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BackgroundDigital diabetes prevention programs (dDPPs) are effective behavior change tools to prevent disease progression in patients at risk for diabetes. At present, these programs are poorly integrated into existing health information technology infrastructure and clinical workflows, resulting in barriers to provider-level knowledge of, interaction with, and support of patients who use dDPPs. Tools that can facilitate patient-provider interaction around dDPPs may contribute to improved patient engagement and adherence to these programs and improved health outcomes. ObjectiveThis study aims to use a rigorous, user-centered design (UCD) methodology to develop a theory-driven system that supports patient engagement with dDPPs and their primary care providers with their care. MethodsThis study will be conducted in 3 phases. In phase 1, we will use systematic UCD, Agile software development, and qualitative research methods to identify key user (patients, providers, clinical staff, digital health technologists, and content experts) requirements, constraints, and prioritization of high-impact features to design, develop, and refine a viable intervention prototype for the engagement system. In phase 2, we will conduct a single-arm feasibility pilot of the engagement system among patients with prediabetes and their primary care providers. In phase 3, we will conduct a 2-arm randomized controlled trial using the engagement system. Primary outcomes will be weight, BMI, and A1c at 6 and 12 months. Secondary outcomes will be patient engagement (use and activity) in the dDPP. The mediator variables (self-efficacy, digital health literacy, and patient-provider relationship) will be measured. ResultsThe project was initiated in 2018 and funded in September 2019. Enrollment and data collection for phase 1 began in September 2019 under an Institutional Review Board quality improvement waiver granted in July 2019. As of December 2020, 27 patients have been enrolled and first results are expected to be submitted for publication in early 2021. The study received Institutional Review Board approval for phases 2 and 3 in December 2020, and phase 2 enrollment is expected to begin in early 2021. ConclusionsOur findings will provide guidance for the design and development of technology to integrate dDPP platforms into existing clinical workflows. This will facilitate patient engagement in digital behavior change interventions and provider engagement in patients’ use of dDPPs. Integrated clinical tools that can facilitate patient-provider interaction around dDPPs may contribute to improved patient adherence to these programs and improved health outcomes by addressing barriers faced by both patients and providers. Further evaluation with pilot testing and a clinical trial will assess the effectiveness and implementation of these tools. Trial RegistrationClinicalTrials.gov NCT04049500; https://clinicaltrials.gov/ct2/show/NCT04049500 International Registered Report Identifier (IRRID)DERR1-10.2196/26750

BackgroundMost adults are not achieving recommended levels of physical activity (150 minutes/week, moderate-to-vigorous intensity). Inadequate activity levels are associated with numerous poor health outcomes, and clinical recommendations endorse physical activity in the front-line treatment of obesity, diabetes, dyslipidemia, and hypertension. A framework for physical activity prescription and referral has been developed, but has not been widely implemented. This may be due, in part, to the lack of feasible and effective physical activity intervention programs designed to coordinate with clinical care delivery. ObjectiveThis manuscript describes the protocol for a pilot randomized controlled trial (RCT) that tests the efficacy of a 13-week online intervention for increasing physical activity in adult primary care patients (aged 21-70 years) reporting inadequate activity levels. The feasibility of implementing specific components of a physical activity clinical referral program, including screening for low activity levels and reporting patient program success to referring physicians, will also be examined. Analyses will include participant perspectives on maintaining physical activity. MethodsThis pilot study includes a 3-month wait-listed control RCT (1:1 ratio within age strata 21-54 and 55-70 years). After the RCT primary end point at 3 months, wait-listed participants are offered the full intervention and all participants are followed to 6 months after starting the intervention program. Primary RCT outcomes include differences across randomized groups in average step count, moderate-to-vigorous physical activity, and sedentary behavior (minutes/day) derived from accelerometers. Maintenance of physical activity changes will be examined for all participants at 6 months after the intervention start. ResultsRecruitment took place between October 2018 and May 2019 (79 participants were randomized). Data collection was completed in February 2020. Primary data analyses are ongoing. ConclusionsThe results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician. Trial RegistrationClinicalTrials.gov NCT03695016; https://clinicaltrials.gov/ct2/show/NCT03695016. International Registered Report Identifier (IRRID)DERR1-10.2196/18891

OBJECTIVE: To assess the relationship between walking for exercise and symptomatic and structural disease progression in individuals with knee osteoarthritis (OA). METHODS: We assessed a nested cohort of participants age 50 years or older within the Osteoarthritis Initiative, a community-based observational study in which subjects were enrolled between 2004 and 2006. We focused on 4 dichotomous outcomes from baseline to the 48-month visit, involving determination of the frequency of knee pain and radiographic severity of knee OA on posteroanterior semiflexed knee radiographs. The outcomes assessed included 1) new frequent knee pain, 2) worsening of radiographic severity of knee OA based on the Kellgren/Lawrence grade, 3) progression of medial joint space narrowing, and 4) improved frequent knee pain. We used a modified version of the Historical Physical Activity Survey Instrument to ascertain those subjects who reported walking for exercise after age 50 years. The survey was administered at the 96-month visit (2012-2014). RESULTS: Of 1,212 participants with knee OA, 45% were male and 73% reported walking for exercise. The mean ± SD age was 63.2 ± 7.9 years, and the mean ± SD body mass index was 29.4 ± 4.6 kg/m2 . The likelihood of new frequent knee pain was reduced in participants with knee OA who walked for exercise as compared to those who were non-walkers (odds ratio [OR] 0.6, 95% confidence interval [95% CI] 0.4-0.8), and progression of medial joint space narrowing was less common in walkers compared to non-walkers (OR 0.8, 95% CI 0.6-1.0). CONCLUSION: In individuals with knee OA who were age 50 years or older, walking for exercise was associated with less frequent development of knee pain. These findings support the notion that walking for exercise should be encouraged for people with knee OA. Furthermore, we offer a proof of concept that walking for exercise could be disease modifying, which warrants further study.

IntroductionMale youth in the United States commonly participate in gridiron (American) football. There are little data substantiating current popular opinion that it is associated with knee pain or osteoarthritis (OA) later in life. We aimed to evaluate the relationship of football with these outcomes in the Osteoarthritis Initiative (OAI).MethodsThis is a study of male OAI participants with knee x-ray readings, symptom assessments, and completed surveys on lifetime physical activity. The OAI is a multicenter, observational cohort recruited from the community not based on football participation status. A history of exposure to American football was ascertained via self-report. Knee radiographs were scored for Kellgren-Lawrence grade (0-4). Radiographic OA (ROA) was defined as Kellgren-Lawrence ≥ 2 in at least one knee. Frequent knee pain meant at least one knee with frequent knee pain. Symptomatic ROA required at least one knee with both ROA and frequent knee pain.ResultsA total of 1166 men had a mean age of 63.7 (SD, 9.2) yr and body mass index of 28.6 (SD, 4.2) kg·m. Thirty-one percent (365/1166) played football at some point in their lives, 95% of whom participated from ages 12 to 18 yr. The ORs for symptomatic ROA from the lowest to highest football participation were 1.2, 1.5, and 2.2, respectively (P for trend = 0.004). Findings were similar for football from ages 12 to 18 yr and for outcomes of knee pain and ROA.ConclusionThis is the first large epidemiologic study to suggest that football participation, including in the teen years, may be detrimental toward knee health. Prospective studies evaluating football players are warranted.

Few proven therapies exist for patients with idiopathic inflammatory myopathies (IIMs), partly due to the lack of reliable and valid outcome measures for assessing treatment responses. The current core set measures developed by the International Myositis Assessment and Clinical Studies group were developed to standardize assessments of disease activity and treatment effect. None of the current measures address functional improvement in muscle weakness. Therefore, supplemental measures to more objectively assess physical activity levels and fatiguability in free-living settings are needed to assess disease activity more comprehensively. Validated physical activity monitors (PAMs) have the potential to serve as an objective functional outcome measure in clinical trials and observational studies. This review examines the current evidence for the use of body-worn PAMs in clinical settings with IIM patients. A practical overview of methods for PAM use in clinical patient populations (including measurement details and data processing) that focuses on IIM patients is also presented. [ABSTRACT FROM AUTHOR]

The diet quality of US adults is poor and cross-sectional analyses suggest self-perception of healthful dietary intake may be overestimated. This analysis assessed the concordance between calculated and perceived diet quality and changes in diet quality among adults seeking weight loss and enrolled in a 12-month randomized behavioral trial. Healthy Eating Index-2015 diet quality (HEI) was calculated from self-administered 24-hour recalls. Perceived diet quality (PDQ) was measured on a 100-point scale. Higher scores indicate better diet quality. Concordance was assessed using the concordance correlation coefficient and Bland-Altman plots. The one hundred and five participants with complete dietary data were mostly female and white. There was good agreement between HEI and PDQ scores at 12 months for less than a third of participants. Most of the disagreement arose from PDQ scores being higher than HEI scores. Even fewer participants had good agreement between HEI changes and PDQ changes. Participants perceived greater improvement in diet quality than indicated by HEI score changes. Concordance was low at 12 months and for change in diet quality. Despite the diet quality of adults seeking weight loss being suboptimal and not improving, many perceived their diet quality and diet quality improvements as better than calculated. Future studies might explore the effect of misperceptions on weight loss outcomes. [ABSTRACT FROM AUTHOR]

Asthma is one of the most common chronic conditions in developed countries. We examined whether physical activity (PA) is related to asthma control and body mass index (BMI) in asthma patients. Cross-sectional data collected on PA (ActiGraph GT3X-BT), asthma control (the Asthma Control Questionnaire; ACQ), and BMI were examined in 206 adults (mean[sd] age 47.2[13.8] years; 49.5% had an obese BMI) with clinically diagnosed asthma. Relationships between PA and continuous BMI and asthma control were assessed using linear regression. Differences in PA across obesity (non-obese: <30 Kg/m2/obese: ≥30 Kg/m2) and asthma control categories (controlled: ≤0.75/uncontrolled: >0.75 ACQ score) were also examined. Median (p25, p75) steps counts and peak cadence were 6035 (4248, 8461) steps/day and 123 (115, 133) steps in a minute, respectively. There were nearly 2000 fewer steps/day among those with uncontrolled asthma versus controlled and among those with obese BMI versus nonobese, respectively (both p < 0.05). In regression models adjusted for relevant covariates each 1-unit increase in ACQ score was associated with −686 [95%CI −997, −13] (p ≤ 0.05) average steps/day. The statistical significance of these findings was attenuated (p ≥ 0.05) when BMI was added to the model. However, the point estimate was not reduced (-766 [95%CI −1060, 34]. Overall step counts were low in this population despite peak cadence values suggesting that most participants could perform moderate intensity activity. Increasing step counts should be considered an important lifestyle intervention goal in obese and non-obese asthma patients with low PA levels. [ABSTRACT FROM AUTHOR]

Objective: We aimed to evaluate the relationship of a history of strength training with symptomatic and structural outcomes of knee osteoarthritis (OA). Methods: This study was a retrospective, cross‐sectional study within the Osteoarthritis Initiative (OAI), a multicenter prospective longitudinal observational study. Data were collected at four OAI clinical sites: Memorial Hospital of Rhode Island, the Ohio State University, the University of Pittsburgh, and the University of Maryland/Johns Hopkins. The study included 2,607 participants with complete data on strength training, knee pain, and radiographic evidence of knee OA (male, 44.2%; mean ± SD age 64.3 ± 9.0 years; mean ± SD body mass index 28.5 ± 4.9 kg/m2). We used a self‐administered questionnaire at the 96‐month OAI visit to evaluate the exposure of strength training participation during four time periods throughout a participant's lifetime (ages 12–18, 19–34, 35–49, and ≥50 years old). The outcomes (dependent variables) were radiographic OA (ROA), symptomatic radiographic OA (SOA), and frequent knee pain. Results: The fully adjusted odds ratios (95% confidence interval) for frequent knee pain, ROA, and SOA among those who participated in strength training any time in their lives were 0.82 (0.68–0.97), 0.83 (0.70–0.99), and 0.77 (0.63–0.94), respectively. Findings were similar when looking at the specific age ranges. Conclusion: Strength training is beneficial for future knee health, counteracting long‐held assumptions that strength training has adverse effects. [ABSTRACT FROM AUTHOR]

Background: Narrative medicine is a powerful approach for strengthening clinicians' therapeutic alliances with patients and helping them understand others' perspectives by giving patients a voice. MyPaTH Story Booth is a cross‐sectional observational study that uses narrative medicine concepts to allow community participants to share their health and healthcare‐related experiences through relatively unstructured interviews (i.e., stories). The archive forms a qualitative research ʻcommonsʼ where researchers can learn about patient and caregiver perspectives and tailor research goals to better address community needs. Brief surveys allow storytellers to classify their stories so that the archive is searchable. Methods: This study assessed sensitivity, specificity, positive predictive and negative predictive values of self‐reported surveys for categorizing 83 stories, compared with a ʻgold standardʼ (most commonly accepted method for interpreting narratives) of qualitative coding. Stories were classified as either having or not having each of 38 different classifications based on US National Library of Medicine (NLM) Health Topics (Type of disorder or condition and Part of the body discussed) or developed with stakeholder input (Type of health/healthcare experience). Results: Survey data assessing ʻPart of the body discussedʼ and ʻType of disorder or conditionʼ typically was highly sensitive (64%–95%) and specific (73%–99%) suggesting high adequacy of surveys in identifying stories. Questions focused on ʻType of health/healthcare experienceʼ showed inconsistent and relatively lower sensitivities (48%–93%) and specificities (30%–79%) suggesting lower adequacy of surveys in identifying stories. Conclusion: Survey items based on NLM Health Topics allowed people to categorize their health narratives into relevant, searchable topics making the database more accessible. [ABSTRACT FROM AUTHOR]

Background: The importance of leisure sedentary behavior (LSB) change in diabetes prevention efforts is not well known. This study examines the relationships between changes in self-reported LSB and the primary intervention goals (weight and moderateintensity to vigorous-intensity physical activity [MVPA]) during a community-based translation of the Diabetes Prevention Program (the Group Lifestyle Balance Program). Methods: A total of 322 adults at risk for type 2 diabetes were recruited from 3 community centers, a worksite, and military site. Community and worksite participants were randomized to immediate or delayed-delivery (control) intervention. All military site participants (n = 99) received immediate intervention. Logistic and linear generalized estimating equations were used to determine associations between LSB changes and weight-related outcomes and MVPA. Results: Results were obtained for 259 (80.4%) participants. The LSB decreased after 6 and 12 months (mean [95% confidence interval]: -25.7 [-38.6 to -12.8] and -16.1 [-28.2 to -3.9] min/d; both P < .05). Each 20-minute reduction in LSB was associated with a 5% increase in odds of meeting the weight-loss goal (6 mo: odds ratio = 1.05 [1.002 to 1.102]; P = .042; adjusted model including MVPA), but LSB was not related to changes in reported MVPA minutes or MVPA goal achievement. Conclusion: Within the context of existing lifestyle intervention programs, reducing sedentary behavior has the potential to contribute to weight loss separately from reported MVPA improvement. [ABSTRACT FROM AUTHOR]

Background: The obesity epidemic is a global concern. Standard behavioral treatment including increased physical activity, reduced energy intake, and behavioral change counseling is an effective lifestyle intervention for weight loss. Purpose: To identify distinct step count patterns among weight loss intervention participants, examine weight loss differences by trajectory group, and examine baseline factors associated with trajectory group membership. Methods: Both groups received group-based standard behavioral treatment while the experimental group received up to 30 additional, one-on-one self-efficacy enhancement sessions. Data were analyzed using group-based trajectory modeling, analysis of variance, chi-square tests, and multinomial logistic regression. Results: Participants (N = 120) were mostly female (81.8%) and white (73.6%) with a mean (SD) body mass index of 33.2 (3.8) kg/m2. Four step count trajectory groups were identified: active (>10,000 steps/day; 11.7%), somewhat active (7500–10,000 steps/day; 28.3%), low active (5000–7500 steps/day; 27.5%), and sedentary (<5000 steps/day; 32.5%). Percent weight loss at 12 months increased incrementally by trajectory group (5.1% [5.7%], 7.8% [6.9%], 8.0% [7.4%], and 13.63% [7.0%], respectively; P =.001). At baseline, lower body mass index and higher perceived health predicted membership in the better performing trajectory groups. Conclusions: Within a larger group of adults in a weight loss intervention, 4 distinct trajectory groups were identified and group membership was associated with differential weight loss. [ABSTRACT FROM AUTHOR]

Objectives Inflammatory myopathies are characterized by muscle weakness that limits the activities of daily living. Daily step count is an accepted metric of physical activity. Wearable technologies such as Fitbit® enable tracking of daily step counts. We assessed the psychometric properties of Fitbit® and compared the accuracy of Fitbit® step counts to ActiGraph®. Methods This was a pilot, proof of concept, prospective observational study with four visits at 0, 1, 3 and 6 months in PM, DM, necrotizing myopathy (NM) or anti-synthetase syndrome (AS) subjects. Six core set measures (manual muscle testing, physician global disease activity, patient global disease activity, and extra-muscular disease activity, HAQ-Disability Index and creatine kinase), three functional tests (six-min walk, timed up-and-go, sit-to-stand tests) and SF-36 physical function-10 (PF10) were collected at each visit. Patients wore waist-worn Fitbit® One and ActiGraph® T3X-BT concurrently for 7 days/month for 6 months. Results Twenty-four (10 DM, 8 PM/NM, 6 AS) patients (17 females/7 males; 91% Caucasian) were enrolled. Test-retest reliability of daily steps was strong in 1-month follow-up (ICC 0.89). Daily steps and peak 1-min cadence showed moderate-strong correlations with physician global disease activity, patient global disease activity, HAQ-Disability Index, SF-36 PF10 and all three functional tests. Fitbit® and ActiGraph® step counts demonstrated good agreement and strong correlation (ICC 0.96). Conclusion Fitbit® daily steps and peak 1-min cadence are reliable and valid measures of physical activity in a cohort of myositis patients. This pilot data suggests that Fitbit® has a potential for use in clinical practice and trials to monitor physical activity in myositis patients, but larger studies are needed for further validation. [ABSTRACT FROM AUTHOR]