Loneliness, social isolation, and cardiovascular disease among nonveteran and veteran women.

We examined the prospective associations of social isolation and loneliness with incident cardiovascular disease (CVD) among aging nonveteran and veteran women, and effect modification by veteran status. Participants with no history of myocardial infarction (MI), stroke, coronary heart disease (CHD), or coronary heart failure from the Women's Health Initiative Extension Study II self-reported social isolation, loneliness, health behaviors, health status, and veteran status. CVD and CVD subevents were physician adjudicated. Hazard ratios (HR) and 95% confidence intervals (CI) for the Interquartile Range (IQR) in social isolation (IQR = 1) and loneliness (IQR=.33) were calculated using Cox proportional hazard models adjusting for sociodemographic, health behavior, and health status characteristics. Veteran status was tested as an effect modifier. Among 52,442 women (Mean age = 79 ± 6.1; veterans n = 1023; 89.2% non-Hispanic White), 3579 major CVD events occurred over an average 5.8 follow-up years. Compared to nonveterans, veteran women reported higher levels of social isolation (p < .01) and loneliness (p < .01). The CVD HR was 1.07 (95% CI, 1.04-1.10) for the IQR in social isolation and 1.03 (95% CI, 1.10-1.06) for the IQR in loneliness. The HR for the IQR in both social isolation and loneliness was 1.10 (95% CI, 1.05-1.15). Social isolation was associated with CHD (HR = 1.12; 95% CI, 1.03-1.21). The CHD HR for the IQR in social isolation was 1.12 (95% CI, 1.03-1.21). Associations did not differ by veteran status (all p-interactions > 0.08). Findings suggest that the adverse associations of social isolation and loneliness with CVD are similar among veteran and nonveteran women.

Association of type 2 diabetes mellitus with dementia-related and non-dementia-related mortality among postmenopausal women: A secondary competing risks analysis of the women's health initiative.

INTRODUCTION: Alzheimer's disease (AD) and AD-related dementias (ADRD) are leading causes of death among older adults in the United States. Efforts to understand risk factors for prevention are needed. METHODS: Participants (n = 146,166) enrolled in the Women's Health Initiative without AD at baseline were included. Diabetes status was ascertained from self-reported questionnaires and deaths attributed to AD/ADRD from hospital, autopsy, and death records. Competing risk regression models were used to estimate the cause-specific hazard ratios (HRs) and 95% confidence intervals (CIs) for the prospective association of type 2 diabetes mellitus (T2DM) with AD/ADRD and non-AD/ADRD mortality. RESULTS: There were 29,393 treated T2DM cases and 8628 AD/ADRD deaths during 21.6 (14.0-23.5) median (IQR) years of follow-up. Fully adjusted HRs (95% CIs) of the association with T2DM were 2.94 (2.76-3.12) for AD/ADRD and 2.65 (2.60-2.71) for the competing risk of non-AD/ADRD mortality. DISCUSSION: T2DM is associated with AD/ADRD and non-AD/ADRD mortality. HIGHLIGHTS: Type 2 diabetes mellitus is more strongly associated with Alzheimer's disease (AD)/AD and related dementias (ADRD) mortality compared to the competing risk of non-AD/ADRD mortality among postmenopausal women. This relationship was consistent for AD and ADRD, respectively. This association is strongest among participants without obesity or hypertension and with younger age at baseline, higher diet quality, higher physical activity, higher alcohol consumption, and older age at the time of diagnosis of type 2 diabetes mellitus.

Menopausal hormone therapy and change in physical activity in the Women's Health Initiative hormone therapy clinical trials.

OBJECTIVE: The menopausal transition results in a progressive decrease in circulating estrogen levels. Experimental evidence in rodents has indicated that estrogen depletion leads to a reduction of energy expenditure and physical activity. It is unclear whether treatment with estrogen therapy increases physical activity level in postmenopausal women. METHODS: A total of 27,327 postmenopausal women aged 50-79 years enrolled in the Women's Health Initiative randomized double-blind trials of menopausal hormone therapy. Self-reported leisure-time physical activity at baseline, and years 1, 3, and 6 was quantified as metabolic equivalents (MET)-h/wk. In each trial, comparison between intervention and placebo groups of changes in physical activity levels from baseline to follow-up assessment was examined using linear regression models. RESULTS: In the CEE-alone trial, the increase in MET-h/wk was greater in the placebo group compared with the intervention group at years 3 ( P = 0.002) and 6 ( P < 0.001). Similar results were observed when analyses were restricted to women who maintained an adherence rate ≥80% during the trial or who were physically active at baseline. In the CEE + MPA trial, the primary analyses did not show significant differences between groups, but the increase of MET-h/wk was greater in the placebo group compared with the intervention group at year 3 ( P = 0.004) among women with an adherence rate ≥80%. CONCLUSIONS: The results from this clinical trial do not support the hypothesis that estrogen treatment increases physical activity among postmenopausal women.

The Association of Total Knee Arthroplasty With Weight Loss in the Look AHEAD (Action for Health in Diabetes) Clinical Trial.

BACKGROUND: Patients who have obesity seldom lose weight after total knee arthroplasty (TKA). The Look AHEAD (Action for Health in Diabetes) trial randomized patients with type 2 diabetes who were overweight or had obesity to a 10-year intensive lifestyle intervention (ILI) or diabetes support and education (DSE). METHODS: Of the total 5,145 participants enrolled who had a median 14-year follow-up, a subset of 4,624 met inclusion criteria. The ILI aimed at achieving and maintaining a 7% weight loss and included weekly counseling the first 6 months, with decreasing frequency thereafter. This secondary analysis was undertaken to determine what effects a TKA had on patients participating in a known successful weight loss program and specifically if there was a negative impact on weight loss or their Physical Component Score. RESULTS: The analysis suggests that the ILI remained effective for maintaining or losing weight after TKA. Participants in ILI had significantly greater percent weight loss than those in DSE both before and after TKA (ILI-DSE before TKA: -3.6% (-5.0, -2.3); after TKA: -3.7% (-4.1, -3.3); both P < .0001). When comparing percent weight loss before to after TKA, there was no significant difference within either the DSE or ILI group (least square means ± standard error ILI: -0.36% ± 0.3, P = .21; DSE: -0.41% ± 0.29, P = .16). Physical Component Scores improved after TKA (P < .001), but no difference was found between TKA ILI and DSE groups before or after surgery. CONCLUSION: Participants who had a TKA did not have an altered ability to adhere to intervention goals to maintain weight loss or obtain further weight loss. The data suggest patients who have obesity can lose weight after TKA on a weight loss program.

Low Diastolic Blood Pressure and Mortality in Older Women. Results From the Women's Health Initiative Long Life Study.

BACKGROUND: Recommended systolic blood pressure targets often do not consider the relationship of low diastolic blood pressure (DBP) levels with cardiovascular disease (CVD) and all-cause mortality risk, which is especially relevant for older people with concurrent comorbidities. We examined the relationship of DBP levels to CVD and all-cause mortality in older women in the Women's Health Initiative Long Life Study (WHI-LLS). METHODS: The study sample included 7,875 women (mean age: 79 years) who underwent a blood pressure measurement at an in-person home visit conducted in 2012-2013. CVD and all-cause mortality were centrally adjudicated. Hazard ratios (HRs) were obtained from adjusted Cox proportional hazards models. RESULTS: After 5 years follow-up, all-cause mortality occurred in 18.4% of women. Compared with a DBP of 80 mm Hg, the fully adjusted HR for mortality was 1.33 (95% confidence interval [CI]: 1.04-1.71) for a DBP of 50 mm Hg and 1.67 (95% CI: 1.29-2.16) for a DBP of 100 mm Hg. The HRs for CVD were 1.14 (95% CI: 0.78-1.67) for a DBP of 50 mm Hg and HR 1.50 (95% CI: 1.03-2.17) for a DBP of 100 mm Hg. The nadir DBP associated with lowest mortality risk was 72 mm Hg overall. CONCLUSIONS: In older women, consideration should be given to the potential adverse effects of low and high DBP. Low DBP may serve as a risk marker. DBP target levels between 68 and 75 mm Hg may avoid higher mortality risk.

Physical activity and risk of benign proliferative epithelial disorders of the breast, in the Women's Health Initiative.

BACKGROUND: Recreational physical activity (PA) has been shown to be inversely associated with breast cancer risk. However, the association of recreational PA with benign proliferative epithelial disorders (BPED) of the breast, conditions associated with increased risk of breast cancer, has not been adequately studied. METHODS: We used data from an ancillary study of benign breast disease conducted among the 68 132 postmenopausal women (aged 50-79 at recruitment) participating in the Women's Health Initiative randomized clinical trials. All clinical trial participants underwent annual or biennial mammogram screening. During the follow-up, for women who reported breast biopsies but were cancer free, the associated histological sections were obtained and subjected to standardized central pathology review. Self-reported recreational PA at baseline (n = 61 684) and at 3 years of the follow-up (n = 55 923) were quantified as metabolic equivalents [MET]-h/week. There were 1624 confirmed BPED cases during an average follow-up time of 7.7 years. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). RESULTS: Higher average PA over 4 years was associated with lower risk of non-atypical BPED (P-trend = 0.02). There was a 6% lower risk of non-atypical BPED for every 5 MET-h/week increase between baseline and year 3 (HR = 0.94, 95% CI 0.89-0.99). Compared with women who remained inactive (PAbaseline and PAyear3 <9 MET-h/week), those who became active (PAbaseline<9 MET-h/week to PAyear3 ≥9 MET-h/weekee), remained active (PAbaseline and PAyear3 ≥9 MET-h/week), or decreased activity (PAbaseline ≥9 MET-h/week to PAyear3 <9 MET-h/week) had lower BPED risk. CONCLUSIONS: Recreational physical activity after menopause was associated with lower BPED risk among postmenopausal women.

Recreational Physical Activity, Sitting, and Androgen Metabolism among Postmenopausal Women in the Women's Health Initiative Observational Study.

BACKGROUND: Prolonged sitting and physical inactivity are associated with higher circulating levels of estrogens. It is unknown whether these risk factors are associated with circulating androgens/androgen metabolites, another set of hormones implicated in the etiology of cancers in postmenopausal women. METHODS: We conducted a cross-sectional analysis of 1,782 postmenopausal women in the Women's Health Initiative Observational Study. Serum concentrations of 12 androgens/androgen metabolites were quantified using liquid chromatography-tandem mass spectrometry. Physical activity and sitting time were self-reported at baseline. We performed linear regression to estimate geometric means (GM) of androgen/androgen metabolite concentrations (pmol/L) according to physical activity and sitting time, adjusting for potential confounders and stratified by menopausal hormone therapy (MHT) use. RESULTS: Physical activity (≥15 vs. 0 MET-h/wk) was inversely associated with estrogen-to-androgen ratios among never/former MHT users (adj-GM = 37.5 vs. 49.6 unconjugated estrone:androstenedione; 20.2 vs. 30.3 unconjugated estradiol:testosterone; all P trend ≤ 0.03) but was not associated among current MHT users. Prolonged sitting (≥10 vs. ≤5 h/d) was positively associated with these ratios among both never/former (adj-GM = 44.2 vs. 38.3, P trend = 0.10; adj-GM = 23.4 vs. 20.2, P trend = 0.17; respectively) and current MHT users (adj-GM = 197 vs. 147; 105 vs. 75.5; respectively; all P trend ≤0.02), but the associations were statistically significant among current MHT users only. The associations persisted after adjustment for BMI. After adjustment for adrenal androgens, physical activity and sitting were not associated with androgen metabolites. CONCLUSIONS: Physical activity and sitting were associated with serum estrogen-to-androgen ratios but not androgen metabolites. IMPACT: This study contributes to our understanding of the link between physical activity, sitting, and cancer risk in postmenopausal women.

The Early STEPS Pilot Study: The Impact of a Brief Consultation Session on Self-reported Parenting Satisfaction.

INTRODUCTION: Evidence-based parenting interventions can augment parental knowledge and skills to reduce parental stress and increase self-efficacy, leading to improved developmental outcomes for children. However, parenting interventions are often multi-session and require considerable time commitments from parents and primary care physicians. We conducted a pilot study to evaluate the effect of a brief consultation session on self-reported parental satisfaction and to assess the feasibility and effectiveness of incorporating occupational therapists (OTs) into a low-income urban pediatric primary care setting to conduct developmental screenings. METHODS: OTs conducted one 45-min consultation on positive parenting practices and promoting child development with parents in a pediatric primary care practice. A one group pretest-posttest design with 6-month follow-up was utilized. Participants included 55 families with 60 children, ages 2 to 65 months 30 days. The primary outcome measure was the change in Parenting Sense of Competence Scale (PSOC) scores from baseline to 6-month follow-up. Additional outcomes were screening results, referral numbers, and follow through in obtaining early intervention services. RESULTS: The paired difference between PSOC scores at baseline and 6 months indicated a significant increase in parenting satisfaction (p < 0.0001). Of 41 children referred, 26 were eligible and obtained services, 12 were lost to follow-up, and 3 did not qualify for services. DISCUSSION: Our preliminary findings suggest one consultation session on positive parenting practices and promoting child development may increase parenting satisfaction. Moreover, OTs can reduce the burden on primary care physicians by providing screenings, consultations, and follow-up. Further research is warranted to evaluate these findings.

Assessing the Contribution of Self-Monitoring Through a Commercial Weight Loss App: Mediation and Predictive Modeling Study.

BACKGROUND: Electronic self-monitoring technology has the potential to provide unique insights into important behaviors for inducing weight loss. OBJECTIVE: The aim of this study is to investigate the effects of electronic self-monitoring behavior (using the commercial Lose It! app) and weight loss interventions (with differing amounts of counselor feedback and support) on 4- and 12-month weight loss. METHODS: In this secondary analysis of the Fit Blue study, we compared the results of two interventions of a randomized controlled trial. Counselor-initiated participants received consistent support from the interventionists, and self-paced participants received assistance upon request. The participants (N=191), who were active duty military personnel, were encouraged to self-monitor their diet and exercise with the Lose It! app or website. We examined the associations between intervention assignment and self-monitoring behaviors. We conducted a mediation analysis of the intervention assignment for weight loss through multiple mediators-app use (calculated from the first principal component [PC] of electronically collected variables), number of weigh-ins, and 4-month weight change. We used linear regression to predict weight loss at 4 and 12 months, and the accuracy was measured using cross-validation. RESULTS: On average, the counselor-initiated-treatment participants used the app more frequently than the self-paced-treatment participants. The first PC represented app use frequencies, the second represented calories recorded, and the third represented reported exercise frequency and exercise caloric expenditure. We found that 4-month weight loss was partially mediated through app use (ie, the first PC; 60.3%) and the number of weigh-ins (55.8%). However, the 12-month weight loss was almost fully mediated by 4-month weight loss (94.8%). Linear regression using app data from the first 8 weeks, the number of self-weigh-ins at 8 weeks, and baseline data explained approximately 30% of the variance in 4-month weight loss. App use frequency (first PC; P=.001), self-monitored caloric intake (second PC; P=.001), and the frequency of self-weighing at 8 weeks (P=.008) were important predictors of 4-month weight loss. Predictions for 12-month weight with the same variables produced an R2 value of 5%; only the number of self-weigh-ins was a significant predictor of 12-month weight loss. The R2 value using 4-month weight loss as a predictor was 31%. Self-reported exercise did not contribute to either model (4 months: P=.77; 12 months: P=.15). CONCLUSIONS: We found that app use and daily reported caloric intake had a substantial impact on weight loss prediction at 4 months. Our analysis did not find evidence of an association between participant self-monitoring exercise information and weight loss. As 12-month weight loss was completely mediated by 4-month weight loss, intervention targets should focus on promoting early and frequent dietary intake self-monitoring and self-weighing to promote early weight loss, which leads to long-term success. TRIAL REGISTRATION: ClinicalTrials.gov NCT02063178; https://clinicaltrials.gov/ct2/show/NCT02063178.

Association of Objectively Measured Timing of Physical Activity Bouts With Cardiovascular Health in Type 2 Diabetes.

OBJECTIVE: Moderate- to vigorous-intensity physical activity (MVPA) improves cardiovascular health. Few studies have examined MVPA timing. We examined the associations of timing of bout-related MVPA with cardiorespiratory fitness and cardiovascular risk in adults with type 2 diabetes. RESEARCH DESIGN AND METHODS: Baseline 7-day hip-worn accelerometry data from Look AHEAD participants (n = 2,153, 57% women) were analyzed to identify bout-related MVPA (≥3 METs/min for ≥10 min). Cardiorespiratory fitness was assessed by maximal graded exercise test. Participants were categorized into six groups on the basis of the time of day with the majority of bout-related MVPA (METs × min): ≥50% of bout-related MVPA during the same time window (morning, midday, afternoon, or evening), <50% of bout-related MVPA in any time category (mixed; the reference group), and ≤1 day with bout-related MVPA per week (inactive). RESULTS: Cardiorespiratory fitness was highly associated with timing of bout-related MVPA (P = 0.0005), independent of weekly bout-related MVPA volume and intensity. Importantly, this association varied by sex (P = 0.02). In men, the midday group had the lowest fitness (ß = -0.46 [95% CI -0.87, -0.06]), while the mixed group in women was the least fit. Framingham risk score (FRS) was associated with timing of bout-related MVPA (P = 0.02), which also differed by sex (P = 0.0007). The male morning group had the highest 4-year FRS (2.18% [0.70, 3.65]), but no association was observed in women. CONCLUSIONS: Timing of bout-related MVPA is associated with cardiorespiratory fitness and cardiovascular risk in men with type 2 diabetes, independent of bout-related MVPA volume and intensity. Prospective studies are needed to determine the impacts of MVPA timing on cardiovascular health.

Association of the Intensive Lifestyle Intervention With Total Knee Replacement in the Look AHEAD (Action for Health in Diabetes) Clinical Trial.

BACKGROUND: Evidence has established obesity as a risk factor for total knee replacement (TKR) due to osteoarthritis. Obesity is a risk factor for TKR. Randomized trials such as Look AHEAD (Action for Health in Diabetes) have shown long-term successful weight loss with an intensive lifestyle intervention (ILI). It is unknown, however, if intentional weight loss can reduce the risk of TKR. METHODS: Look AHEAD randomized persons aged 45-76 with type 2 diabetes who had overweight or obesity to either an ILI to achieve/maintain 7% weight loss or to standard diabetes support and education (DSE). Reported knee pain was assessed using the Visual Analog Scale and Western Ontario McMaster University Osteoarthritis Index questionnaire in 5125 participants without previous TKR. Cox proportional hazard regression was used to model differences in risk of TKR in relation to randomization group assignment (ILI vs DSE) along with baseline body mass index category and baseline knee pain as potential confounders from baseline through Look AHEAD-Extension. RESULTS: Baseline mean ± SD Western Ontario McMaster University Osteoarthritis Index knee pain scores did not differ by treatment assignment (ILI: 3.6 ± 2.9, DSE: 3.9 ± 3.0, P = .08); as expected due to randomization. During follow up, the 631 (12%) participants who reported having a TKR were more likely to have been heavier (P < .001) and older (P < .001) at enrollment, but risk of TKR did not differ by treatment group assignment (hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.91-1.25, P = .43). Heterogeneity of treatment effect was observed according to baseline knee pain (interaction P = .02). In persons without knee pain at baseline, there was a 29% reduced risk of TKR in ILI compared to DSE (HR 0.71, 95% CI 0.52-0.96). However, in persons with knee pain at baseline, there was no statistically significant association of treatment assignment with respect to subsequent TKR incidence (HR 1.11, 95% CI 0.92-1.33). CONCLUSION: Findings suggest that intensive lifestyle change including physical activity, dietary restriction and behavioral changes to achieve weight loss for prevention of TKR may be most effective in preventing TKR prior to the development of knee pain.

Association Between Characteristics of Injurious Falls and Fall Preventive Interventions in Acute Medical and Surgical Units.

BACKGROUND: Hospital falls remain common and approximately 30% of falls in hospital result in injury. The aims of the study were the following: (i) to identify the association between fall interventions present at the time of the injurious fall and injurious faller characteristics and (ii) to identify the association between fall preventive interventions present at the time of the injurious fall and the injurious fall circumstances. METHODS: Secondary data analysis of deidentified case series of injurious falls across 24 acute medical/surgical units in the United States. Variables of interest were falls prevention interventions (physical therapy, bed alarm, physical restraint, room change, or a sitter) in place at the time of fall. Data were analyzed using logistic regression and hazard ratios. RESULTS: There were 1,033 patients with an injurious fall, occurrence peaked between Day 1 and Day 4, with 46.8% of injurious falls having occurred by Day 3 of admission. Injurious fallers with a recorded mental state change 24 hours prior to the fall were more likely to have a bed alarm provided (adjusted odds ratio [OR] 2.56, 95% confidence interval [CI] 1.61, 4.08) and receive a physical restraint as fall prevention interventions (adjusted OR 6.36, 95% CI 4.35, 9.30). Injurious fallers restrained fell later (stay Day 6) than those without a restraint (stay Day 4) (p = .007) and had significantly longer lengths of stay (13 days vs 9 days). CONCLUSIONS: On medical/surgical units, injurious falls occur early following admission suggesting interventions should be commenced immediately. Injurious fallers who had a physical restraint as an intervention had longer lengths of stay.

Weight Loss Intervention Impact on the Physical Fitness Test Scores of Air Force Service Members.

INTRODUCTION: Overweight and obesity are a major public health concern in the United States, including among active duty military personnel. Approximately 51% of active duty personnel are classified as overweight and 15% are classified as obese. This may impact military readiness. The current study aimed to determine if a weight loss intervention impacted fitness test scores among Air Force personnel. MATERIALS AND METHODS: From 2014 to 2016, 204 Air Force members with overweight/obesity were randomized into either a Self-paced or counselor-initiated arm in a weight loss program. Study procedures were approved by the Institutional Review Board of the 59th Medical Wing in San Antonio and were acknowledged by the Institutional Review Board at the University of Tennessee Health Science Center. Fitness test scores from before, during, and after the intervention were used to determine if the intervention resulted in improvements in overall fitness test ratings and scores on individual components of the test. RESULTS: Participants who lost at least 5% of their weight had better fitness ratings during the intervention compared to individuals who did not lose 5%. However, in the overall sample, fitness ratings worsened from preintervention to during the intervention, and from during to postintervention. Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity. CONCLUSIONS: Behavioral weight management interventions that achieve 5% weight loss may help improve military fitness test ratings.

In-Hospital Sequelae of Injurious Falls in 24 Medical/Surgical Units in Four Hospitals in the United States.

BACKGROUND: Up to 50% of patient falls in the hospital result in injury. This study was conducted to determine whether injurious falls were associated with increased hospital length of stay (LOS), discharge to a place other than home, and in-hospital mortality. METHODS: A secondary data analysis from a prospective case-control study was conducted in 24 medical/surgical units in four hospitals in the United States. Patients who fell and sustained an injury were matched with at least one control patient who was on the same unit, at the same time, for a similar number of days on the unit at the time of the fall. Data were collected by viewing patients' electronic health records, as well as the hospitals' incident reporting systems. Logistic regression and Cox regression analyses were conducted. RESULTS: The 1,033 patients (mean age, 63.7 years; 510 males [49.4%]) who sustained an injurious fall were matched with 1,206 controls (mean age, 61.6 years; 486 males [40.3%]). Fallers were significantly more likely than controls to stay longer than 10 days in the hospital (odds ratio [OR], 1.59; 95% confidence interval [CI] = 1.46-1.74) and to be discharged to a place other than home (OR, 1.52; 95% CI = 1.21-1.91). CONCLUSION: Compared to controls, hospital patients who sustained an injurious fall had longer LOS and were more likely discharged to a place other than home. These associations remained when controlling for patient-level confounders, suggesting that the fall altered trajectory was sustained toward these outcomes. Injurious falls were not significantly associated with increased risk of mortality.

Dissemination of the Look AHEAD Intensive Lifestyle Intervention in the United States Military: A Randomized Controlled Trial.

OBJECTIVE: The purpose of this study, "Fit Blue," was to compare a translation of the Look AHEAD (Action for Heath in Diabetes) intensive lifestyle intervention with a self-paced version of the same intervention among active duty military personnel. METHODS: Active duty military personnel (N = 248; 49% male, 34% racial minority) with overweight or obesity were randomized to 12-month distance-based (i.e., phone and email) parallel programs, counselor-initiated (CI) condition or self-paced (SP) condition, from 2014 to 2016. Trained lay interventionists were retired military personnel or had extensive familiarity with the military. RESULTS: The CI condition had greater weight loss at 4 months (CI: mean ± SD = -3.2 ± 3.4 kg; SP: -0.6 ± 2.9 kg; P < 0.0001) and at 12 months (CI: mean ± SD = -1.9 ± 4.1 kg; SP: -0.1 ± 3.8 kg; P < 0.001). Participants in the CI condition also had a greater percent weight loss at both 4 months (CI: 3.5% ± 3.8, SP: 0.6% ± 3.1; P < 0.0001) and 12 months (CI: 2.1% ± 4.7, SP: 0.0% ± 4.0; P < 0.001). In addition, a greater proportion of CI participants lost 5% or more at 4 months (CI: 29.8%, SP: 10.5%; P < 0.001) and at 12 months (CI: 29.5%, SP: 15.6%; P < 0.05). CONCLUSIONS: The CI behavioral weight loss intervention translated from Look AHEAD was well received and is a promising approach for managing weight in an active duty military population.

Community-based physical activity as adjunctive smoking cessation treatment: Rationale, design, and baseline data for the Lifestyle Enhancement Program (LEAP) randomized controlled trial.

Despite advances in behavioral and pharmacological treatment for tobacco use and dependence, quit rates remain suboptimal. Increasing physical activity has shown some promise as a strategy for improving cessation outcomes. However, initial efficacy studies focused on intensive, highly structured exercise programs that may not be applicable to the general population of smokers. We describe the rationale and study design and report baseline participant characteristics from the Lifestyle Enhancement Program (LEAP), a two-group, randomized controlled trial. Adult smokers who engaged in low levels of leisure time physical activity were randomly assigned to treatment conditions consisting of an individualized physical activity intervention delivered by health fitness instructors in community-based exercise facilities or an equal contact wellness control. All participants received standard cognitive behavioral smoking cessation counseling combined with nicotine replacement therapy. The primary outcomes are seven-day point prevalence abstinence at seven weeks, six- and 12 months. Secondary outcomes include self-reported physical activity, dietary intake, body mass index, waist circumference, percent body fat, and nicotine withdrawal symptoms. Participants consist of 392 sedentary smokers (mean [standard deviation] age = 44.6 [10.2] = years; 62% female; 31% African American). Results reported here provide information regarding experiences recruiting smokers willing to change multiple health behaviors including smoking and physical activity.

The Primary Results of the Treating Adult Smokers at Risk for Weight Gain with Interactive Technology (TARGIT) Study.

OBJECTIVE: To evaluate whether a behavioral weight management program combined with a smoking cessation program delivered via interactive technology could prevent postcessation weight gain. METHODS: Three hundred and thirty young adult smokers, age 18 to 35 years, were randomized to a smoking cessation program alone (comparison group), which included behavioral counseling and nicotine replacement, or to a behavioral weight management program adapted from the Look AHEAD trial plus the same smoking cessation program (intervention group). RESULTS: The Treating Adult Smokers at Risk for Weight Gain with Interactive Technology study randomized 164 participants to the comparison group and 166 participants to the intervention group. On average, the participants gained 0.91 kg after 24 months in the trial (comparison group + 1.45 kg and intervention group + 0.32; P = 0.157). The only variable systematically affecting weight change over time was smoking abstinence, in which those who were abstinent, on average, gained 0.14 kg more per month compared with those who continued to smoke (P < 0.001). In exploratory analyses, the intervention participants who were abstinent at 6 months had numerically smaller weight gains compared with abstinent participants in the comparison group, but these differences were not statistically significant. CONCLUSIONS: Providing an intensive weight gain prevention program combined with a smoking cessation program via interactive technology was not associated with greater long-term weight gain prevention.

Associations between hyponatraemia, volume depletion and the risk of falls in US hospitalised patients: a case-control study.

OBJECTIVE: We aimed to determine if abnormal laboratory values which may indicate volume depletion are associated with increased odds of experiencing a hospital-acquired fall. DESIGN: Matched case-control study. SETTING: Four hospitals located in the Southeast USA. PARTICIPANTS: Data from 699 adult fallers and 1189 matched controls (non-fallers) were collected via chart review from 2005 to 2010. Controls were matched to cases by nursing unit, time of fall and length of stay. OUTCOME MEASURES: The primary exposures included serum sodium, blood urea nitrogen (BUN), creatinine, BUN/creatinine ratio and haematocrit. Conditional logistic regression with m:n matching was used to determine adjusted and unadjusted ORs. RESULTS: Serum sodium levels were strongly associated with falls. In models controlling for demographic and other fall risk factors, patients with serum sodium levels of 125 mEq/L or less were associated with increased odds of experiencing a fall as compared with those with serum sodium levels of greater than 134 mEq/L (adjusted OR (aOR)=5.08, 95% CI 1.43 to 18.08). Conversely, elevated BUN, creatinine and elevated BUN/creatinine ratios were not associated with increased odds of experiencing a fall (aOR=0.64, 95% CI 0.49 to 0.84; aOR=0.70, 95% CI 0.54 to 0.92 and aOR=0.77, 95% CI 0.58 to 1.04, respectively.) CONCLUSIONS: Laboratory indices that may indicate volume depletion appear to be unrelated to falls. However, hyponatraemia does appear to be a risk factor for falls, and those with serum sodium levels below 126 mEq/L are at especially high risk. It may be that other deficits associated with hyponatraemia, like altered mental status, are associated with risk of experiencing a hospital-acquired fall. These results indicate that abnormal laboratory values, like low sodium, can be useful for identifying hospitalised patients at risk of falling. Therefore, further investigation into abnormal laboratory values as predictors of hospital-acquired falls is warranted.

Impact of the CMS No-Pay Policy on Hospital-Acquired Fall Prevention Related Practice Patterns.

BACKGROUND AND OBJECTIVES: In October 2008, the Centers for Medicare & Medicaid Services (CMS) stopped reimbursing hospitals for costs related to patient falls. This study aimed to examine whether the CMS no-pay policy influenced four fall prevention practices: bed alarms, sitters, room changes, and physical restraints. RESEARCH DESIGN AND METHODS: Using electronic medical record data collected from four hospitals between 2005 and 2010, this secondary observational analysis examined the associations between the CMS no-pay policy and nursing interventions and medical orders related to fall prevention. Multivariable generalized linear mixed models with logit link function and accommodation for matching was used to assess the associations between the CMS no-pay policy and nursing interventions and medical orders. RESULTS: After the CMS policy change, nurses were more likely to perform one or more fall-related interventions (adjusted odds ratio (aOR): 1.667; 95% confidence interval (CI): 1.097-2.534). Of the four prevention practices, the use of bed alarms (aOR: 2.343; 95% CI: 1.409-3.897) increased significantly after the CMS policy change. DISCUSSION AND IMPLICATIONS: The CMS no-pay policy increased utilization of fall prevention strategies despite little evidence that these measures prevent falls.

The Recruitment Experience of a Randomized Clinical Trial to Aid Young Adult Smokers to Stop Smoking without Weight Gain with Interactive Technology.

Multiple recruitment strategies are often needed to recruit an adequate number of participants, especially hard to reach groups. Technology-based recruitment methods hold promise as a more robust form of reaching and enrolling historically hard to reach young adults. The TARGIT study is a randomized two-arm clinical trial in young adults using interactive technology testing an efficacious proactive telephone Quitline versus the Quitline plus a behavioral weight management intervention focusing on smoking cessation and weight change. All randomized participants in the TARGIT study were required to be a young adult smoker (18-35 years), who reported smoking at least 10 cigarettes per day, had a BMI < 40 kg/m2, and were willing to stop smoking and not gain weight. Traditional recruitment methods were compared to technology-based strategies using standard descriptive statistics based on counts and proportions to describe the recruitment process from initial pre-screening (PS) to randomization into TARGIT. Participants at PS were majority Black (59.80%), female (52.66%), normal or over weight (combined 62.42%), 29.5 years old, and smoked 18.4 cigarettes per day. There were differences in men and women with respect to reasons for ineligibility during PS (p < 0.001; ignoring gender specific pregnancy-related ineligibility). TARGIT experienced a disproportionate loss of minorities during recruitment as well as a prolonged recruitment period due to either study ineligibility or not completing screening activities. Recruitment into longer term behavioral change intervention trials can be challenging and multiple methods are often required to recruit hard to reach groups.