; 24 weeks: -10.3%, p=0.0151). After adjusting for other predictors, change in PDC was 13.8% greater in those with increased app use after 3/15/20. Interview findings indicated Site B’s closure during COVID-19 had a greater impact on patients, but almost all patients reported InCharge Health helped support more consistent medication use. CONCLUSIONS We found significant impacts of the early clinic lock downs, which reduced implementation of the mHealth intervention. This disruption led to reduced patient adherence to hydroxyurea. However, disruptions to mHealth implementation were lower among participants who experienced shorter clinic lock downs and were associated with higher hydroxyurea adherence. Investigation of added strategies to mitigate effects of care interruptions during major emergencies (e.g., patient coaching, health navigation) may “insulate” the implementation of interventions to increase medication adherence. CLINICALTRIAL ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167 INTERNATIONAL REGISTERED REPORT RR2-10.2196/16319

BACKGROUND Individuals living with sickle cell disease often require aggressive treatment of pain associated with vaso-occlusive episodes in the emergency department. Frequently, pain relief is poor. The 2014 National Heart, Lung, and Blood Institute evidence-based guidelines recommended an individualized treatment and monitoring protocol to improve pain management of vaso-occlusive episodes. OBJECTIVE This study will implement an electronic health record–embedded individualized pain plan with provider and patient access in the emergency departments of 8 US academic centers to improve pain treatment for adult patients with sickle cell disease. This study will assess the overall effects of electronic health record–embedded individualized pain plans on improving patient and provider outcomes associated with pain treatment in the emergency department setting and explore barriers and facilitators to the implementation process. METHODS A preimplementation and postimplementation study is being conducted by all 8 sites that are members of the National Heart, Lung, and Blood Institute–funded Sickle Cell Disease Implementation Consortium. Adults with sickle cell disease aged 18 to 45 years who had a visit to a participating emergency department for vaso-occlusive episodes within 90 days prior to enrollment will be eligible for inclusion. Patients will be enrolled in the clinic or remotely. The target analytical sample size of this study is 160 patient participants (20 per site) who have had an emergency department visit for vaso-occlusive episode treatment at participating emergency departments during the study period. Each site is expected to enroll approximately 40 participants to reach the analytical sample size. The electronic health record–embedded individualized pain plans will be written by the patient’s sickle cell disease provider, and sites will work with the local informatics team to identify the best method to build the electronic health record–embedded individualized pain plan with patient and provider access. Each site will adopt required patient and provider implementation strategies and can choose to adopt optional strategies to improve the uptake and sustainability of the intervention. The study is informed by the Technology Acceptance Model 2 and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Provider and patient baseline survey, follow-up survey within 96 hours of an emergency department vaso-occlusive episode visit, and selected qualitative interviews within 2 weeks of an emergency department visit will be performed to assess the primary outcome, patient-perceived quality of emergency department pain treatment, and additional implementation and intervention outcomes. Electronic health record data will be used to analyze individualized pain plan adherence and additional secondary outcomes, such as hospital admission and readmission rates. RESULTS The study is currently enrolling study participants. The active implementation period is 18 months. CONCLUSIONS This study proposes a structured, framework-informed approach to implement electronic health record–embedded individualized pain plans with both patient and provider access in routine emergency department practice. The results of the study will inform the implementation of electronic health record–embedded individualized pain plans at a larger scale outside of Sickle Cell Disease Implementation Consortium centers. CLINICALTRIAL ClinicalTrials.gov NCT04584528; https://clinicaltrials.gov/ct2/show/NCT04584528. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24818

BACKGROUND Sickle cell disease (SCD) is an inherited blood disorder causing acute complications and chronic progressive end organ damage. SCD is associated with significant morbidity, early mortality, impaired health-related quality of life, and increased acute health care utilization. Hydroxyurea is a US Food and Drug Administration–approved medication that reduces disease complications, acute health care utilization, and costs. However, adherence to hydroxyurea is suboptimal. Mobile health (mHealth) interventions have the potential to improve hydroxyurea adherence, but few examples exist that are specific to the SCD population. OBJECTIVE This study aimed to design a mHealth intervention for individuals with SCD to improve adherence to hydroxyurea, using a user-centered design that was informed by specific barriers to hydroxyurea adherence and utilization in this population. METHODS This study consisted of 4 phases. In phase 1, individuals with SCD and health care providers participated in an optimization digital workshop. In phase 2, patients completed surveys pertaining to their interest in mHealth use, barriers and facilitators to hydroxyurea use, and health literacy. Phases 3 and 4 involved semistructured interviews and focus groups, respectively, and used the Health Belief Model (HBM) as the framework to investigate drivers of poor hydroxyurea adherence and to inform the development of an app prototype. In addition, in phase 4, we have incorporated the patients’ feedback on the preliminary app prototype and its features. RESULTS Barriers to hydroxyurea adherence were consistent with the literature and included forgetfulness and several specific thoughts and emotions associated with hydroxyurea use (eg, fear of side effects, depression, stigma, and hopelessness). In addition, more than half of the participants reported potentially low health literacy. Preferred patient app features included 7 key components, namely (1) medication reminders and tracker, (2) disease education, (3) communication, (4) personalization, (5) motivation, (6) support during pain episodes, and (7) social support. Utilizing a user-centered design approach, data obtained from patients and providers were translated into features within the app, mapping to components of the HBM and the specific drivers of hydroxyurea adherence and matching the literacy level of the population, resulting in the development of a novel mobile app called InCharge Health. CONCLUSIONS The InCharge Health app is an mHealth intervention developed with substantial input from users and by mapping the HBM as the framework that guided the choice for its components. InCharge Health is a customized product for the SCD population aimed at optimizing medication adherence, with the end goal of improving quality of life and health outcomes among patients with SCD. The efficacy and implementation of the InCharge Health app as an mHealth intervention to promote hydroxyurea adherence will be tested in a future stepped-wedge multicenter trial for adolescents and adults with SCD.

We determined the impact of 69 African refugee children’s arrival age and weight on subsequent weight gain by following BMI of refugee children. During 6–24 months after arrival in the U.S., 57% of underweight children became normal weight, whereas only 2% of normal weight children moved to the next higher weight category (p

To assess the feasibility, acceptability, and outcomes of 2 versions of a culturally relevant, family-based intervention to prevent excess weight gain in pre-adolescent African-American girls.Three-arm, 12-week parallel group randomized controlled pilot trial.Community centers in Memphis, Tennessee.Sixty African-American girls, aged 8 to 10 years, with a body mass index (BMI)or = 25th percentile of the CDC growth charts, along with their parents/caregivers.The active interventions involved highly interactive weekly group sessions with either girls (child-targeted program) or parents/caregivers (parent-targeted program). Content focused on knowledge and behavior change skills to promote healthy eating and increased physical activity. The comparison intervention focused on global self-esteem.Given the lack of power and the limited time frame of the pilot study, outcomes were evaluated on the basis of implementation measures and changes in physical activity (accelerometer data), and in consumption of sweetened beverages and water, as estimated from questionnaires. Changes in body mass index, waist circumference, and body composition were also examined.The Memphis GEMS pilot intervention met all recruitment, retention, implementation, and participation goals, and was given high rating by both participants and interventionists. With respect to the comparison intervention, girls in both the child-targeted and parent-targeted interventions demonstrated a trend toward reduced body mass index and waist circumference. In addition, girls in the active intervention groups reduced their consumption of sweetened beverages by 34%, increased their level of moderate-to-vigorous activity by 12%, and increased their serving; of water by 1.5%.The findings from this pilot study demonstrated the feasibility, perceived acceptability, and efficacy of culturally relevant, obesity prevention interventions for pre-adolescent African-American girls and their parents/caregivers.

The morbidly obese and especially the super-morbidly obese (> 225% ideal body weight) often require gastric bypass surgery as treatment for long-term remission of their obesity. The extended gastric bypass Roux-en-Y (X-GBP) procedure evolved as a result of a perceived need to increase weight loss in morbidly obese subjects beyond the limitations of the regular gastric bypass Roux-en-Y (R-GBP). We compared weight loss, caloric intake, and percentage of total caloric intake from carbohydrate, protein, and fat in eight R-GBP and eight X-GBP patients at 3, 6, 9, and 12 months following surgery. We found that R-GBP and X-GBP groups were similar in age and height, adjusting for baseline weight differences (p = 0.122). Both groups demonstrated significant weight loss overtime (p < 0.0001), with similar patterns of weight loss at each interval of nonsignificant interaction (p = 0.585). Weight loss for the two groups did not differ statistically. The X-GBP group lost 5% more weight than the R-GBP group by 12 months following surgery. The adjusted average weight loss over 12 months was 56.82 kg for X-GBP and 46.82 kg for R-GBP patients. Furthermore, the X-GBP group ingested fewer calories than the R-GBP group at 3, 6, 9, and 12 months following surgery. The X-GBP group ingested a lower percentage of calories from fat than the R-GBP group at 3, 9, and 12 months following surgery. This study depicts clinical trends in weight loss following X-GBP and R-GBP surgeries. The greater weight loss of the X-GBP group may be due to differences in total caloric intake or the lower percentage of calories ingested from fat. Other possibilities for the greater weight loss shown by the X-GBP group may include changes in malabsorption or resting energy expenditure over time following surgery.

The present study sought to determine the prevalence of smoking as a dieting strategy in a university population. There were 1076 people (458 males, 618 females) asked (1) the types of strategies they used to curb hunger (including smoking) and (2) whether they either began smoking or were currently smoking as a weight loss/maintenance strategy. Results indicated that 32.5% of all smokers (n = 209; 39% of females, 25% of males) reported using smoking as a weight loss strategy. A small percentage of smokers (10% of males, 5% of females) reported beginning to smoke for weight control. Overweight females were much more likely, however, to report that they started smoking for dieting reasons. Females were much more likely to report weight gain as a relapse variable than males. It is concluded that weight gain following smoking cessation, particularly among females, may be a significant relapse variable as well as a significant barrier to smoking cessation.

This study describes body image and weight concern attitudes of pre-adolescent African-American (AA) girls and their parent/caregivers. Cross-sectional survey data were collected from 189 low-income 8- to 10-year-old AA girls and 179 parents/caregivers of AA girls from 2 urban areas, Memphis and Minneapolis/St. Paul. Results demonstrated that most AA girls were either happy with their weight, or did not think about it at all. However, 20% of girls would like to be larger than their current size, and 50% would like to be smaller. Girls in Minneapolis/St. Paul were more likely than Memphis girls to report weight dissatisfaction. One third of parents reported concerns that their daughters were too heavy. Seventy-two percent of parents reported that they were trying to lose weight. Discussions include possible regional differences in weight concern among AA girls, and implications for obesity prevention programs.