A randomized controlled trial to test the effectiveness of two technology-enhanced diabetes prevention programs in primary care: The DiaBEAT-it study.

Objective: To evaluate the effectiveness of two technology-enhanced interventions for diabetes prevention among adults at risk for developing diabetes in a primary care setting. Methods: The DiaBEAT-it study employed a hybrid 2-group preference (Choice) and 3-group randomized controlled (RCT) design. This paper presents weight related primary outcomes of the RCT arm. Patients from Southwest Virginia were identified through the Carilion Clinic electronic health records. Eligible participants (18 and older, BMI ≥ 25, no Type 2 Diabetes) were randomized to either Choice (n = 264) or RCT (n = 334). RCT individuals were further randomized to one of three groups: (1) a 2-h small group class to help patients develop a personal action plan to prevent diabetes (SC, n = 117); (2) a 2-h small group class plus automated telephone calls using an interactive voice response system (IVR) to help participants initiate weight loss through a healthful diet and regular physical activity (Class/IVR, n = 110); or (3) a DVD with same content as the class plus the same IVR calls over a period of 12 months (DVD/IVR, n = 107). Results: Of the 334 participants that were randomized, 232 (69%) had study measured weights at 6 months, 221 (66%) at 12 months, and 208 (62%) at 18 months. Class/IVR participants were less likely to complete weight measures than SC or DVD/IVR. Intention to treat analyses, controlling for gender, race, age and baseline BMI, showed that DVD/IVR and Class/IVR led to reductions in BMI at 6 (DVD/IVR -0.94, p < 0.001; Class/IVR -0.70, p < 0.01), 12 (DVD/IVR -0.88, p < 0.001; Class/IVR-0.82, p < 0.001) and 18 (DVD/IVR -0.78, p < 0.001; Class/IVR -0.58, p < 0.01) months. All three groups showed a significant number of participants losing at least 5% of their body weight at 12 months (DVD/IVR 26.87%; Class/IVR 21.62%; SC 16.85%). When comparing groups, DVD/IVR were significantly more likely to decrease BMI at 6 months (p < 0.05) and maintain the reduction at 18 months (p < 0.05) when compared to SC. There were no differences between the other groups. Conclusions: The DiaBEAT-it interventions show promise in responding to the need for scalable, effective methods to manage obesity and prevent diabetes in primary care settings that do not over burden primary care clinics and providers. Registration: https://clinicaltrials.gov/ct2/show/NCT02162901, identifier: NCT02162901.

Effects of a digital diabetes prevention program on cardiovascular risk among individuals with prediabetes.

OBJECTIVE: To examine changes in cardiovascular disease (CVD) risk outcomes of overweight/obese adults with prediabetes. METHODS: Using data from a randomized control trial of digital diabetes prevention program (d-DPP) with 599 participants. We applied the atherosclerotic CVD (ASCVD) risk calculator to predict 10-year CVD risk for d-DPP and small education (comparison) groups. Between-group risk changes at 4 and 12 months were compared using a repeated measures linear mixed-effect model. We examined within-group differences in proportion of participants over time for specific CVD risk factors using generalized estimating equations. RESULTS: We found no differences between baseline 10-year ASCVD risk. Relative to the comparison group, the d-DPP group experienced greater reductions in predicted 10-year ASCVD risk at each follow-up visit and a significant group difference at 4 months (-0.96%; 95% confidence interval: -1.58%, -0.34%) (but not at 12 months). Additionally, we observed that the d-DPP group experienced a decreased proportion of individuals with hyperlipidemia (18% and 16% from baseline to 4 and 12 months), high-risk total cholesterol (8% from baseline to 12 months), and being insufficiently active (26% and 22% from baseline to 4 and 12 months at follow-up time points. CONCLUSIONS: Our findings suggest that a digitally adapted DPP may promote the prevention of cardiometabolic disease among overweight/obese individuals with prediabetes. However, given the lack of maintenance of effect on ASCVD risk at 12 months, there may also be a need for additional interventions to sustain the effect detected at 4 months.

Effects of a Digital Diabetes Prevention Program: An RCT.

INTRODUCTION: In light of the need to expand the reach and access of clinically proven digital Diabetes Prevention Programs (d-DPPs) and the need for rigorous evidence of effectiveness, the purpose of this study was to determine the effectiveness of a digital Diabetes Prevention Program for improving weight, HbA1c, and cardiovascular risk factors among people with prediabetes compared to enhanced standard care plus waitlist control. STUDY DESIGN: This was a single-blind RCT among participants at risk of developing type 2 diabetes and included 12 months of follow-up. SETTING/PARTICIPANTS: A total of 599 volunteer patients with prediabetes were recruited primarily through electronic medical records and primary care practices. INTERVENTION: Participants were randomized to either a d-DPP (n=299) or a single-session small-group diabetes-prevention education class (n=300) focused on action planning for weight loss. The d-DPPs consisted of 52 weekly sessions, lifestyle coaching, virtual peer support, and behavior tracking tools. MAIN OUTCOME MEASURES: The primary outcome was a change in HbA1c from baseline to 12 months using intent-to-treat analyses. On the basis of multiple comparisons of endpoints, 95% CIs are presented and 2-sided p<0.025 was required for statistical significance. Secondary outcomes included body weight and cardiovascular disease risk factors. RESULTS: Among 599 randomized participants (mean age=55.4 years, 61.4% women), 483 (80%) completed the study. The d-DPPs produced significantly greater reductions in HbA1c (0.08%, 95% CI= -0.12, -0.03) and percentage change in body weight (-5.5% vs -2.1%, p<0.001) at 12 months. A greater proportion of the d-DPPs group achieved a clinically significant weight loss ≥5% (43% vs 21%, p<0.001), and more participants shifted from prediabetes to normal HbA1c range (58% vs 48%, p=0.04). Engagement in d-DPPs was significantly related to improved HbA1c and weight loss. CONCLUSIONS: This d-DPPs demonstrated clinical effectiveness and has significant potential for widespread dissemination and impact, particularly considering the growing demand for telemedicine in preventive healthcare services. TRIAL REGISTRATION: This study is registered at www. CLINICALTRIALS: gov (ClinicalTrials.gov Identifier: NCT03312764).

Psychometric assessment of the Brief Weight-Loss-Related Behavior Self-Efficacy Survey in adults with prediabetes.

Self-efficacy is a commonly examined cognitive determinant of behavior change in weight-loss trials, but there has been little uniformity in its measurement. To address this, a recently developed survey captures self-efficacy as it relates to three behavioral domains of interest to weight-loss interventionists: physical activity (PA), healthful eating, and weight loss. The purpose of this study was to test the psychometric properties of the Brief Weight-Loss-Related Behavior Self-Efficacy Scales in a large sample (n = 599) of adults with prediabetes. Participants completed the self-efficacy survey, as well as measures of PA, dietary intake, weight, and height. The factor structure was scrutinized using exploratory and confirmatory factor analysis, which supported a factor structure with three correlated first-order latent self-efficacy factors, specific to PA, healthful eating, and weight loss. This model is statistically equivalent to a hierarchical model including a second-order factor for overall behavioral weight-management self-efficacy. Measurement equivalence/invariance between relevant demographic groups was also supported by tests for equivalence of covariance matrices. Bivariate correlations between self-efficacy factors and measures of PA, dietary intake, and weight support the concurrent validity of score interpretations. Overall, these psychometric analyses support the validity of these scales' scores as independently reflective of self-efficacy for PA, healthful eating, and weight loss. This instrument is useful in clinical research to identify the cognitive drivers of weight loss and weight loss-inducing behavior. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Using a population health management approach to enroll participants in a diabetes prevention trial: reach outcomes from the PREDICTS randomized clinical trial.

Population health management (PHM) strategies to address diabetes prevention have the potential to engage large numbers of at-risk individuals in a short duration. We examined a PHM approach to recruit participants to a diabetes prevention clinical trial in a metropolitan health system. We examined reach and representativeness and assessed differences from active and passive respondents to recruitment outreach, and participants enrolled through two clinical screening protocols. The PHM approach included an electronic health record (EHR) query, physician review of identified patients, letter invitation, and telephone follow-up. Data describe the reach and representativeness of potential participants at multiple stages during the recruitment process. Subgroup analyses examined proportional reach, participant differences based on passive versus active recruitment response, and clinical screening method used to determine diabetes risk status. The PHM approach identified 10,177 potential participants to receive a physician letter invitation, 60% were contacted by telephone, 2,796 (46%) completed telephone screening, 1,961 were eligible from telephone screen, and 599 were enrolled in 15 months. Accrual was unaffected by shifting clinical screening protocols despite the increase in participant burden. Relative to census data, study participants were more likely to be obese, female, older, and Caucasian. Relative to the patient population, enrolled participants were less likely to be Black and were older. Active respondents were more likely to have a higher income than passive responders. PHM strategies have the potential to reach a large number of participants in a relatively short period, though concerted efforts are needed to increase participant diversity.

Re-thinking Physical Activity Programs for Older Brazilians and the Role of Public Health Centers: A Randomized Controlled Trial Using the RE-AIM Model.

Background: Explored the role of public health centers in the delivery of physical activity programs to older Brazilians. Methods: Total of 114 older adults (81% women) from public health centers across the city of Florianopolis, Brazil, were randomized into three groups: behavior change group (n = 36), traditional exercise group (n = 52), and control group (n = 26). The behavioral change group included 12 weekly meetings (2 h each). The traditional exercise group offered a 12-week exercise class. Individuals in the control group participated only in measurements. Program evaluation included a mixed-methods approach following the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance). Trained interviewers conducted 12 focus groups and 32 interviews with participants in the program, professionals delivering the programs, community health workers, and local and city administrators overseeing public health centers. Participants completed health, quality of life, and fitness assessments at four time points. Results: The study reached 11.5% of the eligible population in the community. Older adults' resistance to change and limited understanding of behavior change science by public health center staff hindered program reach. Physician encouraging patient participation and personal invitations by community health workers were perceived as favorable factors. Results of program effectiveness and maintenance suggest that behavior change strategies may be better suited than traditional exercise classes for decreasing sedentary time and increasing moderate-to-vigorous physical activity, as well as improving participants' quality of life. Only 14% of public health centers in the city adopted the programs. Heavy workload of health educators delivering the programs and limited physical space for program delivery were barriers for adoption. The fidelity of program delivery was high and indicates that the programs are culturally-appropriate for the Brazilian context and feasible for implementation by local health educators. Conclusions: Our findings support the potential for dissemination of behavior change and traditional exercise programs to older adults through public health centers in Brazil. REBEC: RBR-9pkxn2 (retrospectively registered) Register April 20, 2019.

Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS): A type 1 hybrid effectiveness-implementation trial protocol.

BACKGROUND: Diabetes prevention remains a top public health priority; digital approaches are potential solutions to existing scalability and accessibility challenges. There remains a gap in our understanding of the relationship between effectiveness, costs, and potential for sustained implementation of digital diabetes prevention strategies within typical healthcare settings. PURPOSE: To describe the methods and design of a type 1 hybrid effectiveness-implementation trial of a digital diabetes prevention program (DPP) using the iPARIHS and RE-AIM frameworks. METHODS: The trial will contrast the effects of two DPP interventions: (1) small group, in-person class, and (2) a digital DPP consisting of small group support, personalized health coaching, digital tracking tools, and weekly behavior change curriculum. Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the CDC National DPP. Adults at risk for diabetes (BMI ≥25 and 5.7% ≤ HbA1c ≤ 6.4) will be randomly assigned to either the intervention group (n = 241) or the small group (n = 241). Assessment of primary (HbA1c) and secondary (weight loss, costs, cardiovascular risk factors) outcomes will occur at baseline, 4, and 12 months. Additionally, the trial will explore the potential for future adoption, implementation, and sustainability of the digitally-based intervention within a regional healthcare system based on key informant interviews and assessments of organizational administrators and primary care physicians. CONCLUSION: This trial of a digital DPP will allow the research team to determine the relationships between reach, effectiveness, implementation, and costs.

From Bright Bodies to iChoose: Using a CBPR Approach to Develop Childhood Obesity Intervention Materials for Rural Virginia.

This community-based participatory research (CBPR) project used a collaborative process to develop a culturally relevant workbook for parents of overweight children. We followed a mixed methods iterative process to assess clear communication using a CBPR approach. Materials were evaluated using readability tests, the Clear Communication Index (CCI), and the Suitability Assessment of Materials (SAM). In addition, we used surveys and focus groups to investigate parents' perceptions and gather feedback from delivery staff using the workbook. While workbook materials maintained adequate grade reading levels, our iterative process and the use of CCI and SAM led to significant improvements in (a) clearly communicating the objectives of the program, (b) being culturally relevant, and (c) reaching a high satisfaction among users. These findings suggest that evaluative measures for written materials should move beyond readability and need to account for level of clarity and cultural appropriateness of messages. Furthermore, we found that that an iterative process to intervention's material development using clear communication strategies while involving community members, parents, and research partners can lead to workbook materials that are culturally relevant to the target audience, and better communicate program objectives. Finally, this is a potentially generalizable process for improving clear communication of written health information materials.

Redes sociais e a saúde de jovens adultos / Las redes sociales y la salud de los adultos jóvenes / Social networks and the health of young adults

Objective: The purpose of this study was to examinethe relationship between socialenvironmental variables, selected health behaviors,and health status in young adults.Methods: A cross-sectional web-based survey was used to elicit information from randomlyselected participants about their levels of physical activity, health status, social networks, andsocial support. Results: In a total of 938 participants, network variables were not directlyassociated with good health. Satisfaction with support received from friends and family werethe only two social support variables directly associated with good health. Conclusions:Participants’ satisfaction with support received from either family or friends was particularlyimportant to good health, suggesting that the provision of social support alone may not besufficient to improve the health of young adults .

Objetivo: Este estudo tinha por objetivo examinar arelação entre as variáveissocioambientais, comportamentos de saúde específicos e o estado de saúde em jovens adultos.Métodos: Um estudo transversal feito pela na internet com participantes selecionadosaleatoriamente foi utilizado para coletar informações sobre os seus níveis de atividade física,seu estado de saúde, suas redes sociais e o apoio social que recebem. Resultados: Em um totalde 938 participantes, as variáveis de redes sociaisnão foram diretamente associadas a umaboa saúde. Satisfação com o apoio recebido de amigos e familiares foram as duas únicasvariáveis de apoio social diretamente associadas àboa saúde. Conclusões: A satisfação dosparticipantes com o apoio recebido da família ou deamigos foi particularmente importantepara a boa saúde, sugerindo que o apoio social porsi só pode não ser suficiente para melhorara saúde dos jovens adultos .

Objetivo: El estudio objetivó examinar la relaciónentre las variables sociales, ambientales,comportamientos de salud y estados de salud en adultos jóvenes. Métodos: Se utilizó unestudio transversal basado en Internet para recabarinformaciones de participantesaleatoriamente seleccionados acerca de sus nivelesde actividad física, estado de salud, redessociales y soporte social. Resultados: Sobre un total de 938 participantes, las variables de red no fueron directamente asociadas a una buena salud.La satisfacción respecto del apoyorecibido por parte de amigos y familiares fueron las únicas variables de soporte socialdirectamente asociadas a la buena salud. Conclusiones: La satisfacción de los participantescon el apoyo recibido de la familia y amigos fue particularmente importante para la buenasalud, sugiriendo que el soporte social por sí solopuede no resultar suficiente para mejorar lasalud de los jóvenes adultos .