SMART Trial Research Articles

Motivating metrics for household water-use feedback

Motivating more sustainable water consumption is important since population growth and climate change are placing increased pressures on water supplies in Australia and elsewhere. Smart water metering creates new possibilities for feedback of detailed water-use information to householders as a signal of potential opportunities to save water, and a number of recent feedback studies have shown water saving results. However, existing literature lacks an overview of the available options for the presentation of detailed household water-use information; and research into what households understand, and value and prefer in terms of feedback. This paper introduces a framework for the possibilities for feedback; and further explores dimensions of the framework via a detailed post-intervention evaluation of a recent smart water metering trial involving detailed end-use feedback to a sample of households in New South Wales, Australia. The householder evaluation survey and interviews investigate engagement with customised water-use metrics presented during the trial, and explore wider preferences for water-use feedback. Understanding how householders relate to different types of information has an important role to play in maximising household engagement and the potential for more detailed water-use feedback to guide household water management. Therefore the framework and evaluative research findings carry implications for future deployments of residential smart water metering involving feedback. Particularly, the high level of interest and engagement of many study householders with the detailed water-use information highlights important potential for feedback, and lends support to the business case for utilities to pursue smart water metering trials and roll-outs. However, with heterogeneity of customer preferences and responses, more carefully considered approaches to water-use feedback are advised (e.g. more judicious feedback design, and potentially the use of tailoring and/or customer segmentation) to facilitate a greater contribution towards more sustainable water consumption.

Generation of Alloreactive-Anergized Tr1 Cells From Patients on Dialysis for the Induction of Renal Transplant Tolerance

Generation of Alloreactive-Anergized Tr1 Cells From Patients on Dialysis for the Induction of Renal Transplant Tolerance

Prescribing of long-acting beta-2-agonists/inhaled corticosteroids after the SMART trial.

BackgroundAfter the SMART trial evaluating the safety of salmeterol (long-acting beta-2-agonist (LABA)) in asthma patients, regulatory actions were taken to promote a guideline-adherent prescribing of LABA only to patients receiving inhaled corticosteroids (ICS). We aim to analyse LABA- and ICS-related prescription patterns after the SMART trial in Germany.MethodsPatients documented in the Bavarian Association of Statutory Health Insurance Physicians database (approximately 10.5 million people) were included if they had a diagnosis of asthma and at least one prescription of LABA and/or ICS between 2004 and 2008. Annual period prevalence rates (PPRs) were estimated and Cochrane Armitage tests were used for time trend analyses.ResultsHighest annual PPRs were found for budesonide and the fixed combination of salmeterol/fluticasone. The proportion of “concomitant LABA and ICS users” increased from 52.0 to 57.6% within the study period, whereas for “LABA users without ICS” a slight decrease from 6.5 to 5.4% was found. In 2008, the proportion of patients with at least one quarter with a LABA prescription without concomitant ICS was highest in elderly, male patients (≈20%). In the majority of these patients, a concomitant diagnosis of COPD (i.e. asthma-COPD overlap syndrome [ACOS]) was present.ConclusionsBetween 2004 and 2008, we found a moderate increase in guideline-adherent LABA prescribing in a representative German population. Elderly men received a significant number of LABA prescriptions without concomitant ICS probably due to ACOS.Electronic supplementary materialThe online version of this article (doi:10.1186/s12890-015-0051-x) contains supplementary material, which is available to authorized users.

Variable underlying morphology of culprit plaques associated with ST-elevation myocardial infarction: an optical coherence tomography analysis from the SMART trial.

The objective was to assess in vivo culprit lesion morphologies that caused ST-segment elevation myocardial infarction (STEMI) using optical coherence tomography (OCT). Culprit lesions in 80 patients presenting within 6 h of STEMI onset from the CompariSon of Manual Aspiration with Rheolytic Thrombectomy in patients undergoing primary PCI (SMART) trial were evaluated. Underlying morphology of 64 culprit lesions was identifiable by OCT and included 37 lesions with plaque rupture, 25 lesions without plaque rupture, and 2 lesions with calcified nodules. Patients with plaque rupture tended to be younger (64 ± 12 versus 70 ± 10 years, P = 0.08) and less often female (11 versus 40%, P = 0.007) compared with patients without plaque rupture. More thin-cap fibroatheromas were identified (60 versus 20%, P = 0.002); and residual thrombus was greater in the rupture than in the non-rupture group. OCT at 6 months showed more stent malapposition (65 versus 33%, P = 0.04) in the rupture compared with the non-rupture group. OCT analysis showed two dominant culprit lesion morphologies in STEMI: (i) lesions with plaque rupture with a large amount of thrombus or (ii) lesions without plaque rupture and a lesser amount of thrombus.

Cardiovascular safety of conjugated estrogens plus bazedoxifene: meta-analysis of the SMART trials

Objectives Five randomized, phase-3 trials demonstrated the efficacy and safety of conjugated estrogens/bazedoxifene (CE/BZA) in treating menopausal symptoms and preserving bone. This pooled analysis of these studies describes the cardiovascular safety of CE/BZA.Methods We pooled cardiovascular adjudicated safety data from healthy, non-hysterectomized, postmenopausal women who received ≥ 1 dose of CE 0.45 mg/BZA 20 mg (n = 1585), CE 0.625 mg/BZA 20 mg (n = 1583), any CE/BZA dose (n = 4868), or placebo (n = 1241) for up to 2 years in five trials. Venous thromboembolic events (VTEs), coronary heart disease (CHD), and cerebrovascular events were reviewed by three different independent adjudication committees and summarized using a meta-analytic approach.Results The rate of VTEs per 1000 woman-years (95% confidence interval, CI) was 0.3 (0.0–2.0) in women taking CE 0.45 mg/BZA 20 mg, 0 (0.0–1.5) in those taking CE 0.625 mg/BZA 20 mg, 0.7 (0.0–1.5) among women taking any CE/BZA dose, and 0.6 (0.0–2.9) with placebo. The incidence of stroke per 1000 woman-years (95% CI) was 0.4 (0.0–2.4), 0.2 (0.0–1.9), 0.44 (0.0–1.1), and 0.0 (0.0–1.7), respectively. The CHD rate per 1000 woman-years was 2.6 (0.0–5.6), 1.4 (0.0–3.9), 2.4 (1.00–3.7) and 2.0 (0.0–5.2). Compared with placebo, relative risk (95% CI) with any CE/BZA dose was 0.5 (0.1–1.8) for VTE, 0.5 (0.1–2.6) for stroke, and 0.63 (0.23–1.74) for CHD.Conclusions Up to 2 years of CE 0.45 or CE 0.625 mg with BZA 20 mg had an acceptable cardiovascular safety profile, with rates of stroke and CHD comparable to placebo in healthy postmenopausal women. VTE risk was low.

Protocol for the surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy trial (SMART Trial): an RCT evaluating whether prophylactic radiotherapy reduces the incidence of procedure tract metastases

IntroductionPatients with malignant pleural mesothelioma (MPM) may develop painful ‘procedure tract metastasis’ (PTM) at the site of previous pleural interventions. Prophylactic radiotherapy has been used to minimise this complication; however,...

Soft-tissue and alignment correction: the use of smart trials in total knee replacement.

Total knee replacement (TKR) smart tibial trials have load-bearing sensors which will show quantitative compartment pressure values and femoral-tibial tracking patterns. Without smart trials, surgeons rely on feel and visual estimation of imbalance to determine if the knee is optimally balanced. Corrective soft-tissue releases are performed with minimal feedback as to what and how much should be released. The smart tibial trials demonstrate graphically where and how much imbalance is present, so that incremental releases can be performed. The smart tibial trials now also incorporate accelerometers which demonstrate the axial alignment. This now allows the surgeon the option to perform a slight recut of the tibia or femur to provide soft-tissue balance without performing soft-tissue releases. Using a smart tibial trial to assist with soft-tissue releases or bone re-cuts, improved patient outcomes have been demonstrated at one year in a multicentre study of 135 patients (135 knees).

Early changes in coagulation but not inflammatory biomarkers under intermittent ART: the randomized ANRS 106 WINDOW trial.

IntroductionIn the SMART trial, baseline plasma hsCRP, IL6 and D-dimer levels were strongly correlated to all-cause mortality. A case-control study has shown an increase of IL-6 and D-dimer levels after one month of antiretroviral therapy (ART) interruption, which was correlated to viral load. Restarting ART was associated to a decrease in D-dimer but not IL-6 or hsCRP levels. We assessed biomarkers levels up to 96 weeks in ART-experienced adults with plasma HIV RNA levels <400 c/mL randomized in the ANRS 106 WINDOW trial to intermittent ART (IT: six cycles of eight weeks of ART interruption followed by eight weeks of ART) versus continuous treatment (CT).MethodsStored plasma for 160 participants (80 IT and 80 CT), matched by age, sex and CDC classification, were analyzed blinded for IL-6, sCD-14, hsCRP and D-dimer levels at baseline, week 8 (IT group only), week 16 and week 96. Lower levels of detection for IL-6, sCD14, hsCRP and D-Dimer were 1.5 pg/mL, 250 ng/mL, 0.03 µg/mL and 0.21 µg/mL, respectively. The primary objective was to compare changes in IL-6, hsCRP, sCD14 and D-dimer plasma levels from baseline to week 8, 16 and 96 in the IT and CT arms. Biomarkers levels were log10 transformed prior to analysis.ResultsAt baseline, patients were mostly men (86%), with a median age of 40 years, a CD4+ T-cell count of 768/mm3, have received a median of 4.7 years of ART and 85% had HIV RNA <50 c/mL. Proportion of patients with plasma HIV RNA levels<400 c/mL were 6% and 99%, 81% and 97%, 86% and 92% at weeks 8, 16 and 96 in the IT and CT arms, respectively. Plasma biomarkers levels are shown in the Table 1.Compared to baseline, D-dimer levels significantly increased 8 weeks after ART interruption in the IT arm (+23% fold change, 95% CI +9% to +39%) but reverted to baseline levels at week 16 and remained unchanged at week 96. There was no significant change from baseline in the other biomarker levels in the IT arm. Similarly, no significant change from baseline in biomarker levels was seen in the CT arm up to 96 weeks.ConclusionCoagulation and inflammatory biomarkers levels remained stable over 96 weeks in well-suppressed HIV-infected patient on ART. Following ART interruption there was a significant increase in D-dimer but not in inflammatory biomarkers levels. This increase was reversed upon reintroduction of ART. These data suggest that ART interruption increases coagulation rather than inflammatory biomarkers.

Conjugated Estrogen/Bazedoxifene Tablets for the Treatment of Moderate-to-Severe Vasomotor Symptoms Associated with Menopause

Conjugated estrogen/bazedoxifene (CE/BZA) therapy represents a new, progestin-free treatment in the management of postmenopausal health. CE/BZA pairs CE with the selective estrogen receptor modulator, BZA. The rationale for the development of CE/BZA was that BZA, acting primarily as a selective estrogen receptor degrader in uterine and breast tissue, would sufficiently inhibit the proliferative effects of CE on the endometrium. The absence of a progestin would reduce the incidence of uterine bleeding, breast pain and increased breast density associated with progestin-containing hormone therapy. CE/BZA has been evaluated in five multicenter, randomized, double-blind, placebo-controlled, and active-controlled Phase III trials known as the SMART trials. CE/BZA has been shown to maintain the established benefits of estrogen therapy for treatment of vasomotor symptoms and prevention of a loss in bone mineral density (bone mass), while minimizing certain estrogenic effects, particularly in the uterine endometrium and breast.

219 Surgical and large bore pleural interventions in malignant pleural mesothelioma and radiotherapy trial (the SMART trial)

219 Surgical and large bore pleural interventions in malignant pleural mesothelioma and radiotherapy trial (the SMART trial)

Water use signature patterns for analyzing household consumption using medium resolution meter data

[1] Providers of potable water to households and businesses are charged with conserving water. Addressing this challenge requires accurate information about how water is actually being used. So smart meters are being deployed on a large scale by water providers to collect medium resolution water use data. This paper presents water use signature patterns, the first technique designed for medium resolution meters for discovering patterns that explain how households use water. Signature patterns are clusters (subsets) of water meter readings specified by patterns on volumes and calendar dates. Four types of signature pattern are introduced in this paper: continuous flow days; exceptional peak use days; programmed patterns with recurrent hours; and normal use partitioned by season and period of the day. Signature patterns for each household are calculated using efficient selection rules that scale for city populations and years of data collection. Data from a real-world, large-scale, smart metering trial are analyzed using water use signature patterns. The results demonstrate that water use behaviors are distinctive, for both individuals and populations. Signatures can identify behaviors that are promising targets for water conservation. Pattern discovery can be automated with an efficient and scalable computer program. By identifying relevant consumption patterns in medium resolution meter data, water use signature patterns can help to achieve the water conservation potential of large-scale smart metering.

FRI0247 Serum level of interleukin 33, a novel independent predictive biomarker of clinical response to rituximab in rheumatoid arthritis: results from the smart trial

BackgroundInterleukin-33 (IL33) is a recently identified member of the interleukin-1 family that binds to its ST2 receptor expressed on various cells including mast cells, T-cells and also B1-cells in mice...

Abstract 2521: Associations between changes in circulating inflammatory biomarkers and reduced BMI achieved in SMART and PREFER behavioral weight loss interventions.

Abstract OBJECTIVE Obesity, increasingly recognized to be associated with low-grade systemic inflammation, is a global pandemic that has been linked to several forms of malignancies, including breast, colon, and endometrial cancer (EC). The goal of this study was to explore longitudinal inflammatory biomarker changes in overweight and obese participants of the SMART and PREFER behavioral weight loss trials, focusing on participants who were most successful in reducing body mass index (BMI) by the 12th month of the intervention. We hypothesized that overweight and obese individuals undergoing intentional weight loss would experience changes in the levels of proinflammatory cytokines and several other biomarkers associated with the development of EC and other malignancies. METHODS Participants were selected on the basis of weight loss over a period of 12 months in two major behavioral weight loss trials ― SMART and PREFER ― conducted at the University of Pittsburgh. Serum samples were obtained at baseline, 6 and 12 months from 68 participants (baseline mean body mass index (BMI) was 33.62 ± 4.1 kg/m2). Twenty-six bead based xMAP immunoassays were used for this study, including cytokines, chemokines, and hormones. These biomarkers were chosen on the basis of their link to inflammation and cancer development in previous research. Repeated measures mixed models were used to evaluate the association between changes in biomarkers and BMI from baseline with and without adjustment for covariates, including age, gender, and race. RESULTS Participants lost an average of 16.83 kg from baseline to 12 months, with the largest change occurring in the first 6 months of the intervention. Both repeated measures ANOVA models (with and without covariates) demonstrated that among 26 biomarkers, changes in adiponectin, CRP, C-Peptide, IGFBP-1, insulin, leptin, PAI-1 (total), resistin, sE-selectin were significantly associated with BMI change. CONCLUSIONS This study contributes to an emerging literature beginning to explore biological mechanisms that may contribute to health benefits of even moderate weight loss. Results also emphasize the importance of further studies of biomarkers that showed significant changes after weight loss to determine the molecular pathways involved. Citation Format: Faina Y. Linkov, Marina Komaroff, Robert Edwards, Anna Lokshin, Mindi Styn, Dana Bovbjerg, Lora Burke. Associations between changes in circulating inflammatory biomarkers and reduced BMI achieved in SMART and PREFER behavioral weight loss interventions. [abstract]. In: Proceedings of the 104th Annual Meeting of the American Association for Cancer Research; 2013 Apr 6-10; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2013;73(8 Suppl):Abstract nr 2521. doi:10.1158/1538-7445.AM2013-2521

Mortality in well controlled HIV in the continuous antiretroviral therapy arms of the SMART and ESPRIT trials compared with the general population

Due to the success of antiretroviral therapy (ART), it is relevant to ask whether death rates in optimally treated HIV are higher than the general population. The objective was to compare mortality rates in well controlled HIV-infected adults in the SMART and ESPRIT clinical trials with the general population. Non-IDUs aged 20-70 years from the continuous ART control arms of ESPRIT and SMART were included if the person had both low HIV plasma viral loads (≤400 copies/ml SMART, ≤500 copies/ml ESPRIT) and high CD4(+) T-cell counts (≥350 cells/μl) at any time in the past 6 months. Standardized mortality ratios (SMRs) were calculated by comparing death rates with the Human Mortality Database. Three thousand, two hundred and eighty individuals [665 (20%) women], median age 43 years, contributed 12,357 person-years of follow-up. Sixty-two deaths occurred during follow up. Commonest cause of death was cardiovascular disease (CVD) or sudden death (19, 31%), followed by non-AIDS malignancy (12, 19%). Only two deaths (3%) were AIDS-related. Mortality rate was increased compared with the general population with a CD4(+) cell count between 350 and 499 cells/μl [SMR 1.77, 95% confidence interval (CI) 1.17-2.55]. No evidence for increased mortality was seen with CD4(+) cell counts greater than 500 cells/μl (SMR 1.00, 95% CI 0.69-1.40). In HIV-infected individuals on ART, with a recent undetectable viral load, who maintained or had recovery of CD4(+) cell counts to at least 500 cells/μl, we identified no evidence for a raised risk of death compared with the general population.

A Multicenter, Prospective Study to Evaluate the Use of Contrast Stress Echocardiography in Early Menopausal Women at Risk for Coronary Artery Disease: Trial Design and Baseline Findings

This multisite prospective trial, Stress Echocardiography in Menopausal Women At Risk for Coronary Artery Disease (SMART), aimed to evaluate the prognostic value of contrast stress echocardiography (CSE), coronary artery calcification (CAC), and cardiac biomarkers for prediction of cardiovascular events after 2 and 5 years in early menopausal women experiencing chest pain symptoms or risk factors. This report describes the study design, population, and initial test results at study entry. From January 2004 through September 2007, 366 early menopausal women (age 54±5 years, Framingham risk score 6.51%±4.4 %, range 1%-27%) referred for stress echocardiography were prospectively enrolled. Image quality was enhanced with an ultrasound contrast agent. Tests for cardiac biomarkers [high-sensitivity C-reactive protein (hsCRP), atrial natriuretic protein (ANP), brain natriuretic protein (BNP), endothelin (ET-1)] and cardiac computed tomography (CT) for CAC were performed. CSE (76% exercise, 24% dobutamine) was abnormal in 42 women (11.5%), and stress electrocardiogram (ECG) was positive in 22 women (6%). Rest BNP correlated weakly with stress wall motion score index (WMSI) (r=0.189, p<0.001). Neither hsCRP, ANP, endothelin, nor CAC correlated with stress WMSI. Predictors of abnormal CSE were body mass index (BMI), diabetes mellitus, family history of premature coronary artery disease (CAD), and positive stress ECG. Twenty-four women underwent clinically indicated coronary angiography (CA); 5 had obstructive (≥50%), 15 had nonobstructive (10%-49%), and 4 had no epicardial CAD. The SMART trial is designed to assess the prognostic value of CSE in early menopausal women. Independent predictors of positive CSE were BMI, diabetes mellitus, family history of premature CAD, and positive stress ECG. CAC scores and biomarkers (with the exception of rest BNP) were not correlated with CSE results. We await the follow-up data.

96 Surgical and large bore pleural interventions in malignant pleural mesothelioma and radiotherapy trial (The SMART Trial)

96 Surgical and large bore pleural interventions in malignant pleural mesothelioma and radiotherapy trial (The SMART Trial)

Abstract 19444: The Effect of Daily Feedback on Changes in Dietary Intake and Adherence to Fat and Energy Goals

Introduction: Dietary self-monitoring is essential for successful weight management. Tailored feedback messages delivered in real-time can enhance motivation and improve dietary adherence. This study examined the effect of daily, tailored feedback messages on dietary intake and adherence to energy and fat goals in the SMART Trial, a 24-month behavioral weight loss study. Methods: Participants (N=210) were randomly assigned to self-monitor via a paper diary, personal digital assistant (PDA), or PDA that provided daily feedback messages based on self-monitoring entries. The message library was changed at 12 months to limit desensitization. To assess the effect of feedback, changes in dietary intake and adherence to energy and fat goals were compared between the groups that did (FB, n=70) or did not (NFB, n=140) receive feedback. Dietary intake was assessed every 6 months and modeled as percent change from baseline using linear mixed modeling. Marginal modeling with generalized estimating equations was applied to examine the probability of being adherent to energy and fat goals. Results: Participants (78% White, 84% female) had a mean age of 46.8 years and BMI of 34.0 kg/m 2 . At baseline, mean energy intake was 2090 kcal, and 33.7% of calories were from fat. At 24 months, FB group achieved significantly greater reductions in energy (-23.4% vs. -14.1%, p=.02) and saturated fat intake (-9.3% vs. 3.4%, p=.03) compared to the NFB group. Overall, a higher percent of the FB group was adherent; however, adherence declined at 12 months and then rebounded (see Figure). Conclusions: Receiving daily, tailored feedback messages appeared to enhance reductions in energy and saturated fat intake. The decline and later improvements in adherence in the FB group suggest that the message library may need to be changed more often. Findings suggest that daily feedback can improve dietary and self-monitoring adherence, important strategies in weight management and CVD prevention.

Use of smart trials for soft-tissue balancing in total knee replacement surgery

Smart trials are total knee tibial trial liners with load bearing and alignment sensors that will graphically show quantitative compartment load-bearing forces and component track patterns. These values will demonstrate asymmetrical ligament balancing and misalignments with the medial retinaculum temporarily closed. Currently surgeons use feel and visual estimation of imbalance to assess soft-tissue balancing and tracking with the medial retinaculum open, which results in lower medial compartment loads and a wider anteroposterior tibial tracking pattern. The sensor trial will aid the total knee replacement surgeon in performing soft-tissue balancing by providing quantitative visual feedback of changes in forces while performing the releases incrementally. Initial experience using a smart tibial trial is presented.

Global antimicrobial resistance: from surveillance to stewardship. Part 1: surveillance and risk factors for resistance

22nd European Congress of Clinical Microbiology and Infectious DiseasesLondon, UK, 31 March–3 April 2012As concerns about global antibiotic resistance shift from Gram-positive to Gram-negative bacteria, the annual congress of the European Society of Clinical Microbiology and Infectious Diseases, in London (UK) provided a valuable opportunity for the nearly 10,000 delegates to discuss the latest global trends. In this first report from the conference, the authors review data from the SMART trial, which recently marked a decade of monitoring antibiotic resistance of Gram-negative bacteria from intra-abdominal infections, and from the rapidly developing European Antimicrobial Resistance Surveillance Network. The authors also focus on the spread of nonmetallo-β-lactamase carbapenemases, and likely risk factors for resistance.

Abstract P373: Changes in Adipokines with Weight Loss and Regain in a 24-Month Behavioral Weight Loss Study: The SMART Trial

Background: Weight regain commonly occurs in many adults who intentionally lose weight. Failure to maintain weight loss can lead to an increased risk for chronic diseases, such as type 2 diabetes and atherosclerosis. A potential mechanism behind the increased risk includes the increased secretion of pro-inflammatory adipokines (TNF-α and IL-6) and the decreased secretion of anti-inflammatory adipokines (adiponectin and IL-10). Objectives: We conducted an ancillary study to a 24-month behavioral weight loss trial. The purpose of the study was to examine the association between weight loss and regain and changes in body fat from baseline to 24 months and changes in TNF-α, IL-6, IL-10, and adiponectin. Methods: The analysis included a subsample of participants (n=67) from the SMART Trial who lost and regained at least 10 lbs during the 24-month trial. All participants received standard behavioral treatment for weight loss in group sessions during the first 18 months beginning with weekly sessions, which decreased in frequency over time. Linear mixed modeling was used to examine the association of percent changes in weight and body fat with percent changes in adipokines. Results: The sample was 81% female and 87% White with a mean (±SD) age of 48.4±7.34 years. At entry into study the mean weight was 96.4±15.6 kg and mean BMI was 34.5±4.35 kg/m 2 . Percent body fat was on average 42.1±6.13%. Mean weight change from baseline to six months was -10.7±5.19% and from baseline to 24 months was -3.34±6.66% while mean change in percent body fat was -8.07±11.6% from baseline to six months and -3.03±9.57% from baseline to 24 months. Weight loss over time was significantly associated with an increase in adiponectin [b(se)=-1.7(0.34), p&lt;.0001] and a decrease in IL-6 [b(se)=1.26(0.49), p=0.01]. A similar pattern of associations was observed for reduction in body fat over time with an increase for adiponectin [b(se)=-0.76(0.19), p&lt;.0001] and a decrease for IL-6 [b(se)=0.68(0.25), p=.006]. There were no significant associations found for either weight loss or change in percent body fat with change in IL-10 [weight: b(se)=0.51(0.54), p=.35; body fat: b(se)=0.43(0.28), p=.12] and TNF-alpha [weight: b(se)=0.35(0.44), p=.43; body fat: b(se)=0.19(0.24), p=.43] over 24-months. Conclusion: Weight loss and reduction in body fat were significantly associated with improvements in two of the adipokines. However, by 24 months, when weight regain occurred, those changes were attenuated. Implementing strategies that support healthy behaviors and sustained weight loss can help prevent a state of chronic systemic inflammation and prevent adverse health outcomes.