Vitamin D Supplementation and Prevention of Type 2 Diabetes.

BACKGROUND: Observational studies support an association between a low blood 25-hydroxyvitamin D level and the risk of type 2 diabetes. However, whether vitamin D supplementation lowers the risk of diabetes is unknown. METHODS: We randomly assigned adults who met at least two of three glycemic criteria for prediabetes (fasting plasma glucose level, 100 to 125 mg per deciliter; plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter; and glycated hemoglobin level, 5.7 to 6.4%) and no diagnostic criteria for diabetes to receive 4000 IU per day of vitamin D3 or placebo, regardless of the baseline serum 25-hydroxyvitamin D level. The primary outcome in this time-to-event analysis was new-onset diabetes, and the trial design was event-driven, with a target number of diabetes events of 508. RESULTS: A total of 2423 participants underwent randomization (1211 to the vitamin D group and 1212 to the placebo group). By month 24, the mean serum 25-hydroxyvitamin D level in the vitamin D group was 54.3 ng per milliliter (from 27.7 ng per milliliter at baseline), as compared with 28.8 ng per milliliter in the placebo group (from 28.2 ng per milliliter at baseline). After a median follow-up of 2.5 years, the primary outcome of diabetes occurred in 293 participants in the vitamin D group and 323 in the placebo group (9.39 and 10.66 events per 100 person-years, respectively). The hazard ratio for vitamin D as compared with placebo was 0.88 (95% confidence interval, 0.75 to 1.04; P = 0.12). The incidence of adverse events did not differ significantly between the two groups. CONCLUSIONS: Among persons at high risk for type 2 diabetes not selected for vitamin D insufficiency, vitamin D3 supplementation at a dose of 4000 IU per day did not result in a significantly lower risk of diabetes than placebo. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; D2d ClinicalTrials.gov number, NCT01942694.).

Long-Term Effectiveness of the TIME Intervention to Improve Diabetes Outcomes in Low-Income Settings: a 2-Year Follow-Up.

BACKGROUND: We previously found that a 6-month multidimensional diabetes program, TIME (Telehealth-Supported, Integrated Community Health Workers, Medication-Access) resulted in improved clinical outcomes. OBJECTIVE: To follow TIME participant clinical outcomes for 24 months PARTICIPANTS: Low-income Latino(a)s with type 2 diabetes DESIGN AND INTERVENTION: We collected post-intervention clinical data for five cohorts (n = 101, mean n = 20/cohort) who participated in TIME programs from 2018 to 2020 in Houston, Texas. MAIN MEASURES: We gathered HbA1c (primary outcome), weight, body mass index (BMI), and blood pressure data at baseline, 6 months (intervention end), and semiannually thereafter until 24 months after baseline to assess sustainability. We also evaluated participant loss to follow-up until 24 months. KEY RESULTS: Participants decreased HbA1c levels during the intervention (p < 0.0001) and maintained these improvements at each timepoint from baseline to 24 months (p range: < 0.0001 to 0.015). Participants reduced blood pressure levels during TIME and maintained these changes at each timepoint from baseline until 18 months (systolic p range < 0.0001 to 0.0005, diastolic p range: < 0.0001 to 0.008) but not at 24 months (systolic: p = 0.065; diastolic: p = 0.85). There were no significant weight changes during TIME or post-intervention: weight (p range = 0.07 to 0.77), BMI (p range = 0.11 to 0.71). Attrition rates (loss to follow-up during the post-intervention period) were 5.9% (6 months), 24.8% (12 months), 35.6% (18 months), and 41.8% (24 months). CONCLUSIONS: It is possible for vulnerable populations to maintain long-term glycemic and blood pressure improvements using a multiple dimensional intervention. Attrition rates rose over time but show promise given the majority of post-intervention timepoints occurred during the COVID-19 pandemic when low-income populations were most susceptible to suboptimal healthcare access. Future studies are needed to evaluate longitudinal outcomes of diabetes interventions conducted by local clinics rather than research teams.

A Telehealth-supported, Integrated care with CHWs, and MEdication-access (TIME) Program for Diabetes Improves HbA1c: a Randomized Clinical Trial.

BACKGROUND: Many individuals with diabetes live in low- or middle-income settings. Glycemic control is challenging, particularly in resource-limited areas that face numerous healthcare barriers. OBJECTIVE: To compare HbA1c outcomes for individuals randomized to TIME, a Telehealth-supported, Integrated care with CHWs (Community Health Workers), and MEdication-access program (intervention) versus usual care (wait-list control). DESIGN: Randomized clinical trial. PARTICIPANTS: Low-income Latino(a) adults with type 2 diabetes. INTERVENTIONS: TIME consisted of (1) CHW-participant telehealth communication via mobile health (mHealth) for 12 months, (2) CHW-led monthly group visits for 6 months, and (3) weekly CHW-physician diabetes training and support via telehealth (video conferencing). MAIN MEASURES: Investigators compared TIME versus control participant baseline to month 6 changes of HbA1c (primary outcome), blood pressure, body mass index (BMI), weight, and adherence to seven American Diabetes Association (ADA) standards of care. CHW assistance in identifying barriers to healthcare in the intervention group were measured at the end of mHealth communication (12 months). KEY RESULTS: A total of 89 individuals participated. TIME individuals compared to control participants had significant HbA1c decreases (9.02 to 7.59% (- 1.43%) vs. 8.71 to 8.26% (- 0.45%), respectively, p = 0.002), blood pressure changes (systolic: - 6.89 mmHg vs. 0.03 mmHg, p = 0.023; diastolic: - 3.36 mmHg vs. 0.2 mmHg, respectively, p = 0.046), and ADA guideline adherence (p < 0.001) from baseline to month 6. At month 6, more TIME than control participants achieved > 0.50% HbA1c reductions (88.57% vs. 43.75%, p < 0.001). BMI and weight changes were not significant between groups. Many (54.6%) TIME participants experienced > 1 barrier to care, of whom 91.7% had medication issues. CHWs identified the majority (87.5%) of barriers. CONCLUSIONS: TIME participants resulted in improved outcomes including HbA1c. CHWs are uniquely positioned to identify barriers to care particularly related to medications that may have gone unrecognized otherwise. Larger trials are needed to determine the scalability and sustainability of the intervention. CLINICAL TRIAL: NCT03394456, accessed at https://clinicaltrials.gov/ct2/show/NCT03394456.

Telemedicine Training and Support for Community Health Workers: Improving Knowledge of Diabetes.

Background: Community health workers (CHWs) are a well-established source to improve patient health care, yet their training and support remain suboptimal. This limits program expansion and potentially compromises patient safety. The objective of the study was to evaluate the feasibility and acceptability of weekly training and support by telemedicine (videoconferencing). Materials and Methods: CHWs (n = 6) who led diabetes group visits for low-income Latinos met weekly with a health care professional for training and support. Feasibility and acceptability outcome measures included telemedicine usability, knowledge of diabetes (baseline to 6 months), and program satisfaction. Results: Telemedicine training and support were found to be feasible and acceptable as measured by usability (Telehealth Usability Questionnaire: average 4.7/5.0, ±0.4), knowledge (Diabetes Knowledge Test: pretest 15.8 ± 1.3, posttest 21.8 ± 1.2, p < 0.001, respectively), and satisfaction (Texas Department of State Health Services survey: average 5.8/6.0, ±0.5). All CHWs preferred telemedicine to in-person training. Conclusions: Telemedicine is a feasible and acceptable modality to train and support CHWs.

Levels of adherence needed to achieve significant weight loss.

BACKGROUND/OBJECTIVES: Positive associations have been found between adherence and weight loss in behavioral weight-management interventions. However, less attention has been given to the level of adherence needed to reach clinically significant weight loss. This study examined the levels of adherence associated with a ≥ 5% - < 10% or ≥ 10% weight loss in a community-based, intensive behavioral weight management program, Weight Watchers® (WW), which included three modes of access: (1) 24-weekly WW meetings over 6 months, (2) the WW member website, and (3) the WW mobile application. METHODS: A total of 292 participants were randomized to a WW (n = 147) or a self-help (SH) (n = 145) condition. To assess the impact of adherence, only participants in the WW condition were included in analyses (n = 147). Adherence was defined as use of the three modes of access. Measured heights and weights were obtained at baseline and 6 months. Receiver-operating characteristic curve analyses were conducted to determine the minimal level of adherence associated with clinically significant weight loss. RESULTS: In a 6-month period, increased likelihood of achieving a weight loss ≥ 5% - < 10% was associated with attending approximately one-third (35.4%) of weekly meetings, use of the member website about 25% of days, and use of the mobile application 16.1% of days. Attendance at approximately two-thirds (64.5%) of meetings, use of the member website 41.6% of days, and use of the mobile application 14.7% of days were associated with a clinically significant weight loss of ≥ 10%. Meeting attendance was the strongest predictor of weight loss at 6 months. CONCLUSIONS: Although adherence to a behavioral weight management program was an important predictor of weight loss, extremely high levels were not needed to achieve clinically significant weight loss. These results are important to help patients and treatment providers understand realistic goals for weight management.

Eating disorders: A 25-year perspective.

I founded Eating Disorders: The Journal of Treatment & Prevention 25 years ago, and its character, reputation, and success are highly attributable to Arnold Andersen, John Foreyt, and Margo Maine, the three original senior editors, whose perspectives follow in this article. Having made the decision to retire from the journal, I asked the senior editors to transition to the emeritus board along with me, which I explain further in my own Last Word, "Goodbye, Eating Disorders," in this volume (Cohn, 2017). Over our 25 years of collaboration, the senior editors have acquired unique insights into the evolution of the eating disorders field; so, I asked them to contribute retrospective essays in which they also look forward within their primary areas of expertise-presented here in alphabetical order. - Leigh Cohn, Editor-in-Chief.

Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.

BACKGROUND: Weight loss is recommended for overweight or obese patients with type 2 diabetes on the basis of short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among such patients. METHODS: In 16 study centers in the United States, we randomly assigned 5145 overweight or obese patients with type 2 diabetes to participate in an intensive lifestyle intervention that promoted weight loss through decreased caloric intake and increased physical activity (intervention group) or to receive diabetes support and education (control group). The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina during a maximum follow-up of 13.5 years. RESULTS: The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years. Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). The intensive lifestyle intervention also produced greater reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors, except for low-density-lipoprotein cholesterol levels. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83 and 1.92 events per 100 person-years, respectively; hazard ratio in the intervention group, 0.95; 95% confidence interval, 0.83 to 1.09; P=0.51). CONCLUSIONS: An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the National Institutes of Health and others; Look AHEAD ClinicalTrials.gov number, NCT00017953.).

Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.

Look AHEAD (Action for Health in Diabetes) was a randomized controlled trial that examined the impact of long-term participation in an intensive weight loss intervention on cardiovascular disease (CVD) morbidity and mortality in people with type 2 diabetes (T2D). The results from this trial suggest that intensive lifestyle interventions are effective in helping patients to achieve management of cardiovascular risk factors and reducing the need to initiate medication usage to manage these conditions, though the benefits in terms of the prevention of CVD morbidity and mortality beyond those achieved through aggressive medical management of hypertension and dyslipidemia is not clear. Additional benefits of participation in an intensive lifestyle intervention such as lowered chronic kidney disease risk, blood pressure, medication usage, improved sleep apnea, and partial remission of diabetes are discussed.

Findings from an online behavioural weight management programme provided with or without a fortified diet beverage.

The present multi-centre randomised weight-loss trial evaluated the efficacy of a low-intensity 12-week online behavioural modification programme, with or without a fortified diet beverage using a 2 × 2 factorial design. A total of 572 participants were randomised to: (1) an online basic lifestyle information (OBLI) intervention, consisting of one online informational class about tips for weight management; (2) an online behavioural weight management (OBWM) intervention, entailing 12 weekly online classes focused on weight-loss behaviour modification; (3) an OBLI intervention plus a fortified diet cola beverage (BEV) containing green tea extract (total catechin 167 mg), soluble fibre dextrin (10 g) and caffeine (100 mg) (OBLI+BEV); (4) OBWM+BEV. Assessments included height, weight, dual-energy X-ray absorptiometry-derived body composition, and waist circumference (WC). Attrition was 15·7 %. Intention-to-treat (ITT) models demonstrated a main effect for type of Internet programme, with those assigned to the OBWM condition losing significantly more weight (F= 7·174; P= 0·008) and fat mass (F= 4·491; P= 0·035) than those assigned to the OBLI condition. However, there was no significant main effect for the OBWM condition on body fat percentage (F= 2·906; P= 0·089) or WC (F= 3·351; P= 0·068), and no significant main effect for beverage use or significant interactions between factors in ITT models. A 12-week, low-intensity behaviourally based online programme produced a greater weight loss than a basic information website. The addition of a fortified diet beverage had no additional impact.

Mexican American children have differential elevation of metabolic biomarkers proportional to obesity status.

OBJECTIVES: There is a health disparity for obesity among Mexican Americans compared with other racial/ethnic groups. In particular, Mexican American children who are obese are likely to become obese adults. The purpose of this study was to examine traditional and nontraditional risk factors in a subset of Mexican American children before their participation in a larger clinical weight loss study. METHODS: Venous blood samples were collected from self-identified Mexican American children (12-14 years old) who were assigned to 1 of 3 weight groups based on their standardized body mass index; normal weight (N = 66), overweight (N = 23), or obese (N = 39). Serum was analyzed for interleukin-6, tumor necrosis factor-α, C-peptide, ghrelin, glucagon-like protein, gastric inhibitory polypeptide-1, glucagon, insulin, leptin, macrophage chemoattractant protein 1, and pancreatic polypeptide using a Luminex MagPix-based assay. Total cholesterol, high-density lipoprotein-cholesterol, triglycerides, and glucose were analyzed using enzymatic assays. Data were analyzed for significance using separate analysis of variance tests, with significance set at P < 0.05. RESULTS: Relative to normal weight and overweight children, obese children had significantly elevated C-peptide (P < 0.0001), insulin (P < 0.0001), leptin (P < 0.0001), macrophage chemoattractant protein 1 (P = 0.005), and tumor necrosis factor-α (P = 0.006). CONCLUSIONS: We observed that Mexican American children as a function of body weight had elevated serum concentrations of several biomarkers that have been linked to chronic disease development in adults. More research is needed to understand how these differences affect disease risk in adulthood.

A one-year school-based diet/exercise intervention improves non-traditional disease biomarkers in Mexican-American children.

School-based interventions are an effective way to treat childhood obesity. The purpose of the present study was to biologically validate an established school-based intervention designed to reduce standardised body mass index (zBMI) over a period of 12 months. This intervention focused on a subset of Mexican-American children who were participating in a larger clinical weight loss study. Plasma samples were analysed from self-identified Mexican-American children (12-14 years) who were randomised to either a school-based intervention (IN, n = 152) or self-help control (CN, n = 69). Treatment was 4 days week⁻¹ of exercise (45 min day⁻¹) and 1 day week⁻¹ of nutritional counselling for 6 months. Fasting (>8 h) blood samples were collected at baseline, 6 months (end of active intervention) and 12 months (6 months after the end of the active intervention). Plasma resistin, adiponectin and leptin concentration were measured using a multiplex assay. Separate linear mixed models and a P < 0.05 were used to test for significance. Significant group × time interactions were found for resistin (P < 0.0001), adiponectin (P = 0.001) and leptin (P = 0.013). For resistin, IN was 12% lower at 6 months than CN. Adiponectin concentration in IN was greater at 6 months (26%) and 12 months (8%) than CN. Leptin concentration was 22% lower for IN at 12 months than CN. We have previously reported that our school-based intervention reduced zBMI and now reported alterations in biologically relevant disease biomarkers. Some of the observed changes were only present at the end of the active intervention (resistin), while others persisted until 12 months (leptin and adiponectin). These changes underscore the effectiveness of our school-based intervention at not only improving zBMI but also at reducing disease risk.

Behavioral weight-loss interventions for patients with NAFLD: A systematic scoping review.

BACKGROUND: Clinically significant weight loss-which requires sustained dietary and physical activity changes-is central to treating NAFLD. Although behavioral interventions have demonstrated effectiveness in promoting weight loss among primary prevention populations, the data are limited among patients with NAFLD who need weight loss for treatment. We undertook this scoping review to map the existing data on the characteristics, weight-loss outcomes, and determinants of success of interventions evaluated among patients with NAFLD. METHODS: We searched Medline, EMBASE, Cochrane, PsycINFO, and Web of Science from inception to January 1, 2023 to identify publications reporting weight loss among adults with NAFLD in behavioral weight-loss interventions. We summarized interventions and classified them as successful if there was an average weight loss of ≥ 5% from baseline across enrolled participants or achieved by ≥ 50% of enrolled participants. RESULTS: We included 28 studies: 10 randomized control trials, ten quasi-experimental, and 8 observational studies. Intervention delivery, duration, and counseling frequency varied; 12 were successful. Retention was highest among telephone interventions and lowest among "real-world" face-to-face interventions. Patients who were women, younger, and/or had multiple metabolic conditions were most likely to dropout. Successful interventions had biweekly counseling, specific physical activity, and calorie targets, behavioral theory grounding, and promoted goal-setting, self-monitoring, and problem-solving. CONCLUSION: There are limited data on behavioral weight-loss interventions in NAFLD. Research is needed to develop effective interventions generalizable to diverse patient populations and that maximize adherence, particularly among patients who are diabetic, women, and younger.

The use of low-calorie sweeteners by children: implications for weight management.

The rise in pediatric obesity since the 1970s has been well established in the United States and is becoming a major concern worldwide. As a potential means to help slow the obesity epidemic, low-calorie sweeteners (LCS) have gained attention as dietary tools to assist in adherence to weight loss plans or prevention of excess weight gain. Observational studies tend to show positive correlations between LCS consumption and weight gain in children and adolescents. Although the data are intriguing, these epidemiologic studies do not establish that LCS cause weight gain, because there are likely many lifestyle and genetic differences between children and families who choose to consume LCS and those who do not. Short-term randomized controlled trials have shown LCS use to be BMI neutral or to have modest weight-reducing effects in overweight and obese adolescents. The long-term effects of LCS in children and adolescents are unknown. Some compelling research is currently underway and may provide needed insight into the potential role of LCS in weight management. The paucity of data regarding the effects of LCS use in children and adolescents creates challenges in decision-making for health care providers and parents.

The use of low-calorie sweeteners by adults: impact on weight management.

The application of low-calorie sweeteners (LCS) in foods and beverages has increased over the past 35 y. At the same time, many characteristics of the American diet have changed, including variations in fat and carbohydrate content and composition, increased nutrient additions, and new dietary patterns due to changing lifestyles and attitudes toward food and the changing cost of food. During this same time period, the prevalence of overweight and obesity has increased from ~30 to 70% of adults in the United States. Clearly, these trends lead to a variety of hypotheses and efforts to explain the role of LCS in this association. The aim of this review is to gain clarity on the role of LCS in weight management and their impact on diet quality. In addition, because the majority of studies aimed at identifying associations between LCS and these outcomes are based on observational data, the pitfalls in designing and evaluating data from observational studies are also discussed. We conclude that there is no evidence that LCS can be claimed to be a cause of higher body weights in adults. Similarly, evidence supporting a role for LCS in weight management is lacking. Due to the confounders in most observational studies, randomized controlled trials are needed to advance understanding.

The application of the Yerkes-Dodson law in a childhood weight management program: examining weight dissatisfaction.

OBJECTIVE: To determine the effect of dissatisfaction with one's weight on outcomes in a weight management program. METHODS: Participants included 149 children between the ages of 11 and 14 years who were enrolled in an intensive weight loss intervention. All participants had a body mass index (BMI) ≥ 85th percentile. Children were divided into tertiles based on their level of weight dissatisfaction as assessed by the Kids' Eating Disorder Survey. RESULTS: Analysis revealed significant differences across levels of weight dissatisfaction categories for weight loss. Specifically, children in the moderate dissatisfaction group lost weight while participants in low and high groups gained weight over 6 months. CONCLUSION: As the Yerkes-Dodson law would predict, these findings suggest that moderate levels of weight dissatisfaction are associated with improved outcomes in a weight management program.

Brief report: gum chewing affects standardized math scores in adolescents.

UNLABELLED: Gum chewing has been shown to improve cognitive performance in adults; however, gum chewing has not been evaluated in children. This study examined the effects of gum chewing on standardized test scores and class grades of eighth grade math students. Math classes were randomized to a gum chewing (GC) condition that provided students with gum during class and testing, or a control condition with no gum (NGC). Participants included 108 students. The math sections of the Texas Assessment of Knowledge and Skills (TAKS) and the Woodcock Johnson III Tests of Achievement (WJ-III), and math class grades were used to assess academic performance. Students in the gum chewing condition improved standardized test scores and maintained higher grades in math class compared to those in the no-gum chewing condition. These results are encouraging as gum chewing may be a cost-effective and easily implemented method to increase student performance. TRIAL REGISTRATION: NCT00792116.

Smaller weight changes in standardized body mass index in response to treatment as weight classification increases.

OBJECTIVES: To compare the differential efficacy of a weight loss program for Mexican-American children who are overweight, obese, and severely obese. STUDY DESIGN: Study participants were enrolled in an intensive weight loss intervention aimed at improving eating and physical activity behaviors with behavior modification strategies. Participants included 212 children (45% female) between the ages of 9 and 14 (mean = 12.0, standard deviation = 0.7). All participants were classified as overweight, obese, or severely obese. RESULTS: Repeated measures analyses revealed that children in the overweight, obese, and severely obese weight categories differed significantly in standardized body mass index (zBMI) decreases at baseline, 3, 6, and 12 months (F = 4.57, P < .01, η(p)(2) = .06). Follow-up paired samples t tests showed a significant change in zBMI from baseline to 3 and 6 months for children in the overweight, obese, and severely obese weight categories. However, at 12 months only the overweight and obese students continued to show significant improvement from baseline in zBMI. CONCLUSIONS: These findings suggest that an intensive behavioral weight loss intervention that has demonstrated efficacy for decreasing zBMI may have incrementally smaller effects for children as weight classification increases.

Evaluation of treatment effects in obese children with co-morbid medical or psychiatric conditions.

The need for effective treatments for pediatric overweight is well known. To evaluate the applicability of an evidence-based treatment in an applied clinic setting that includes children with severe obesity and comorbid medical or psychiatric conditions. Forty-eight overweight children and their families were provided an evidence-based intervention at a for-profit clinic. Unlike typical lab-based samples, participants were self-selected and included children who were very overweight and/or had comorbid conditions. Change in standardized BMI was assessed. Overall, participants demonstrated a significant reduction in standardized BMI, t (40)=6.6, p<.001. Further analyses indicated that participants who were severely obese and children with a comorbidity significantly reduced their zBMI (t (11)=4.0, p<.01; t (14)=3.9, p<.01, respectively). Children who were severely obese reduced their BMI percentile by .2 (SD=.2) and those with a comorbidity reduced their BMI percentile by .6 (SD=.9). Nonsignificant interaction effects indicated comparable weight reductions in severely obese and overweight/obese participants, F (1,39) = 1.49, ns. Also, those with comorbidities and those without comorbidities experienced similar weight reductions, F (1,39)=.7, ns. This study provides promising evidence for the applicability of an evidence-based treatment for weight management in clinical practice.

Return on Investment: Medical Savings of an Employer-Sponsored Digital Intensive Lifestyle Intervention, Weight Loss.

OBJECTIVE: This study aimed to determine the medical cost impact and return on investment (ROI) of a large, commercial, digital, weight-management intensive lifestyle intervention (ILI) program (Real Appeal). METHODS: Participants in this program were compared with a control group matched by age, sex, geographic region, health risk, baseline medical costs, and chronic conditions. Medical costs were defined as the total amount paid for all medical expenses, inclusive of both the insurers' and the study participants' responsibility. RESULTS: In the 3 years following program registration, the intent-to-treat (ITT) cohort had significantly lower medical expenditures than the matched controls, with an average of -$771 or 12% lower costs (P = 0.002). Among 4,790 ITT participants, a total savings of $3,693,090 compared with total program costs of $1,639,961 translated into a 2.3:1 ROI. Program completers (n = 3,990), who attended more sessions than the overall ITT group, had greater mean weight loss (-4.4%), greater cost savings (-$956 or 14%), and an ROI of 2.0:1 over the 3-year time frame compared with matched controls. CONCLUSIONS: The findings demonstrated that the digital weight-management ILI was associated with a significantly positive ROI. Employers and payers willing to cover the cost of an ILI that produces both weight loss and demonstrated cost benefits can improve health and save money for their population with overweight or obesity.

Mentored implementation to initiate a diabetes program in an underserved community: a pilot study.

INTRODUCTION: Community clinics often face pragmatic barriers, hindering program initiation and replication of controlled research trial results. Mentoring is a potential strategy to overcome these barriers. We piloted an in-person and telehealth mentoring strategy to implement the Telehealth-supported, Integrated Community Health Workers (CHWs), Medication-access, group visit Education (TIME) program in a community clinic. RESEARCH DESIGN AND METHODS: Participants (n=55) were low-income Latino(a)s with type 2 diabetes. The study occurred in two, 6-month phases. Phase I provided proof-of-concept and an observational experience for the clinic team; participants (n=37) were randomized to the intervention (TIME) or control (usual care), and the research team conducted TIME while the clinic team observed. Phase II provided mentorship to implement TIME, and the research team mentored the clinic team as they conducted TIME for a new single-arm cohort of participants (n=18) with no previous exposure to the program. Analyses included baseline to 6-month comparisons of diabetes outcomes (primary outcome: hemoglobin A1c (HbA1c)): phase I intervention versus control, phase II (within group), and research-run (phase I intervention) versus clinic-run (phase II) arms. We also evaluated baseline to 6-month CHW knowledge changes. RESULTS: Phase I: compared with the control, intervention participants had superior baseline to 6-month improvements for HbA1c (mean change: intervention: -0.73% vs control: 0.08%, p=0.016), weight (p=0.044), target HbA1c (p=0.035), hypoglycemia (p=0.021), medication non-adherence (p=0.0003), and five of six American Diabetes Association (ADA) measures (p<0.001-0.002). Phase II: participants had significant reductions in HbA1c (mean change: -0.78%, p=0.006), diastolic blood pressure (p=0.004), body mass index (0.012), weight (p=0.010), medication non-adherence (p<0.001), and six ADA measures (p=0.007-0.005). Phase I intervention versus phase II outcomes were comparable. CHWs improved knowledge from pre-test to post-tests (p<0.001). CONCLUSIONS: A novel, mentored approach to implement TIME into a community clinic resulted in improved diabetes outcomes. Larger studies of longer duration are needed to fully evaluate the potential of mentoring community clinics.