Sandra R. Wilson

Translating the Diabetes Prevention Program Lifestyle Intervention for Weight Loss Into Primary Care A Randomized Trial

BACKGROUND The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes mellitus (DM) among high-risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care. METHODS We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n = 79), (2) a self-directed DVD intervention (n = 81), or (3) usual care (n = 81). During a 3-month intensive intervention phase, the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) from baseline to 15 months. RESULTS At baseline, participants had a mean (SD) age of 52.9 (10.6) years and a mean BMI of 32.0 (5.4); 47% were female; 78%, non-Hispanic white; and 17%, Asian/Pacific Islander. At month 15, the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group (P < .001) and -1.6 ± 0.3 in the self-directed group vs usual care (P = .02). The percentages of participants who achieved the 7% DPP-based weight-loss goal were 37.0% (P = .003) and 35.9% (P = .004) in the coach-led and self-directed groups, respectively, vs 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level. CONCLUSION Proven effective in a primary care setting, the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00842426.

Asthma in the elderly: Current understanding and future research needs—a report of a National Institute on Aging (NIA) workshop

Asthma in the elderly is underdiagnosed and undertreated, and there is a paucity of knowledge on the subject. The National Institute on Aging convened this workshop to identify what is known and what gaps in knowledge remain and suggest research directions needed to improve the understanding and care of asthma in the elderly. Asthma presenting at an advanced age often has similar clinical and physiologic consequences as seen with younger patients, but comorbid illnesses and the psychosocial effects of aging might affect the diagnosis, clinical presentation, and care of asthma in this population. At least 2 phenotypes exist among elderly patients with asthma; those with longstanding asthma have more severe airflow limitation and less complete reversibility than those with late-onset asthma. Many challenges exist in the recognition and treatment of asthma in the elderly. Furthermore, the pathophysiologic mechanisms of asthma in the elderly are likely to be different from those seen in young asthmatic patients, and these differences might influence the clinical course and outcomes of asthma in this population.

Health-related quality of life in patients with idiopathic pulmonary fibrosis: a systematic review

Background: Idiopathic pulmonary fibrosis (IPF) profoundly affects the quality of patients’ lives. A systematic review was performed to evaluate critically the published literature and to examine what is known about health-related quality of life (HRQL) in patients with IPF. Methods: The MEDLINE, EMBASE, Health and Psychosocial Instruments, and Cochrane Library databases were searched to 1 April 2004. Abstracts and bibliographies of published articles were scanned and contact was made with investigators. Included studies analysed HRQL (or quality of life) in at least 10 patients with IPF. Two reviewers independently selected studies, evaluated their quality according to predetermined criteria, and abstracted data on study design, patients’ demographic and clinical characteristics, and quality of life outcome measures. Results: Seven studies met the inclusion criteria. The studies enrolled 512 patients with IPF and used three different instruments to measure HRQL. All studies had important limitations in methodological quality; none measured longitudinal changes in HRQL over time. Patients reported substantially impaired HRQL, especially in domains that measured physical health and level of independence. Patients with IPF appear to have similar impairments in HRQL to those with chronic obstructive pulmonary disease. Measures of dyspnoea were moderately correlated with scores from domains that measured physical health (R2 = 0.03–0.66) and energy/fatigue/pep (R2 = 0.19–0.55), but measures of pulmonary function and gas exchange did not correlate as strongly with these and other domains. Conclusion: Studies of HRQL in patients with IPF suggest that, in addition to the obvious effect on physical health, general health, energy level, respiratory symptoms, and level of independence are also impaired. Variability in HRQL among patients is not fully explained by measures of dyspnoea or pulmonary function, suggesting that HRQL measures provide unique information. More research is needed to identify or design appropriate measurement instruments for patients with IPF and to examine changes in HRQL over time or in response to specific treatments.

Education of Parents of Infants and Very Young Children with Asthma: A Developmental Evaluation of the Wee Wheezers Program

A randomized control trial of the Wee Wheezers asthma education program was conducted with 76 children < 7 years of age, 31% of whom were on a medication regimen consistent with mild, 51% with moderate, and 18% with moderately severe/severe asthma. Treatment children showed improved morbidity at 3-month follow-up relative to the changes in the controls: increased symptom-free days in the preceding 2 weeks (mean change of +2.2 vs. -2.6 in the controls; p = .004) and month (+2.0 vs. -3.8; p < .02), fewer nights of parental sleep interruption in a typical week (+0.7 vs. +1.8; p < or = .05), and a trend toward fewer asthma sick days (-0.2 vs +0.7; p = ns). These improvements were accompanied by significantly better parental asthma management compared with controls (more consistent use of preventive medications, p < or = .01; early symptom intervention, [corrected] p < or = .05) and trends toward more restrictions on smoking in the home (p < .07) and decreased parental confusion about asthma treatment (p < .11). This study provides evidence that a multisession program of asthma education for parents can improve parental asthma management and clinical outcomes in very young children and provides information on the validity and sensitivity of various asthma outcome measures in this age group.

Secondhand Tobacco Smoke in Children With Asthma: Sources of and Parental Perceptions About Exposure in Children and Parental Readiness To Change

BACKGROUND Secondhand smoke triggers childhood asthma. Understanding sources of exposure, parental beliefs about exposure, and readiness to change that exposure are important for designing smoke exposure reduction interventions. METHODS As part of screening for a clinical trial of a smoke exposure reduction intervention, 519 smoke-exposed children 3 to 12 years old with asthma provided urine specimens for cotinine testing, and their primary caregivers completed questionnaires. RESULTS The urine cotinine to creatinine ratio (CCR) was lowest if neither the primary caregiver nor day-care provider smoked (mean CCR, 14.0; SD, 14.4), greater if either smoked (mean CCR, 22.2; SD, 21.3; and mean, CCR, 26.3; SD, 22.2, respectively), and greatest if both smoked (mean CCR, 39.6; SD, 27.5; p < 0.01). Parental perception of their childs exposure was weakly associated with the childs CCR (r(2) = 0.11, p < 0.001). Most parents (58.3%) reported that tobacco smoke exposure had small/no negative effect on their childs asthma. Substantial proportions of those for whom a specific exposure reduction action was relevant were classified as contemplating, preparing, or had recently taken action to reduce their childs exposure, including smoking cessation (61.3%), keeping the child out of smoke-exposed places (72.7%), and making the childs home (49.2%) and areas out of the home smoke free (66.9%). CONCLUSIONS Smoking by the primary caregiver and day-care provider are important sources of exposure for children with asthma. Parental assessment of their childs exposure is associated with biologically confirmed exposure but cannot be relied on to assess that exposure. Although the harm of smoke exposure was frequently underestimated, many parents appeared receptive to considering action to reduce their childs exposure. TRIAL REGISTRATION (Clinicaltrials.gov). Identifier: NCT00217958.

Mediators of asthma outcomes

BACKGROUND Patient adherence, the level of asthma self-management skills, exposure to stress, and depression can have considerable influence on a wide range of asthma outcomes and thus are considered asthma outcome mediators. OBJECTIVE National Institutes of Health institutes and other federal agencies convened an expert group to recommend standardized measures for 7 domains of asthma clinical research outcomes measures. Although the review of mediators of these outcomes was not within the scope of any specific outcome topic, a brief summary is presented so that researchers might consider potential mediators. METHODS We prepared a summary of key mediators of asthma outcomes based on expertise and knowledge of the literature. RESULTS The rationale for including measures of adherence, self-management skills, and exposures to stress in asthma clinical research is presented, along with a brief review of instruments for collecting this information from clinical research participants. CONCLUSIONS Appropriate measurement of adherence, self-management skills, and exposures to stress will enhance characterization of study participants and provide information about the potential impact these factors can have on mediating the effects of treatment interventions.

Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial

BackgroundEfficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings.DesignE-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240) recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided α level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up.Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level) and moderators (e.g., age, gender, race/ethnicity, baseline mental status) of the interventions effect on weight change also will be examined.DiscussionThis study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care.Trial registrationNCT00842426

Behavioral Weight Loss and Physical Activity Intervention in Obese Adults with Asthma. A Randomized Trial

RATIONALE The effect of weight loss on asthma in obese adults warrants rigorous investigation. OBJECTIVES To examine an evidence-based, practical, and comprehensive lifestyle intervention targeting modest weight loss and increased physical activity for asthma control. METHODS The trial randomized 330 obese adults with uncontrolled asthma to receive usual care enhanced with a pedometer, a weight scale, information about existing weight management services at the participating clinics, and an asthma education DVD, or with these tools plus the 12-month intervention. MEASUREMENTS AND MAIN RESULTS The primary outcome was change in Asthma Control Questionnaire (ACQ) scores from baseline to 12 months. Participants (mean [SD] age, 47.6 [12.4] yr) were 70.6% women, 20.0% non-Hispanic black, 20.3% Hispanic/Latino, and 8.2% Asian/Pacific Islander. At baseline, they were obese (mean [SD] body mass index, 37.5 [5.9] kg/m(2)) and had uncontrolled asthma (Asthma Control Test score, 15.1 [3.8]). Compared with control subjects, intervention participants achieved significantly greater mean weight loss (±SE) (intervention, -4.0 ± 0.8 kg vs. control, -2.1 ± 0.8 kg; P = 0.01) and increased leisure-time activity (intervention, 418.2 ± 110.6 metabolic equivalent task-min/wk vs. control, 178.8 ± 109.1 metabolic equivalent task-min/wk; P = 0.05) at 12 months. But between-treatment mean (±SE) differences were not significant for ACQ changes (intervention, -0.3 ± 0.1 vs. control, -0.2 ± 0.1; P = 0.92) from baseline (mean [SD], 1.4 [0.8]), nor for any other clinical asthma outcomes (e.g., spirometric results and asthma exacerbations). Among all participants regardless of treatment assignment, weight loss of 10% or greater was associated with a Cohen d effect of 0.76 and with 3.78 (95% confidence interval, 1.72-8.31) times the odds of achieving clinically significant reductions (i.e., ≥0.5) on ACQ as stable weight (<3% loss or gain from baseline). The effects of other weight change categories were small. CONCLUSIONS Moderately and severely obese adults with uncontrolled asthma can safely participate in evidence-based lifestyle intervention for weight loss and active living. The modest average weight and activity improvements are comparable to those shown to reduce cardiometabolic risk factors in studies of similar interventions in other populations but are not associated with significant net benefits for asthma control or other clinical asthma outcomes in the current population. Instead, weight loss of 10% or greater may be required to produce clinically meaningful improvement in asthma. Clinical trial registered with www.clinicaltrials.gov (NCT00901095).

The Effect of an Inhaled Corticosteroid on Glucose Control in Type 2 Diabetes

Objective: To determine the effect of inhaled corticosteroid (ICS) therapy on glucose control in adults with type 2 diabetes mellitus and coexisting asthma or chronic obstructive pulmonary disease (COPD). Design: A prospective randomized, double-blind, double-dummy placebo-controlled, crossover investigation of inhaled steroids and oral leukotriene blockers. Setting: A United States Department of Veterans Affairs Health Care System outpatient setting. Participants: Adults with type 2 diabetes and asthma or COPD. Methods: Subjects (n=12) were randomized to receive either inhaled fluticasone propionate (440 μg twice daily) and oral placebo, or inhaled placebo and oral montelukast (10 mg/day). After 6 weeks, subjects were switched to the opposite therapy for 6 weeks. The primary outcome measure was the change in the percentage of glycosylated hemoglobin (%HbA1c) at 6 weeks relative to the baseline value. Results: Ten patients completed the study. The difference between the mean within-subject changes in %HbA1c associated with 6-week periods of fluticasone and the mean changes associated with montelukast therapy was small but statistically significant (mean difference=0.25; P<0.025). Neither fluticasone nor oral montelukast therapy for 6 weeks led to a significantly different mean % HbA1c compared with the relevant baseline (mean differences=0.11 and −0.14, respectively). Conclusion: The absence of a clinically significant within-subject difference in the changes in %HbA1c associated with fluticasone versus oral montelukast therapy, or between either therapy or baseline does not warrant recommending changes in therapy for asthma or diabetes in patients with these co-morbid conditions. However, we suggest that clinicians carefully monitor blood glucose control when diabetic patients initiate ICS, especially with higher dosages.

Adapting community based participatory research (CBPR) methods to the implementation of an asthma shared decision making intervention in ambulatory practices

Abstract Objective: Translating research findings into clinical practice is a major challenge to improve the quality of healthcare delivery. Shared decision making (SDM) has been shown to be effective and has not yet been widely adopted by health providers. This paper describes the participatory approach used to adapt and implement an evidence-based asthma SDM intervention into primary care practices. Methods: A participatory research approach was initiated through partnership development between practice staff and researchers. The collaborative team worked together to adapt and implement a SDM toolkit. Using the RE-AIM framework and qualitative analysis, we evaluated both the implementation of the intervention into clinical practice, and the level of partnership that was established. Analysis included the number of adopting clinics and providers, the patients’ perception of the SDM approach, and the number of clinics willing to sustain the intervention delivery after 1 year. Results: All six clinics and physician champions implemented the intervention using half-day dedicated asthma clinics while 16% of all providers within the practices have participated in the intervention. Themes from the focus groups included the importance of being part the development process, belief that the intervention would benefit patients, and concerns around sustainability and productivity. One year after initiation, 100% of clinics have sustained the intervention, and 90% of participating patients reported a shared decision experience. Conclusions: Use of a participatory research process was central to the successful implementation of a SDM intervention in multiple practices with diverse patient populations.