Adapting to Evolving Technologies and Treatment Guidelines in a Procedural Trial: A Qualitative Review of the CREST-2 Experience.

Multiple challenges confront procedural trials, including slow enrollment, lack of equipoise among patients and physicians, and failure to achieve adequate masking. Nonetheless, randomized clinical trials provide the best evidence of efficacy. The evolution of technology, techniques, and standards of care during the conduct of procedural trials challenges external validity. In this study, we review how a multicenter trial of revascularization of asymptomatic carotid arteries for stroke prevention has managed changes in treating carotid stenosis and medical management of atherothrombotic disease. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov number: NCT02089217.

Looking for opportunities to co-enroll: The DISCOVERY study experience.

BACKGROUND: Conducting high-quality stroke trials is complex and costly. Often these trials compete for the attention of researchers and the availability of patients. Enrolling patients in more than one study concurrently has the potential to accelerate recruitment into individual studies. DISCOVERY is a multicenter, inception cohort study of cognitive impairment and dementia following ischemic or hemorrhagic stroke. At the request of site investigators, a DISCOVERY committee reviews individual studies for approval of possible concurrent co-enrollment into DISCOVERY. The purpose of this report is to summarize the characteristics and outcomes of studies reviewed by committee for possible co-enrollment. METHODS: This analysis covers studies reviewed from 07/01/2020 to 04/26/2022 by the Site Management Committee (SMC) of the DISCOVERY Recruitment and Retention Core. Characterization of each study included study type, number and length of follow-up visits, and whether there were protocol-required blood draws, brain imaging studies, or cognitive tests. Studies were scored for patient burden and scientific overlap with Discovery. The primary outcome was SMC approval to co-enroll. RESULTS: 59 studies were reviewed, and 69.5% (n = 41, 21 clinical trials; 20 observational studies) were found by the SMC to be appropriate for co-enrollment. Higher patient burden and greater scientific overlap with DISCOVERY reduced the rates of approval for co-enrollment. CONCLUSION: A large number of diverse stroke studies are being run concurrently across the DISCOVERY study network, however, about two-thirds of the studies were considered appropriate for consideration of co-enrollment. Future studies should study how co-enrollment might improve trial network efficiency.

HomeStyles-2 for SNAP-Ed families with children in middle childhood: Cluster randomized trial protocol.

BACKGROUND: Childhood obesity prevention efforts are needed in the United States, especially for families with low income. The purpose of this study is to determine whether HomeStyles-2, a nutrition education and childhood obesity prevention program for families with children in middle childhood (ages 6 to 11 years), motivates parents to re-shape their home environments and weight-related lifestyle practices to be more supportive of meeting national nutrition and physical activity recommendations and weight status of their children more so than those in the control condition. METHODS: A research-practice partnership with Florida's Supplemental Nutrition Assistance Program-Education (SNAP-Ed) program was formed to conduct a cluster randomized trial to evaluate the HomeStyles-2 intervention. SNAP-Ed-eligible individuals who are parents/caregivers of children aged 6-11 living in the study catchment area will be invited to enroll in the study and participate in a six-lesson series using the HomeStyles-2 program or an attention control program. The primary outcome measures related to parent weight-related behaviors will be assessed on the individual level. Linear mixed models with a hierarchical design will be used to assess outcomes of interest. DISCUSSION: This study has the potential to demonstrate the effectiveness of a new curriculum implemented in a federal nutrition education program. Because of the COVID-19 pandemic, adjustments were made to the intervention design to allow for virtual delivery of the intervention through SNAP-Ed. This unanticipated change will offer much-needed research on the effectiveness of virtual nutrition education, which may help to expand SNAP-Ed's reach across the country. TRIAL REGISTRATION: NCT05019339.

Cooking, Shopping, and Eating Behaviors of African American and Hispanic Families: Implications for a Culturally Appropriate Meal Kit Intervention.

Families with low incomes face barriers to preparing healthy meals, including decreased food access and limited time, and may turn to fast, low-quality, and inexpensive foods. Affordable and accessible meal kits may reduce these barriers. The objective of this study was to explore the cooking, eating, and shopping behaviors of African American (AA) and Hispanic participants living in the United States with low incomes and determine the knowledge of and preferences for a culturally appropriate meal kit intervention. Trained researchers conducted focus groups using a semi-structured questionnaire with AA and Hispanic food preparers with low incomes. Participant cooking, eating, and shopping behaviors and knowledge of and preferences for a culturally appropriate meal kit intervention were evaluated using thematic analysis. AA participants (n = 16) reported cooking on average 2 to 3 days per week and more often on weekends. Hispanic participants (n = 15) reported cooking 5 days per week and more often during the week. Both groups identified cost as the number one consideration when shopping. Most were unfamiliar with meal kits but indicated they would try an affordable meal kit. AA and Hispanic participants differed in their cooking, eating, and shopping behaviors but were equally interested in trying meal kits if affordable and culturally appropriate.

Acceptability and Willingness to Pay for a Meal Kit Program for African American Families with Low Income: A Pilot Study.

Food insecurity is a persistent issue among individuals with low income and is associated with various nutrition- and health-related consequences. Creative approaches to increasing food access should be investigated as possible solutions. Meal kits, which are boxes or bags of fresh and shelf-stable ingredients for one or more meals, along with a step-by-step recipe showing how to cook each meal at home, may serve as a creative solution. Meal kits have historically been marketed to higher-income demographics. The purpose of this pilot study was to investigate the utilization, acceptability, and willingness to pay for a healthy meal kit program among African American main food preparers with children and low income (n = 36). Participants received a healthy meal kit with three recipes and ingredients, a cooking incentive, and a nutrition handout weekly for six weeks. Data were collected on participants' use, acceptability, and willingness to pay for the meal kits and analyzed using descriptive statistics. The intervention was highly utilized, and participants reported high acceptability ratings for most recipes. After the intervention, participants were willing to pay $88.61 ± 47.47 for a meal kit with three meals, each with four portions, which was higher than indicated at baseline and similar to the cost to produce the kits. Meal kits may offer a creative solution to improving food access if affordable for families with low income.