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Objective The Action for Health in Diabetes (Look AHEAD) study previously reported that intensive lifestyle intervention (ILI) reduced incident depressive symptoms and improved health-related quality of life (HRQOL) over nearly 10 years of intervention compared with a control group (the diabetes support and education group [DSE]) in participants with type 2 diabetes and overweight or obesity. The present study compared incident depressive symptoms and changes in HRQOL in these groups for an additional 6 years following termination of the ILI in September 2012. Methods A total of 1,945 ILI participants and 1,900 DSE participants completed at least one of four planned postintervention assessments at which weight, mood (via the Patient Health Questionnaire-9), antidepressant medication use, and HRQOL (via the Medical Outcomes Scale, Short Form-36) were measured. Results ILI participants and DSE participants lost 3.1 (0.3) and 3.8 (0.3) kg [represented as mean (SE); p = 0.10], respectively, during the 6-year postintervention follow-up. No significant differences were observed between groups during this time in incident mild or greater symptoms of depression, antidepressant medication use, or in changes on the physical component summary or mental component summary scores of the Short Form-36. In both groups, mental component summary scores were higher than physical component summary scores. Conclusions Prior participation in the ILI, compared with the DSE group, did not appear to improve subsequent mood or HRQOL during 6 years of postintervention follow-up.

Context Observational studies suggest that low vitamin D status may be a risk factor for cancer. Objective In a population with prediabetes and overweight/obesity that is at higher risk of cancer than the general population, we sought to determine if vitamin D supplementation lowers the risk of cancer and precancers. Methods The Vitamin D and type 2 diabetes (D2d) cancer outcomes study (D2dCA) is an ancillary study to the D2d study, which was conducted at 22 academic medical centers in the United States. Participants had prediabetes and overweight/obesity and were free of cancer for the previous 5 years. Participants were randomized to receive vitamin D3 4000 IU daily or placebo. At scheduled study visits (4 times/year), cancer and precancer events were identified by questionnaires. Clinical data were collected and adjudicated for all reported events. Cox proportional hazard models compared the hazard ratio (HR) of incident cancers and precancers between groups. Results Over a median follow-up period of 2.9 years, among 2385 participants (mean age 60 years and 25-hydroxyvitamin D 28 ng/mL), there were 89 cases of cancer. The HR of incident cancer for vitamin D vs placebo was 1.07 (95% CI 0.70, 1.62). Of 241 participants with incident precancers, 239 had colorectal adenomatous polyps. The HR for colorectal polyps for vitamin D vs placebo was 0.83 (95% CI 0.64, 1.07). Conclusion In the D2d population of participants with prediabetes and overweight/obesity, not selected for vitamin D insufficiency, vitamin D supplementation did not have a significant effect on risk of incident cancer or colorectal polyps.

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.

Objective This study was designed to determine whether intensive lifestyle intervention (ILI) aimed at weight loss lowers cancer incidence and mortality. Methods Data from the Look AHEAD trial were examined to investigate whether participants randomized to ILI designed for weight loss would have reduced overall cancer incidence, obesity-related cancer incidence, and cancer mortality, as compared with the diabetes support and education (DSE) comparison group. This analysis included 4,859 participants without a cancer diagnosis at baseline except for nonmelanoma skin cancer. Results After a median follow-up of 11 years, 684 participants (332 in ILI and 352 in DSE) were diagnosed with cancer. The incidence rates of obesity-related cancers were 6.1 and 7.3 per 1,000 person-years in ILI and DSE, respectively, with a hazard ratio (HR) of 0.84 (95% CI: 0.68-1.04). There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25). Conclusions An ILI aimed at weight loss lowered incidence of obesity-related cancers by 16% in adults with overweight or obesity and type 2 diabetes. The study sample size likely lacked power to determine effect sizes of this magnitude and smaller.

BackgroundMany individuals with diabetes live in low- or middle-income settings. Glycemic control is challenging, particularly in resource-limited areas that face numerous healthcare barriers.ObjectiveTo compare HbA1c outcomes for individuals randomized to TIME, aTelehealth-supported,Integrated care with CHWs (Community Health Workers), andMEdication-access program (intervention) versus usual care (wait-list control).DesignRandomized clinical trial.ParticipantsLow-income Latino(a) adults with type 2 diabetes.InterventionsTIME 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 MeasuresInvestigators 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 ResultsA 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 > 0.50% HbA1c reductions (88.57% vs. 43.75%,p > 1 barrier to care, of whom 91.7% had medication issues. CHWs identified the majority (87.5%) of barriers.ConclusionsTIME 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 TrialNCT03394456, accessed athttps://clinicaltrials.gov/ct2/show/NCT03394456

Objective: This study evaluated weight changes after cessation of the 10-year intensive lifestyle intervention (ILI) in the Look AHEAD (Action for Health in Diabetes) study. It was hypothesized that ILI participants would be more likely to gain weight during the 2-year observational period following termination of weight-loss-maintenance counseling than would participants in the diabetes support and education (DSE) control group. Methods: Look AHEAD was a randomized controlled trial that compared the effects of ILI and DSE on cardiovascular morbidity and mortality in participants with overweight/obesity and type 2 diabetes. Look AHEAD was converted to an observational study in September 2012. Results: Two years after the end of the intervention (EOI), ILI and DSE participants lost a mean (SE) of 1.2 (0.2) kg and 1.8 (0.2) kg, respectively (P = 0.003). In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001). Two years after the EOI, ILI participants reported greater use of weight-control behaviors than DSE participants. Conclusions: Both groups lost weight during the 2-year follow-up period, but more ILI than DSE participants gained ≥ 2% of EOI weight. Further understanding is needed of factors that affected long-term weight change in both groups.

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

Objective Fasting plasma glucose (FPG), 2-hour plasma glucose (2hPG) from a 75-g oral glucose tolerance test (OGTT) and glycated hemoglobin (HbA1c) can lead to different results when diagnosing prediabetes and diabetes. The Hemoglobin Glycation Index (HGI) quantifies the interindividual variation in glycation resulting in discrepancies between FPG and HbA1c. We used data from the Vitamin D and Type 2 Diabetes (D2d) study to calculate HGI, to identify HGI-associated variables, and to determine how HGI affects prediabetes and diabetes diagnosis. Measurements A linear regression equation [HbA1c (%) = 0.0164 × FPG (mg/dL) + 4.2] was derived using the screening cohort (n = 6829) and applied to calculate predicted HbA1c. This was subtracted from the observed HbA1c to determine HGI in the baseline cohort with 2hPG data (n = 3945). Baseline variables plus prediabetes and diabetes diagnosis by FPG, HbA1c, and 2hPG were compared among low, moderate, and high HGI subgroups. Results The proportion of women and Black/African American individuals increased from low to high HGI subgroups. Mean FPG decreased and mean HbA1c increased from low to high HGI subgroups, consistent with the HGI calculation; however, mean 2hPG was not significantly different among HGI subgroups. Conclusions High HGI was associated with Black race and female sex as reported previously. The observation that 2hPG was not different across HGI subgroups suggests that variation in postprandial glucose is not a significant source of population variation in HGI. Exclusive use of HbA1c for diagnosis will classify more Black individuals and women as having prediabetes compared with using FPG or 2hPG.

Objective To examine the effects of an intensive lifestyle intervention (ILI) on cardiovascular disease (CVD), the Action for Health in Diabetes (Look AHEAD) trial randomized 5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education. Although the primary outcome did not differ between the groups, there was suggestive evidence of heterogeneity for prespecified baseline CVD history subgroups (interaction P = 0.063). Event rates were higher in the ILI group among those with a CVD history (hazard ratio 1.13 [95% CI: 0.90-1.41]) and lower among those without CVD (hazard ratio 0.86 [95% CI: 0.72-1.02]). Methods This study conducted post hoc analyses of the rates of the primary composite outcome and components, adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes. Results Interaction P values for the primary and two secondary composites were similar (0.060-0.064). Of components, the interaction was significant for nonfatal MI (P = 0.035). This interaction was not due to confounding by baseline variables, different intervention responses for weight loss and physical fitness, or hypoglycemic events. In those with a CVD history, statin use was high and similar by group. In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group. Conclusions Intervention response heterogeneity was significant for nonfatal MI. Response heterogeneity may need consideration in a CVD-outcome trial design.

IntroductionCommunity 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 methodsParticipants (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.ResultsPhase 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 (pConclusionsA 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.

OBJECTIVE Patients with type 2 diabetes are encouraged to lose weight, but excessive weight loss in older adults may be a marker of poor health and subsequent mortality. We examined weight change during the postintervention period of Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) with diabetes support and education (DSE) (control) in overweight/obese individuals with type 2 diabetes and sought to identify predictors of excessive postintervention weight loss and its association with mortality. RESEARCH DESIGN AND METHODS These secondary analyses compared postintervention weight change (year 8 to final visit; median 16 years) in ILI and DSE in 3,999 Look AHEAD participants. Using empirically derived trajectory categories, we compared four subgroups: weight gainers (n = 307), weight stable (n = 1,561), steady losers (n = 1,731), and steep losers (n = 380), on postintervention mortality, demographic variables, and health status at randomization and year 8. RESULTS Postintervention weight change averaged −3.7 ± 9.5%, with greater weight loss in the DSE than the ILI group. The steep weight loss trajectory subgroup lost on average 17.7 ± 6.6%; 30% of steep losers died during postintervention follow-up versus 10–18% in other trajectories (P < 0001). The following variables distinguished steep losers from weight stable: baseline, older, longer diabetes duration, higher BMI, and greater multimorbidity; intervention, randomization to control group and less weight loss in years 1–8; and year 8, higher prevalence of frailty, multimorbidity, and depressive symptoms and lower use of weight control strategies. CONCLUSIONS Steep weight loss postintervention was associated with increased risk of mortality. Older individuals with longer duration of diabetes and multimorbidity should be monitored for excessive unintentional weight loss.

OBJECTIVE: Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) and diabetes support and education (DSE) (control) in 5,145 individuals with overweight/obesity and type 2 diabetes, found no significant differences in all-cause or cardiovascular mortality or morbidity during 9.6 (median) years of intervention. Participants in ILI who lost ≥10% at 1 year had lower risk of composite cardiovascular outcomes relative to DSE. Since effects of ILI may take many years to emerge, we conducted intent-to-treat analyses comparing mortality in ILI over 16.7 years (9.6 years of intervention and then observation) to DSE. In a secondary exploratory analysis, we compared mortality by magnitude of weight loss in ILI relative to DSE. RESEARCH DESIGN AND METHODS: Primary outcome was all-cause mortality from randomization to 16.7 years. Other outcomes included cause-specific mortality, interactions by subgroups (age, sex, race/ethnicity, and cardiovascular disease history), and an exploratory analysis by magnitude of weight loss in ILI versus DSE as reference. Analyses used proportional hazards regression and likelihood ratio. RESULTS: The incidence of all-cause mortality did not differ significantly in ILI and DSE (549 and 589 participants, respectively) (hazard ratio [HR] 0.91 [95% CI 0.81, 1.02]; P = 0.11). There were no significant differences between treatments in cause-specific mortality or within prespecified subgroups. ILI participants who lost ≥10% at 1 year had a 21% reduced risk of mortality (HR 0.79 [95% CI 0.67, 0.94]; P = 0.007) relative to DSE. CONCLUSIONS: ILI focused on weight loss did not significantly affect mortality risk. However, ILI participants who lost ≥10% had reduced mortality relative to DSE.

We previously found that a 6-month multidimensional diabetes program, TIME (Telehealth-Supported, Integrated Community Health Workers, Medication-Access) resulted in improved clinical outcomes.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.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.Participants decreased HbA1c levels during the intervention (p0.0001) 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 range0.0001 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).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.

OBJECTIVETo conduct post hoc secondary analysis examining the association between change in physical activity. Measured with self-report and accelerometry, from baseline to 1 and 4 years and cardiovascular disease (CVD) outcomes in the Look AHEAD Trial.RESEARCH DESIGN AND METHODSParticipants were adults with overweight/obesity and type 2 diabetes with physical activity. Data at baseline and year 1 or 4 (n = 1,978). Participants were randomized to diabetes support and education or intensive lifestyle intervention. Measures included accelerometry-measured moderate-to-vigorous physical activity (MVPA), self-reported physical activity, and composite (morbidity and mortality) CVD outcomes.RESULTSIn pooled analyses of all participants, using Cox proportional hazards models, each 100 MET-min/week increase in accelerometry-measured MVPA from baseline to 4 years was associated with decreased risk of the subsequent primary composite outcome of CVD. Results were consistent for changes in total MVPA (hazard ratio 0.97 [95% CI 0.95, 0.99]) and MVPA accumulated in ≥10-min bouts (hazard ratio 0.95 [95% CI 0.91, 0.98]), with a similar pattern for secondary CVD outcomes. Change in accelerometry-measured MVPA at 1 year and self-reported change in physical activity at 1 and 4 years were not associated with CVD outcomes.CONCLUSIONSIncreased accelerometry-measured MVPA from baseline to year 4 is associated with decreased risk of CVD outcomes. This suggests the need for long-term engagement in MVPA to reduce the risk of CVD in adults with overweight/obesity and type 2 diabetes.

OBJECTIVE To assess the cost-effectiveness (CE) of an intensive lifestyle intervention (ILI) compared with standard diabetes support and education (DSE) in adults with overweight/obesity and type 2 diabetes, as implemented in the Action for Health in Diabetes study. RESEARCH DESIGN AND METHODS Data were from 4,827 participants during their first 9 years of study participation from 2001 to 2012. Information on Health Utilities Index Mark 2 (HUI-2) and HUI-3, Short-Form 6D (SF-6D), and Feeling Thermometer (FT), cost of delivering the interventions, and health expenditures was collected during the study. CE was measured by incremental CE ratios (ICERs) in costs per quality-adjusted life year (QALY). Future costs and QALYs were discounted at 3% annually. Costs were in 2012 U.S. dollars. RESULTS Over the 9 years studied, the mean cumulative intervention costs and mean cumulative health care expenditures were $11,275 and $64,453 per person for ILI and $887 and $68,174 for DSE. Thus, ILI cost $6,666 more per person than DSE. Additional QALYs gained by ILI were not statistically significant measured by the HUIs and were 0.07 and 0.15, respectively, measured by SF-6D and FT. The ICERs ranged from no health benefit with a higher cost based on HUIs to $96,458/QALY and $43,169/QALY, respectively, based on SF-6D and FT. CONCLUSIONS Whether ILI was cost-effective over the 9-year period is unclear because different health utility measures led to different conclusions.

OBJECTIVE To describe baseline characteristics of the Vitamin D and Type 2 Diabetes (D2d) study, the first large U.S. diabetes prevention clinical trial to apply current American Diabetes Association (ADA) criteria for prediabetes. RESEARCH DESIGN AND METHODS This is a multicenter (n = 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D3) compared with placebo on incident diabetes in U.S. adults at risk for diabetes. Eligible participants were at risk for diabetes, defined as not meeting criteria for diabetes but meeting at least two 2010 ADA glycemic criteria for prediabetes: fasting plasma glucose (FPG) 100–125 mg/dL, 2-h postload glucose (2hPG) after a 75-g oral glucose load 140–199 mg/dL, and/or a hemoglobin A1c (HbA1c) 5.7–6.4% (39–46 mmol/mol). RESULTS A total of 2,423 participants (45% of whom were women and 33% nonwhite) were randomized to cholecalciferol or placebo. Mean (SD) age was 60 (9.9) years and BMI 32.1 (4.5) kg/m2. Thirty-five percent met all three prediabetes criteria, 49% met the FPG/HbA1c criteria only, 9.5% met the 2hPG/FPG criteria only, and 6.3% met the 2hPG/HbA1c criteria only. Black participants had the highest mean HbA1c and lowest FPG concentration compared with white, Asian, and other races (P < 0.01); 2hPG concentration did not differ among racial groups. When compared with previous prediabetes cohorts, the D2d cohort had lower mean 2hPG concentration but similar HbA1c and FPG concentrations. CONCLUSIONS D2d will establish whether vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria.

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

Purpose The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. Methods This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n = 50). Group visits met for 3 hours each month for a 6-month duration. Main measures included baseline and 6-month clinical outcomes (ie, A1C, lipids), concordance with 8 standard of care guidelines (ie, screens for cervical, breast, and colon cancer) from the US Preventive Task Force and American Diabetes Association, and participant acceptability. Results Compared to control participants, the intervention group resulted in significantly better clinical outcomes or guideline concordance for the following areas: target A1C levels, retinal eye exams, diabetes foot exams, mammograms, and urine microalbumin. Significantly more individuals in the control group gained weight, whereas a greater number of participants in the intervention group lost weight. Intervention participants found the group visits highly acceptable. Conclusions Integrating CHWs as part a comprehensive diabetes group visit program is a feasible and effective system-level intervention to improve glycemic control and achieve guideline concordance.

Intentional weight loss is an important treatment option for overweight persons with type 2 diabetes mellitus (DM), but the effects on long term fracture risk are not known. The purpose of this Look AHEAD analysis was to evaluate whether long term intentional weight loss would increase fracture risk in overweight or obese persons with DM. Look AHEAD is a multicenter, randomized clinical trial. Recruitment began in August 2001 and follow-up continued for a median of 11.3 years at 16 academic centers. 5145 persons aged 45 – 76 with DM were randomized to either an intensive lifestyle intervention (ILI) with reduced calorie consumption and increased physical activity designed to achieve and maintain ≥7% weight loss or to diabetes support and education intervention (DSE). Incident fractures were ascertained every 6 months by self-report and confirmed with central adjudication of medical records. The baseline mean age of participants was 59 years, 60% were women, 63% were Caucasian, and the mean BMI was 36 kg/m2. Weight loss over the intervention period (median 9.6 years) was 6.0% in ILI and 3.5% in DSE. 731 participants had a confirmed incident fracture (358 in DSE v. 373 in ILI). There were no statistically significant differences in incident total or hip fracture rates between the ILI and DSE groups. However, compared to the DSE group, the ILI group had a statistically significant 39% increased risk of a frailty fracture (HR = 1.39, 95% CI 1.02, 1.89). An intensive lifestyle intervention resulting in long term weight loss in overweight/obese adults with DM was not associated with an overall increased risk of incident fracture but may be associated with an increased risk of frailty fracture. When intentional weight loss is planned, consideration of bone preservation and fracture prevention is warranted.

Summary Objective To compare depressive symptomatology as assessed by two frequently used measures, the Beck Depression Inventory (BDI‐1A) and Patient Health Questionnaire (PHQ‐9). Methods Investigators conducted a cross‐sectional secondary analysis of data collected as part of the follow‐up observational phase of the Look AHEAD study. Rates of agreement between the BDI‐1A and PHQ‐9 were calculated, and multivariable logistic regression was used to examine the relationship between differing depression category classifications and demographic factors (ie, age, sex, race/ethnicity) or comorbidities (ie, diabetes control, cardiovascular disease). Results A high level of agreement (κ = 0.47, 95% CI (0.43 to 0.50)) was found in the level of depressive symptomatology between the BDI‐1A and PHQ‐9. Differing classifications (minimal, mild, moderate, and severe) occurred in 16.8% of the sample. Higher scores on the somatic subscale of the BDI‐1A were significantly associated with disagreement as were having a history of cardiovascular disease, lower health‐related quality of life, and minority racial/ethnic classification. Conclusions Either the BDI‐1A or PHQ‐9 can be used to assess depressive symptomatology in adults with overweight/obesity and type 2 diabetes. However, further assessment should be considered in those with related somatic symptoms, decreased quality of life, and in racial/ethnic minority populations.

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 D(3) 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 D(3) 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, .)

Stress is a core issue to be addressed in lifestyle medicine. Not only does it influence disease directly (eg, cardiovascular disease), it also indirectly affects health by having a negative influence on other behaviors such as sleep and physical activity. The importance of stress is further highlighted by the fact that it is one of the most highly ranked health risks for employees globally. Practitioners are encouraged to attend to both significant life stressors and those that are encountered daily. Stress reduction strategies are further discussed.

Background: Prior studies have supported the efficacy of diabetes group visits. However, the benefit of diabetes group visits for low-income and underserved individuals is not clear. The purpose of this study was to conduct a narrative review in order to clarify the efficacy of diabetes group visits in low-income and underserved settings. Methods: The authors performed a narrative review, categorizing studies into nonrandomized and randomized. Results: A total of 14 studies were identified. Hemoglobin A1c was the most commonly measured outcome, which improved for the majority of group visit participants. Preventive care showed consistent improvement for intervention arms. There were several other study outcomes including metabolic (i.e., blood pressure), behavioral (i.e., exercise), functional (i.e., quality of life), and system-based (i.e., cost). Conclusion: Diabetes group visits for low-income and underserved individuals resulted in superior preventive care but the impact on glycemic control remains unclear.

There are conflicting recommendations and highly variable practices regarding the level of A1c to initiate insulin for individuals with newly diagnosed diabetes. This is complicated in low-income settings where adverse reactions or negative perceptions of insulin are often magnified.Compare the clinical outcomes of insulin and Oral Agents (OAs) in low-income settings in the United States.We conducted a retrospective chart review in community clinics serving low -income individuals with newly diagnosed type 2 diabetes who were initiated on insulin or OAs. The primary outcome was change of hemoglobin A1c (A1c) from baseline to 12 months. Secondary outcomes consisted of other clinical measures including Emergency Department (ED) visits.A total of 18% (88/489) of patients were started on insulin. The adjusted average decrease of A1c from baseline was greater in the OA group (insulin: -1.97% vs. OA: -2.52%; p0.001). In a subset analysis of individuals with A1cs11%, significantly more patients were started on OAs (insulin: n=51, OA: n=93; p0.001) and A1c improvements were similar at 12 months (insulin: -5.06% [12.94% to 7.88%] OA: -4.62% [12.57% to 7.96%]; p=0.846). Baseline A1c predicted insulin initiation (p0.001): For every one-unit increase in baseline A1c, the odds of insulin initiation increased by 47.5%. Individuals in the insulin group had more ED visits per year (0.169 vs. 0.0025; p0.005).Given the positive clinical outcomes of OAs even with markedly elevated A1c levels in addition to the healthcare system benefits, they are a promising initial therapy for low-income adults with newly diagnosed type 2 diabetes.

Behavioral strategies are a foundation for assisting patients in making lifestyle changes in adopting healthy eating. The Diabetes Prevention Program (DPP) and Look AHEAD are examples of two long-term studies that support the use of behavioral strategies to impact obesity. The initial results of the DPP have been extended globally with considerable success. In applying these techniques, consideration for cultural adaptation, ongoing support, and the context in which individuals live is critical for sustained health behavior changes. Given that obesity can be defined as a pandemic, the results from these programs are promising as they suggest that real benefits are attainable through well-established behavioral change strategies.

Previous studies revealed that higher levels of acculturation are related to obesity in Hispanic adults. Conflicting findings exist regarding this relationship in children, and little is known about the impact of acculturation on children’s success in pediatric weight management programs. The purposes of the study were to (1) examine the relationship between acculturation and overweight/obese weight status and (2) determine the impact of acculturation on the changes in weight status among overweight/obese children 12 and 24 months after having participated in a weight management intervention. This is a secondary analysis of aggregated data from three randomized control trials that occurred between 2005 and 2009. Height, weight, and level of acculturation using the Child Short Scale for Hispanics (C-SASH) were measured in a sample of Hispanic children (n = 559). Logistic regression models were used to study phase 1 (n = 559) and phase 2 (n = 142), controlling for child and family characteristics. Children reporting high levels of acculturation had a 52 % lower odds of being overweight or obese. Among overweight/obese children who participated in the intervention, high levels of acculturation demonstrated greater reductions in standardized body mass index (zBMI) at 24 months. The results of this study indicate a need to tailor weight management programs for Hispanic children who have lower levels of acculturation.

Summary Background While overweight and obese children are more likely to have overweight or obese parents, less is known about the effect of parental weight status on children's success in weight management programmes. Objectives This study was a secondary data analysis of a randomized controlled trial and investigated the impact of having zero, one or two obese parents on children's success in a school-based weight management programme. Methods Sixty-one Mexican–American children participated in a 24-week school-based weight management intervention which took place in 2005–2006. Children's heights and weights were measured at baseline, 3, 6 and 12 months. Parental weight status was assessed at baseline. Repeated measures anova and ancova were conducted to compare changes in children's weight within and between groups, respectively. Results Within-group comparisons revealed that the intervention led to significant decreases in standardized body mass index (zBMI) for children with zero (F = 23.16, P

Background: There are variable recommendations regarding initiating monotherapy or dual therapy in patients with newly diagnosed type 2 diabetes (T2D). Clear initial strategies are of particular importance in underserved settings where access to care and financial burdens are significant barriers. Objectives: To provide descriptive data of metabolic outcomes to therapy regimens for low-income individuals with newly diagnosed T2D placed on oral hypoglycemic agents (OAs). Methods: We conducted a retrospective chart review of low-income individuals with newly diagnosed T2D initiated on OAs. We provided descriptive data and then evaluated the effects of OA regimens (ie, mono-, dual-, transition [from mono to dual or vice versa] therapy) on hemoglobin A1c (A1c) (baseline to 12 months). Results: A total of 309 patients were included in the study. At 12 months, the mean decrease in A1c for the entire sample was −2.36% (9.37% to 7.01%). Patients prescribed dual therapy had a greater change of A1c compared to those taking monotherapy with metformin (−1.11%, P < .01). Patients who transitioned therapies did not differ in change of A1c compared to monotherapy. Conclusion: Initiation of dual therapy was superior to metformin monotherapy or transitioning therapies and may be preferred for low-income individuals with newly diagnosed T2D.

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% –

Objective:To assess whether an average of 10 years of lifestyle intervention designed to reduce weight and increase physical activity lowers the prevalence of cognitive impairment among adults at increased risk due to type 2 diabetes and obesity or overweight.Methods:Central adjudication of mild cognitive impairment and probable dementia was based on standardized cognitive test battery scores administered to 3,802 individuals who had been randomly assigned, with equal probability, to either the lifestyle intervention or the diabetes support and education control. When scores fell below a prespecified threshold, functional information was obtained through proxy interview.Results:Compared with control, the intensive lifestyle intervention induced and maintained marked differences in weight loss and self-reported physical activity throughout follow-up. At an average (range) of 11.4 (9.5–13.5) years after enrollment, when participants' mean age was 69.6 (54.9–87.2) years, the prevalence of mild cognitive impairment and probable dementia was 6.4% and 1.8%, respectively, in the intervention group, compared with 6.6% and 1.8%, respectively, in the control group (p = 0.93). The lack of an intervention effect on the prevalence of cognitive impairment was consistent among individuals grouped by cardiovascular disease history, diabetes duration, sex, and APOE ε4 allele status (all p ≥ 0.50). However, there was evidence (p = 0.03) that the intervention effect ranged from benefit to harm across participants ordered from lowest to highest baseline BMI.Conclusions:Ten years of behavioral weight loss intervention did not result in an overall difference in the prevalence of cognitive impairment among overweight or obese adults with type 2 diabetes.Clinicaltrials.gov identifier:NCT00017953 (Action for Health in Diabetes).Level of evidence:This study provides Class II evidence that for overweight adults with type 2 diabetes, a lifestyle intervention designed to reduce weight and increase physical activity does not lower the risk of cognitive impairment.

BACKGROUND: Lifestyle interventions have been shown to improve physical function over the short term; however, whether these benefits are sustainable is unknown. The long-term effects of an intensive lifestyle intervention (ILI) on physical function were assessed using a randomized post-test design in the Look AHEAD trial. METHODS: Overweight and obese (body mass index ≥ 25 kg/m(2)) middle-aged and older adults (aged 45–76 years at enrollment) with type 2 diabetes enrolled in Look AHEAD, a trial evaluating an ILI designed to achieve weight loss through caloric restriction and increased physical activity compared to diabetes support and education (DSE), underwent standardized assessments of performance-based physical function including a 4- and 400-m walk, lower extremity physical performance (expanded Short Physical Performance Battery, SPPB(exp)), and grip strength approximately 11 years postrandomization and 1.5 years after the intervention was stopped (n = 3,783). RESULTS: Individuals randomized to ILI had lower odds of slow gait speed (

Intentional weight loss is an important treatment option for overweight persons with type 2 diabetes mellitus (DM), but the effects on long-term fracture risk are not known. The purpose of this Look AHEAD analysis was to evaluate whether long-term intentional weight loss would increase fracture risk in overweight or obese persons with DM. Look AHEAD is a multicenter, randomized clinical trial. Recruitment began in August 2001 and follow-up continued for a median of 11.3 years at 16 academic centers. A total of 5145 persons aged 45 to 76 years with DM were randomized to either an intensive lifestyle intervention (ILI) with reduced calorie consumption and increased physical activity designed to achieve and maintain ≥7% weight loss or to diabetes support and education intervention (DSE). Incident fractures were ascertained every 6 months by self-report and confirmed with central adjudication of medical records. The baseline mean age of participants was 59 years, 60% were women, 63% were white, and the mean BMI was 36 kg/m

OBJECTIVE To assess the relative impact of an intensive lifestyle intervention (ILI) on use and costs of health care within the Look AHEAD trial. RESEARCH DESIGN AND METHODS A total of 5,121 overweight or obese adults with type 2 diabetes were randomly assigned to an ILI that promoted weight loss or to a comparison condition of diabetes support and education (DSE). Use and costs of health-care services were recorded across an average of 10 years. RESULTS ILI led to reductions in annual hospitalizations (11%, P = 0.004), hospital days (15%, P = 0.01), and number of medications (6%, P < 0.001), resulting in cost savings for hospitalization (10%, P = 0.04) and medication (7%, P < 0.001). ILI produced a mean relative per-person 10-year cost savings of $5,280 (95% CI 3,385–7,175); however, these were not evident among individuals with a history of cardiovascular disease. CONCLUSIONS Compared with DSE over 10 years, ILI participants had fewer hospitalizations, fewer medications, and lower health-care costs.

Summary Obesity has been associated with accelerated biological ageing and immunosenescence. As the prevalence of childhood obesity is increasing, we wanted to determine if associations between obesity and immunosenescence would manifest in children. We studied 123 Mexican American adolescents aged 10–14 (mean 12·3 ± 0·7) years, with body weights ranging from 30·1 to 115·2 kg (mean 52·5 ± 14·5 kg). Blood samples were obtained to determine proportions of naive, central memory (CM), effector memory (EM), senescent and early, intermediate and highly differentiated subsets of CD4+ and CD8+ T cells. Overweight and obese children had significantly lowered proportions of early CD8+ T cells (B = −11·55 and –5·51%, respectively) compared to healthy weight. Overweight children also had more EM (B = +7·53%), late (B = +8·90%) and senescent (B = +4·86%) CD8+ T cells than healthy weight children, while obese children had more intermediate CD8+ (B = +4·59%), EM CD8+ (B = +5·49%), late CD4+ (B = +2·01%) and senescent CD4+ (B = +0·98%) T cells compared to healthy weight children. These findings withstood adjustment for potentially confounding variables, including age, gender and latent cytomegalovirus and Epstein–Barr virus infections. We conclude that excess body mass, even in adolescence, may accelerate immunosenescence and predispose children to increased risks of incurring immune-related health problems in adulthood.

OBJECTIVE: To describe baseline characteristics of the Vitamin D and Type 2 Diabetes (D2d) study, the first large U.S. diabetes prevention clinical trial to apply current American Diabetes Association (ADA) criteria for prediabetes. RESEARCH DESIGN AND METHODS: This is a multicenter (n = 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D(3)) compared with placebo on incident diabetes in U.S. adults at risk for diabetes. Eligible participants were at risk for diabetes, defined as not meeting criteria for diabetes but meeting at least two 2010 ADA glycemic criteria for prediabetes: fasting plasma glucose (FPG) 100–125 mg/dL, 2-h postload glucose (2hPG) after a 75-g oral glucose load 140–199 mg/dL, and/or a hemoglobin A(1c) (HbA(1c)) 5.7–6.4% (39–46 mmol/mol). RESULTS: A total of 2,423 participants (45% of whom were women and 33% nonwhite) were randomized to cholecalciferol or placebo. Mean (SD) age was 59 (9.9) years and BMI 32 (4.5) kg/m(2). Thirty-five percent met all three prediabetes criteria, 49% met the FPG/HbA(1c) criteria only, 9.5% met the 2hPG/FPG criteria only, and 6.3% met the 2hPG/HbA(1c) criteria only. Black participants had the highest mean HbA(1c) and lowest FPG concentration compared with white, Asian, and other races (P < 0.01); 2hPG concentration did not differ among racial groups. When compared with previous prediabetes cohorts, the D2d cohort had lower mean 2hPG concentration but similar HbA(1c) and FPG concentrations. CONCLUSIONS: D2d will establish whether vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria.

Currently, 34% of U.S. adults are obese.1 The U.S. Preventive Services Task Force recommends that all adults with a body mass index ≥ 30 kg/m2 be offered intensive counseling for weight loss, or be referred to programs that offer it.2 However, it is not practical to provide intensive counseling to such a large number of individuals. If patient selection could be improved, weight loss programs might achieve lower attrition rates and improved weight losses. The NIH guidelines on evaluation and treatment of obesity state that readiness for weight loss should be assessed in persons presenting for treatment, while noting that such assessment is “easier said than done.”3 However, a recent review challenged the notion that weight loss readiness – a person’s self-reported desire and willingness to make changes to lose weight – is important to assess in clinical settings.4 Self-reported readiness, the review concluded, predicted neither treatment adherence nor the magnitude of weight loss among persons pursuing a variety of weight control methods. The authors suggested that the lack of significant findings may be a function of the limited range of readiness among people who voluntarily engage in weight loss programs. Another explanation may be the limitation of self-report assessments of readiness. Individuals may overestimate their readiness because they do not clearly understand what behaviors are needed to make them successful, or because they greatly desire the outcome of weight loss. We examined the ability of a behavioral task at screening to predict weight loss, session attendance, and physical activity at 1 year among participants who received an intensive lifestyle intervention in the Look AHEAD study.5 Look AHEAD’s careful screening procedures included a 2-week run-in period, in which candidates were required to record (but not required to alter) their food intake for at least 12 of 14 days.6 Look AHEAD investigators believed that participants’ keeping food records during the run-in would predict record keeping during treatment. Keeping food records during treatment, in turn, is positively correlated with weight loss.7–12 Thus, in the current study, we assessed performance of a specific behavior, expected to be related to weight loss, rather than asking about general readiness to lose weight. We specifically sought to determine whether the completeness of record keeping during the screening period would predict weight loss outcomes at 1 year.

This study evaluated 24-month outcomes of a school-based intensive lifestyle weight management program targeting overweight Mexican-American adolescents.We recruited a total of 71 adolescents (32 males; 45.1%) between the ages of 10 and 14 years, at or above the 85th percentile for body mass index (BMI). Participants were randomized to a 6-month instructor-led intervention (ILI) or a self-help (SH) program. Both interventions were aimed at modifying eating and physical activity behaviors using behavior modification strategies. We assessed changes in participants' standardized BMI and BMI percentile at baseline, 1, and 2 years.Repeated-measures analyses showed that ILI participants showed significantly greater decreases in standardized BMI at 1 and 2 years (F = 8.58, p.01; and F = 9.27, p.01, respectively) compared with SH controls. Similar results were found for changes in BMI and BMI percentile. At 2 years, the ILI condition decreased their average BMI percentile by 3.9 percentile points, compared to an increase of 1.6 percentile points in the SH condition.A school-based intervention resulted in improved weight outcomes in overweight Mexican-American adolescents and results were maintained over 2 years.

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.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.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).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.).

Studies have shown an association between nut consumption and health benefits in adults such as lower lipid levels, lower body mass indices, and reduced risk of coronary artery disease. Few studies have demonstrated these health benefits in children. To determine the association between peanut consumption and weight, intake of nutrients of concern, high-density lipoprotein, low-density lipoprotein, and cholesterol in Mexican American children, baseline data from 262 sixth-grade students (48% female) in a school-based weight management program were analyzed to compare differences between peanut and non-peanut eaters. It was hypothesized that Mexican American children who consume peanuts will be less overweight and have a better nutrient and lipid profile when compared to those who do not eat peanuts. Participants completed a food frequency questionnaire as a baseline dietary assessment before beginning the program. Children were identified as either a peanut consumer (n = 100) or non-peanut consumer (n = 162). Body mass index measurements were taken on all participants. A smaller sample of participants submitted blood for lipid analysis. Analyses revealed that children in the peanut consumer group were less likely to be overweight or obese than children in the non-peanut consumer group (χ(2) = 13.9, P = .001), had significantly higher intakes of several vitamins and micronutrients (i.e., magnesium, vitamin E), and had lower low-density lipoprotein and total cholesterol levels. These results illustrate that consumption of peanuts and/or peanut butter is associated with lower weight status, improved diet, and lipid levels among Mexican American children. Future research is needed to clarify the role of peanut consumption in children's overall health.