Six-month Changes Research Articles

Abstract 4136978: Six-month Changes in Lipid Management in the Veterans Affairs Lipid Optimization Reimagined Quality Improvement (VALOR-QI) Program

Background: US Veterans have a high burden of cardiovascular disease (CVD). While cholesterol management is one of the most effective approaches for reducing CVD burden, over two-thirds of Veterans with atherosclerotic cardiovascular disease (ASCVD) are not optimally managed. Aims: To evaluate LDL-C monitoring, lipid lowering therapy (LLT) use, and LDL-C levels at baseline and six-months for Veterans in the Veterans Affairs Lipid Optimization Reimagined Quality Improvement (VALOR-QI) Program. Methods: VALOR-QI is a national quality improvement collaboration between the US Department of Veterans Affairs and the American Heart Association (AHA) with the goal of improving lipid management among Veterans with ASCVD. To assess and address barriers to achieving optimal lipid levels, Clinical Champions, Health Care Coaches, and participating providers from 50 VA sites work with AHA QI Consultants. Eligible Veterans (those with an ASCVD diagnosis at two outpatient or one inpatient visit or one ASCVD procedure) were considered engaged in VALOR-QI if they had a qualifying appointment with a participating provider during the program. We examined rates of LDL-C monitoring and LLT use at baseline (start of site monitoring) and 6 months after. Among Veterans who were in the program ≥6 months and had >1 LDL-C measure, we investigated percent meeting an LDL-C goal of <70 mg/dL at their first LDL-C (closest to their first visit with priority given to labs within 365 days before their first visit) and follow-up LDL-C (closest to 6 months after entering the program) and mean LDL-C change (paired t-test). Results: Six months after starting VALOR-QI, sites had a 41% increase in LDL-C monitoring and a 6% increase in LLT use. Among 29,610 Veterans engaged in the program ≥6 months with at least two lipid labs [mean (SD) age 71.0 (9.3) years, 95% men, 72% white race], the proportion who met the LDL-C goal <70 mg/dL increased from 44% at their first measure to 51% at 6-month follow-up. Among these Veterans, we observed a mean LDL-C decrease of 5.1 mg/dL (95% CI: -5.50, -4.78). Conclusion: We observed an increase in lipid monitoring and LLT use and improved LDL-C at 6-month follow-up among US Veterans engaged in VALOR-QI.

Blackcurrant Anthocyanins Attenuate Estrogen -Deficiency-Induced Bone Loss through Modulating Microbial-Derived Short-Chain Carboxylic Acids and Phytoestrogen Metabolites in Peri- and Early Postmenopausal Women.

The present study aimed to assess the effects of blackcurrant (BC) anthocyanins on concentrations of microbial-derived short-chain carboxylic acids (SCCAs) and metabolites of phytoestrogens. We then examined their associations with six-month changes in whole-body bone mineral density (BMD) and biomarkers of bone metabolism. Fecal and blood samples from a pilot randomized controlled trial were collected and analyzed from 37 eligible peri- and early postmenopausal women aged 45-60 years who were randomized into one of three treatment groups consuming one placebo capsule (control), 392 mg BC (low BC) or 784 mg BC (high BC) daily for six months. Significant differences were observed between groups at baseline in acetic, propionic, valeric, caproic and heptanoic acids (p < 0.05). Isobutyric acid significantly decreased from baseline (0 months) to six months in the control group (p < 0.05) and the high BC group had a significantly greater concentration than the control group at six months (p < 0.05). Butyric acid was significantly greater in the high BC group than low BC at six months (p < 0.05). Six-month changes in caproic and isobutyric acids showed weak correlations with changes in whole-body BMD (r = 0.3519, p < 0.05 and r = 0.3465, p < 0.05, respectively). Isovaleric and valeric acids displayed weak correlations with BALP (r = 0.3361, p < 0.05) and OPG (r = 0.3593, p < 0.05), respectively. Enterodiol was positively correlated with BALP (r = 0.6056, p < 0.01) while enterolactone was positively correlated with osteocalcin (r = 0.5902, p < 0.001) and negatively correlated with sclerostin (r = -0.3485, p < 0.05). The results suggest that BC may be a potential dietary agent to reduce postmenopausal bone loss through modulating microbially-derived SCCAs and phytoestrogen metabolites.

Testing a family system-based intervention (ENTREN-F Programme) for a paediatric obesity sample by a randomized controlled trial

This study evaluated the effectiveness of ‘ENTREN-F’ –a multi-component, family system-based intervention-for managing paediatric obesity at National Health Primary Care. A 3-arm, parallel-design, single-blinded randomized controlled trial (RCT), 165 families were randomized: Arm 1) ENTREN-F(n = 62) is a 12-week cognitive-behavioural intervention (CBT) family system-based programme, addressing lifestyle changes, children's emotional and social development and the family system, Arm 2) ‘ENTREN’ (n = 52) is a CBT family-based programme for children and parents, not addressing the family system, and Arm 3) Control group (CG) (n = 51) covers individual behavioural monitoring. All children were clinical interviewed to assess a diagnosis. Their effectiveness was assessed against six-month changes in children's body mass index (BMI) z-score, children's psychological well-being, levels of expressed maternal emotion, depression symptoms, parental feeding practices, levels of physical activity and sedentary lifestyles. The maintenance of the changes was evaluated for two years. High-attendance rates for ENTREN-F (72.6% vs. 66% vs. 33%, respectively) indicated its greater acceptance. After programme completion, the BMI z-score reduced by .5 points in almost 50% ENTREN-F (n = 22/45), 21.9% ENTREN (n = 7/32) and 11.8% (n = 2/17) CG participants. There were no significant differences between the three trial arms for anthropometric, psychological, or family-related measures. At the two-year follow-up, both ENTREN-F and ENTREN showed similar long-term effectiveness without between-group differences, and weight trajectories were favourable. ENTREN-F appears effective for childhood obesity management; however, the COVID-19 pandemic limited the sample size. Also, the tendency towards multiple differences in child and family outcomes could not be statistically shown. It also provides further evidence of the role of psychological and family-related factors that may underlie the origin and maintenance of weight gain.

Blackcurrants shape gut microbiota profile and reduce risk of postmenopausal osteoporosis via the gut-bone axis: Evidence from a pilot randomized controlled trial

This study aimed to investigate the effects of blackcurrant (BC) on gut microbiota abundance and composition, inflammatory and immune responses, and their relationship with bone mass changes. The effects of BC on bone mineral density (BMD), gut microbiota, and blood inflammatory and immune biomarkers were evaluated using DXA, stool and fasting blood collected from a pilot three-arm, randomized, double-blind, placebo-controlled clinical trial. Fifty-one peri- and early postmenopausal women aged 45–60 years were randomly assigned into one of three treatment groups for 6 months: control, low BC (392 mg/day) and high BC (784 mg/day); and 40 women completed the trial. BC supplementation for 6 months effectively mitigated the loss of whole-body BMD (P<.05). Six-month changes (%) in peripheral IL-1β (P=.056) and RANKL (P=.052) for the high BC group were marginally significantly lower than the control group. Six-month changes in whole-body BMD were inversely correlated with changes in RANKL (P<.01). In proteome analysis, four plasma proteins showed increased expression in the high BC group: IGFBP4, tetranectin, fetuin-B, and vitamin K-dependent protein S. BC dose-dependently increased the relative abundance of Ruminococcus 2 (P<.05), one of six bacteria correlated with BMD changes in the high BC group (P<.05), suggesting it might be the key bacteria that drove bone protective effects. Daily BC consumption for 6 months mitigated bone loss in this population potentially through modulating the gut microbiota composition and suppressing osteoclastogenic cytokines. Larger-scale clinical trials on the potential benefits of BC and connection of Ruminococcus 2 with BMD maintenance in postmenopausal women are warranted.Trial Registration: NCT04431960, https://classic.clinicaltrials.gov/ct2/show/NCT04431960.

Longitudinal changes in triceps skinfold thickness and serum albumin during chemotherapy in patients with pancreatic cancer: Gender-based prognostic insights—A prospective cohort study.

e16308 Background: Cachexia, characterized by distinct fat loss and poor nutritional status, is common in patients with pancreatic cancer. This study investigated the association between triceps skinfold thickness(TSF), indicative of body fat, and serum albumin levels, reflecting nutritional status, with overall survival(OS) in patients with pancreatic cancer. Methods: A prospective cohort of 353 patients with pancreatic cancer from April 2018 to June 2021 who received chemotherapy was queried. TSF(mm) and serum albumin(g/dL) were measured at baseline and every three weeks during follow-up. The optimal cutoffs for their six-month changes(six-month value minus initial value) were determined. We performed a landmark analysis of OS six months after the diagnosis of pancreatic cancer and assessed the factors influencing OS. Gender-specific survival analysis was conducted, culminating in the construction of nomograms for risk stratification. Results: Two hundred ninety-two patients survived over six months, with a median follow-up of 40.9 months. Changes in TSF, albumin, and protein levels over six months and initial albumin levels were independently associated with OS. Cancer stage, response to chemotherapy, and six-month serum CA 19-9 levels were also independent factors for OS. Gender-stratified analysis revealed gender-specific prognostic factors: TSF changes over six months£ 0 were associated with reduced OS (hazard ratio [HR], 1.84; 95% confidence interval [CI], 1.14–2.95) in men; initial albumin levels£ 3.5g/dl (HR, 5.73; 95% CI, 2.48–13.21) and albumin changes over six months£ -0.7g/dl (HR, 3.03; 95% CI, 1.51–6.07) were associated with reduced OS in women. Patients were categorized into low-, medium-, and high-risk groups for each gender based on nomogram scores, and increased risk levels were associated with elevated mortality risk. Conclusions: This was the first prospective cohort study to demonstrate that changes in TSF and albumin levels were associated with OS in pancreatic cancer patients undergoing chemotherapy in a gender-dependent manner.

Associations of radiologic characteristics of the neonatal hypothalamus with early life adiposity gain.

The mediobasal hypothalamus (MBH) is a key brain area for regulation of energy balance. Previous neuroimaging studies suggest that T2-based signal properties indicative of cellular inflammatory response (gliosis) are present in adults and children with obesity, and predicts greater adiposity gain in children at risk of obesity. The current study aimed to extend this concept to the early life period by considering if, in full-term healthy neonates (up to n = 35), MRI evidence of MBH gliosis is associated with changes in early life (neonatal to six months) body fat percentage measured by DXA. In this initial study, neonatal T2 signal in the MBH was positively associated with six-month changes in body fat percentage. This finding supports the notion that underlying processes in the MBH may play a role in early life growth and, by extension, childhood obesity risk.

Comparisons of Metabolic Measures to Predict T1D vs Detect a Preventive Treatment Effect in High-Risk Individuals.

Metabolic measures are frequently used to predict type 1 diabetes (T1D) and to understand effects of disease-modifying therapies. Compare metabolic endpoints for their ability to detect preventive treatment effects and predict T1D. Six-month changes in metabolic endpoints were assessed for (1) detecting treatment effects by comparing placebo and treatment arms from the randomized controlled teplizumab prevention trial, a multicenter clinical trial investigating 14-day intravenous teplizumab infusion and (2) predicting T1D in the TrialNet Pathway to Prevention natural history study. For each metabolic measure, t-Values from t tests for detecting a treatment effect were compared with chi-square values from proportional hazards regression for predicting T1D. Participants in the teplizumab prevention trial and participants in the Pathway to Prevention study selected with the same inclusion criteria used for the teplizumab trial were studied. Six-month changes in glucose-based endpoints predicted diabetes better than C-peptide-based endpoints, yet the latter were better at detecting a teplizumab effect. Combined measures of glucose and C-peptide were more balanced than measures of glucose alone or C-peptide alone for predicting diabetes and detecting a teplizumab effect. The capacity of a metabolic endpoint to detect a treatment effect does not necessarily correspond to its accuracy for predicting T1D. However, combined glucose and C-peptide endpoints appear to be effective for both predicting diabetes and detecting a response to immunotherapy. These findings suggest that combined glucose and C-peptide endpoints should be incorporated into the design of future T1D prevention trials.

An Analysis of Patient-Reported Outcomes Measurement Information System (PROMIS) in Non-operative Posterolateral Elbow Dislocations.

The purpose of our study is to analyze the outcomes of traumatic posterolateral elbow dislocations using patient-reported outcomes measurement information system (PROMIS). We hypothesized that physical function (PF) and upper extremity (UE) scores inPROMIS will significantly improve over six months of follow-up and correlate with a positive change in the patient-acceptable symptom state (PASS). This is a seven-year retrospective study of 165 consecutive adult patients with traumatic posterolateral elbow dislocations. Demographic information, PROMIS PF, PROMIS UE, PROMIS pain interference (PI), PROMIS depression, and PASS were recorded over six months of follow-up. At the time of injury, mean PROMIS scores were PF 41.24 (SD 11.16), UE 34.27 (SD 11.87), PI 60.44 (SD 8.07), and depression 49.82 (SD 10.42). At six months, the mean PROMIS scores were PF 39.71 (SD 9.71), UE 33.95 (SD 9.09), PI 57.35 (SD 8.59), and depression 51.43 (SD 10.62). The overall six-month changes in PROMIS scores were PF -1.53, UE -0.32, PI -3.09, and depression +1.61. At the 6-month follow-up, 41.7% responded positively on the PASS, which correlated only with PROMIS PI. Among patients who improved from negative to positive response on PASS, the PROMIS PF, UE, and depression scores did not significantly improve. Only PROMIS PI correlated with PASS at the six-month follow-up; PROMIS PI significantly improved among simple posterolateral elbow dislocation patients at both short-term and long-term follow-up points. PROMIS PF, UE, and depression did not significantly differ between time of injury and short-term and long-term follow-up points.

Physical exercise for the treatment of non-ulcerated chronic venous insufficiency.

Physical exercise for the treatment of non-ulcerated chronic venous insufficiency.

A Payer-Provider Partnership for Endocrine Targeted Automatic eConsults: Implementation and Early Impact on Diabetes and Cost Outcomes.

In the United States, many individuals with diabetes mellitus (DM) do not achieve treatment goals despite the availability of effective interventions. Provider clinical inertia is one cause of these unfavorable outcomes. Targeted automatic eConsults (TACos) are an emerging technology-based intervention with potential to address clinical inertia in primary care (PC). TACos prospectively identify at-risk patients and use unsolicited specialist recommendations to prompt treatment intensification. Through a payer-provider collaboration, a TACos intervention was piloted for adults with uncontrolled DM (HbA1c >8%) to understand impact on DM clinical inertia and outcomes. Clinical inertia was assessed by measuring whether a PC provider implemented recommended therapeutic changes. Six-month changes in HbA1c and health care costs per member per month were evaluated using an observational matched design and intention-to-treat (ITT) analysis. The analysis included 196 individuals who received a TACos between February 2021 and August 2021 (ITT group) matched to 392 controls based on clinical and demographic criteria. TACos recommendations were implemented 65% of the time. Median percent change in HbA1c was significantly greater for the ITT group versus controls (-10.9% vs. -10.2%; P = 0.0359). Median total costs were 7.9% lower in the ITT group (P = 0.0900). A per protocol analysis was done to examine effects between ITT group individuals with an implemented TACos recommendation (n = 126) and controls. Median percent change in HbA1c was significantly greater (-19.5% vs. -10.2%; P < 0.0001), but there was no difference in total costs (-7.9%; P = 0.1753). TACos may feasibly address clinical inertia in PC and improve HbA1c for uncontrolled DM.

Evaluation of disparities in impact of mental health intensive case management on 6-month symptoms, functioning, and quality of life between black and white veterans diagnosed with schizophrenia.

Substantial health disparities have been reported between Black and White Americans diagnosed with schizophrenia. The nature and extent of these disparities among individuals receiving services in an equal-access health care system remains understudied. The purpose of this study was to examine disparities in enrollment characteristics, service delivery and clinical outcomes between Black and White veterans diagnosed with schizophrenia who received care in the Veterans Health Administration (VHA), an equal-access health care system. National program evaluation data from the VHA Intensive Community Mental Health Recovery (ICMHR) program were used to evaluate disparities between 2436 Black and 3565 White veterans who enrolled between 1999 and 2013. Veterans and case managers completed measures of sociodemographic factors, clinical history, clinical characteristics, and justice system involvement at enrollment and six months. Chi square and ANOVAs were used to evaluate enrollment and service delivery differences. Six-month changes were evaluated using multiple regression controlling for potentially confounding baseline characteristics. Effect sizes were evaluated with Cohen's d. Results indicated differences between Black and White veterans in clinical history, justice system involvement, and clinical characteristics at enrollment. Minimal differences in service delivery were noted and longitudinal analyses revealed no significant differences between Black and White veterans on the majority of outcomes. Fewer racial disparities in service use and outcomes were observed in ICMHR than in standard non-VA clinic settings. This study demonstrates that disparities may emerge more strongly from systemic rather than individual-level differences.

Effect of dietary patterns on cardiovascular risk factors in people with type 2 diabetes. A systematic review and network meta-analysis

AimsTo identify the most effective dietary pattern for improving cardiovascular risk factors in people with type 2 diabetes. MethodsPubMed, Embase, the Cochrane library, SCOPUS and Web of Science were systematically searched for randomized controlled trials comparing the effects of dietary patterns on body weight, blood pressure, HbA1c and lipids after 6 and 12 months. Treatment effects were synthesized using Bayesian network meta-analysis. Six-month changes in HbA1c, SBP and LDL-C were used to estimate relative risk reductions (RRR) for cardiovascular events. ResultsSeventy-three RCTs on eight different dietary patterns were included. All reduced body weight and HbA1c after 6 months, with the largest effects from the low carbohydrate (body weight −4.8 kg, 95 %credibility interval (95 %CrI) −6.5;−3.2 kg) and Mediterranean diet (HbA1c −1.0 %, 95 %CrI -15;−0.4 % vs usual diet). There were no significant 6-month blood pressure or lipid effects. Dietary patterns had non-statistically significant 12-months effects. The Mediterranean diet resulted in the largest expected RRR for cardiovascular events: −16 % (95 %CI -31;3.0) vs usual diet. ConclusionsIn patients with type 2 diabetes, all dietary patterns outperformed usual diet in improving body weight and HbA1c after 6 months and clinically relevant cardiovascular risk reduction could be achieved. There was insufficient evidence to select one optimal dietary pattern.

The Expression of Dispositional Behavior and Psychological Attitudes in the Context of Social Risk

The aim of the research is to reveal the distribution of psychological attitudes (preferences) of risk specialists according to the structural-operational components of the activity, to reveal the expression of social-psychological attitudes of self-confidence observed in specific situations with six-month changes, to review the connection among needs, situations and unconscious actions. Structural similarities of a person’s dispositional behavior and psychological attitudes are considered by us in terms of requirement, situation and unconscious actions. In a given social situation, the content of a person’s specific requirements can be significantly different depending on the specific role of the person. The psychological attitudes of professionals are mostly expressed in official activities, when a task arises to give preference to some structural-functional component (“motive-goal-action-result”). The analysis shows that changes in the social attitudes of professionals in the professional field related to the new situation and over time did not have a significant impact on the whole group. Meanwhile, the data of each participant has been changed to some extent.

Evaluation of factors associated with medication adherence in patients with bipolar disorder using a medication event monitoring system: a 6‐month follow‐up prospective study

BackgroundNon-adherence in patients with bipolar disorder (BD) results in symptoms, such as aggravation, BD recurrence, emergency room visits, re-hospitalization, and poor psychosocial outcomes. Though non-adherence rates have been reported to range between 30–50% in patients with BD, the problem of adherence is often either overlooked by the physician or denied by the patient. An essential first step to enhancing medication adherence is to objectively estimate adherence. The Medication Event Monitoring System (MEMS), which is a pill bottle cap with a microprocessor, is an accurate device for assessing medication adherence. Using the MEMS, we aimed to measure medication adherence in patients with BD and evaluate the factors associated with and 6-month changes in medication adherence.MethodsParticipants with BD were recruited from the psychiatric outpatient clinic of the Korea University Guro Hospital. The medication adherence of each participant was assessed using the MEMS, a self-report, pill count, and clinician rating. MEMS-measured adherence was reassessed after 6 months. Patient demographics were recorded and clinical assessments were conducted. Data were analyzed using Kappa statistics and Pearson’s correlation analysis.ResultsOf the 59 participants, 50 records were included in the analysis. Patient adherence and adherence rate assessed by the MEMS were lower than those assessed by the other measures. MEMS-measured adherence was correlated more closely with pill counts than with self-reports or clinician ratings. MEMS-measured adherence was negatively associated with prescription duration and the Brief Psychiatric Rating Scale—Affect Subscale Score. Six-month changes in MEMS-measured adherence were positively associated with attitude toward drugs and negatively associated with weight gain assessed by the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale.ConclusionsClinicians may have to consider the limited accuracy of self-reporting and clinician rating methods and exercise caution when assessing the medication adherence of patients with BD using these methods. Our findings may assist clinicians in the assessment and improvement of medication adherence in patients with BD and, consequently, may be useful for the treatment and prevention of BD recurrence.

Effect of race on cardiometabolic responses to once-weekly exenatide: insights from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL)

BackgroundTo determine whether there were racial differences in short-term cardiometabolic responses to once-weekly exenatide (EQW) in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).MethodsEXSCEL enrolled 14,752 patients with type 2 diabetes (hemoglobin A1c (HbA1c) 6.5–10.0% [48–86 mmol/mol]) with or without cardiovascular disease who were randomized double-blind to EQW or placebo. Background glucose-lowering/other cardiovascular therapies were unaltered for 6 months post-randomization unless clinically essential, facilitating comparison of EQW-associated effects in 14,665 evaluable participants self-identifying as White (n = 11,113), Asian (n = 1444), Black (n = 870), or Other Race (n = 1,238. Placebo-adjusted 6 month absolute changes in cardiometabolic variables were assessed using generalized linear models.ResultsMean 6-month placebo-adjusted HbA1c reductions were similar in the four groups (range 0.54–0.67% [5.9 to 7.3 mmol/mol], P = 0.11 for race×treatment interaction), with no significant difference in Asians (reference) versus other groups after covariate adjustment (all P ≥ 0.10). Six-month placebo-adjusted mean changes in systolic (−1.8 to 0.0 mmHg) and diastolic (0.2 to 1.2 mmHg) blood pressure, serum LDL (− 0.06 to 0.02 mmol/L) and HDL (0.00 to 0.01 mmol/L) cholesterol, and serum triglycerides (−0.1 to 0.0 mmol/L) were similar in the racial groups (P ≥ 0.19 for race×treatment interaction and all P ≥ 0.13 for comparisons of Asians with other races). Resting pulse rate increased more in Asians (4 beats/min) than in other groups (≤ 3 beats/min, P = 0.016 for race×treatment interaction and all P ≤ 0.050 for comparisons of Asians with other races).ConclusionsShort-term cardiometabolic responses to EQW were similar in the main racial groups in EXSCEL, apart from a greater pulse rate increase in Asians.Trial registration: https://clinicaltrials.gov NCT01144338.

Effect of a 6-month sedentary behavior reduction intervention on well-being and workplace health in desk workers with low back pain

BACKGROUND: Research suggests reducing sedentary behavior improves low back pain; however, the impact on presenteeism, health, productivity, and sleep in desk workers with chronic low back pain is not known. OBJECTIVE: Evaluate the effect of a sedentary behavior intervention on multiple dimensions of workplace health. METHODS: 24 participants with chronic low back pain and desk jobs were randomized to either a sedentary behavior reduction intervention group or control. Outcomes included a modified Global Physical Activity Questionnaire (GPAQ), the Stanford Presenteeism Scale (SPS), Profile of Mood States (POMS), Health and Work Questionnaire (HWQ), SF-36 Health Survey (SF-36), and Pittsburgh Sleep Quality Index (PSQI). Six-month changes in outcomes were compared across intervention groups using ANCOVA regression, adjusting for baseline values. Cohen’s d effect sizes were calculated for outcomes to explain the magnitude of group differences. RESULTS: The intervention group reported 1.5 hours/day less sitting time (p &lt; 0.001) compared to controls at 6 months. SF-36 subscales of energy/fatigue, social functioning, and pain improved, and sleep disturbance was reduced among intervention participants. Productivity, concentration, and presenteeism were unchanged. CONCLUSIONS: A sedentary behavior reduction intervention may improve well-being and workplace health without impacting productivity and concentration in desk workers with chronic low back pain.

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol

The Lupus Intervention Fatigue Trial (LIFT) is a prospective, randomized controlled trial to assess the effectiveness of a six-month motivational interviewing intervention program versus an educational control to reduce fatigue in persons with systematic lupus erythematosus (SLE). Participants are randomized using a stratified, 1:1 allocation design to the LIFT intervention or control arm. We plan to enroll 236 participants to achieve the target of 200 persons with six-month follow-up for the primary endpoint. Specific aims of this study are to evaluate the impact of the LIFT intervention on 1) self-reported measures of fatigue and 2) impact on accelerometer-measured physical activity. The primary study outcome is six-month change in fatigue from baseline, assessed by the Fatigue Severity Score (FSS). Additional outcomes include objective measures of physical activity, including non-sedentary behavior and moderate-to-vigorous activity (secondary outcome), and adherence to the LIFT dietary intervention, as assessed by nutrient density (diet quality) and recommended food groups/eating patterns (exploratory outcome) in persons with SLE. Intervention effectiveness will be assessed using an intention-to-treat two-arm comparison of six-month change in FSS, with one interim monitoring analysis. A two-sample independent group t-test will compare the six-month changes in FSS between the study arms. Intervention effect durability will be assessed 12-months after baseline (6 months after completion of the intervention). Enrollment began in June 2019 and is expected to end in June 2023. This study will inform future intervention strategies that promote physical activity and improved diet quality to reduce fatigue in persons with SLE.

Descriptive, Injunctive, and Collective Norms: An Expansion of the Theory of Normative Social Behavior (TNSB)

ABSTRACT We propose and test several hypotheses derived from the expanded theory of normative social behavior (TNSB) that also includes collective norms (with descriptive and injunctive norms). Data come from a quasi-experiment intervention to promote safer driving among adolescents in Serbia. The intervention was administered among high school students, most of whom were on the verge of receiving their driver’s licenses. Longitudinal data were collected from treatment and control schools at baseline (N = 1,449) and four months later at end line (N = 1,072). Descriptive norms at baseline predicted six-month changes in safer-driving intentions among women (β = .010 p < .05) but not among men. Main-effects of injunctive and collective norms were not significant. However, a significant interaction between descriptive norms and collective norms emerged among men (though not among women) and injunctive norms interacted with both collective norms and descriptive norms among women (but not among men). Initial evidence adds credence to the idea of enhancing the TNSB by adding both injunctive and collective (together with descriptive) norms as drivers of behaviors.

Six-month changes in ghrelin and glucagon-like peptide-1 with weight loss are unrelated to long-term weight regain in obese older adults

Background and objectiveWeight loss (WL) and subsequent regain are complex physiologic processes, and our understanding of the hormonal changes associated with these processes continues to evolve. We aimed to examine the effects of behavioral WL on 6-month changes in ghrelin and GLP-1 and evaluate the effects of these changes in gut hormones on weight regain among older adults.Subjects and methodsOne hundred seventy-seven obese (BMI: 33.5 (3.5) kg/m2) older adults (66.9 ± 4.7 years, 71.2% female, 67.6% white) were randomized to WL (WL; n = 68), WL plus aerobic training (n = 79), or WL plus resistance training (n = 75) for 18 months. Ghrelin, GLP-1, power of food scale (PFS), and weight were measured at baseline, 6 months, and 18 months.ResultsThere was no differential treatment effect on change in either gut hormone, however, there was a significant time effect across all groups (p < 0.001), with increases in ghrelin (∆ = +106.77 pg/ml; 95% CI = + 84.82, +128.71) and decreases in GLP-1 (∆ = −4.90 pM; 95% CI = −6.27, −3.51) at 6-month. Ratings on the PFS decreased from baseline to 6-month and there was significant loss of weight from baseline to either 6- or 18-month, ∆ = −7.96 kg; 95% CI = −7.95, −8.78 and ∆ = −7.80 kg; 95% CI = −8.93, −6.65, respectively (p < 0.001). Changes in ghrelin and GLP-1 at 6-month did not predict weight regain from 6- to 18-month.Discussion and conclusionAmong older adults with obesity and cardiometabolic disease, the intensive phase of dietary WL results in increasing levels of ghrelin and decreasing levels of GLP-1 that are unrelated to weight regain a year later. Registered with ClinicalTrials.gov (NCT01547182).

Prospective analysis of gait characteristics in chronic inflammatory demyelinating polyradiculoneuropathy

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a disorder that may lead to functional impairment, including gait abnormalities. Our aim was to analyze gait characteristics in patients with CIDP compared to healthy controls (HC). Moreover, we sought to determine changes of gait parameters after six-month follow-up period. Twenty-four patients with CIDP and 24 HCs performed basic walking task, dual-motor task, dual-mental task, and combined task using the same GAITRite system. Lower limb MRC-SS and lower limb INCAT disability score were assessed. Fourteen patients were retested after six months. Majority of gait parameters showed significant differences in all experimental conditions when compared between CIDP and HCs. The most consistent findings in CIDP were shorter stride length (SL), prolonged cycle time (CT) and double support time (DS), as well as increased variation of SL and of swing time (ST) (p < 0.05). During follow-up, INCAT improved in nine (64.3%) of 14 patients and MRC-SS improved in eight (57.1%) patients. Six-month changes of CT and its variation during combined task significantly differentiated patients with improved vs. non-improved INCAT (p < 0.05). In conclusion, patients with CIDP had slower gait with prolonged DS and with shorter SL compared to HCs. Increased variation of SL and of ST in CIDP may suggest a potential risk for instability and falls. Shorter CT duration and less CT variation during time correlated well with improvement in disability.