Goals for Reaching Optimal Wellness (GROWell): A clinical trial protocol of a digital dietary intervention for pregnant and postpartum people with prenatal overweight or obesity.

BACKGROUND: Excess gestational weight gain (EGWG) is associated with multiple pregnancy complications and health risks for birthing people and their infants. Likewise, postpartum weight retention (PPWR), or not losing all pregnancy weight, has long-term health consequences. EGWG among people who enter pregnancy with overweight or obesity have worse obstetric outcomes and increased PPWR compared to women who gain within Institute of Medicine guidelines. METHODS: This study protocol describes the details of a blinded, randomized clinical trial of GROWell: Goals for Reaching Optimal Wellness, a mHealth tool designed to improve diet quality among people who enter pregnancy with overweight or obese BMIs to help them achieve appropriate GWG and safe postpartum pregnancy weight loss. Individuals with overweight and obesity will be randomly assigned to an attention control or intervention arm. The intervention group will receive personalized, goal-oriented text messages regarding dietary choices, while the attention control group will receive text messages about healthy pregnancy, labor, delivery, and early infancy. Both groups will complete online surveys at baseline, follow up, 3 and 6 months postpartum. RESULTS AND DISCUSSION: Currently, 162 subjects have been enrolled. Outcomes associated with GWG and pregnancy are expected in late 2023, while outcomes on postpartum weight retention GROWell adherence are expected in late 2024. The results of this trial will support the use of an evidence-based mHealth tool to be integrated into clinical practice to reduce EGWG and PPWR among pregnant people with overweight and obese BMIs, a resource that is currently lacking. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04449432. Registered on June 26, 2020.

Perceptions of Exercise and Its Challenges in Patients With Nonalcoholic Fatty Liver Disease: A Survey-Based Study.

Exercise is a foundational treatment for nonalcoholic fatty liver disease (NAFLD); however, the majority of patients are unable to initiate and maintain effective exercise habits and remain at increased risk for progressive liver disease. Barriers and limitations to exercise in patients with NAFLD have not been fully identified. We performed a single survey of 94 patients with biopsy-proven NAFLD to understand baseline physical activity and sedentary behavior, self-perceived fitness, limitations to exercise, potential solutions to increase physical activity behavior, and perception of exercise as a foundational treatment for NAFLD. For exploratory analyses, we evaluated differences in responses to the survey by grouping severity of hepatic fibrosis as follows: nonalcoholic fatty liver (NAFL); early stage (nonalcoholic steatohepatitis [NASH] F0, NASH F1, NASH F2); and late stage (NASH F3, NASH F4). Zero weekly total physical activity was reported by 29% of patients with NAFLD. Late-stage NASH had significantly lower vigorous (P = 0.024), walking (P = 0.029), total weekly activity (P = 0.043), and current fitness level (P = 0.022) compared to early stage NASH. Overall, 72% of patients with NAFLD reported limitations to exercise, with the greatest proportion citing lack of energy (62%), fatigue (61%), prior/current Injury (50%), and shortness of breath (49%). A preference for personal training to increase their physical activity was indicated by 66% of patients with NAFLD, and 63% preferred exercise over medication to treat NAFLD. Conclusion: The majority of patients with NAFLD have limitations to exercise but prefer exercise as a treatment option for NAFLD in the form of personal training. Patients with NAFLD may have unique physiologic limitations to exercise that worsen with fibrosis severity. Exercise interventions or services that are personalized and scalable may improve sustainability of exercise habits in the long term.

Feasibility, acceptability, and potential effectiveness of an online expressive writing intervention for COVID-19 resilience.

BACKGROUND & PURPOSE: The COVID-19 pandemic has negatively impacted mental health in the general population. In this trial, our objective was to assess whether a 6-week expressive writing intervention improves resilience in a sample from the general population in the midst of the COVID-19 pandemic. MATERIALS & METHODS: This 6-week trial was conducted online. Eligible participants (n=63) were a sample of adults who self-identified as having been significantly affected by the COVID-19 pandemic. PRIMARY OUTCOME: Connor-Davidson Resilience Scale (CD-RISC). SECONDARY OUTCOMES: Perceived Stress Scale - 10-Item (PSS-10); Center for Epidemiologic Studies Depression Scale - Revised (CESD-R); Post-Traumatic Growth Inventory (PTGI). RESULTS: Resilience measures (CD-RISC) increased from baseline (66.6 ± 14.9) to immediately post-intervention (73.0 ± 12.4; p=0.014; Cohen's d =0.31), and at a 1- month follow-up (72.9 ± 13.6; p=0.024; Cohen's d =0.28). Across the same timepoints, perceived stress scores (PSS-10) decreased from baseline (21.8 ± 6.6) to immediately post-intervention (18.3 ± 7.0; p=0.008; Cohen's d =0.41), and at the 1- month follow-up to (16.8 ± 6.7; p=0.0002; Cohen's d =0.56). Depression symptoms (CESD-R) decreased from baseline (23.3 ± 15.3) at 6 weeks (17.8 ± 15.4; p=0.058; Cohen's d =0.22), and 10 weeks (15.5 ± 12.7; p=0.004; Cohen's d =0.38). Posttraumatic growth (PTGI) increased from baseline (41.7 ± 23.4) at 6 weeks (55.8 ± 26.4; p=0.004; Cohen's d =0.44), and at the 1-month follow-up (55.9 ± 29.3; p=0.008; Cohen's d =0.49). CONCLUSION: An online expressive writing intervention was effective at improving resilience in the midst of the COVID-19 pandemic. NCT#: NCT04589104.

Expressive writing to improve resilience to trauma: A clinical feasibility trial.

BACKGROUND AND PURPOSE: Trauma is highly prevalent, with estimates that up to 90% of the U.S. population have been exposed to a traumatic event. The adverse health consequences of trauma exposure are diverse and often long-lasting. While expressive writing has been shown to improve emotional and physical health in numerous populations, the feasibility and potential effectiveness of a novel expressive writing program provided in a clinical setting to improve resilience is unknown. Our objective was to determine the feasibility and potential effectiveness of a 6-week expressive writing course provided in a clinical setting to improve resilience in individuals with a history of trauma. MATERIALS AND METHODS: This prospective, observational trial of a 6-week expressive writing intervention (Transform Your Life: Write to Heal) was conducted in an academic outpatient integrative clinic. Eligible participants were a self-referred sample of 39 English-speaking adults who identified as having had a trauma, or significant emotional/physical upheaval, within the past year. Main outcome measures included: Feasibility: Enrollment, Retention in Program and Trial, Adherence. Acceptability: Adverse Events; Participant Ratings. Primary Psychological Outcome: Connor-Davidson Resilience Scale (CD-RISC). Secondary Psychological Outcomes: Perceived Stress Scale - 10 item (PSS-10); Center for Epidemiologic Studies Depression Scale (CES-D); Rumination Response Scale (RRS). RESULTS: All measures of feasibility including those related to enrollment, retention, and adherence support feasibility. All measures of acceptability including adverse events and participant ratings support the intervention as being safe, well-received and personally valuable. Resilience scores increased from baseline (64.3 ±â€¯14.40) to post-intervention (74.2 ±â€¯13.15), t(37) = 4.61, p < 0.0005; Cohen's d = 0.75. In addition, across the same period, Perceived Stress scores decreased close to a standard deviation (20.5 ±â€¯7.43 to 14.3 ±â€¯6.64), t(37) = -4.71, p < 0.0005, Cohen's d = 0.76; depression symptoms decreased (from 19.0 ±â€¯13.48 to 12.7 ±â€¯11.68), t(37) = -3.21, p = 0.003, Cohen's d = 0.52; and rumination scores decreased from 48.5 ±â€¯12.56 to 39.8 ±â€¯10.07), t(37) = -5.03, p < 0.0005, Cohen's d = 0.82. Effect sizes ranged from medium to large. CONCLUSION: The Transform Your Life: Write to Heal program is feasible to offer in a clinical setting, was well-received by participants, and demonstrated preliminary findings of effectiveness. Our study suggests that this novel 6-week writing intervention including expressive, transactional, poetic, affirmative, legacy, and mindful writing prompts increases resilience, and decreases depressive symptoms, perceived stress, and rumination in an outpatient sample of those reporting trauma in the past year. The program appears suitable to be evaluated in a larger randomized controlled trial.

Efficacy and Safety of Massage for Osteoarthritis of the Knee: a Randomized Clinical Trial.

BACKGROUND: Current treatment options for knee osteoarthritis have limited effectiveness and potentially adverse side effects. Massage may offer a safe and effective complement to the management of knee osteoarthritis. OBJECTIVE: Examine effects of whole-body massage on knee osteoarthritis, compared to active control (light-touch) and usual care. DESIGN: Multisite RCT assessing the efficacy of massage compared to light-touch and usual care in adults with knee osteoarthritis, with assessments at baseline and weeks 8, 16, 24, 36, and 52. Subjects in massage or light-touch groups received eight weekly treatments, then were randomized to biweekly intervention or usual care to week 52. The original usual care group continued to week 24. Analysis was performed on an intention-to-treat basis. PARTICIPANTS: Five hundred fifty-one screened for eligibility, 222 adults with knee osteoarthritis enrolled, 200 completed 8-week assessments, and 175 completed 52-week assessments. INTERVENTION: Sixty minutes of protocolized full-body massage or light-touch. MAIN MEASURES: Primary: Western Ontario and McMaster Universities Arthritis Index. Secondary: visual analog pain scale, PROMIS Pain Interference, knee range of motion, and timed 50-ft walk. KEY RESULTS: At 8 weeks, massage significantly improved WOMAC Global scores compared to light-touch (- 8.16, 95% CI = - 13.50 to - 2.81) and usual care (- 9.55, 95% CI = - 14.66 to - 4.45). Additionally, massage improved pain, stiffness, and physical function WOMAC subscale scores compared to light-touch (p < 0.001; p = 0.04; p = 0.02, respectively) and usual care (p < 0.001; p = 0.002; p = 0.002; respectively). At 52 weeks, the omnibus test of any group difference in the change in WOMAC Global from baseline to 52 weeks was not significant (p = 0.707, df = 3), indicating no significant difference in change across groups. Adverse events were minimal. CONCLUSIONS: Efficacy of symptom relief and safety of weekly massage make it an attractive short-term treatment option for knee osteoarthritis. Longer-term biweekly dose maintained improvement, but did not provide additional benefit beyond usual care post 8-week treatment. TRIAL REGISTRATION: clinicaltrials.gov NCT01537484.

Complementary Therapies for Significant Dysfunction from Tinnitus: Treatment Review and Potential for Integrative Medicine.

Tinnitus is a prevalent and costly chronic condition; no universally effective treatment exists. Only 20% of patients who report tinnitus actually seek treatment, and when treated, most patients commonly receive sound-based and educational (SBE) therapy. Additional treatment options are necessary, however, for nonauditory aspects of tinnitus (e.g., anxiety, depression, and significant interference with daily life) and when SBE therapy is inefficacious or inappropriate. This paper provides a comprehensive review of (1) conventional tinnitus treatments and (2) promising complementary therapies that have demonstrated some benefit for severe dysfunction from tinnitus. While there has been no systematic study of the benefits of an Integrative Medicine approach for severe tinnitus, the current paper reviews emerging evidence suggesting that synergistic combinations of complementary therapies provided within a whole-person framework may augment SBE therapy and empower patients to exert control over their tinnitus symptoms without the use of medications, expensive devices, or extended programs.

Patient engagement as a risk factor in personalized health care: a systematic review of the literature on chronic disease.

BACKGROUND: The role of patient engagement as an important risk factor for healthcare outcomes has not been well established. The objective of this article was to systematically review the relationship between patient engagement and health outcomes in chronic disease to determine whether patient engagement should be quantified as an important risk factor in health risk appraisals to enhance the practice of personalized medicine. METHODS: A systematic review of prospective clinical trials conducted between January 1993 and December 2012 was performed. Articles were identified through a medical librarian-conducted multi-term search of Medline, Embase, and Cochrane databases. Additional studies were obtained from the references of meta-analyses and systematic reviews on hypertension, diabetes, and chronic care. Search terms included variations of the following: self-care, self-management, self-monitoring, (shared) decision-making, patient education, patient motivation, patient engagement, chronic disease, chronically ill, and randomized controlled trial. Studies were included only if they: (1) compared patient engagement interventions to an appropriate control among adults with chronic disease aged 18 years and older; (2) had minimum 3 months between pre- and post-intervention measurements; and (3) defined patient engagement as: (a) understanding the importance of taking an active role in one's health and health care; (b) having the knowledge, skills, and confidence to manage health; and (c) using knowledge, skills and confidence to perform health-promoting behaviors. Three authors and two research assistants independently extracted data using predefined fields including quality metrics. RESULTS: We reviewed 543 abstracts to identify 10 trials that met full inclusion criteria, four of which had 'high' methodological quality (Jadad score ≥ 3). Diverse measurement of patient engagement prevented robust statistical analyses, so data were qualitatively described. Nine studies documented improvements in patient engagement. Five studies reported reduction in clinical markers of disease (for example HbA1C). All studies reported improvements in self-reported health status. CONCLUSIONS: This review suggests patient engagement should be quantified as part of a comprehensive health risk appraisal given its apparent value in helping individuals to effectively self-manage chronic disease. Patient engagement measures should include assessment of the knowledge, confidence and skills to prevent and manage chronic disease, plus the behaviors to do so.

A Systematic Review of the Literature on Health and Wellness Coaching: Defining a Key Behavioral intervention in Healthcare.

PRIMARY OBJECTIVE: Review the operational definitions of health and wellness coaching as published in the peer-reviewed medical literature. BACKGROUND: As global rates of preventable chronic diseases have reached epidemic proportions, there has been an increased focus on strategies to improve health behaviors and associated outcomes. One such strategy, health and wellness coaching, has been inconsistently defined and shown mixed results. METHODS: A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-guided systematic review of the medical literature on health and wellness coaching allowed for compilation of data on specific features of the coaching interventions and background and training of coaches. RESULTS: Eight hundred abstracts were initially identified through PubMed, with 284 full-text articles ultimately included. The majority (76%) were empirical articles. The literature operationalized health and wellness coaching as a process that is fully or partially patient-centered (86% of articles), included patient-determined goals (71%), incorporated self-discovery and active learning processes (63%) (vs more passive receipt of advice), encouraged accountability for behaviors (86%), and provided some type of education to patients along with using coaching processes (91%). Additionally, 78% of articles indicated that the coaching occurs in the context of a consistent, ongoing relationship with a human coach who is trained in specific behavior change, communication, and motivational skills. CONCLUSIONS: Despite disparities in how health and wellness coaching have been operationalized previously, this systematic review observes an emerging consensus in what is referred to as health and wellness coaching; namely, a patient-centered process that is based upon behavior change theory and is delivered by health professionals with diverse backgrounds. The actual coaching process entails goal-setting determined by the patient, encourages self-discovery in addition to content education, and incorporates mechanisms for developing accountability in health behaviors. With a clear definition for health and wellness coaching, robust research can more accurately assess the effectiveness of the approach in bringing about changes in health behaviors, health outcomes and associated costs that are targeted to reduce the global burden of chronic disease.