National Diabetes Prevention Program Research Articles

A Statewide Physician Champion Initiative to Prevent Diabetes: Lessons Learned from North Carolina.

The North Carolina Medical Society (NCMS) and American Medical Association (AMA) collaborated to support diabetes prevention efforts in North Carolina (NC) with a physician champion initiative focused on tracking and increasing referrals to the National Diabetes Prevention Program (DPP). Three focus areas to effectively engage and utilize physician champions included: (1) self-adoption within their practice, (2) engagement and outreach with other healthcare leaders, and (3) influence to peers and colleagues. Six NC physician champions were selected to support the work from January 2020 to January 2023. This resulted in increased outreach to physicians about Diabetes Free NC, increased materials/education for physicians on prediabetes identification and management, and 1943 referrals to the National DPP. This work can be further translated and applied to other states to aid prevention efforts. Physician champions' expertise coupled with adequate resources can allow them to play a key role in chronic disease prevention and management.

Adding a Brief Continuous Glucose Monitoring Intervention to the National Diabetes Prevention Program: A Multimethod Feasibility Study.

The National Diabetes Prevention Program (DPP) promotes lifestyle changes to prevent diabetes. However, only one-third of DPP participants achieve weight loss goals, and changes in diet are limited. Continuous glucose monitoring (CGM) has shown potential to raise awareness about the effects of diet and activity on glucose among people with diabetes, yet the feasibility of including CGM in behavioral interventions for people with prediabetes has not been explored. This study assessed the feasibility of adding a brief CGM intervention to the Arizona Cooperative Extension National DPP. Extension DPP participants were invited to participate in a single CGM-based education session and subsequent 10-day CGM wear period, during which participants reflected on diet and physical activity behaviors occurring prior to and after hyperglycemic events. Following the intervention, participants completed a CGM acceptability survey and participated in a focus group reflecting on facilitators and barriers to CGM use and its utility as a behavior change tool. A priori feasibility benchmarks included opt-in participation rates ≥ 50%, education session attendance ≥ 80%, acceptability scores ≥ 80%, and greater advantages than disadvantages of CGM emerging from focus groups, as analyzed using the Key Point Summary (KPS) method. Thirty-five DPP members were invited to participate; 27 (77%) consented, and 24 of 27 (89%) attended the brief CGM education session. Median survey scores indicated high acceptability of CGM (median = 5, range = 1-5), with nearly all (n = 23/24, 96%) participants believing that CGM should be offered as part of the DPP. In focus groups, participants described how CGM helped them make behavior changes to improve their glucose (e.g., reduced portion sizes, increased activity around eating events, and meditation). In conclusion, adding a single CGM-based education session and 10-day CGM wear to the DPP was feasible and acceptable. Future research will establish the efficacy of adding CGM to the DPP on participant health outcomes and behaviors.

391 Value estimation of the Diabetes Prevention Program: How well does clinical trial-based cost-effectiveness apply to the real world?

OBJECTIVES/GOALS: Many economic evaluations rely on clinical trial data that may not represent real world populations and intervention effectiveness. We compare risk and cost-effectiveness for the Diabetes Prevention Program (DPP) clinical trial cohort and a real world population eligible for the national DPP to assess the impact of using real world data. METHODS/STUDY POPULATION: To produce real world (US population) representative results, we identified National Health and Nutrition Examination Survey (NHANES) subjects eligible for the national DPP and adjusted projections using survey weights. We used clinical predictive models to estimate individual diabetes risk, and microsimulation to estimate lifetime costs, benefits, and net monetary benefits (NMB) for lifestyle intervention and metformin. We compared results across the DPP clinical trial and NHANES populations. RESULTS/ANTICIPATED RESULTS: Three-year risk of diabetes onset for the DPP trial population (mean of 19.7%, median of 10.3%) exceeded corresponding risk for the NHANES population (mean of 14.6%, median of 4.8%). The proportion of individuals with a three-year diabetes risk < 10% for the DPP trial population (49%) was less than the corresponding proportion for NHANES (67%). Mean NMB for metformin for the DPP trial population ($9,749) exceeded the corresponding value for NHANES ($5,391). The proportion of subjects with negative NMB was 49% for the DPP trial population and 67% for NHANES. Lifestyle intervention had a mean NMB of $34,889 for the DPP trial population and $28,652 for NHANES. Only 20% of the NHANES population eligible for national DPP met inclusion/exclusion criteria for the DPP trial. DISCUSSION/SIGNIFICANCE: Real world populations eligible for the national DPP include a greater proportion of low-risk individuals, and for these people, prevention programs may confer smaller benefits. Technology assessments based on clinical trial data should be revised using real world population and treatment effect data.

Pilot Study to Assess the Effectiveness of the Sustainable Culturally Adaptive Nutrition Program (SCAN) to Improve Adherence to the National Diabetes Prevention Program.

The Sustainable Culturally Adapted Nutrition Program (SCAN) is a novel adaptation to the National Diabetes Prevention Program (NDPP) that aims to improve attendance and effectiveness. This paper presents its feasibility and impact through the initial 6-month outcomes. A pragmatic quasi-experimental pilot study with intervention (DPP plus SCAN) and control (DPP only) groups. Sustainable Culturally Adapted Nutrition Program participants were recruited from federally qualified health center (FQHC) clinic patients enrolled in a NDPP in Houston, Texas. Participants needed to be (1) ≥18years old, (2) body mass index >25, (3) no prior diagnosis of diabetes, and (4) not pregnant. Sustainable Culturally Adapted Nutrition Program cooking classes were designed to teach skills to prepare fresh produce, and utilized Motivational Interviewing (MI) techniques to encourage participants to adapt these skills for foods that were culturally important to them. (1) National Diabetes Prevention Program attendance, (2) BMI and (3) percent weight loss. We used linear mixed models to test the association between weights and NDPP attendance. 22 intervention and 15 control participants completed the program to the 6-month point. Intervention participants had increased DPP attendance over controls (7.14 vs 6.87 session). Intervention participants also demonstrated on average, 1.5% weight loss for each additional SCAN class attended (P = .144). The SCAN adaptation shows promising results for effectively increasing both NDPP attendance and weight loss.

Nationwide Effectiveness and Efficiency of the National Diabetes Prevention Policy Versus the Penny-per-Ounce Excise Tax Policy on Sugar-Sweetened Beverages.

Diabetes has reached epidemic levels in the United States (US). This review compared two nationwide diabetes prevention policies: the National Diabetes Prevention Program (DPP) and the Penny-per-Ounce Excise (POE) tax policy on sugar-sweetened beverages (SSBs) based on their efficiency and efficacy in reducing the number of new cases of diabetes in the US.Thestudy made a recommendationfor the implementation of one or both policies based on the comparison. The national DPP focuses on screening for prediabetes in overweight/obese individuals and having positive subjects participate in a potentially insured one-year weight loss program with CDC-approved coaches. The POE tax on SSBs on the other hand is based on taxing SSBs with the objective that it will reduce new cases of diabetes due to a lower consumption of these beverages, or a switch to healthier alternatives. Studies that predicted the impact of either policy at the national level were used to compare both policies. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference in net costs saved by the difference in net effectiveness (diabetes cases prevented per year); thereby comparing both policies in terms of costs saved for each diabetes case prevented per year. Using only nationwide US predictions, it has been estimated that the POE tax on SSB will produce the most cost savings with a greater impact on reducing new cases of diabetes if implemented; therefore, this tax should be recommended, in addition to the already implemented DPP.

Tailoring of Health-Promotion Video Messaging for Reproductive-Aged Women at Risk for Developing Cardiometabolic Disease: Qualitative Focus-Groups Study.

Targeting reproductive-aged women at high risk for type 2 diabetes (T2D) provides an opportunity for prevention earlier in the life course. A woman's experiences during her reproductive years may have a large impact on her future risk of T2D. Her risk is 7 to 10 times higher if she has had gestational diabetes (GDM). Despite these risks, T2D is preventable. Evidence-based programs, such as the National Diabetes Prevention Program (DPP), can reduce the risk of developing T2D by nearly 60%. However, only 0.4% of adults with prediabetes have participated in the DPP to date and reproductive-aged women are 50% less likely to participate than older women. In prior work, our team developed a mobile 360° video to address diabetes risk awareness and promote DPP enrollment among at-risk adults; this video was not designed, however, for reproductive-aged women. This study aims to obtain feedback from reproductive-aged women with cardiometabolic disease risk about a 360° video designed to promote enrollment in the DPP, and to gather suggestions about tailoring video messages to reproductive-aged women. Focus groups and a qualitative descriptive approach were used. Women with at least 1 previous pregnancy, aged 18 to 40 years, participated in one of three focus groups stratified by the following health risks: (1) a history of GDM or a hypertensive disorder of pregnancy, (2) a diagnosis of prediabetes, or (3) a BMI classified as obese. Focus-group questions addressed several topics; this report shared findings regarding video feedback. The 3 focus-group discussions were conducted via Zoom and were recorded and transcribed for analysis. Deductive codes were used to identify concepts related to the research question and inductive codes were created for novel insights shared by participants. The codes were then organized into categories and themes. The main themes identified were positive feedback, negative feedback, centering motherhood, and the importance of storytelling. While some participants said the video produced a sense of urgency for health-behavior change, all participants agreed that design changes could improve the video's motivating effect on health-behavior change in reproductive-aged women. Participants felt a tailored video should recognize the complexities of being a mother and how these dynamics contribute to women's difficulty engaging in healthy behaviors without stirring feelings of guilt. Women desired a video with a positive, problem-solving perspective, and recommended live links as clickable resources for practical solutions promoting health behavior change. Women suggested using storytelling, both to describe how complications experienced during pregnancy impact long-term health and to motivate health behavior change. Reproductive-aged women require tailored lifestyle-change messaging that addresses barriers commonly encountered by this population (eg, parenting or work responsibilities). Moreover, messaging should prioritize a positive tone that harnesses storytelling and human connection while offering realistic solutions.

Feasibility of a Type 2 Diabetes Prevention Program at Nationwide Level in General Practice: A Pilot Study in Italy.

Lifestyle interventions halt the progression of prediabetes to frank type 2 diabetes (T2D). However, the feasibility of a diabetes prevention program promoting tailored interventions on a national scale and conducted by primary care physicians is unclear. General practitioners located in ten different regions throughout Italy enrolled random subjects without known metabolic diseases to identify individuals with prediabetes and prescribe them an intervention based on physical activity. Using a simple stepwise approach, people referring to their primary care physician for any reason were screened for their diabetes risk with a web-based app of the Findrisc questionnaire. Those at risk for T2D, i.e., with a Findrisc score >9, were invited to come back after overnight fasting to measure fasting glycaemia (FG). Those with 100 ≤ FG < 126 mg/dL were considered as people with prediabetes and compiled the Physical Activity Readiness Questionnaire (PAR-Q) to then receive a personalised prescription of physical activity. Overall, 5928 people were enrolled and compiled the questionnaire. Of these, 2895 (48.8%) were at risk for T2D. Among these, FG was measured in 2168 subjects (participation rate 75%). The numbers of individuals with undetected prediabetes and T2D according to FG were 755 and 79 (34.8% and 3.6% of those assessing FG), respectively. Of the 755 subjects in the prediabetes range, 739 compiled the PAR-Q and started a personalised program of physical activity (participation rate 97%). Physicians involved in the study reported a mean of 6 min to perform the screening. Overall, these data suggest the feasibility of a national diabetes prevention program developed by general practitioners using a simple stepwise approach starting from a web app to intercept individuals with prediabetes.

Using Trends in Biometric Data to Predict Interest in Enrolling in an Employer-Sponsored National Diabetes Prevention Program Focusing on Diet and Exercise: A Retrospective Cohort Study

Using Trends in Biometric Data to Predict Interest in Enrolling in an Employer-Sponsored National Diabetes Prevention Program Focusing on Diet and Exercise: A Retrospective Cohort Study

Implementation of Session Zero as a Recruitment Strategy in the National Diabetes Prevention Program's Lifestyle Change Program.

The purpose of the study was to understand the extent to which organizations offering the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program (National DPP) lifestyle change program implement session zero (a pre-enrollment session designed to recruit, engage, and enroll participants in programs), the stated purpose(s) for offering session zero, the content of session zero, and best practices for using session zero for recruitment. Researchers conducted a survey of all organizations offering the National DPP lifestyle change program that were registered with the CDC's Diabetes Prevention Recognition Program and their affiliated delivery locations. Most (79.5%) delivery locations reported implementing session zero; of these, most used session zero as a recruitment strategy (81.1%) and orientation session (72.8%), whereas few (17.7%) used session zero solely to complete participant enrollment paperwork. Most (60.7%) delivery locations that implement session zero offer all their sessions at the same location, offer one session per upcoming participant cohort (66.7%), and use a consistent agenda (83.0%). Out of a list of activities informed by behavior change theory, the most common was offering an opportunity to enroll in the year-long lifestyle change program at the end of session zero (71.1%). Most National DPP delivery locations implement session zero as a recruitment and orientation session. Most delivery locations reported including some activities informed by behavior change theory, but delivery locations could offer more theoretically informed activities during their session zero. The findings provide practice-based considerations for implementing session zero for recruitment into lifestyle change programs.

The effect of parental diabetes prevention program participation on weight loss in dependent children: a prospective cohort study

IntroductionObesity has reached epidemic proportions in children and adolescents in the United States. Children’s behaviors are strongly influenced by parental behaviors, and weight loss in parents is positively associated with weight changes in their overweight/obese children. Research is limited on how parents’ National Diabetes Prevention Program (DPP) participation affects the health outcomes of their dependent children. Analyzing the impact of parental DPP participation on weight loss in their dependent children may provide valuable insight into an important secondary benefit of DPP participation.MethodsIn this study, we identified 128 adults with prediabetes who were offered the opportunity to participate in a DPP (n = 54 DPP participants and n = 74 DPP non-participants) and who had at least one child 3 to 17 years of age living with them. Age and BMI percentile for dependent children were collected from insurance claims data for 203 children (n = 90 children of DPP participants and n = 113 children of DPP non-participants). Parental practices related to diet and physical activity were assessed by surveys.ResultsThere were no significant changes in BMI percentiles of overweight or obese children (i.e. BMI percentile ≥ 50%) of DPP participants vs DPP non-participants with prediabetes over one-year. Parents who enrolled and did not enroll in the DPP did not report differences in their parenting practices related to diet and physical activity.DiscussionThese results are not consistent with the literature that suggests parent-based interventions may influence their children’s weight trajectories. Limitations include small sample size, short time span of intervention, and limited availability of additional health/biographic data on dependent children. Future studies should collect primary outcome data on children, investigate whether there is a minimum duration of parental involvement and level of parental adherence, and assess the effect of parent–child dynamics on child weight trajectories.

Corrigendum: Application of implementation mapping to develop strategies for integrating the National Diabetes Prevention Program into primary care clinics

Corrigendum: Application of implementation mapping to develop strategies for integrating the National Diabetes Prevention Program into primary care clinics

A structural equation model of CFIR inner and outer setting constructs, organization characteristics, and national DPP enrollment

BackgroundThe National Diabetes Prevention Program (DPP) has made great strides in increasing accessibility to its year-long, evidence-based lifestyle change program, with around 3000 organizations having delivered the program. This large dissemination effort offers a unique opportunity to identify organization-level factors associated with program implementation and reach (enrollment) across diverse settings. The purpose of this study was to quantitatively examine the relationships among Consolidated Framework for Implementation Research (CFIR) Inner Setting and Outer Setting constructs and the implementation outcome of reach.MethodsThis study analyzed data from a 2021 cross-sectional online survey with 586 National DPP Staff (lifestyle coaches, master trainers, program coordinators) with information about their organization, implementation outcomes, and responses to quantitative CFIR Inner Setting and Outer Setting construct items. Structural equation modeling was used to test a hypothesized path model with Inner and Outer Setting variables to explore direct and indirect pathways to enrollment.ResultsThe CFIR items had good internal consistency and indicated areas of implementation strength and weakness. Eight variables included as part of the CFIR structural characteristics and one organization characteristic variable had significant direct relationships with enrollment. The length of delivery, number of lifestyle coaches, number of full-time staff, large organization size, and organizations delivering in rural, suburban, and/or urban settings all had positive significant direct relationships with enrollment, while academic organizations and organizations with only non-White participants enrolled in their National DPP lifestyle change programs had a negative association with enrollment.ConclusionsParticipant reach is an important implementation outcome for the National DPP and vital to making population-level decreases in diabetes incidence in the USA. Our findings suggest that to facilitate enrollment, program implementers should focus on organizational structural characteristics such as staffing. Strengths of this study include the use of adapted and newly developed quantitative CFIR measures and structural equation modeling. Health prevention programs can use the methods and findings from this study to further understand and inform the impact of organization factors on implementation outcomes.

Telehealth Diabetes Prevention Program for Adults With Prediabetes in an Academic Medical Center Setting: Protocol for a Hybrid Type III Trial.

Diabetes is a costly epidemic in the United States associated with both health and economic consequences. These consequences can be mitigated by participation in structured lifestyle change programs such as the National Diabetes Prevention Program (DPP) led by the Centers for Disease Control and Prevention. Mississippi consistently has among the highest rates of diabetes and prediabetes nationally. Implementing the National DPP through large health care systems can increase reach and accessibility for populations at the highest risk for diabetes. Translational research on the National DPP in Mississippi has not been studied. This study aims to evaluate the implementation and impact of the National DPP delivered using telehealth modalities at the University of Mississippi Medical Center in Jackson, Mississippi. An effectiveness-implementation hybrid type III research design is proposed. The study design is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework and the Practical, Robust Implementation and Sustainability Model. Participants are being recruited via provider referral, and the DPP is being delivered by trained lifestyle coaches. Study participants include adult (≥18 years) patients eligible for the DPP with at least 1 encounter at 1 of 3 ambulatory clinic specialties (lifestyle medicine, family medicine, and internal medicine) between January 2019 and December 2023. The National DPP eligibility criteria include a BMI ≥25 kg/m2 and hemoglobin A1c between 5.7% and 6.4%. The University of Mississippi Medical Center criteria include Medicare or Medicaid beneficiaries. The University of Mississippi Medical Center's a priori implementation plan was developed using the Consolidated Framework for Implementation Research and includes 23 discrete strategies. The primary aim will use an embedded mixed method process analysis to identify and mitigate challenges to implementation. The secondary aim will use a nonrandomized quasi-experimental design to assess the comparative effectiveness of the DPP on health care expenditures. A propensity score matching method will be implemented to compare case subjects to control subjects. The primary outcomes include patient referrals, participant enrollment, retention, engagement, the incidence of diabetes, and health care resource use and costs. At baseline, of the 26,151 patients across 3 ambulatory clinic specialties, 1010 (3.9%) had prediabetes and were eligible for the National DPP. Of the 1010 patients, more than half (n=562, 55.6%) were aged 65 years or older, 79.5% (n=803) were Medicare beneficiaries, 65.9% (n=666) were female, and 70.8% (n=715) were obese. This is the first translational study of the National DPP in Mississippi. The findings will inform implementation strategies impacting the uptake and sustainability of the National DPP delivered in an academic medical setting using distance learning and telehealth modalities. ClinicalTrials.gov NCT04822480; https://clinicaltrials.gov/study/NCT03622580. DERR1-10.2196/50183.

Delivering the National Diabetes Prevention Program: Assessment of Outcomes in In-Person and Virtual Organizations.

The Centers for Disease Control and Prevention's Diabetes Prevention Recognition Program (DPRP) has helped organizations deliver the National Diabetes Prevention Program (National DPP) lifestyle change program for over 10 years. Four delivery modes are now approved: in person, online (self-paced, asynchronous delivery), distance learning (remote, synchronous delivery), and combination (hybrid delivery using more than one delivery mode). We assessed outcomes using data from 333,715 participants who started the 12-month program between January 1, 2012, and December 31, 2018. The average number of sessions attended was highest for in-person participants (15.0), followed by online (12.9), distance learning (12.2), and combination (10.7). The average number of weeks in the program was highest for in-person participants (28.1), followed by distance learning (20.1), online (18.7), and combination (18.6). The average difference between the first and last reported weekly physical activity minutes reflected an increase for in person (42.0), distance learning (27.1), and combination (15.0), but a decrease for online (-19.8). Among participants retained through session 6 or longer, average weekly physical activity minutes exceeded the program goal of 150 for all delivery modes. Average weight loss (percent of body weight) was greater for in person (4.4%) and distance learning (4.7%) than for online (2.6%) or combination (2.9%). Average participant weight loss increased gradually by session for all delivery modes; among participants who remained in the program for 22 sessions, average weight loss exceeded the program goal of 5% for all delivery modes. In summary, if participants stay in the program, most have positive program outcomes regardless of delivery mode; they have some outcome improvement even if they leave early; and their outcomes improve more the longer they stay. This highlights the benefits of better retention and increased enrollment in the National DPP lifestyle change programs, as well as enhancements to online delivery.

Patterns of Sustainability Capacity Among Organizations That Deliver the National Diabetes Prevention Program: A Latent Profile Analysis.

Since the launch of the National Diabetes Prevention Program (DPP) in 2010, more than 3,000 organizations have registered with the Centers for Disease and Control and Prevention to deliver the program; today, however, only approximately 2,000 organizations are registered, indicating challenges with sustainability. We used the Program Sustainability Assessment Tool (PSAT) to explore patterns of sustainability capacity among National DPP delivery organizations. We used data from a cross-sectional online survey conducted in August and September 2021 of staff members (N = 440) at National DPP delivery organizations. We conducted a latent profile analysis to identify latent subpopulations on the basis of respondent PSAT domain scores. Regression analyses were used to estimate associations between derived latent classes, PSAT scores, and respondent characteristics. The 4-class model included 4 groups of capacity for program sustainability, ranging from low to high: low (class 1) with 8.0% of the sample, medium-low (class 2) with 22.0%, medium-high (class 3) with 41.6%, and high (class 4) with 28.4%. Program evaluation (mean score = 5.1 [SD = 1.4]) and adaptation (mean score = 5.3 [SD = 1.3]) were the domains with the highest scores, while funding stability (mean score = 4.0 [SD = 1.6]) and Partnerships (mean score = 4.0 [SD = 1.7]) had the lowest scores. In our sample of National DPP delivery organizations, most reported relatively high capacity for program sustainability, and key indicators associated with sustainability capacity were virtual delivery, location of delivery, funding sources, and organization type. Similar to sustainability capacity findings from other PSAT studies, our study found that funding stability and partnerships are areas to strengthen. This insight is useful in sustainability planning at organizational and national levels across multiple programs.

Therapeutic Lifestyle Intervention Targeting Enhanced Cardiometabolic Health and Function for Persons with Chronic Spinal Cord Injury in Caregiver/Care-Receiver Co-Treatment: A Study Protocol of a Multisite Randomized Controlled Trial.

Chronic spinal cord injury (SCI) significantly accelerates morbidity and mortality, partly due to the increased risk of cardiometabolic diseases (CMD), including neurogenic obesity, dyslipidemia, and impaired glucose metabolism. While exercise and dietary interventions have shown some transient benefits in reducing CMD risk, they often fail to improve clinically relevant disease markers and cardiovascular events. Moreover, SCI also places caregiving demands on their caregivers, who themselves experience health and functional decline. This underscores the need for more substantial interventions that incorporate appropriate physical activity, heart-healthy nutrition, and behavioral support tailored to the SCI population. This randomized clinical trial (RCT) protocol will (1) assess the health and functional effects, user acceptance, and satisfaction of a 6-month comprehensive therapeutic lifestyle intervention (TLI) adapted from the National Diabetes Prevention Program (DPP) for individuals with chronic SCI and (2) examine the impact of a complementary caregiver program on the health and function of SCI caregivers and evaluate user acceptance and satisfaction. Caregivers (linked with their partners) will be randomized to 'behavioral support' or 'control condition'. Dyadic couples comprise individuals with SCI (18-65 years, >1-year post-injury, ASIA Impairment Scale A-C, injury levels C5-L1) and non-disabled SCI caregivers (18-65 years). Both groups undergo lock-step circuit resistance training, a calorie-restricted Mediterranean-style diet, and 16 educational sessions focused on diet/exercise goals, self-monitoring, psychological and social challenges, cognitive behavioral therapy, and motivational interviewing. The outcome measures encompass the cardiometabolic risks, cardiorespiratory fitness, inflammatory stress, multidimensional function, pain, life quality, independence, self-efficacy, program acceptance, and life satisfaction for SCI participants. The caregiver outcomes include multidimensional function, pain, quality of life, independence, and perceived caregiver burden. This study evaluates the effects and durability of a structured, multi-modal intervention on health and function. The results and intervention material will be disseminated to professionals and consumers for broader implementation. ClinicalTrials.gov, ID: NCT02853149 Registered 2 August 2016.

A pre-conception clinical trial to reduce intergenerational obesity and diabetes risks: The NDPP-NextGen trial protocol

BackgroundIntrauterine exposure to maternal overweight/obesity or diabetes transmits risks to offspring, perpetuating a disease cycle across generations. Prenatal interventions to reduce maternal weight or dysglycemia have limited impact, while postpartum interventions can alter the intrauterine environment only if child-bearing continues. Efficacious preconception interventions are needed, especially for underserved populations, and with the potential to be scaled up sustainably. Research is also needed to assess intervention effects at conception, throughout pregnancy, and among offspring. MethodsThis two-arm, parallel randomized clinical trial will include 360 biological females with overweight/obesity and moderate-to-high likelihood of pregnancy within 24 months. Participants will be randomized 1:1 to a yearlong pre-conception lifestyle intervention based on the National Diabetes Prevention Program (NDPP-NextGen) or usual care. Data collection will occur at enrollment (before conception), post-conception (<8 weeks gestation), late pregnancy (28–32 weeks gestation), and delivery (before discharge) for participants who become pregnant within 24 months of enrollment. Main outcomes are post-conception body mass index (<8 weeks gestation; primary outcome), post-conception fasting glucose (<8 weeks gestation; secondary outcome), and neonatal adiposity (<2 days post-birth). Additional clinical, behavioral, perinatal and offspring data will be collected, and biospecimens (blood, urine, stool, cord blood) will be banked for future ancillary studies. ConclusionThis clinical trial will evaluate an intervention model (NDPP-NextGen) with potential to improve maternal health among the >50% of US females with overweight/obesity or diabetes risks in pregnancy. If successful, it can be scaled among >1800 organizations delivering NDPP in the United States to benefit the health of future generations.

Uptake, retention, and outcomes of the National Diabetes Prevention Program by enrollee characteristics and program type

AimsTo describe National Diabetes Prevention Program (NDPP) uptake, retention, and outcomes by enrollee characteristics and program type. MethodsWe studied 776 adult University of Michigan employees, dependents, and retirees with prediabetes and overweight or obesity who enrolled in one of four CDC-recognized NDPPs at no out-of-pocket cost. Programs included 1) an in-person classroom-based program led by certified diabetes educators in an endocrinology outpatient clinic; 2) an in-person classroom-based program led by trained peer instructors in community settings; 3) an in-person fitness-focused program led by trained lifestyle coaches; and 4) an online digital program led by personal health coaches with virtual group meetings. Data from the insurer and surveys were analyzed. ResultsOlder individuals with hypertension and cardiovascular disease were more likely to enroll in classroom-based programs. Program time, location, and perceived focus on diet or physical activity influenced program selection. Retention, weight loss, and physical activity were greater among enrollees in in-person classroom-based programs. Changes in blood pressure, lipid levels, self-rated health, and health-related quality-of-life did not differ by program, nor did Type 2 diabetes mellitus incidence. ConclusionsIndividuals with prediabetes who enrolled in a NDPP achieved health benefits regardless of the type of program they chose.

Diet Quality Outcomes of a Cooperative Extension Diabetes Prevention Program

ObjectiveThe effectiveness of the National Diabetes Prevention Program (DPP) in improving diet quality (DQ) in community settings is largely unknown. This study aimed to evaluate the DQ changes of Extension DPP participants. MethodsA single-group, repeated-measures design was used to evaluate an Extension-implemented DPP using the PreventT2 curriculum. Participants were overweight adults with or at high risk for prediabetes (n = 88). Weight and DQ (Healthy Eating Index–2015, Dietary Screener Questionnaire) were evaluated using mixed-effects regression. ResultsThere was no change in the Healthy Eating Index–2015 total score. Predicted fiber, fruit, and vegetable intake increased (P < 0.05) but remained below recommendations. Conclusions and ImplicationsClinically meaningful DQ changes of Extension DPP participants were limited. The effect of the DPP on DQ in Extension and other implementation settings should be evaluated through randomized controlled trials. Diabetes Prevention Program curriculum revisions that include more specific dietary goals and educational tools may promote greater DQ changes in DPP participants.

335-OR: Participant Engagement and Weight Loss in the National Diabetes Prevention Program before and during COVID

The CDC’s National Diabetes Prevention Program (NDPP) aims to prevent or delay type 2 diabetes (T2D) through lifestyle change and weight loss. Due to challenges implementing in-person programs during the COVID-19 pandemic, many CDC-recognized organizations transitioned to offer the NDPP virtually. This analysis used NDPP data collected as part of routine care at Scripps Health, a large, non-profit health system in San Diego, CA. There were 273 individuals who participated in the NDPP before COVID (in-person sessions; October 2016 - January 2020) and 73 during COVID (virtual sessions; August 2020 - June 2021). Participants who attended virtually and in-person were, on average, 59.59±12.71 and 59.90±13.93 years old, and the majority were women (69% and 83%), White (65% and 45%), married (81% and 62%), and college graduates (66% and 44%), respectively. Chi-square, Fisher’s exact, and unpaired t-tests examined differences between the in-person vs. virtual cohorts. Compared to in-person, virtual participants consisted of significantly more men (31% vs. 17%, p= .01), but fewer Hispanics (14% vs. 43%, p&amp;lt; .01), Spanish-speakers (1% vs. 17%, p &amp;lt; .05), individuals with less than high school education (0% vs. 18%, p &amp;lt; .05), and individuals with household income of less than $24,000 (1% vs. 17%, p &amp;lt; .05). While the number of core sessions attended was not significantly different (M=20.19 vs. M=18.82; p&amp;gt; .05), average percent weight loss was significantly lower for individuals in the virtual sessions than in the in-person sessions (M=3.35 vs. M=4.50; p= .05). Although the NDPP has continued to reach participants despite the pandemic’s challenges, participation by racial and ethnic minority and socioeconomically disadvantaged individuals declined when the program transitioned to virtual delivery. More research is needed to examine patient-centered approaches to improve outcomes and engage underserved communities that are disproportionately affected by prediabetes and T2D. Disclosure E.San diego: None. M.Chichmarenko: None. E.Soriano: None. S.R.Spierling bagsic: None. N.Orendain: None. A.L.Fortmann: Employee; Dexcom, Inc. M.Ruiz: None. A.Philis-tsimikas: Advisory Panel; Dexcom, Inc., Novo Nordisk A/S, Sanofi, Other Relationship; Medtronic, Research Support; Novo Nordisk A/S, Lilly, Viking Therapeutics, NIH - National Institutes of Health. Funding National Institutes of Health (UL1TR002550, KL2TR002552)