Group Health & Wellness Coaching: development and validation of the required competencies.

BACKGROUND: As the popularity and demonstrated effectiveness of Health and Wellness Coaching (HWC) continue to grow to address chronic disease prevalence worldwide, delivery of this approach in a group format is gaining traction, particularly in healthcare. Nonetheless, very little empirical work exists on group coaching and there are currently no published competencies for Group Health and Wellness Coaching (GHWC). METHODS: We used a well-established two-phase (Development and Judgment) process to create and validate GHWC competencies with strong content validity. RESULTS: Seven highly qualified Subject Matter Experts systematically identified and proposed the GHWC competencies, which were then validated by 78 National Board Certified Health and Wellness Coaches (NBC-HWCs) currently practicing GHWC who rated the importance and use frequency of each one. The validation study led to 72 competencies which are organized into the structure and process of GHWC. CONCLUSIONS: GHWC requires not only coaching skills, but significant group facilitation skills to guide the group process to best support members in maximizing health and well-being through self-directed behavioral change. As the presence of HWC continues to grow, it is imperative that GHWC skill standards be accepted and implemented for the safety of the public, the effectiveness of the intervention, and the value analysis of the field. Such standards will guide curriculum development, allow for a more robust research agenda, and give practical guidance for health and wellness coaches to responsibly run groups. High quality standards for GHWC are particularly needed in health care, where a Level III Current Procedural Terminology (CPT®) code for GHWC has been approved in the United States since 2019 and reimbursement of such has been approved by the Centers for Medicare and Medicaid for 2024.

Health Coaching Impacts Stage-Specific Transitions in Multiple Health Behaviors for Patients at High Risk for Coronary Heart Disease and Type 2 Diabetes: A Multigroup Latent Transition Analysis.

BACKGROUND: Multiple behavior change interventions have gained traction in the behavioral health space. Yet, previous studies on health coaching (HC) focused on testing its effect on stages of change for individual health behaviors. OBJECTIVE: The purpose of this study was to examine the effects of HC on stages of change across multiple health behavior domains among patients at high risk of coronary heart disease and type 2 diabetes. METHODS: This secondary analysis of a randomized clinical trial included 200 primary care patients (mean age of 47.7 years, 49.0% women, 60.5% Whites) who completed transtheoretical model-based questionnaires related to weight reduction, exercise, healthier eating, and stress management. Multigroup latent transition analysis was used to compare the stage of change distributions and transitions over time between HC and controls at baseline, midpoint of the intervention (3 months), and postintervention (6 months). RESULTS: Three distinct categories of behavior change were identified ("Contemplation," "Preparation to Action," and "Action"), and membership in these categories changed over time as a function of intervention exposure. Both groups exhibited positive transitions through stages of change from baseline to 3 months. Pronounced intervention effects emerged from 3 to 6 months, revealing larger differences in transition probabilities between the groups. In particular, HC increased patients' likelihood of transitioning from "Contemplation" to both "Preparation for Action" and "Action," as well as from "Preparation for Action" to "Action." The control group remained stagnant during the same period. CONCLUSIONS: Although HC produces changes across multiple behavioral domains, it was most effective for patients who were reluctant or ambivalent about changing their behaviors.

Network Psychometrics of the 10-Item Perceived Stress Scale Among Patients With High Cardiovascular and Type 2 Diabetes Risk Using Exploratory Graph Analysis.

BACKGROUND: No studies have explored the internal structure of the 10-item Perceived Stress Scale in patients with high cardiovascular and diabetes risk. OBJECTIVE: We scrutinized the dimensionality of the scale in this patient group using exploratory graph analysis, a technique within the developing field of network psychometrics. METHODS: Analyses were conducted on 200 primary care patients. A bootstrap version of exploratory graph analysis assessed the stability of the dimensions based on structural consistency, item stability, and network loadings. RESULTS: Exploratory graph analysis revealed a 2-dimensional structure; structural consistency of the first dimension was high (0.863), whereas that for the second was low (0.667). Items belonging to the latter dimension did not cluster consistently with each other (ie, low item stability) and were not strongly associated with any particular dimension (ie, weak network loadings). CONCLUSION: Exploratory graph analysis offers unique outputs, making it easy to assess the dimensional integrity of scales. Further research is warranted regarding the second dimension of the Perceived Stress Scale.

Latent Profile/Class Analysis Identifying Differentiated Intervention Effects.

BACKGROUND: The randomized clinical trial is generally considered the most rigorous study design for evaluating overall intervention effects. Because of patient heterogeneity, subgroup analysis is often used to identify differential intervention effects. In research of behavioral interventions, such subgroups often depend on a latent construct measured by multiple correlated observed variables. OBJECTIVES: The purpose of this article was to illustrate latent class analysis/latent profile analysis as a helpful tool to characterize latent subgroups, conduct exploratory subgroup analysis, and identify potential differential intervention effects using clinical trial data. METHODS: After reviewing different approaches for subgroup analysis, latent class analysis/latent profile analysis was chosen to identify heterogeneous patient groups based on multiple correlated variables. This approach is superior in this specific scenario because of its ability to control Type I error, assess intersection of multiple moderators, and improve interpretability. We used a case study example to illustrate the process of identifying latent classes as potential moderators based on both clinical and perceived risk scores and then tested the differential effects of health coaching in improving health behavior for patients with elevated risk of developing coronary heart disease. RESULTS: We identified three classes based on one clinical risk score and four perceived risk measures for individuals with high risk of developing coronary heart disease. Compared to other classes we assessed, individuals in the class with low clinical risk and low perceived risk benefit most from health coaching to improve their physical activity levels. DISCUSSION: Latent class analysis/latent profile analysis offers a person-centered approach to identifying distinct patient profiles that can be used as moderators for subgroup analysis. This offers tremendous opportunity to identify differential intervention effects in behavioral research.

The Relative Contributions of Live and Recorded Online Mindfulness Training Programs to Lower Stress in the Workplace: Longitudinal Observational Study.

BACKGROUND: Despite numerous gaps in the literature, mindfulness training in the workplace is rapidly proliferating. Many "online" or "digital mindfulness" programs do not distinguish between live teaching and recorded or asynchronous sessions, yet differences in delivery mode (eg, face-to-face, online live, online self-guided, other) may explain outcomes. OBJECTIVE: The aim of this study was to use existing data from an online mindfulness solutions company to assess the relative contribution of live and recorded mindfulness training to lower perceived stress in employees. METHODS: Perceived stress and the amount of live and recorded online mindfulness training accessed by employees were assessed during eMindful's One-Percent Challenge (OPC). The OPC is a 30-day program wherein participants are encouraged to spend 1% of their day (14 minutes) practicing mindfulness meditation on the platform. We used linear mixed-effects models to assess the relationship between stress reduction and usage of components of the eMindful platform (live teaching and recorded options) while controlling for potential reporting bias (completion) and sampling bias. RESULTS: A total of 8341 participants from 44 companies registered for the OPC, with 7757 (93.00%) completing stress assessments prior to the OPC and 2360 (28.29%) completing the postassessment. Approximately one-quarter of the participants (28.86%, 2407/8341) completed both assessments. Most of the completers (2161/2407, 89.78%) engaged in the platform at least once. Among all participants (N=8341), 8.78% (n=707) accessed only recorded sessions and 33.78% (n=2818) participated only in the live programs. Most participants engaged in both live and recorded options, with those who used any recordings (2686/8341, 32.20%) tending to use them 3-4 times. Controlling for completer status, any participation with the eMindful OPC reduced stress (B=-0.32, 95% CI -0.35 to -0.30, SE=0.01, t2393.25=-24.99, P<.001, Cohen d=-1.02). Participation in live programs drove the decrease in stress (B=-0.03, SE=0.01, t3258.61=-3.03, P=.002, d=-0.11), whereas participation in recorded classes alone did not. Regular practice across the month led to a greater reduction in stress. CONCLUSIONS: Our findings are in stark contrast to the rapid evolution of online mindfulness training for the workplace. While the market is reproducing apps and recorded teaching at an unprecedented pace, our results demonstrate that live mindfulness programs with recorded or on-demand programs used to supplement live practices confer the strongest likelihood of achieving a significant decrease in stress levels.

Health Behavior Trajectories in High Cardiovascular Risk Populations: Secondary Analysis of a Clinical Trial.

BACKGROUND: The application of latent class growth analysis (LCGA) has been limited in behavioral studies on high-cardiovascular-risk populations. AIM: The current study aimed to identify distinct health behavior trajectories in high-cardiovascular-risk populations using LCGA. We also examined the baseline individual characteristics associated with different health behavior trajectories and determined which trajectory is associated with improved cardiovascular risk outcomes at 52 weeks. METHODS: This secondary analysis of a clinical trial included 200 patients admitted to primary care clinics. Latent class growth analysis was conducted to identify the trajectories of physical activity and dietary intake; these were measured at 4 different time points during a 52-week study period. Analysis of variance/χ2 test was used to assess the associations between baseline individual characteristics and trajectories, and logistic regression analysis was used to identify associations between trajectories and cardiovascular risk outcomes at 52 weeks. RESULTS: Three trajectories were identified for physical activity (low-, moderate-, and high-stable). Risk perception, patient activation, and depressive symptoms predicted the trajectories. High-stable trajectory for physical activity was associated with better cardiovascular risk outcomes at the 52-week follow-up. Two trajectories (low-stable and high-decreasing) were identified for percent energy from fat, but the factors that can predict trajectories were limited. CONCLUSIONS: Interventions are needed to target patients who begin with a lower physical activity level, with the goal of enhanced cardiovascular health. The predictors identified in the study may facilitate earlier and more tailored interventions.

The ONE-MIND Study: Rationale and protocol for assessing the effects of ONlinE MINDfulness-based cancer recovery for the prevention of fatigue and other common side effects during chemotherapy.

Cancer patients often experience poor quality of life (QoL) during chemotherapy (CT) treatments due to side effects including fatigue, insomnia, pain and nausea/vomiting. Mindfulness-based cancer recovery (MBCR) is an evidence-based intervention for treating such symptoms, but has not been investigated as an adjunctive treatment during CT. This study aims to determine the efficacy of an online group MBCR programme delivered during CT in 12 real-time interactive weekly sessions for managing fatigue (primary outcome). Secondary outcomes include sleep disturbance, pain, nausea/vomiting, mood, stress and QoL. Exploratory outcomes include cognitive function, white blood cell counts and return to work. The study is a two-armed randomised controlled waitlist trial with 2:1 allocation to treatment (online group MBCR during CT) or control (waitlist usual care; online MBCR following CT completion) with a target sample size of N = 178. Participants are breast or colorectal cancer patients undergoing common CT regimens in Calgary, Canada. Online assessments using validated self-reported instruments will take place at baseline, post-MBCR, post-CT and 12 months' post-baseline. If online MBCR delivered during CT significantly reduces fatigue in cancer patients' post-CT and also impacts secondary symptoms, this would provide evidence for including mindfulness training as an adjunctive symptom management therapy during CT.

Advancing a new evidence-based professional in health care: job task analysis for health and wellness coaches.

BACKGROUND: The pressing need to manage burgeoning chronic disease has led to the emergence of job roles such as health and wellness coaches (HWCs). As use of this title has increased dramatically, so has the need to ensure consistency, quality and safety for health and wellness coaching (HWC) provided in both practice and research. Clear and uniform role definitions and competencies are required to ensure appropriate scope of practice, to allow best practices to emerge, and to support the implementation of well-designed, large scale studies to accumulate a rigorous evidence base. Since the nascent field is replete with heterogeneity in terms of role delineations and competencies, a collaborative volunteer non-profit organization, the National Consortium for Credentialing Health and Wellness Coaches (NCCHWC), has been built over the past six years to support professionalization of the field. METHODS: In 2014, a professionally led Job Task Analysis (JTA) was conducted with 15 carefully selected subject matter experts (SMEs) with diverse education and professional backgrounds who were practicing HWC in a wide variety of settings. After establishing a thorough list of specific tasks employed during HWC, the expert panel discussed the knowledge and skills necessary to competently perform the tasks. Subsequently, a large validation survey assessed the relative importance and frequency of each identified job task in conducting HWC. RESULTS: The JTA identified 21 job tasks as essential to HWC. In the subsequent validation survey, 4026 practicing health and wellness coaches were invited to rate each of the 21 job tasks in terms of their importance and frequency. A response rate of 25.6 % provided a diverse sample (n = 1031) in terms of background, and represented a wide variety of training programs from academia, industry, the private sector and associations. Per best practices, the subset of practicing HWCs (n = 885) provided importance and frequency ratings to be used to calculate task and domain weights that can serve as a foundation for a NCCHWC national certification examination. CONCLUSIONS: This JTA provides a significant step forward in the building of a clear and consistent definition of HWC that will allow for uniform practice standards and enable more stringent methodology to evaluate this promising approach within evidence-based medicine.

Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) of the BraveNet practice-based research network: study protocol.

BACKGROUND: Integrative medicine (IM) provides patient-centered care and addresses the full range of physical, emotional, mental, social, spiritual, and environmental influences that affect a person's health. IM is a "whole systems" approach that employs multiple modalities as opposed to an isolated complementary therapy. Thus, studying outcomes of IM is more challenging than evaluating an isolated intervention. Practice-based research networks (PBRNs) allow for clinicians/investigators at multiple diverse sites using common methodology to pool their data, increase participant sample size and increase generalizability of results. To conduct real-world, practice-based research, the Bravewell Collaborative founded BraveNet in 2007 as the first national integrative medicine PBRN. METHODS AND DESIGN: Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) is a prospective, non-randomized, observational evaluation conducted at fourteen clinical sites. Participants receive a non-standardized, personalized, multimodal IM approach for various medical conditions. Using the REDCap electronic platform, an anticipated 10,000 study participants will complete patient-reported outcome measures including Patient Reported Outcomes Measurement Information System (PROMIS)-29, Perceived Stress Scale-4, and the Patient Activation Measure at baseline, 2, 4, 6, 12, 18 and 24 months. Extractions from participants' electronic health records include IM services received, as well as ICD diagnostic codes, and CPT billing codes associated with each IM visit. Repeated-measures analyses will be performed on data to assess change from baseline through 24 months with planned subgroup analyses to include specific clinical population and specific IM intervention or combinations. DISCUSSION: As the PRIMIER registry grows, we anticipate that our results would provide an indication of the promise of PBRN research efforts in IM. Analyses will incorporate a large sample of participants and an expected 10-year observation period and will provide the ability to evaluate the effect of IM on outcomes for specific clinical populations and specific IM interventions or combinations. As such, PRIMIER will serve as a national platform for future evaluations of IM best practices. TRIAL REGISTRATION: Clinical Trials.gov NCT01754038.

Supporting Sustainable Health Behavior Change: The Whole is Greater Than the Sum of Its Parts.

Behavior change is the foundation for effective lifestyle prescriptions, yet such change is individualized, nonlinear and typically requires ongoing support. Health and wellness coaching (HWC) is a behavior change intervention with rapidly accruing evidence of positive impact on health behaviors such as exercise, nutrition and stress management. Furthermore, HWC enhances prevention and mitigates exacerbation of chronic lifestyle diseases, at least in the short-term (up to 6 months post intervention). Although the impact on long-term stability of behavior change remains unclear, it is evident that effective partnering with patients using key communication strategies, autonomy promotion, and flexible permissiveness can empower patients to develop healthy lifestyles. This partnership can be cultivated by clinicians as well as clinical team members including nationally board-certified coaches. Although much research is needed regarding the ongoing maintenance of lifestyle changes beyond 6 months, this article seeks to equip clinicians with current evidence, theoretical insights and practical strategies from a "coach approach" to foster more intrinsic forms of motivation which, in turn, empowers patients to adopt and maintain health-promoting behaviors.

Predicting physical activity by the personality styles of the five-factor model.

OBJECTIVE: Low neuroticism, high extraversion, and high conscientiousness are related to physical activity (PA). We tested whether the small size and heterogeneity of these relationships result because personality traits influence one another as well as because some narrow facets rather than the broad domains contain more specific variance relevant to PA. METHOD: Participants were men and women enrolled in the University of North Carolina Alumni Heart Study who completed the Revised NEO Personality Inventory (NEO-PI-R) and reported their past month's average activity on an 8-point scale. In Study 1, we examined prospective correlations between the five NEO-PI-R domains and PA. In Studies 2 and 3, we used multinomial logistic regression to examine associations between PA and trait pair combinations (personality styles) controlling for age, sex, educational achievement, relationship status, and depression. RESULTS: Study 1 revealed that lower neuroticism (N) and agreeableness (A) and higher conscientiousness (C) predicted more PA. Taken together, Studies 2 and 3 found that the combination of high Extraversion (E) and high openness (O) was related to higher PA and that combinations of low E and high A and low E and low C were related to lower PA. Study 3, which examined the activity facet of E (E4), found that E4 is an important driver of E-PA associations. CONCLUSIONS: Personality traits do not operate in isolation. They may influence how other traits are expressed and such nonadditive effects can impact PA. Assessment of personality styles could help to identify individuals at risk for PA avoidance and may be useful for developing personalized interventions. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

African American Patients' Perspectives on Determinants of Hemodialysis Adherence and Use of Motivational Interviewing to Improve Hemodialysis Adherence.

INTRODUCTION: Compared to White patients, African American (AA) patients have a four-fold higher prevalence of kidney failure and higher hemodialysis non-adherence. Adherence behaviors are influenced by psychosocial factors, including personal meaning of a behavior and self-confidence to enact it. We assessed perspectives of AA hemodialysis patients on unique factors impacting dialysis adherence, and use of motivational interviewing, an evidence-based intervention, to improve these factors, dialysis adherence, and outcomes in AAs. METHODS: Self-identified AA hemodialysis patients (N=22) watched a brief video describing motivational interviewing and then completed a semi-structured interview or focus group session. Interview questions explored unique barriers and facilitators of hemodialysis adherence in AAs, and perceived utility of motivational interviewing to address these obstacles. Verbatim transcripts and an iterative inductive/deductive approach were used to develop a hierarchical coding system. Three experienced coders independently coded the same two transcripts. Coding was compared and discrepancies were reconciled by a fourth coder or consensus. Transcripts, quotations, and codes were managed using Microsoft Excel 2016 and SPSS version 28.0. RESULTS: Themes and sub-themes emerged and culminated in a novel conceptual model informed by three theoretical models of behavior change: Theory of Self-Care Management for Vulnerable Populations; Social Cognitive Theory; and Self Determination Theory. This conceptual model will inform the design of a culturally tailored, motivational interviewing-based intervention to improve dialysis adherence in AAs. CONCLUSIONS: Integrating AA hemodialysis patient perspectives is critical for enhancing dialysis care delivery and the design of effective interventions such as motivational interviewing to improve dialysis adherence in AA and promote kidney health equity. AA hemodialysis patients view motivational interviewing as a tool to clarify patient priorities, build trust, and promote patient-provider therapeutic alliance. Cultural tailoring of motivational interviewing to address unique barriers of AAs with kidney failure will improve adherence and health outcomes in these vulnerable patients.

The BraveNet prospective observational study on integrative medicine treatment approaches for pain.

BACKGROUND: Chronic pain affects nearly 116 million American adults at an estimated cost of up to $635 billion annually and is the No. 1 condition for which patients seek care at integrative medicine clinics. In our Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP), we observed the impact of an integrative approach on chronic pain and a number of other related patient-reported outcome measures. METHODS: Our prospective, non-randomized, open-label observational evaluation was conducted over six months, at nine clinical sites. Participants received a non-standardized, personalized, multimodal approach to chronic pain. Validated instruments for pain (severity and interference levels), quality of life, mood, stress, sleep, fatigue, sense of control, overall well-being, and work productivity were completed at baseline and at six, 12, and 24 weeks. Blood was collected at baseline and week 12 for analysis of high-sensitivity C-reactive protein and 25-hydroxyvitamin D levels. Repeated-measures analysis was performed on data to assess change from baseline at 24 weeks. RESULTS: Of 409 participants initially enrolled, 252 completed all follow-up visits during the 6 month evaluation. Participants were predominantly white (81%) and female (73%), with a mean age of 49.1 years (15.44) and an average of 8.0 (9.26) years of chronic pain. At baseline, 52% of patients reported symptoms consistent with depression. At 24 weeks, significantly decreased pain severity (-23%) and interference (-28%) were seen. Significant improvements in mood, stress, quality of life, fatigue, sleep and well-being were also observed. Mean 25-hydroxyvitamin D levels increased from 33.4 (17.05) ng/mL at baseline to 39.6 (16.68) ng/mL at week 12. CONCLUSIONS: Among participants completing an integrative medicine program for chronic pain, significant improvements were seen in pain as well as other relevant patient-reported outcome measures. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01186341.

Prerandomization withdrawals from a Type 2 diabetes self-care support intervention trial are associated with lack of available support person coparticipant.

OBJECTIVES: Dyadic interventions, involving two persons with a preexisting close relationship, offer the opportunity to activate support persons (SPs) to improve health for adults with chronic conditions. Requiring SP coparticipation can challenge recruitment and bias samples; however, the associations between voluntary SP coparticipation and recruitment outcomes across patient characteristics are unknown. METHODS: The Family/Friend Activation to Motivate Self-care 2.0 randomized controlled trial (RCT) enrolled adults with Type 2 diabetes (T2D) from an academic health system. Participants were asked-but not required-to invite an SP to coenroll. Using data from the electronic health record we sought to describe RCT enrollment in the setting of voluntary SP coparticipation. RESULTS: In a diverse sample of adults with (T2D) (48% female, 44% minoritized race/ethnicity), most participants (91%) invited SPs and (89%) enrolled with SPs. However, prerandomization withdrawal was significantly higher among participants who did not have consenting SPs than those who did. Females were less likely to invite SPs than males and more Black PWD were prerandomization withdrawals than randomized. DISCUSSION: Voluntary SP coenrollment may benefit recruitment for dyadic sampling; however, more research is needed to understand if these methods systematically bias sampling and to prevent these unintended biases.

Well-being outcomes of a family-focused intervention for persons with type 2 diabetes and support persons: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

AIMS: Type 2 diabetes self-management occurs within social contexts. We sought to test the effects of Family/friend Activation to Motivate Self-care (FAMS), a self-care support intervention delivered via mobile phones, on psychosocial outcomes for persons with diabetes (PWDs) and their support persons. METHODS: PWDs had the option to enroll with a friend/family member as a support person in a 15-month RCT to evaluate FAMS versus enhanced usual care. FAMS included 9 months of monthly phone coaching and text message support for PWDs, and text message support for enrolled support persons. RESULTS: PWDs (N = 329) were 52% male and 39% reported minoritized race or ethnicity ; 50% enrolled with elevated diabetes distress. Support persons (N = 294) were 26% male and 33% reported minoritized race or ethnicity. FAMS improved PWDs' diabetes distress (d = -0.19) and global well-being (d = 0.21) during the intervention, with patterns of larger effects among minoritized groups. Post-intervention (9-month) and sustained (15-month) improvements were driven by changes in PWDs' self-efficacy, self-care behaviors, and autonomy support. Among support persons, FAMS improved helpful involvement without increasing burden or harmful involvement. CONCLUSIONS: FAMS improved PWDs' psychosocial well-being, with post-intervention and sustained improvements driven by improved self-efficacy, self-care, and autonomy support. Support persons increased helpful involvement without adverse effects.

Well-being outcomes of a family-focused intervention for persons with type 2 diabetes and support persons: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

Aims: Type 2 diabetes self-management occurs within social contexts. We sought to test the effects of Family/friends Activation to Motivate Self-care (FAMS), a self-care support intervention delivered via mobile phones, on psychosocial outcomes for persons with diabetes (PWDs) and their support persons. Methods: PWDs had the option to enroll with a friend/family member as a support person in a 15-month RCT to evaluate FAMS versus enhanced usual care. FAMS included 9-months of monthly phone coaching and text message support for PWDs, and text message support for enrolled support persons. Results: PWDs (N=329) were 52% male and 39% from minoritized racial or ethnic groups; 50% enrolled with elevated diabetes distress. Support persons (N=294) were 26% male and 33% minoritized racial or ethnic groups. FAMS improved PWDs' diabetes distress ( d =-0.19) and global well-being ( d =0.21) during the intervention, with patterns of larger effects among minoritized groups. Post-intervention and sustained (15-month) improvements were driven by changes in PWDs' self-efficacy, self-care behaviors, and autonomy support. Among support persons, FAMS improved helpful involvement without increasing burden or harmful involvement. Conclusions: FAMS improved PWDs' psychosocial well-being, with post-intervention and sustained improvements driven by improved self-efficacy, self-care, and autonomy support. Support persons increased helpful involvement without adverse effects.

Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

Aims: Family/friends Activation to Motivate Self-care (FAMS) is a self-care support intervention delivered via mobile phones. We evaluated FAMS effects on hemoglobin A1c (HbA1c) and intervention targets among adults with type 2 diabetes in a 15-month RCT. Methods: Persons with diabetes (PWDs) and their support persons (family/friend, optional) were randomized to FAMS or control. FAMS included monthly phone coaching and text messages for PWDs, and text messages for support persons over a 9-month intervention period. Results: PWDs (N=329) were 52% male, 39% from minoritized racial or ethnic groups, with mean HbA1c 8.6±1.7%. FAMS improved HbA1c among PWDs with a non-cohabitating support person (-0.64%; 95% CI [-1.22%, -0.05%]), but overall effects were not significant. FAMS improved intervention targets including self-efficacy, dietary behavior, and family/friend involvement during the intervention period; these improvements mediated post-intervention HbA1c improvements (total indirect effect -0.27%; 95% CI [-0.49%, -0.09%]) and sustained HbA1c improvements at 12 months (total indirect effect -0.19%; 95% CI [-0.40%, -0.01%]). Conclusions: Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons suggesting future family interventions should emphasize inclusion of these relationships. Future work should also seek to identify intervention targets that mediate improvements in HbA1c.

Demographic, Clinical, and Psychosocial Predictors of Exercise Adherence: The STRRIDE Trials.

Purpose: To identify baseline demographic, clinical, and psychosocial predictors of exercise intervention adherence in the Studies of a Targeted Risk Reduction Intervention through Defined Exercise (STRRIDE) trials. Methods: A total of 947 adults with dyslipidemia or prediabetes were enrolled into an inactive control group or one of ten exercise interventions with doses of 10-23 kcal/kg/week, intensities of 40-80% of peak oxygen consumption, and training for 6-8-months. Two groups included resistance training. Mean percent aerobic and resistance adherence were calculated as the amount completed divided by the prescribed weekly minutes or total sets of exercise times 100, respectively. Thirty-eight clinical, demographic, and psychosocial measures were considered for three separate models: 1) clinical + demographic factors, 2) psychosocial factors, and 3) all measures. A backward bootstrapped variable selection algorithm and multiple regressions were performed for each model. Results: In the clinical and demographic measures model (n=947), variables explained 16.7% of the variance in adherence (p<0.001); lesser fasting glucose explained the greatest amount of variance (partial R2 = 3.2%). In the psychosocial factors model (n=561), variables explained 19.3% of the variance in adherence (p<0.001); greater 36-Item Short Form Health Survey (SF-36) physical component score explained the greatest amount of variance (partial R2 = 8.7%). In the model with all clinical, demographic, and psychosocial measures (n=561), variables explained 22.1% of the variance (p<0.001); greater SF-36 physical component score explained the greatest amount of variance (partial R2 = 8.9%). SF-36 physical component score was the only variable to account for >5% of the variance in adherence in any of the models. Conclusions: Baseline demographic, clinical, and psychosocial variables explain approximately 22% of the variance in exercise adherence. The limited variance explained suggests future research should investigate additional measures to better identify participants who are at risk for poor exercise intervention adherence.

Race and sex differences in dropout from the STRRIDE trials.

Purpose: To determine if race and sex differences exist in determinants and timing of dropout among individuals enrolled in an exercise and/or caloric restriction intervention. Methods: A total of 947 adults with dyslipidemia (STRRIDE I, STRRIDE AT/RT) or prediabetes (STRRIDE-PD) were randomized to either inactive control or to 1 of 10 exercise interventions, ranging from doses of 8-23 kcal/kg/week, intensities of 50%-75% V˙O2 peak, and durations of 6-8 months. Two groups included resistance training, and one included a dietary intervention (7% weight loss goal). Dropout was defined as an individual withdrawn from the study, with the reasons for dropout aggregated into determinant categories. Timing of dropout was defined as the last session attended and aggregated into phases (i.e., "ramp" period to allow gradual adaptation to exercise prescription). Utilizing descriptive statistics, percentages were generated according to categories of determinants and timing of dropout to describe the proportion of individuals who fell within each category. Results: Black men and women were more likely to be lost to follow-up (Black men: 31.3% and Black women: 19.6%), or dropout due to work responsibilities (15.6% and 12.5%), "change of mind" (12.5% and 8.9%), transportation issues (6.3% and 3.6%), or reported lack of motivation (6.3% and 3.6%). Women in general noted lack of time more often than men as a reason for dropout (White women: 22.4% and Black women: 22.1%). Regardless of race and sex, most participants dropped out during the ramp period of the exercise intervention; with Black women (50%) and White men (37.1%) having the highest dropout rate during this period. Conclusion: These findings emphasize the importance of targeted retention strategies when aiming to address race and sex differences that exist in determinants and timing of dropout among individuals enrolled in an exercise and/or caloric restriction intervention.

Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

AIMS: Family/friend Activation to Motivate Self-care (FAMS) is a self-care support intervention delivered via mobile phones. We evaluated FAMS' effects on hemoglobin A1c (HbA1c) and intervention targets among adults with type 2 diabetes in a 15-month RCT. METHODS: Persons with diabetes (PWDs) were randomized to FAMS or control with their support person (family/friend, optional). FAMS included monthly phone coaching and text messages for PWDs, and text messages for support persons over a 9-month intervention period. RESULTS: PWDs (N = 329) were 52 % male, 39 % reported minoritized race or ethnicity, with mean HbA1c 8.6 ± 1.7 %. FAMS improved HbA1c among PWDs with a non-cohabitating support person (-0.64 %; 95 % CI [-1.22 %, -0.05 %]), but overall mean effects were not significant. FAMS improved intervention targets including self-efficacy, dietary behavior, and family/friend involvement during the intervention period; these improvements mediated post-intervention HbA1c improvements (total indirect effect -0.27 %; 95 % CI [-0.49 %, -0.09 %]) and sustained HbA1c improvements at 12 months (total indirect effect -0.19 %; 95 % CI [-0.40 %, -0.01 %]). CONCLUSIONS: Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons suggesting future family interventions should emphasize inclusion of these relationships. Future work should also seek to identify intervention targets that mediate improvements in HbA1c.