In 1999, Rosenbloom and Winter [1] labeled type 2 diabetes mellitus (T2DM) in youth as an emerging epidemic, identifying racial and ethnic minority groups, whose proportion in the US population continues to increase [2], at highest risk. T2DM is a chronic state of hyperglycemia that clusters in families because of genetic, cultural, behavioral, and environmental risk factors [3,4]. In 2018, an estimated 32.4 million (10.5%) people of all ages in the United States had T2DM, and an additional 88 million adults (34.5%; ≥18 years) and 1 in 5 youths (12-18 years) were estimated to have had prediabetes [5,6]. Predictions indicate that with rising incidence rates, the proportion of US youth (<20 years) with T2DM may quadruple between 2010 (22,820 youths) and 2050 (84,131 youths [7]), and African American (AA) youth represent a vulnerable pediatric population with high risk [7,8].

Alarmingly, T2DM presents a more severe and aggressive disease course in youth than in adults [9], and there is no optimal treatment for T2DM in youth [10]. In a retrospective analysis of youth and adults with obesity and impaired glucose tolerance, adolescents experienced more severe insulin resistance than adults with similar adiposity and glycemic status [9]. Of particular concern are the results from the recent RISE (Restoring Insulin Secretion) Pediatric Medication Study that evaluated whether β-cell function and metabolic control could be effectively altered by a pharmacological intervention [11]. Results from this randomized controlled trial with 91 pubertal youths (10-19 years) with obesity and existing impaired glucose tolerance randomized to 12 months of metformin showed that the early pharmacologic intervention was ineffective in slowing disease progression [11]. These findings underscore the need for strategies to prevent or delay the onset of T2DM in youth at high risk [12].

Prediabetes is a precursor to T2DM, characterized by hyperglycemic parameters below the diabetes threshold [13,14]. An estimated 5% to 10% of prediabetes cases advance to T2DM per annum [15], and according to the American Diabetes Association (ADA), up to 70% of people with prediabetes will progress to T2DM at some point in their lifetime [16]. Although prediabetes may never progress to T2DM, unfavorable cardiometabolic profiles remain among people with prediabetes, putting them at increased risk for cardiovascular-related morbidities and premature mortality [17]. Consequently, youth with prediabetes are faced with earlier and prolonged exposure to myriad cardiometabolic abnormalities, accentuating the critical need for obesity treatment in the primary prevention of T2DM in youth [7,10].

Studies have indicated that adults with prediabetes can mitigate T2DM prognosis by taking preventive action, such as participation in the National Diabetes Prevention Program (DPP) [18]. The DPP began as a multisite randomized controlled trial, which demonstrated the effectiveness of a 12-month intensive lifestyle intervention over pharmaceutical treatment for preventing or delaying T2DM among adult participants with prediabetes across all racial and ethnic groups [19]. At 2.8- and 10-year follow-up, participants randomized to the lifestyle intervention group reduced their risk of developing T2DM by 58% and 34% compared with 31% and 18% in the metformin group, respectively [20,21]. In 2010, US Congress authorized the Centers for Disease Control and Prevention to lead the dissemination of the DPP [18] as a targeted strategy and population approach to reduce the incidence of T2DM among adults with prediabetes [22].

Intensive lifestyle modification is the recommended treatment for pediatric patients with prediabetes [23]; however, there is no gold standard lifestyle intervention to prevent T2DM in youth. Previous studies have demonstrated the feasibility of lifestyle interventions for youth with overweight or obesity and those at risk for T2DM and the importance of tailored interventions for racial and ethnic minority groups; however, limited efficacy has been shown in reducing T2DM risk and improving obesity outcomes [24-26]. Intervention studies with youth have also been hindered by the insufficient representation of racial and ethnic minority youth at high risk for T2DM in obesity treatment trials [27]. Power to Prevent is a diabetes prevention intervention from the Centers for Disease Control and Prevention based on the DPP and tailored for AA families [28]. To our knowledge, this intervention has not yet been evaluated among AA families with children at risk for T2DM or disseminated through health care institutions. Given the restrictions on in-person gatherings because of the COVID-19 pandemic and the consistent literature reporting high attrition rates among in-person interventions, there is a need for novel and sustainable implementation modalities for delivering lifestyle interventions to racial and ethnic minority families at high risk for T2DM [24].

Telehealth has demonstrated effectiveness in delivering obesity and prediabetes treatment [29-33] and has mitigated barriers to accessing care for millions of Americans [31]. In particular, videoconferencing has been widely used to deliver effective T2DM care for adult and young patients [33-36] and has recently established efficacy for group-based interventions [37-39]. In a review of 17 lifestyle intervention studies, the authors found that tablet-based group videoconferencing was feasible, accessible, and acceptable, regardless of participants’ digital literacy (technology skills) [37]. Across studies, videoconferencing groups cultivated cohesiveness and bonding similar to in-person settings, and participants developed behavioral skills including lifestyle behaviors to treat obesity and demonstrated improved health outcomes along with high attendance rates (66%-93.8%) and few dropouts [37]. Intervention group sizes averaged from 5 to 7 participants and met weekly for 1 hour over 12 to 26 sessions in total [37]. The use of telehealth technology to deliver a family-based lifestyle diabetes prevention intervention tailored for AA families is likely to offer a scalable approach to reduce T2DM among high-risk youth [40-42].

The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot trial proposes implementing and evaluating a diabetes prevention intervention based on the Power to Prevent program for AA parents of children (8-11 years) who are both overweight or obese and at risk for T2DM. Historically, a lengthy effectiveness study conducted under ideal circumstances would be the next step in identifying a gold standard lifestyle intervention to prevent T2DM in AA youth; however, standard effectiveness studies are limited by their inability for rapid translation and the need for subsequent implementation studies to validate utility in real-world settings [43]. Hybrid research designs leverage the rigor of clinical trials and implementation science to foster rapid translation and effective implementation [33,43]. Thus, in partnership with the Center for Telehealth at the University of Mississippi Medical Center (UMMC) and pediatric weight management clinic, we propose a novel effectiveness-implementation hybrid type II research design [43] with the coprimary aim to (1) conduct a 30-week, single-arm pilot trial with at-risk parents of at-risk children to assess the early efficacy of Power to Prevent delivered using small group-based videoconferencing to reduce BMI in parents (n=20) and stabilize or reduce BMI z scores in children (n=20), while (2) conducting a comprehensive evaluation of a multifaceted implementation strategy for the uptake of the intervention by the pediatric weight management clinic at the UMMC in Jackson, Mississippi. The protocol described below was approved by the UMMC’s Institutional Review Board (#2020V0249).

The Diabetes Belt is a distinct geographic region in the southern United States where county-level adult T2DM rates (≥11%) are especially high and obesity and physical inactivity account for one-third of all diagnosed cases [44]. Mississippi is the only state in which every county (82 counties) is represented by the Diabetes Belt. According to America’s Health Rankings 2019 Report, Mississippi had the third-highest adult T2DM rate (14.3%) in the United States, followed by the second highest adult obesity (39.5%) and physical inactivity (32%) rates [45]. Recent data from the National Survey of Children’s Health (2018-2019) reported in the State of Obesity Report, 2020 [46], identified Mississippi as having the second-highest youth (10-17 years) obesity rate (22.3%) nationally. In addition, AA adults (45.7% [45]) and youth (25.4% [47]) had higher rates of obesity compared with their White counterparts (36.3% [45] and 21.7% [47], respectively). Mississippi also has the highest percentage of Black population (37.8% [48]), and 42% of Mississippi youth are Black compared with 14% nationally [49]. Mississippians experience persistently high rates of poverty (19.7%) and child poverty (27%) [48], and the state is mostly rural and medically underserved [50]; social and environmental factors contribute to poor health and disease. In this context, AA youth in Mississippi are among those at highest risk for T2DM.

The UMMC is the state’s only academic medical center and has the only children’s hospital in the state. In 2019, 4464 AA children aged 8 to 11 years were treated by a UMMC pediatric clinic, and between November 2019 and April 2020, 170 AA children aged 8 to 11 years were identified with the risk for T2DM in the UMMC’s Prediabetes Registry. UMMC is a minority-serving, research-intensive health care organization with a state-mandated requirement to provide not less than 50% of their services to indigent persons (Mississippi Legal Code Annotated 37-115-27; 2017). The UMMC is also a national leader in telehealth [51] and has one of only 2 National Centers of Excellence in Telehealth in the nation [52]. The UMMC Center for Telehealth has successfully intervened with adults with uncontrolled T2DM [53] using remote patient monitoring and is piloting a similar single-arm feasibility trial with pediatric patients (10-17 years) [54]. Health systems with telehealth technology are encouraged to implement and evaluate weight loss interventions for patients at risk for T2DM [32,40,55], and Mississippi is at the forefront of advancing telehealth and adopting mandates for telehealth care reimbursement [51-53,56]. Thus, Mississippi is an ideal location to test the effectiveness and implementation of lifestyle interventions using telehealth in clinical care settings to treat obesity and prevent T2DM in AA youth at the highest risk for diabetes in the United States.

In-person participant screening and enrollment will be conducted in the UMMC pediatric weight management clinic beginning in December 2020. Preliminary screening will the conducted by the clinical provider using a patient eligibility checklist that will screen for both child and parent eligibility. The lifestyle coach will immediately meet in the clinic room following the clinical encounter to conduct a full screening and provide detailed study information to interested parents and children. Consent forms will be verbally described to parents and children, and parent consent, parent permission, and child assent will be obtained before study enrollment.

Children will be eligible to participate if they are AA, overweight or obese (≥85th percentile for age- and sex-specific BMI), and aged between 8 and 11 years. The child age range was selected to allow for intervention occurring before the average age of youth-onset T2DM, 13 years [10]. The criteria for parents (biological, grandparent, or legal guardian) of eligible children included AA, overweight or obese (BMI ≥25 kg/m²), and coresidence with the child. Although mothers represent most participants in family-based studies, we will not use parents’ sex as an inclusion criterion. Parents and children must also be at risk for T2DM based on the following criteria: (1) parents’ T2DM risk will be assessed using the A1CNow⁺ system to measure point-of-care hemoglobin A_1c (HbA_1c), which uses a drop of nonfasting blood (5.7%-6.4%), and the ADA prediabetes screening tool (score ≥5); (2) child risk will be based on the BMI percentile (≥85th percentile) and parents’ risk (BMI ≥25 and ADA screening or HbA_1c).

Consistent with previous T2DM prevention interventions [26,57], we will exclude families if the child or parent has a history of T2DM or a screening HbA_1c level greater than 6.4%, is taking glucose-lowering medications, is participating in a supervised weight loss program, is pregnant or breastfeeding, has conditions limiting participation, has undergone weight loss surgery, or is moving out of state within 6 months. If a parent becomes pregnant during the study, we will include only child data (index participant) in the analyses. Technology literacy will not be included as an exclusion criterion. Participants will receive technology instruction from the telehealth center and be provided technical support as needed.

The power calculation, across 5 scenarios, shows detectable effect sizes, ≥−2.5 (SD 0.05) BMI in parents [58] and in children, where a modest reduction in BMI z score (≥0 to <−0.1, SD 0.05) has been associated with improved cardiometabolic risk [59]. In the first 3 scenarios, assuming 10% attrition [37], a minimum of 18 dyads are needed. In scenarios 4 and 5, detectable effect sizes are reported in the case of 0% (n=20 dyads) and 20% (n=16 dyads) attrition. We anticipate 20% attrition, which is consistent with the group- and family-based telehealth lifestyle intervention literature [60-62]. Analyses are based on α=.05 and a conservative two-sided test. An effect size of 1.0 is considered substantial and 0.5 is considered medium. We will obtain reliable effect size estimates to design a pilot randomized controlled trial.

Family Systems Theory, undergirded by family motivation and Social Learning Theory, and the Telehealth in Chronic Disease (TECH) model are the foundations for the TELE-GEN conceptual model (Figure 1). Social Learning Theory is used to guide intensive lifestyle interventions, such as the DPP [63]. The conceptual basis for the TELE-GEN intervention has evolved from pediatric obesity and T2DM prevention research using Family Systems Theory [64,65] and Social Learning Theory [66,67]. Successful Social Learning Theory–based intervention approaches include helping families make changes to the home food, physical activity, and screen time environment, increasing family motivation to make positive changes, and increasing family functioning around food, physical activity, and sedentary behaviors. These activities are thought to increase family efficacy for making lifestyle modifications and ultimately improving intervention outcomes. This theoretical approach is bolstered by applying the TECH model, which outlines effective pathways for the uptake of clinical telehealth interventions [68]. The TELE-GEN conceptual model is displayed in Figure 1.

Power to Prevent [28] is a diabetes prevention intervention based on the DPP [63] and the Small Steps, Big Rewards Program [69] and is tailored for AA families. The goal of the program is to achieve a 5% to 7% weight loss by making modifications to dietary, physical activity, and sedentary behaviors. In the proposed pilot trial, modification to family dietary, physical activity (≥150 min per week), and sedentary behaviors will be targeted, in addition to individual-level parent behaviors. The Power to Prevent Leader Guide and participant materials will be adapted and used in each session. The scientific literature strongly supports family-based approaches to treating youth with overweight or obesity [70]. Thus, group-based sessions (60 min) will be conducted with parents and target the adoption, maintenance, and self-regulation of family-focused dietary, physical activity, and sedentary behaviors. Parent participants will meet weekly for 11 weeks and then monthly for 4 pilot maintenance sessions (15 sessions in total; frequency and duration supported by the literature [71]). Sessions for all groups will be facilitated by a racially concordant lifestyle coach (interventionist) who will be trained in accordance with the Centers for Disease Control and Prevention Diabetes Prevention Recognition Program standards [72]. Wi-Fi–equipped iPads (12.9”) with cellular connectivity will be used to link families to videoconferencing sessions and to cooking and family-friendly physical activity video demonstrations via YouTube.

Participant sociodemographic characteristics at baseline will be described using means and SDs, medians and ranges, or frequencies with percentages where applicable. The primary outcome evaluation will assess the change in child BMI z score (index participant) and parent BMI (coparticipant) from baseline to 12 and 30 weeks using repeated measures analysis of covariance with child Tanner stage as the covariate. Secondary analyses will include the comparison of anthropometric, biomarker, behavioral, psychosocial, and environmental measures adjusted for other factors. Generalized linear modeling will be used to assess the effect of the intervention, both unadjusted and adjusted (controlling for demographics, baseline BMI z score, and BMI). Data will be analyzed according to intention-to-treat principles [106-108].

The proposed implementation strategy has 2 targets: (1) the UMMC’s pediatric weight management clinical setting and clinical care team, which will be modified to support the uptake of the intervention and integration of the lifestyle coach into the clinical care team and (2) parents and children with T2DM risk referred to and engaged in intensive obesity treatment for the prevention of T2DM. The multifaceted implementation plan includes 4 discrete strategies: (1) creating a new clinical team, (2) changing the service site, (3) intervening with families, and (4) assessing organizational readiness [109]. In accordance with the recommendations for reporting implementation protocols [110], each strategy is operationalized in Table 2.

Qualitative meeting notes and clinical and intervention observations will be reviewed and synthesized on an ongoing basis to make immediate adaptations to screening and enrollment procedures, implementation strategies, and intervention session delivery and facilitation. All other evaluation data analyses will be conducted in 3 phases. In phase 1, qualitative and quantitative data sources will be independently analyzed. In phase 2, we will use a side-by-side comparison convergence approach where the qualitative findings are outlined and then converged with the respective quantitative results and efficacy outcomes for synthesis. In phase 3, the interpretation of findings, we will seek to understand if and how our strategy worked, for who, and in what context.