Engagement, Acceptability, and Effectiveness of the Self-Care and Coach-Supported Versions of the Vira Digital Behavior Change Platform Among Young Adults at Risk for Depression and Obesity: Pilot Randomized Controlled Trial.

BACKGROUND: Adolescence and early adulthood are pivotal stages for the onset of mental health disorders and the development of health behaviors. Digital behavioral activation interventions, with or without coaching support, hold promise for addressing risk factors for both mental and physical health problems by offering scalable approaches to expand access to evidence-based mental health support. OBJECTIVE: This 2-arm pilot randomized controlled trial evaluated 2 versions of a digital behavioral health product, Vira (Ksana Health Inc), for their feasibility, acceptability, and preliminary effectiveness in improving mental health in young adults with depressive symptoms and obesity risk factors. METHODS: A total of 73 participants recruited throughout the United States were randomly assigned to use Vira either as a self-guided product (Vira Self-Care) or with support from a health coach (Vira+Coaching) for 12 weeks. The Vira smartphone app used passive sensing of behavioral data related to mental health and obesity risk factors (ie, activity, sleep, mobility, and language patterns) and offered users personalized insights into patterns of behavior associated with their daily mood. Participants completed self-reported outcome measures at baseline and follow-up (12 weeks). All study procedures were completed via digital communications. RESULTS: Both versions of Vira showed strong user engagement, acceptability, and evidence of effectiveness in improving mental health and stress. However, users receiving coaching exhibited more sustained engagement with the platform and reported greater reductions in depression (Cohen d=0.45, 95% CI 0.10-0.82) and anxiety (Cohen d=0.50, 95% CI 0.13-0.86) compared to self-care users. Both interventions also resulted in reduced stress (Vira+Coaching: Cohen d=-1.05, 95% CI -1.57 to --0.50; Vira Self-Care: Cohen d=-0.78, 95% CI -1.33 to -0.23) and were perceived as useful and easy to use. Coached users also reported reductions in sleep-related impairment (Cohen d=-0.51, 95% CI -1.00 to -0.01). Moreover, participants increased their motivation for and confidence in making behavioral changes, with greater improvements in confidence among coached users. CONCLUSIONS: An app-based intervention using passive mobile sensing to track behavior and deliver personalized insights into behavior-mood associations demonstrated feasibility, acceptability, and preliminary effectiveness for reducing depressive symptoms and other mental health problems in young adults. Future directions include (1) optimizing the interventions, (2) conducting a fully powered trial that includes an active control condition, and (3) testing mediators and moderators of outcome effects. TRIAL REGISTRATION: ClinicalTrials.gov NCT05638516; https://clinicaltrials.gov/study/NCT05638516.

A Cluster-Randomized Study of Technology-Assisted Health Coaching for Weight Management in Primary Care.

PURPOSE: We undertook a trial to test the efficacy of a technology-assisted health coaching intervention for weight management, called Goals for Eating and Moving (GEM), within primary care. METHODS: This cluster-randomized controlled trial enrolled 19 primary care teams with 63 clinicians; 9 teams were randomized to GEM and 10 to enhanced usual care (EUC). The GEM intervention included 1 in-person and up to 12 telephone-delivered coaching sessions. Coaches supported goal setting and engagement with weight management programs, facilitated by a software tool. Patients in the EUC arm received educational handouts. We enrolled patients who spoke English or Spanish, were aged 18 to 69 years, and either were overweight (body mass index 25-29 kg/m2) with a weight-related comorbidity or had obesity (body mass index ≥30 kg/m2). The primary outcome (weight change at 12 months) and exploratory outcomes (eg, program attendance, diet, physical activity) were analyzed according to intention to treat. RESULTS: We enrolled 489 patients (220 in the GEM arm, 269 in the EUC arm). Their mean (SD) age was 49.8 (12.1) years; 44% were male, 41% Hispanic, and 44% non-Hispanic Black. At 12 months, the mean adjusted weight change (standard error) was -1.4 (0.8) kg in the GEM arm vs -0.8 (1.6) kg in the EUC arm, a nonsignificant difference (P = .48). There were no statistically significant differences in secondary outcomes. Exploratory analyses showed that the GEM arm had a greater change than the EUC arm in mean number of weekly minutes of moderate to vigorous physical activity other than walking, a finding that may warrant further exploration. CONCLUSIONS: The GEM intervention did not achieve clinically important weight loss in primary care. Although this was a negative study possibly affected by health system resource limitations and disruptions, its findings can guide the development of similar interventions. Future studies could explore the efficacy of higher-intensity interventions and interventions that include medication and bariatric surgery options, in addition to lifestyle modification.

Administrative Analysis of the Home-Based Older Persons Upstreaming Prevention Physical Therapy Program: A Pilot Observational Study.

Introduction Traditionally, physical therapist (PT) services do not commence until an injury, fall, or health issue has already occurred although there is increasing evidence that preventative programs administered by PTs may decrease the fall risk among elderly individuals. The purpose of this study was to examine billing, reimbursement, and administrative outcomes of the previously established and investigated prevention-based screening and intervention HOP-UP-PT (Home-based Older Persons Upstreaming Prevention-Physical Therapy) program delivered by a physical therapist in the home of older adults after being referred by a community partner. A randomized controlled trial of the HOP-UP-PT program demonstrated an 8-fold reduction in falls for participants at moderate and high fall risk compared to those who did not participate in the program. Methods A prospective observational study was performed to examine administrative and payment outcomes of HOP-UP-PT participation. Participants were referred into the HOP-UP-PT program via a local community center. Physician authorization for physical therapy participation was obtained for each participant as required for payment under United States' Center for Medicare and Medicaid Services (CMS) guidelines. The HOP-UP-PT program is preventative physical therapy delivered in the person's home with five in person visits (approximately one per month) followed by a monthly telehealth visit and a final in-person visit. Interventions included a balance program, home safety recommendations, health coaching, and addressing individual risks of falling or becoming homebound. A retrospective analysis was performed on the administrative and insurance payment data from this study which was then analyzed descriptively. Results Six participants with four different insurances completed the 7-month program (mean age=77 years) in 2021. The physical therapy visits were submitted to the participants' Medicare Part B plan. One participant's physical therapy visits were not submitted for payment as the health system did not have an active agreement with that health insurer. Due to the unclear status of telehealth visits in 2021, these services were not submitted to the insurance company for payment. All other PT visits were paid by the insurance companies. The mean amount paid for the initial evaluation code was $102.83 and the mean payment for the ~15 minute treatment codes was $25.90 per unit. Initial pilot data demonstrated a potential for a 4.2% positive operating margin when considering salary costs and travel. The mean delay from the initial referral into the HOP-UP-PT program until the physician provided written authorization for physical therapy was 69.7 days. Conclusion This study demonstrated initial evidence that payment for prevention-focused outpatient physical therapist services delivered in the home was feasible, however delays and costs in procuring physician authorization was a substantial barrier to prevention-focused physical therapy. A 4.2% operating margin demonstrated that, when efficiently operated, similar programs are likely to be viable. Furthermore, if telehealth services would have been paid, the operating margin was estimated to increase to 32%. Physical therapists are highly qualified to deliver efficient, effective preventative services which has the potential to reduce falls and institutionalization and subsequent healthcare cost savings.

Prescription Digital Therapeutics for Substance Use Disorder in Primary Care: Mixed Methods Evaluation of a Pilot Implementation Study.

BACKGROUND: Delivering prescription digital therapeutics (ie, evidence-based interventions designed to treat, manage, or prevent disorders via websites or smartphone apps) in primary care could increase patient access to substance use disorder (SUD) treatments. However, the optimal approach to implementing prescription digital therapeutics in primary care remains unknown. OBJECTIVE: This pilot study is a precursor to a larger trial designed to test whether implementation strategies (practice facilitation [PF] and health coaching [HC]) improve the delivery of prescription digital therapeutics for SUDs in primary care. This mixed methods study describes outcomes among patients in the 2 pilot clinics and presents qualitative findings on implementation. METHODS: From February 10 to August 6, 2021, a total of 3 mental health specialists embedded in 2 primary care practices of the same integrated health system were tasked with offering app-based prescription digital therapeutics to patients with SUD. In the first half of the pilot, implementation activities included training and supportive tools. PF (at 1 clinic) and HC (at 2 clinics) were added in the second half. All study analyses relied on secondary data, including electronic health records and digital therapeutic vendor data. Primary outcomes were the proportion of patients reached by the prescription digital therapeutics and fidelity related to ideal use. We used qualitative methods to assess the adherence to planned activities and the barriers and facilitators to implementing prescription digital therapeutics. RESULTS: Of all 18 patients prescribed the apps, 10 (56%) downloaded the app and activated their prescription, and 8 (44%) completed at least 1 module of content. Patients who activated the app completed 1 module per week on average. Ideal use (fidelity) was defined as completing 4 modules per week and having a monthly SUD-related visit; 1 (6%) patient met these criteria for 10 weeks (of the 12-week prescription period). A total of 5 (28%) patients had prescriptions while HC was available, 2 (11%) were successfully contacted, and both declined coaching. Clinicians reported competing clinical priorities, technical challenges, and logistically complex workflows in part because the apps required a prescription. Some pilot activities were impacted by staff turnover that coincided with the COVID-19 pandemic. The facilitators to implementation were high engagement and the perception that the apps could meet patient needs. CONCLUSIONS: The pilot study encountered the barriers to implementing prescription digital therapeutics in a real-world primary care setting, especially staffing shortages, turnover, and competing priorities for clinic teams. The larger randomized trial will clarify the extent to which PF and HC improve the implementation of digital therapeutics. TRIAL REGISTRATION: ClinicalTrials.gov NCT04907045; https://clinicaltrials.gov/study/NCT04907045.

A community health-coaching referral program following discharge from treatment for chronic low back pain - a qualitative study of the patient's perspective.

BACKGROUND: Global policy and guidelines for low back pain (LBP) management promote physical activity and self-management yet adherence is poor and a decline in outcomes is common following discharge from treatment. Health coaching is effective at improving exercise adherence, self-efficacy, and social support in individuals with chronic conditions, and may be an acceptable, cost-effective way to support people in the community following discharge from treatment for LBP. AIM: This qualitative study aimed to understand which aspects of a community over-the-phone health-coaching program, were liked and disliked by patients as well as their perceived outcomes of the service after being discharged from LBP treatment. METHODS: A purposive sampling approach was used to recruit 12 participants with chronic LBP, from a large randomised controlled trial, who were randomly allocated to receive a health coaching program from the Get Healthy Service® in Australia. Semi-structured interviews were conducted, and a general inductive thematic analysis approach was taken. RESULTS: The main themes uncovered regarding the intervention included the positive and negative aspects of the health coaching service and the relationship between the participant and health coach. Specifically, the participants spoke of the importance of the health coach, the value of goal setting, the quality of the advice received, the benefits of feeling supported, the format of the coaching service, and LBP-specific knowledge. They also reported the health coach and the coaching relationship to be the primary factors influencing the program outcomes and the qualities of the coaching relationship they valued most were connection, communication, care, and competence. The sub-themes uncovered regarding the outcomes of the intervention included positive impacts (a greater capacity to cope, increased confidence, increased motivation and increased satisfaction) and negative impacts (receiving no personal benefit). CLINICAL IMPLICATIONS: In an environment where self-management and self-care are becoming increasingly important, understanding the patient's experience as part of a coaching program is likely to lead to improved quality of health coaching care, more tailored service delivery and potentially more effective and cost-effective community-based care for individuals with chronic LBP in the community after being discharged from treatment. TRIAL REGISTRATION: The GBTH trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000889954) on 10/9/2020. Ethical approval was prospectively granted by the Western Sydney Local Health District Human Research and Ethics Committee (2020/ETH00115). Written informed consent was obtained from all participants. The relevant sponsor has reviewed the study protocol and consent form.

A nurse coaching intervention to improve support to individuals living with ALS.

OBJECTIVE: Health coaching may supplement the multidisciplinary ALS clinic model to facilitate patient-centered health behavior change. The aim of this study was to determine the effects of nurse health coaching (NHC) on the quality of life and self-efficacy of individuals living with ALS. METHODS: Twenty-nine participants were randomized at 1:1 to the standard of care and coaching arms. All participants attended multidisciplinary ALS clinic visits quarterly, at which times they completed assessments of quality of life and self-efficacy. Those in the coaching arm participated in monthly coaching with a nurse coach over 12 months. The coaching sessions utilized motivational interviewing to identify personal goals along with barriers and solutions to achieve them. Linear mixed-effect models were used to quantify the effect of coaching on quality of life and self-efficacy outcomes. Thematic analysis was performed to summarize the participants' experiences with coaching. RESULTS: Adherence to the coaching intervention was good. No effects of coaching were observed on the primary outcomes of quality of life and self-efficacy, although debriefed participants reported that they would recommend it to others. Patients and caregivers reflected on the impacts of coaching that extended beyond the pre-defined study outcomes and measures put in place to gauge effectiveness. CONCLUSIONS: The elicited qualitative themes illustrating patient experience of coaching demonstrate the utility of nurse coaching as an important adjunct support to complement the multidisciplinary ALS clinic model.

Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for Young Adult Cancer Survivors: Design and Methods of Opt2Move Full Factorial Trial.

Background: Opt2Move is a theory-guided moderate and vigorous physical activity (MVPA) promotion trial that uses multiphase optimization strategy (MOST) methodology to evaluate the individual and combined effects of four intervention components in a full factorial experiment among young adult cancer survivors (YACS; N = 304). All participants will receive the core mHealth MVPA intervention, which includes a Fitbit and standard self-monitoring Opt2Move smartphone application. YACS will be randomized to one of 16 conditions to receive between zero and four additional components each with two levels (yes v. no): E-Coach, buddy, general mindfulness, and MVPA-specific mindfulness. Objective: The primary aim is to determine the individual and combined effects of the components on MVPA post-intervention (12-weeks) and at 24-week follow-up. The secondary aim is to examine how changes in MVPA are associated with patient-reported outcomes, light-intensity activity, sedentary time, and sleep duration and quality. Potential mediators and moderators of component effects will also be examined. Results: Results will support the selection of a package of intervention components optimized to maximize MVPA to be tested in a randomized controlled trial. Conclusion: Opt2Move represents the first systematic effort to use MOST to design an optimized, scalable mHealth MVPA intervention for YACS and will lead to an improved understanding of how to effectively change YACS' MVPA and ultimately, improve health and disease outcomes.

A Rubric to Assess the Design and Intervention Quality of Randomized Controlled Trials in Health and Wellness Coaching.

Objective: To collect health and wellness coaching (HWC) literature related to treatment of obesity and Type 2 Diabetes (T2D) for systematic assessment using a novel rubric. Data Source: Pubmed, CINAHL, and PsychInfo. Study Inclusion and Exclusion: Given 282 articles retrieved, only randomized and controlled trials meeting a HWC criteria-based definition were included; studies with intervention <4 months or <4 sessions were excluded. Data Extraction: Rubric assessment required details of two theoretical frameworks (i.e., study design and HWC intervention design) be extracted from each included paper. Data Synthesis: Data were derived from a 28-item rubric querying items such as sampling characteristics, statistical methods, coach characteristics, HWC strategy, and intervention fidelity. Results: 29 articles were reviewed. Inter-rater rubric scoring yielded high intraclass correlation (r = .85). Rubric assessment of HWC literature resulted in moderate scores (56.7%), with study design scoring higher than intervention design; within intervention design, T2D studies scored higher than obesity. Conclusions: A novel research design rubric is presented and successfully applied to assess HWC research related to treatment of obesity and T2D. Most studies reported beneficial clinical findings; however, rubric results revealed moderate scores for study and intervention design. Implications for future HWC research are discussed.

A qualitative study of stakeholders' experiences with and acceptability of a technology-supported health coaching intervention (SHARE-S) delivered in coordination with cancer survivorship care.

PURPOSE: Healthy cancer survivorship involves patients' active engagement with preventative health behaviors and follow-up care. While clinicians and patients have typically held dual responsibility for activating these behaviors, transitioning some clinician effort to technology and health coaches may enhance guideline implementation. This paper reports on the acceptability of the Shared Healthcare Actions & Reflections Electronic systems in survivorship (SHARE-S) program, an entirely virtual multicomponent intervention incorporating e-referrals, remotely-delivered health coaching, and automated text messages to enhance patient self-management and promote healthy survivorship. METHODS: SHARE-S was evaluated in single group hybrid implementation-effectiveness pilot study. Patients were e-referred from the clinical team to health coaches for three health self-management coaching calls and received text messages to enhance coaching. Semi-structured qualitative interviews were conducted with 21 patient participants, 2 referring clinicians, and 2 health coaches to determine intervention acceptability (attitudes, appropriateness, suitability, convenience, and perceived effectiveness) and to identify important elements of the program and potential mechanisms of action to guide future implementation. RESULTS: SHARE-S was described as impactful and convenient. The nondirective, patient-centered health coaching and mindfulness exercises were deemed most acceptable; text messages were less acceptable. Stakeholders suggested increased flexibility in format, frequency, timing, and length of participation, and additional tailored educational materials. Patients reported tangible health behavior changes, improved mood, and increased accountability and self-efficacy. CONCLUSIONS: SHARE-S is overall an acceptable and potentially effective intervention that may enhance survivors' self-management and well-being. Alterations to tailored content, timing, and dose should be tested to determine impact on acceptability and outcomes.

Invitation to do remission of pre-diabetes to normoglycemia.

By integrating health coaching into maritime medical clinics, we can provide tailored support to individuals at risk of developing diabetes and empower them to take control of their health.

Self-determined motivational health coaching ('SAMI') during outpatient treatment to promote physical activity of people with serious mental illness: a pilot controlled trial.

BACKGROUND: Brief motivational coaching, integrated into health care; seems promising to address physical inactivity of people with serious mental illness (SMI). AIMS: To test the impact of a self-determined health coaching approach (the "SAMI" intervention) during outpatient mental health treatment on moderate-to-vigorous physical activity (MVPA) of people with SMI. METHODS: Adults (mean age = 41.9, SD = 10.9) with an ICD-10 diagnosis of mental illness were semi-randomized to the SAMI-intervention group (IG) or control group (CG). The IG received 30 minutes of health coaching based on the self-determination theory (SDT). MVPA and sedentary time (ST) were measured with the International Physical Activity Questionnaire - short form (IPAQ-SF) and symptoms of mental illness with the Brief Symptom Inventory (BSI-18), each at baseline and follow-up (3-4 months). Differences in primary (MVPA) and secondary (ST, BSI-18) outcomes were evaluated using negative binomial regressions and general linear models. RESULTS: In the IG (n = 30), MVPA increased from 278 (interquartile range [IQR] = 175-551) to 435 (IQR = 161-675) min/week compared to a decrease from 250 (IQR = 180-518) to 155 (IQR = 0-383) min/week in the CG (n = 26; adjusted relative difference at follow-up: Incidence Rate Ratio [IRR] = 2.14, 95% CI: 1.17-3.93, p = 0.014). There were no statistically significant differences in ST and BSI-18. CONCLUSIONS: Brief self-determined health coaching during outpatient treatment could increase post-treatment MVPA in people with SMI, potentially up to a clinically relevant level. However, great uncertainty (for all outcomes) weakens the assessment of clinical relevance.

Initial Perspectives From Rural-Residing Adults on a Digital Cognitive Health Coaching Intervention: Exploratory Qualitative Analysis.

BACKGROUND: A growing body of research has examined lifestyle-based interventions for dementia prevention. Specifically, health coaching interventions have been linked to decreased risk of Alzheimer disease (AD) comorbidities, such as diabetes. Despite the association, there is a lack of research examining the efficacy and perception of digital health coaching on reducing AD risk. Understanding the perceived benefits of participating in a digital health coach program is critical to ensure long-term use, including participant adherence and engagement. OBJECTIVE: The purpose of this study is to examine the initial attitudes toward a digital health coaching intervention aimed at preventing cognitive decline among at-risk, rural participants. METHODS: This exploratory qualitative study is part of the ongoing Digital Cognitive Multidomain Alzheimer Risk Velocity Study (DC-MARVel; ClinicalTrials.gov NCT04559789), a 2-year randomized control trial examining the effects of a digital health coaching intervention on dementia risk, cognitive decline, and general health outcomes. Participants were recruited from the northwest region of Arkansas via word of mouth, email, local radio, and social media. At the time of the analysis, 103 participants randomly assigned to the health coaching group completed an average of 4 coaching sessions over a 4-month period. The intervention included asynchronous messages 1-2 times per week from their health coach that contained health education articles based on the participant's goals (eg, increase physical activity), unlimited access to their coach for questions and recommendations, and monthly meetings with their coach via videoconference or phone to discuss their goals. Participants were asked 2 open-ended questions, "What were your top 1 or 2 takeaways from your recent Health Coaching session?" and "Is there anything you would change about our Health Coaching sessions?" A thematic analysis was conducted using feedback responses from 80 participants (mean age, SD 7.6 years). RESULTS: The following four themes emerged from participants' feedback: (1) healthy lifestyle and behavioral changes, (2) a sense of self-awareness through introspection, (3) value in coach support, and (4) a desire for a change in program format (eg, frequency). In total, 93% (n=74) of participants expressed that the intervention needed no changes. CONCLUSIONS: Initial participation in the digital cognitive health coaching intervention was well received, as evidenced by participants reporting value in goal setting and strategies for healthy lifestyle and behavioral changes as well as self-reflection on their personal lifestyle choices. Feedback about their assigned coach also offers insight into the importance of the coach-participant relationship and may serve as a significant factor in overall participant success. Given the exploratory nature of this study, more robust research is needed to elicit more information from participants about their experiences to fully understand the acceptability of the digital health coaching intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04559789; https://clinicaltrials.gov/show/NCT04559789. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/31841.

A randomized clinical trial testing a health literacy intervention to reduce disparities in access to care among Justice-Impacted Adults (JIA).

BACKGROUND: Low health literacy is costly and observed among justice-impacted adults (JIA), a group that often faces numerous barriers in accessing healthcare and a disproportionate burden of illness. Health literacy interventions for JIA are critically needed to improve healthcare access and related outcomes. METHODS: This manuscript describes the protocol for a longitudinal mixed-methods randomized clinical trial that assesses the effectiveness of a coach-guided health literacy intervention on JIA's healthcare access. The intervention was previously piloted with justice impacted adults. We will recruit 300 JIA ages 18 + in San Diego, California. Participants will be randomized 1:1 to the Treatment Group (i.e., coach-guided intervention providing 12 sessions of individualized health coaching and service navigation over 6 months) or the Control Group (i.e., self-study of the health coaching program, and brief service navigation support). We will quantitatively assess JIA's healthcare access defined as: use of healthcare, health insurance status, and regular source of care at 6-months as the primary outcomes. Participants will also be surveyed at 12-months. Statistical analyses will incorporate the intent-to-treat (ITT) principle and we will estimate mixed-effects logistic regression for the primary outcomes. We will also conduct qualitative interviews at 6 and 12-months with 40 purposively sampled participants, stratified by study arm, who reported healthcare access barriers at baseline. Interviews will explore participants' satisfaction with the intervention, healthcare attitudes, self-efficacy for and barriers to healthcare access over time, perceived contribution of the intervention to health and well-being, and diffusion of intervention-related information within participants' social networks. We will conduct deductive thematic analyses of qualitative data. DISCUSSION: Low health literacy among JIA is a foundational challenge requiring tailored intervention strategies. Findings from this trial may inform policies and the structure of service delivery models to build health literacy among JIA in institutional and community settings throughout the United States and elsewhere. TRIAL REGISTRATION: This study is registered with the United States' ClinicalTrials.gov registry under protocol # 161,903.

Impact of a Health Coach-Led, Text-Based Digital Behavior Change Intervention on Weight Loss and Psychological Well-Being in Patients Receiving a Procedureless Intragastric Balloon Program: Prospective Single-Arm Study.

BACKGROUND: Digital health interventions show promise for weight management. However, few text-based behavior change interventions have been designed to support patients receiving intragastric balloons, and none have simultaneously evaluated weight loss, psychological well-being, and behavior change despite the crucial interplay of these factors in weight management. OBJECTIVE: This study aims to assess whether a health coach-led, asynchronous, text-based digital behavior change coaching intervention (DBCCI) delivered to participants receiving an intragastric balloon and its aftercare program was feasible and acceptable to participants and supported improved outcomes, including weight loss, psychological well-being, and lifestyle behavior change conducive to weight loss maintenance. METHODS: This 12-month, single-arm prospective study enrolled adults aged 21 to 65 years with BMI ≥27 kg/m2 receiving a procedureless intragastric balloon (PIGB) at 5 bariatric clinics in the United Kingdom and the Netherlands. Participants received the DBCCI and the clinic-led PIGB aftercare program (remotely delivered) for 6 months after PIGB placement and then no intervention for an additional 6 months. The DBCCI was an evidence-based, personalized intervention wherein health coaches supported participants via exchanged asynchronous in-app text-based messages. Over the 12-month study, we assessed percentage of total body weight loss and psychological well-being via self-administered validated questionnaires (Warwick-Edinburgh Mental Wellbeing Scale, Generalized Anxiety Disorder Scale, Impact of Weight on Quality of Life-Lite-Clinical Trials Version, Loss of Control Over Eating Scale-Brief, Weight Efficacy Lifestyle Questionnaire-Short Form, and Barriers to Being Active Quiz). Participant engagement with and acceptability of the intervention were assessed via self-reported surveys. RESULTS: Overall, 107 participants (n=96, 89.7% female; mean baseline BMI 35.4, SD 5.4 kg/m2) were included in the analysis. Mean total body weight loss was 13.5% (SEM 2.3%) at the end of the DBCCI and 11.22% (SEM 2.3%) at the 12-month follow-up (P<.001). Improvements were observed for all psychological well-being measures throughout the 12 months except for the Generalized Anxiety Disorder Scale (improvement at month 1) and Barriers to Being Active Quiz (improvements at months 3 and 6). Surveys showed high levels of engagement with and acceptability of the DBCCI. CONCLUSIONS: This study provides evidence that the health coach-led, asynchronous, text-based DBCCI was engaging and acceptable to participants with overweight and obesity. The DBCCI, delivered alongside the PIGB and its aftercare program, supported improved weight loss outcomes and psychological well-being versus baseline and was associated with lifestyle behavior changes known to help achieve and maintain long-term weight loss and improved health outcomes. Follow-up findings suggest a potential need for longer-term, more intense coaching to focus on weight loss maintenance and support ongoing self-coaching. This could be achieved by leveraging generative artificial intelligence to provide ongoing automated behavior change coaching support to augment human-led care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05884606; https://clinicaltrials.gov/study/NCT05884606.

The Tennessee Heart Health Network effectiveness study: A stepped wedge cluster randomized controlled trial to assess the effectiveness of statewide quality improvement cooperative participation on cardiovascular outcomes.

BACKGROUND: Cardiovascular disease (CVD) is the primary cause of premature morbidity and mortality in the United States and Tennessee ranks among the highest in CVD events. While patient-centered outcomes research (PCOR) evidence-based approaches that reach beyond the traditional doctor-patient visit hold promise to improve CVD care and prevent serious complications, most primary care providers lack time, knowledge, and infrastructure to implement these proven approaches. Statewide primary care quality improvement (QI) collaboratives hold potential to help address primary care needs, however, little is known regarding their effectiveness in improving uptake of PCOR evidence-based population health approaches and improving CVD outcomes. This study describes the design and implementation of a stepped-wedge cluster randomized controlled trial to assess the effectiveness of participation in a statewide quality improvement cooperative (The Tennessee Heart Health Network [TN-HHN]) on cardiovascular outcomes. METHODS/DESIGN: The TN-HHN Effectiveness Study randomized 77 practices to 4 waves (i.e., clusters), with each wave beginning three months after the start of the prior wave and lasting for 18 months. All practice clusters received one of three Network interventions, and outcomes are measured for each three months both in the control phase and the intervention phase. Primary outcomes include Center for Medicare and Medicaid Services measures for aspirin use, blood pressure control, cholesterol control, and smoking cessation (ABCS). CONCLUSIONS: This trial, upon its conclusion, will allow us to assess the effect of participation in a statewide quality improvement cooperative on cardiovascular outcomes as well as key contributors to successful practice transformation.

Health Coaching Intervention to Improve Self-Care Management of Hypertension Among Older People in Indonesia: A Randomized Controlled Study Protocol.

Purpose: One-third of the global population is predicted to be diagnosed with hypertension (HTN) in 2025, with the percentage highest among older people. Without proper self-care management, uncontrolled HTN causes negative health consequences and decreases the quality of life. The previous scoping review identified various challenges that older adults may face in dealing with HTN and that effective approaches should consider each individual's circumstances and attributes. This study aims to investigate the efficacy and sustainable impact of an Indonesian adaptation of an 8-week nurse health coaching intervention on self-care management and self-efficacy among older people with HTN. Patients and Methods: The coaching sessions will last for 30 min weekly for 8 weeks. The data will be measured at three points: baseline (initial), 1 week after the eighth health coaching session, and 3 months after concluding the intervention. Discussion: This study will be the first health coaching intervention research based on motivational interviewing and cognitive behavioral therapy approach with Indonesian background adjustment. The study result will help develop a guideline for nurses and other health workers providing health coaching for older people in Indonesia and other countries with similar characteristics in terms of sociodemographics or lifestyle. Trial Registration: thaiclinicaltrials.org Identifier: TCTR20230410001 (Date of registration: April 9, 2023).

Arriba por la Vida Estudio: a randomized controlled trial promoting standing behavior to reduce sitting time among postmenopausal Latinas.

Postmenopausal Hispanic/Latina (N = 254) women with a body mass index (BMI) ≥ 25 kg/m2 were randomized to an intervention to reduce sitting time or a comparison condition for 12 weeks. The standing intervention group received three in-person health-counseling sessions, one home visit, and up to eight motivational interviewing calls. The heart healthy lifestyle comparison group (C) received an equal number of contact hours to discuss healthy aging. The primary outcome was 12-week change in sitting time measured via thigh-worn activPAL. Group differences in outcomes were analyzed using linear mixed-effects models. Participants had a mean age of 65 (6.5) years, preferred Spanish language (89%), BMI of 32.4 (4.8) kg/m2, and sat for an average of 540 (86) minutes/day. Significant between-group differences were observed in reductions of sitting time across the 12-week period [Mdifference (SE): C - 7.5 (9.1), SI - 71.0 (9.8), p < 0.01]. Results demonstrate that coaching models to reduce sitting are feasible and effective.

Self-Management Programs and the Pursuit of Behavior Change.

A self-management intervention is a personalized approach to individuals aiming to engage individuals in a behavior change to develop skills to live better with their condition. Self-management involves an iterative process between participants and providers in which goals are formulated and feedback is given. All respiratory societies advocate self-management as part of chronic care because it may improve quality of life and health-care utilization. Self-management is an integral part of pulmonary rehabilitation. Self-management interventions usually involve education and exercise prescription, and that is an asset of current programs; however, recent reports indicate that effective strategies for motivation and a behavior change focus are often missed. A recent systematic review on self-management urges the need for a specific aspect and characteristic of self-management interventions: iterative interactions between participants and health-care professionals competent in using behavior change practices to elicit participants' motivation, confidence, and competence to develop skills to better manage their disease. A recent review of self-care intervention in chronic disease states that the major deficits found in self-care interventions included a lack of attention and/or innovation to the psychological consequences of chronic illness, technology, and behavior change techniques to help patients manage symptoms. There is a need for exploration of mechanisms to explain the relationships between both anxiety and depression, and adherence to treatment in COPD. The latter is particularly appropriate for pulmonary rehabilitation, for which greater adherence is needed. This report aims to introduce basic aspects of behavior change and a proposed roadmap to introduce behavior change into pulmonary rehabilitation and chronic care programs.

A pilot randomised controlled trial exploring the feasibility and efficacy of a human-AI sleep coaching model for improving sleep among university students.

Objective: Sleep quality is a crucial concern, particularly among youth. The integration of health coaching with question-answering (QA) systems presents the potential to foster behavioural changes and enhance health outcomes. This study proposes a novel human-AI sleep coaching model, combining health coaching by peers and a QA system, and assesses its feasibility and efficacy in improving university students' sleep quality. Methods: In a four-week unblinded pilot randomised controlled trial, 59 university students (mean age: 21.9; 64% males) were randomly assigned to the intervention (health coaching and QA system; n = 30) or the control conditions (QA system; n = 29). Outcomes included efficacy of the intervention on sleep quality (Pittsburgh Sleep Quality Index; PSQI), objective and self-reported sleep measures (obtained from Fitbit and sleep diaries) and feasibility of the study procedures and the intervention. Results: Analysis revealed no significant differences in sleep quality (PSQI) between intervention and control groups (adjusted mean difference = -0.51, 95% CI: [-1.55-0.77], p = 0.40). The intervention group demonstrated significant improvements in Fitbit measures of total sleep time (adjusted mean difference = 32.5, 95% CI: [5.9-59.1], p = 0.02) and time in bed (adjusted mean difference = 32.3, 95% CI: [2.7-61.9], p = 0.03) compared to the control group, although other sleep measures were insignificant. Adherence was high, with the majority of the intervention group attending all health coaching sessions. Most participants completed baseline and post-intervention self-report measures, all diary entries, and consistently wore Fitbits during sleep. Conclusions: The proposed model showed improvements in specific sleep measures for university students and the feasibility of the study procedures and intervention. Future research may extend the intervention period to see substantive sleep quality improvements.

Feasibility and acceptability of multidisciplinary team training in health coaching: Case study in adolescent rheumatology.

The central importance of the biopsychosocial model of chronic disease is increasingly recognised in the management of long-term conditions (LTC), which are often associated with chronic pain, fatigue and disability. Despite the physical and mental health impact, 'struggle' to maintain self-efficacy, gap in effective transition to adult pathways and long term consequences of poor disease control and lifestyle choices in young people with LTCs, innovation in this age range is rarely reported in generic journals. This paper explores the feasibility and acceptability of health coaching with young service users to increase engagement and self-management, achieved through multidisciplinary team (MDT) training in Adolescent Rheumatology.