Virtual versus usual in-office care for multiple sclerosis: The VIRTUAL-MS multi-site randomized clinical trial study protocol.

BACKGROUND: Multiple sclerosis (MS) affects nearly 1 million people and is estimated to cost $85.4 billion in the United States annually. People with MS have significant barriers to receiving care and telemedicine could substantially improve access to specialized, comprehensive care. In cross-sectional analyses, telemedicine has been shown to be feasible, have high patient and clinician satisfaction, reduce patient costs and burden, and enable a reasonable assessment of disability. However, no studies exist evaluating the longitudinal impact of telemedicine care for MS. Here we describe the study protocol for VIRtual versus UsuAL In-office care for Multiple Sclerosis (VIRTUAL-MS). The main objective of the study is to evaluate the impact of telemedicine for MS care on: patient clinical outcomes, economic costs, patient, and clinician experience. METHODS: This two-site randomized clinical trial will enroll 120 adults with a recent diagnosis of MS and randomize 1:1 to receive in-clinic vs. telemedicine care for 24 months. The primary outcome of the study is worsening in any one of the four Multiple Sclerosis Functional Composite 4 (MSFC4) measures at 24 months. Other study outcomes include patient and clinician satisfaction, major healthcare costs, Expanded Disability Status Scale, treatment adherence, and digital outcomes. CONCLUSION: The results of this study will directly address the key gaps in knowledge about longitudinal telemedicine-enabled care in an MS population. It will inform clinical care implementation as well as design of trials in MS and other chronic conditions. TRIAL REGISTRATION: NCT05660187.

Factors influencing how informal caregivers of people with multiple sclerosis access and use a curated intervention website: Analysis from an RCT.

Objective: Healthcare consumers and providers are increasingly turning to digital solutions, such as curated websites. Knowing who accesses/benefits from these may improve design and development. This study investigated website usage of informal caregivers of people with multiple sclerosis and shifts in outcome plausibly associated with usage. Methods: Secondary analysis of data from a randomized clinical trial of 148 caregivers compared effectiveness of a website + tele-coaching to a website only intervention for caregivers. Groupwise differences in means/proportions were tested using t-tests and chi-square. Modified Poisson regression with a robust variance estimator and ordinal logistic regression tested the relationship between group and likelihood of website log-in. Ordinal logistic regression models examined whether caregiver characteristics were associated with website use. Generalized estimating equations (GEE) with an autoregressive correlation structure modeled the relationship between website usage and outcomes. Results: Females were more likely to access the website than males (60% vs. 43%; p = 0.05). Though not statistically significant, a possible association (POR: .85, 95% CI: .69, 1.03) between caregiver burden and website access emerged; caregivers experiencing highest levels of burden appeared less likely to engage. Usage patterns differed by treatment arm: the website-only group accessed the Caring for yourself topic significantly more (61.67% vs. 38.33%: p = .04) with similar, but insignificant, trends for other topics. Conclusions: Clinicians can be confident referring females with moderate levels of burden to website-based interventions. By contrast, male caregivers and those experiencing high levels of burden may be less likely to access these resources, pointing to the need for alternative interventions. Trial Registration: Clinicaltrials.gov, registration number: NCT0466208.

Effect of 2-Arm Intervention on Emotional Outcomes in Informal Caregivers of Individuals With Multiple Sclerosis: A Randomized Pilot Study Trial.

BACKGROUND: Caregivers of people with multiple sclerosis (MS) report poor emotional outcomes yet few interventions have been tested. The goal of this study was to compare the effectiveness of a remotely delivered intervention with 2 arms (ie, website and telecoaching vs website only) aimed at reducing depression, anxiety, stress, and distress in informal caregivers of individuals with MS. METHODS: From March 2021 through August 2021, 151 care-givers were enrolled in the study. The intervention occurred over a 4-month period. The website plus telecoaching arm received (a) a monthly coaching session focused on information, skill building, and support that was delivered by a licensed social worker via videoconference or telephone, and (b) had access to a study-designed website for caregivers of individuals with MS. The website-only arm did not receive coaching sessions and had the same website access. Data were obtained at baseline, immediately after the intervention period, and 6 weeks after the intervention. RESULTS: A linear mixed-effects model using an autoregressive covariance structure was used. It showed that the group by time interaction was statistically significant for the overall composite emotion score (depression, anxiety, stress) (P = .037) and the stress subscale score (P = .047), and it indicated that the website plus telecoaching arm demonstrated greater effectiveness at reducing the overall composite emotion and stress subscale scores. CONCLUSIONS: Use of a remotely delivered psychoeducational intervention that included individual coaching sessions as well as website access demonstrated preliminary efficacy in improving emotional outcomes in caregivers of individuals with MS. Further testing of the intervention with a larger sample is recommended.

Fatigue as an Understudied Barrier to Participation in Life Roles.

Fatigue is one of the most burdensome and disabling symptoms in numerous acute and chronic conditions and is associated with reduced participation in all aspects of daily life, for example, parenting, employment, and socialization. Historically, occupational practitioners played key roles in fatigue management by creating and implementing interventions. The American Occupational Therapy Foundation convened a Planning Grant Collective workshop with the goal to develop collaborative research ideas and proposals to advance the understanding and management of fatigue. Participants from occupational therapy and other disciplines, with expertise with fatigue or who were conducting research on fatigue, participated in a 3-day virtual workshop. Four main topics emerged: implementation science, treatment taxonomy, trial design and comparative effectiveness, and phenotyping. This white paper describes the proceedings, summarizes the discussions, and outlines recommendations from the PGC workshop on fatigue.

Psychometric Properties and Clinical Utility of the Distress Thermometer in Caregivers of Persons With Multiple Sclerosis.

BACKGROUND: Caregivers of persons with multiple sclerosis (MS) report high levels of distress. The National Comprehensive Cancer Network Distress Thermometer (DT) is used extensively with patients with cancer and their caregivers but has not been tested in nononcology caregivers. The purpose of this study was to examine the psychometric properties and clinical utility of the barometer portion of the DT in caregivers of persons with MS. METHODS: A secondary analysis was performed of data from a randomized trial comparing the effectiveness of 2 interventions aimed at reducing psychological outcomes associated with caregiving. The DT and the 4-item Patient-Reported Outcomes Measurement Information System Anxiety and Depression scales, which were administered at baseline, were used for all analyses. Construct validity (known groups) and convergent validity (interscale correlations) were evaluated. Receiver operating characteristic curve analysis was used to evaluate clinical diagnostic test evaluation. RESULTS: The DT had good construct validity supported by strong correlations for known-groups analyses and good convergent validity (r = 0.70-0.72). The DT also demonstrated good discrimination for anxiety (area under the curve [AUC] = 0.83) and depression (AUC = 0.80). The optimal screening cut point on the DT was 4 for anxiety and 5 for depression. CONCLUSIONS: The barometer portion of the DT demonstrates good psychometric properties and clinical utility in caregivers of persons with MS. This is the first examination of the DT in MS care partners.

Characterizing fatigue phenotypes with other symptoms and clinically relevant outcomes among people with multiple sclerosis.

PURPOSE: Fatigue is a common symptom of multiple sclerosis (MS) and can adversely affect all aspect of quality of life. The etiology of fatigue remains unclear, and its treatments are suboptimal. Characterizing the phenotypes of fatigued persons with MS may help advance research on fatigue's etiology and identify ways to personalize fatigue interventions to improve quality of life. The purpose of this study was to identify fatigue phenotypes; examine phenotype stability overtime; and characterize phenotypes by health and function, social and environmental determinants, psychosocial factors, and engagement in healthy behaviors. METHODS: We conducted a longitudinal study over a 3-month period with 289 fatigued participants with MS. To identify fatigue phenotypes and determine transition probabilities, we used latent profile and transition analyses with valid self-report measures of mental and physical fatigue severity, the mental and physical impact of fatigue, depression, anxiety, and sleep quality. We used ANOVAs and effect sizes to characterize differences among phenotypes. RESULTS: The best fitting model included six subgroups of participants: Mild Phenotype, Mild-to-Moderate Phenotype, Moderate-to-Severe Phenotype, Severe Phenotype, Fatigue-dominant Phenotype, and Mental Health-dominant Phenotype. The transition analysis indicated that phenotypic membership was highly stable. Variables with a large eta squared effect size included environmental barriers, self-efficacy, and fatigue catastrophizing. CONCLUSION: These results indicate that the magnitude of fatigue experienced may be more important to consider than the type of fatigue when characterizing fatigue phenotypes. Future research should explore whether tailoring interventions to environmental barriers, self-efficacy, and fatigue catastrophizing reduce the likelihood of transitioning to a more severe phenotype.

Disentangling self-reported fatigue, depression, and cognitive impairment in people with multiple sclerosis.

BACKGROUND: Fatigue is a common problem among people with multiple sclerosis (MS) and can have a negative effect on mental, physical, and social function. Self-reported measures of MS fatigue are often operationalized as a multi-dimensional symptom. However, questions remain about how best to account for the multi-dimensional aspects of self-reported fatigue and whether these aspects are distinct entities. Thus, the purpose of this study was to explore the overlap and distinctions between self-reported measures of the severity and impact of fatigue, between mental and physical fatigue, and between mental fatigue, depressive symptoms, and cognitive impairment. METHODS: An observational study was conducted with 289 participants with MS . The questionnaires were the Unidimensional Fatigue Impact Scale (UFIS), the Chalder Fatigue Scale (CFS), the Fatigue Scale for Motor and Cognitive Functions (FSMC), the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNSQ), and the Quality of Life in Neurological Disorders short form for depression (Neuro-QoL). Spearman's correlation coefficient was used to examine the bivariate correlations between composite and subscale scores. Exploratory structural equation modeling (ESEM) was used to determine the factor structure under a pre-specified number of factors to retain in the modeling of multiple items across questionnaires and examine model fit. Subsequently for poor fitting models in an iterative procedure to determine a better fitting multidimensional model, we posited a bifactor confirmatory factor analysis model. RESULTS: The bivariate correlation analysis revealed that subscales from the same questionnaire measuring different aspects of fatigue had the highest correlations (r = 0.61-0.68), subscales from different questionnaires measuring the same aspect of fatigue had the next highest correlations (r = 0.43-0.60), and subscales from different questionnaires measuring different aspects of fatigue had the lowest correlations (r = 0.34-0.40). Bifactor models with a general fatigue factor and subdomains pertaining to impact, severity, and mental and physical fatigue had relatively good model fits compared to models omitting the subdomains. However, an ESEM model using subscales from the CFS and FSMC fit poorly and did not adequately identify separate factors for mental and physical fatigue. An ESEM model with separate factors for self-reported mental fatigue, depressive symptoms, and cognitive impairment was a good fit. CONCLUSIONS: The working study hypothesis that fatigue constructs would be moderately correlated yet distinct entities was generally supported by the results of the study. However, we found that our hypothesized separation into a latent dimension existed only when the items or subscales came from the same questionnaire, in which case their level of specificity in terms of target, action, context, and time elements for measuring fatigue were consistent. The implications for the principle of compatibility in measuring self-reported MS fatigue are discussed.

Response heterogeneity in a randomized controlled trial of telerehabilitation interventions among adults with multiple sclerosis.

INTRODUCTION: Telerehabilitation may be effective on average but is not equally effective among all people with multiple sclerosis (MS). Thus, the purpose of this secondary analysis of a randomized controlled trial was to explore whether baseline characteristics of participants with MS influence fatigue and physical activity outcomes of three telerehabilitation interventions. METHODS: Participants were randomized to contact-control intervention (CC), physical activity-only intervention (PA-only), and physical activity plus fatigue self-management intervention (FM+). The 12-week interventions were delivered over the phone. Sociodemographic (age and income), clinical (comorbidities, mental function and physical function), psychosocial (self-efficacy, outcome expectations and goal-setting), and behavioural baseline characteristics (step count and fatigue self-management behaviors) were used in a moderated regression analysis and a responder analysis to examine their influence on the Fatigue Impact Scale (FIS) and Godin Leisure-Time Exercise Questionnaire (GLTEQ) at post-test (i.e. immediately post-interventions). RESULTS: No interactions terms were statistically significant in the moderation analysis. However, the responder analysis showed that baseline psychosocial characteristics and mental function were significantly different (p < 0.05) between responders and non-responders. Specifically, non-responders on the FIS at post-test in the PA-only intervention had significantly lower baseline scores in goal setting for engaging in fatigue self-management behaviours. Also, non-responders on the GLTEQ at post-test in the FM+ intervention had significantly worse baseline scores in mental function. DISCUSSION: Further research is needed to understand the complex relationship among baseline characteristics, telerehabilitation and response heterogeneity. We discuss how research on examining response heterogeneity may be advanced by conducting mega-clinical trials, secondary analyses of big data, meta-analyses and employing non-traditional research designs. TRIAL REGISTRATION: Clinicaltrials.gov (NCT01572714).

Predictors of fatigue self-management behaviors in adults with multiple sclerosis.

BACKGROUND: Fatigue is one of the most common and disabling symptoms in people with multiple sclerosis (MS). Fatigue self-management behaviors may be effective in reducing the impact of fatigue in people with MS. However, few studies have examined the factors that influence engagement in fatigue self-management behaviors. OBJECTIVE: Identify factors that directly and indirectly influence fatigue self-management behaviors. METHODS: Participants with MS (n = 287) completed online questionnaires at baseline and 6-weeks. Guided by the Self- and Family Management Framework, we examined the influence of health status, resources and environment, healthcare utilization, and self-management processes on fatigue self-management behaviors at 6-weeks. Multiple regression and path analyses were conducted. RESULTS: The final regression model variables accounted for 41.58% of the variance in fatigue self-management behaviors, which included outcome expectations (ß= 0.287), disability (ß= 0.265), environmental barriers (ß= 0.188), self-efficacy (ß= 0.153), symptom severity (ß= 0.113), living in an urban community (ß= -0.108), and living alone (ß= 0.103). Path analysis indicated that outcome expectations may mediate the relationship between disability levels and fatigue self-management behavior. CONCLUSIONS: Health status (i.e., disability and symptom severity), environmental factors (e.g., living situation), and self-management processes (i.e., self-efficacy and outcome expectations) may play an important role in influencing engagement in fatigue self-management behaviors.

Psychoeducational Interventions for Caregivers of Persons With Multiple Sclerosis: Protocol for a Randomized Trial.

BACKGROUND: Of the approximately 1 million people living with multiple sclerosis in the United States, more than half receive informal, unpaid care or support from family or friends (caregivers). These caregivers report high levels of stress, anxiety, and negative emotions. Few researchers have conducted psychoeducational interventions for these caregivers. OBJECTIVE: This paper presents a protocol for a randomized clinical trial that aims to test the efficacy of two interventions for improving stress, anxiety, depression, and negative emotions for caregivers of persons with multiple sclerosis. METHODS: Participants included any self-identified family or friend caregiver of a person with multiple sclerosis. Data collection began in April 2021 and is expected to continue until November 2021. Participants will be randomized to receive either a website-only or a website-coaching intervention delivered for 6 weeks. Data will be collected at baseline, 6 weeks after baseline (after delivery of intervention), and 6 weeks later. RESULTS: The protocol was approved by the institutional review board of the Case Western Reserve University on January 21, 2021 (protocol 20201484). As of May 2021, 66 participants were enrolled. CONCLUSIONS: Our findings will have implications for identifying the efficacy of two types of interventions developed for caregivers of persons with multiple sclerosis to reduce negative psychological outcomes associated with caregiving. TRIAL REGISTRATION: ClinicalTrials.gov NCT04662008; http://clinicaltrials.gov/ct2/show/NCT04662008. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30617.

REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis.

INTRODUCTION: Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system. It is considered a major cause of non-traumatic disability in young adults. One of the most common and disabling symptoms of MS is fatigue. MS fatigue can impact all aspects of quality of life, including physical, mental and social function. Fortunately, fatigue self-management interventions, such as 'Managing Fatigue: A 6 week energy conservation course', can decrease the impact of fatigue and improve health-related quality of life. The purpose of this study is to compare three modes of delivering the Managing Fatigue intervention-two remote delivery formats (teleconference and internet) and one in-person format-on perceptions of fatigue and its impact on physical, mental and social function. METHODS AND ANALYSIS: A non-inferiority randomised clinical trial is being conducted to compare the three delivery formats (1:1:1 allocation ratio) among 582 participants with MS living in the Midwestern and Northeastern United States. The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale). Outcomes are being measured at baseline, 2 months, 3 months and 6 months. The primary analysis tool will be linear mixed effects model. The prespecified inferiority margin for the primary outcome is 10 points. We will also examine whether baseline characteristics (eg, sociodemographic) moderate outcomes of the Managing Fatigue intervention and whether changes in self-efficacy and fatigue self-management behaviours mediate changes in outcomes. ETHICS AND DISSEMINATION: The protocol is approved centrally by the institutional review board at Case Western Reserve University. Eligible participants give consent before being enrolled and randomised into the study. The study results will be disseminated through relevant advocacy organisations, newsletters to participants, publication in peer-reviewed journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: NCT03550170; Pre-results.

Randomized controlled trial of SystemCHANGE™ weight management intervention in neurological conditions.

OBJECTIVE: This randomized controlled pilot study examined the feasibility and efficacy of a SystemCHANGE™ (SC) weight management intervention in adults with either multiple sclerosis or stroke. METHODS: Participants (n = 61) were randomized into two interventions: SC, which taught skills to modify personal environments, or active-control (AC), which taught health behavior guidelines. Sessions were held weekly for 12 weeks. Feasibility measures included recruitment and attrition rates. The primary outcome of body weight and secondary outcomes of emotional well-being and healthy behaviors were measured before and after the interventions. RESULTS: Average recruitment rate was 3.6 participants per month. Attrition rate was 14.8%. On average, 9.1 sessions were completed for SC and 10.7 for AC. Differences in weight loss were non-significant between interventions (P = 0.182), but significantly declined across both interventions (P = 0.011). Physical activity (P = 0.002), depression (P < 0.001), anxiety (P = 0.023), and self-efficacy (P = 0.022) all significantly improved for SC compared to AC. CONCLUSIONS: SC was feasible to implement and efficacious in improving secondary outcomes of emotional well-being and healthy behaviors, but was not efficacious in improving the primary outcome of weight loss. More research is needed to optimize SC. PRACTICE IMPLICATIONS: SC might be an alternative approach to cognitive-behavioral therapy for promoting emotional well-being and healthy behaviors.

Intervention Mediators in a Randomized Controlled Trial to Increase Physical Activity and Fatigue Self-management Behaviors Among Adults With Multiple Sclerosis.

BACKGROUND: People with multiple sclerosis (MS) often experience fatigue, which is aggravated by inactivity. Identifying mediators of changes in physical activity (PA) and fatigue self-management (FSM) behaviors could optimize future interventions that reduce the impact of MS fatigue. PURPOSE TO: examine the effects of telephone-delivered interventions on Social Cognitive Theory constructs and test whether these constructs mediated secondary outcomes of PA and FSM behaviors. METHODS: Participants with MS (n = 208; Mean age = 52.1; Female = 84.6%) were randomized into contact-control intervention (CC), PA-only intervention, and PA+FSM intervention. Step count (Actigraphy) and FSM behaviors as well as self-efficacy, outcome expectations, and goal setting for PA and FSM were measured at baseline, post-test (12 weeks), and follow-up (24 weeks). Path analyses using bias-corrected bootstrapped 95% confidence intervals (CI) determined whether constructs at post-test mediated behaviors at follow-up when adjusting for baseline measures. RESULTS: Path analysis indicated that PA-only (ß = 0.50, p < .001) and PA+FSM interventions (ß = 0.42, p < .010) had an effect on goal setting for PA, and that PA + FSM intervention had an effect on self-efficacy for FSM (ß = 0.48, p = .011) and outcome expectations for FSM (ß = 0.42, p = .029). Goal setting for PA at post-test mediated the effects of PA-only (ß = 159.45, CI = 5.399, 371.996) and PA + FSM interventions (ß = 133.17, CI = 3.104, 355.349) on step count at follow-up. Outcome expectations for FSM at post-test mediated the effects of PA + FSM intervention on FSM behaviors at follow-up (ß = 0.02, CI = 0.001, 0.058). CONCLUSIONS: Goal setting for PA and outcome expectations for FSM may be important constructs to target in telephone-delivered interventions designed to reduce the impact of MS fatigue. TRIAL REGISTRATION: Clinicaltrials.gov (NCT01572714).

Beyond supervised therapy: Promoting behavioral changes in people with MS.

A critical aspect of many rehabilitation interventions for people with multiple sclerosis (MS) is incorporating strategies that support behavior change. The main purpose of this topical review was to summarize recent randomized clinical trials (RCTs) of rehabilitation interventions in which participants learn and apply skills or engage in healthy behaviors. The Capability, Opportunity, Motivation, and Behavior (COM-B) framework was used to broadly classify behavior-change strategies. The included RCTs varied widely in terms of dosing, delivery format, and types of interventionist. Commonly used behavior-change strategies include education, persuasion, and training. We recommend that researchers and clinicians use frameworks like Behavior Change Wheel and Behavior Change Technique Taxonomy to describe and classify intervention strategies used to promote behavior change. We also recommend more sophisticated RCTs be conducted (e.g. sequential multiple assignment randomized trial and three-arm RCTs) to better understand ways of promoting behavior change in rehabilitation interventions.

Randomized Controlled Trial of a Telephone-Delivered Physical Activity and Fatigue Self-management Interventions in Adults With Multiple Sclerosis.

OBJECTIVE: To compare the effectiveness of telephone-delivered interventions on fatigue, physical activity, and quality of life outcomes in adults with multiple sclerosis (MS). DESIGN: A single-blinded, randomized controlled trial. Participants were randomized to contact-control intervention (CC), physical activity-only intervention (PA-only), and physical activity plus fatigue self-management intervention (FM+). Outcomes were measured at baseline (2wk prerandomization), posttest (14wk postrandomization), and follow-up (26wk postrandomization). SETTING: Telephone-delivered in Midwest and Northeast regions of the United States. PARTICIPANTS: Inactive adults with MS (N=208) and moderate-to-severe fatigue. INTERVENTIONS: Three or 6 group teleconferences followed by 4 individually tailored phone calls delivered during 12 weeks. An occupational therapist and research assistant delivered the teleconferences and tailored phone calls, respectively. MAIN OUTCOME MEASURES: Primary outcomes were self-report fatigue and physical activity measured with the Fatigue Impact Scale and Godin Leisure-Time Exercise Questionnaire, respectively. Secondary outcomes included quality of life measured with the Multiple Sclerosis Impact Scale and moderate-to-vigorous exercise and step count measured with an accelerometer. RESULTS: Linear mixed effects models showed FM+ significantly improved self-reported fatigue (ß=-11.08; P=.03) and physical activity (ß=0.54; P=.01) compared with CC at posttest. However, FM+ had nonsignificant differences compared with PA-only on self-report fatigue (ß=-1.08, P=.84) and physical activity (ß=0.09; P=.68) at posttest. PA-only had significant improvements compared with CC on moderate-to-vigorous exercise (ß=0.38; P=.02) at posttest and step count at posttest (ß=1.30; P<.01) and follow-up (ß=1.31; P=.01) measured with an accelerometer. FM+ and PA-only had nonsignificant differences compared with CC on quality of life. CONCLUSIONS: Group teleconferences followed by tailored phone calls have a small yet statistically significant effect in promoting physical activity and reducing fatigue impact in people with MS.

Two Family Interventions to Reduce BMI in Low-Income Urban Youth: A Randomized Trial.

BACKGROUND: Our primary aim was to evaluate the effects of 2 family-based obesity management interventions compared with a control group on BMI in low-income adolescents with overweight or obesity. METHODS: In this randomized clinical trial, 360 urban-residing youth and a parent were randomly assigned to 1 of 2 behaviorally distinct family interventions or an education-only control group. Eligible children were entering the sixth grade with a BMI ≥85th percentile. Interventions were 3 years in length; data were collected annually for 3 years. Effects of the interventions on BMI slope (primary outcome) over 3 years and a set of secondary outcomes were assessed. RESULTS: Participants were primarily African American (77%), had a family income of <25 000 per year, and obese at enrollment (68%). BMI increased over time in all study groups, with group increases ranging from 0.95 to 1.08. In an intent-to-treat analysis, no significant differences were found in adjusted BMI slopes between either of the family-based interventions and the control group (P = .35). No differences were found between the experimental and control groups on secondary outcomes of diet, physical activity, sleep, perceived stress, or cardiometabolic factors. No evidence of effect modification of the study arms by sex, race and/or ethnicity, household income, baseline levels of child and parent obesity, or exposure to a school fitness program were found. CONCLUSIONS: In this low-income, adolescent population, neither of the family-based interventions improved BMI or health-related secondary outcomes. Future interventions should more fully address poverty and other social issues contributing to childhood obesity.

Wellness and multiple sclerosis: The National MS Society establishes a Wellness Research Working Group and research priorities.

BACKGROUND: People with multiple sclerosis (MS) have identified "wellness" and associated behaviors as a high priority based on "social media listening" undertaken by the National MS Society (i.e. the Society). OBJECTIVE: The Society recently convened a group that consisted of researchers with experience in MS and wellness-related research, Society staff members, and an individual with MS for developing recommendations regarding a wellness research agenda. METHOD: The members of the group engaged in focal reviews and discussions involving the state of science within three approaches for promoting wellness in MS, namely diet, exercise, and emotional wellness. RESULTS: That process informed a group-mediated activity for developing and prioritizing research goals for wellness in MS. This served as a background for articulating the mission and objectives of the Society's Wellness Research Working Group. CONCLUSION: The primary mission of the Wellness Research Working Group is the provision of scientific evidence supporting the application of lifestyle, behavioral, and psychosocial approaches for promoting optimal health of mind, body, and spirit (i.e. wellness) in people with MS as well as managing the disease and its consequences.

Using mHealth Technology in a Self-Management Intervention to Promote Physical Activity Among Adults With Chronic Disabling Conditions: Randomized Controlled Trial.

BACKGROUND: Physical activity is considered a comprehensive approach for managing limitations in physical function among adults with chronic disabling conditions. However, adults with chronic disabling conditions often face many barriers to engaging in physical activity. A strategy to promote physical activity among adults with chronic disabling conditions is to encourage the use of mobile health (mHealth) apps. OBJECTIVE: The objective of this pilot study was to examine the potential benefits of using commercially available mHealth apps in a self-management intervention among 46 adults with musculoskeletal or neurological conditions. METHODS: Participants were randomized to one of 3 intervention groups: (1) mHealth-based self-management intervention, (2) paper-based self-management intervention, and (3) contact-control intervention. Participants in all 3 groups met in person once and received 3 follow-up phone calls with a trained graduate assistant. Participants in the mHealth-based and paper-based groups received a computer tablet or a paper diary, respectively, to facilitate goal setting, self-monitoring, and action planning. Participants in the contact-control group received information on healthy behaviors without being taught skills to change behaviors. The following outcomes were measured at baseline and at the 7th week: physical activity (Physical Activity and Disability Survey-revised), psychosocial factors (self-efficacy, self-regulation, and social support), and physical function (Patient Report Outcomes Measurement Information System, 6-min walk test, 1-min chair stands, and 1-min arm curls). RESULTS: Repeated-measures multivariate analysis of variance (MANOVA) indicated significant differences between groups in physical activity levels (Wilks λ=0.71, F6,76=2.34, P=.04). Both the mHealth-based and paper-based groups had large effect size increases in planned exercise and leisure-time physical activity compared with the contact-control group (Cohen d=1.20 and d=0.82, respectively). Repeated-measures MANOVA indicated nonsignificant differences between groups in psychosocial factors (Wilks λ=0.85, F6,76=1.10, P=.37). However, both the mHealth-based and paper-based groups had moderate effect size improvements in self-efficacy (d=0.48 and d=0.75, respectively) and self-regulation (d=0.59 and d=0.43, respectively) compared with the contact-control group. Repeated-measures MANOVA indicated nonsignificant differences between groups in physical function (Wilks λ=0.94, F8,66=0.27, P=.97). There were small and nonsignificant changes between the mHealth-based and paper-based groups with regard to most outcomes. However, the mHealth-based group had moderate effect size increases (d=0.47) in planned exercise and leisure-time physical activity compared with the paper-based group. CONCLUSIONS: We found that using commercially available mHealth apps in a self-management intervention shows promise in promoting physical activity among adults with musculoskeletal and neurological conditions. Further research is needed to identify the best ways of using commercially available mobile apps in self-management interventions. TRIAL REGISTRATION: Clinicaltrials.gov NCT02833311; https://clinicaltrials.gov/ct2/show/NCT02833311 (Archived by WebCite at http://www.webcitation.org/6vDVSAw1w).

A mixed methods study of multiple health behaviors among individuals with stroke.

BACKGROUND: Individuals with stroke often have multiple cardiovascular risk factors that necessitate promoting engagement in multiple health behaviors. However, observational studies of individuals with stroke have typically focused on promoting a single health behavior. Thus, there is a poor understanding of linkages between healthy behaviors and the circumstances in which factors, such as stroke impairments, may influence a single or multiple health behaviors. METHODS: We conducted a mixed methods convergent parallel study of 25 individuals with stroke to examine the relationships between stroke impairments and physical activity, sleep, and nutrition. Our goal was to gain further insight into possible strategies to promote multiple health behaviors among individuals with stroke. This study focused on physical activity, sleep, and nutrition because of their importance in achieving energy balance, maintaining a healthy weight, and reducing cardiovascular risks. Qualitative and quantitative data were collected concurrently, with the former being prioritized over the latter. Qualitative data was prioritized in order to develop a conceptual model of engagement in multiple health behaviors among individuals with stroke. Qualitative and quantitative data were analyzed independently and then were integrated during the inference stage to develop meta-inferences. The 25 individuals with stroke completed closed-ended questionnaires on healthy behaviors and physical function. They also participated in face-to-face focus groups and one-to-one phone interviews. RESULTS: We found statistically significant and moderate correlations between hand function and healthy eating habits (r = 0.45), sleep disturbances and limitations in activities of daily living (r =  - 0.55), BMI and limitations in activities of daily living (r =  - 0.49), physical activity and limitations in activities of daily living (r = 0.41), mobility impairments and BMI (r =  - 0.41), sleep disturbances and physical activity (r =  - 0.48), sleep disturbances and BMI (r = 0.48), and physical activity and BMI (r =  - 0.45). We identified five qualitative themes: (1) Impairments: reduced autonomy, (2) Environmental forces: caregivers and information, (3) Re-evaluation: priorities and attributions, (4) Resiliency: finding motivation and solutions, and (5) Negative affectivity: stress and self-consciousness. Three meta-inferences and a conceptual model described circumstances in which factors could influence single or multiple health behaviors. DISCUSSION: This is the first mixed methods study of individuals with stroke to elaborate on relationships between multiple health behaviors, BMI, and physical function. A conceptual model illustrates addressing sleep disturbances, activity limitations, self-image, and emotions to promote multiple health behaviors. We discuss the relevance of the meta-inferences in designing multiple behavior change interventions for individuals with stroke.