Examining the Utility of a Telehealth Warm Handoff in Integrated Primary Care for Improving Patient Engagement in Mental Health Treatment: Randomized Video Vignette Study.

BACKGROUND: A warm handoff from a physician to a mental health provider is often patients' first contact with psychological services and provides a unique opportunity for improving treatment engagement in integrated primary care (IPC) settings. OBJECTIVE: In light of the COVID-19 pandemic, this study sought to examine the impact of different types of telehealth mental health referrals on both the anticipated likelihood of accepting treatment services and anticipated likelihood of continued treatment engagement. METHODS: A convenience sample of young adults (N=560) was randomized to view 1 of 3 video vignettes: warm handoff in IPC, referral as usual (RAU) in IPC, or RAU in standard primary care. RESULTS: Logistic associations between referral type and the likelihood of referral acceptance (χ21=10.9, P=.004) and the likelihood of continued engagement (χ21=32.6, P<.001) were significant. Participants who received a warm handoff were significantly more likely to anticipate both accepting the referral (b=0.35; P=.002; odds ratio 1.42, 95% CI 1.15-1.77) and engaging in continued treatment (b=0.62; P<.001; odds ratio 1.87, 95% CI 1.49-2.34) compared with those who received RAU in the standard primary care condition. Furthermore, 77.9% (436/560) of the sample indicated that they would be at least somewhat likely to access IPC mental health services for their own mental health concerns if they were readily available in their own primary care physician's office. CONCLUSIONS: A telehealth warm handoff resulted in the increased anticipated likelihood of both initial and continued engagement in mental health treatment. A telehealth warm handoff may have utility in fostering the uptake of mental health treatment. Nonetheless, a longitudinal assessment in a primary care clinic of the utility of a warm handoff for fostering referral acceptance and continued treatment engagement is needed to hone the adoptability of a warm handoff process and demonstrate practical evidence of effectiveness. The optimization of a warm handoff would also benefit from additional studies examining patient and provider perspectives about the factors affecting treatment engagement in IPC settings.

Efficacy of a Commercial Weight Management Program Compared With a Do-It-Yourself Approach: A Randomized Clinical Trial.

Importance: Given the prevalence of obesity, accessible and effective treatment options are needed to manage obesity and its comorbid conditions. Commercial weight management programs are a potential solution to the lack of available treatment, providing greater access at lower cost than clinic-based approaches, but few commercial programs have been rigorously evaluated. Objective: To compare the differences in weight change between individuals randomly assigned to a commercial weight management program and those randomly assigned to a do-it-yourself (DIY) approach. Design, Setting, and Participants: This 1-year, randomized clinical trial conducted in the United States, Canada, and United Kingdom between June 19, 2018, and November 30, 2019, enrolled 373 adults aged 18 to 75 years with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 25 to 45. Assessors were blinded to treatment conditions. Interventions: A widely available commercial weight management program that included reduced requirements for dietary self-monitoring and recommendations for a variety of DIY approaches to weight loss. Main Outcomes and Measures: The primary outcomes were the difference in weight change between the 2 groups at 3 and 12 months. The a priori hypothesis was that the commercial program would result in greater weight loss than the DIY approach at 3 and 12 months. Analyses were performed on an intention-to-treat basis. Results: The study include 373 participants (272 women [72.9%]; mean [SD] BMI, 33.8 [5.2]; 77 [20.6%] aged 18-34 years, 74 [19.8%] aged 35-43 years, 82 [22.0%] aged 44-52 years, and 140 [37.5%] aged 53-75 years). At 12 months, retention rates were 88.8% (166 of 187) for the commercial weight management program group and 95.7% (178 of 186) for the DIY group. At 3 months, participants in the commercial program had a mean (SD) weight loss of -3.8 (4.1) kg vs -1.8 (3.7) kg among those in the DIY group. At 12 months, participants in the commercial program had a mean (SD) weight loss of -4.4 (7.3) kg vs -1.7 (7.3) kg among those in the DIY group. The mean difference between groups was -2.0 kg (97.5% CI, -2.9 to -1.1 kg) at 3 months (P < .001) and -2.6 kg (97.5% CI, -4.3 to -0.8 kg) at 12 months (P < .001). A greater percentage of participants in the commercial program group than participants in the DIY group achieved loss of 5% of body weight at both 3 months (40.7% [72 of 177] vs 18.6% [34 of 183]) and 12 months (42.8% [71 of 166] vs 24.7% [44 of 178]). Conclusions and Relevance: Adults randomly assigned to a commercial weight management program with reduced requirements for dietary self-monitoring lost more weight and were more likely to achieve weight loss of 5% at 3 and 12 months than adults following a DIY approach. This study contributes data on the efficacy of commercial weight management programs and DIY weight management approaches. Trial Registration: ClinicalTrials.gov Identifier: NCT03571893.

Persistence of Depressive Symptoms and Risk of Incident Cardiovascular Disease With and Without Diabetes: Results from the REGARDS Study.

BACKGROUND: Baseline depressive symptoms are associated with subsequent adverse cardiovascular (CV) events in subjects with and without diabetes but the impact of persistent symptoms vs. improvement remains controversial. OBJECTIVE: Examine long-term changes in depressive symptoms in individuals with and without diabetes and the associated risk for adverse CV events. DESIGN: REGARDS is a prospective cohort study of CV risk factors in 30,000 participants aged 45 years and older. PARTICIPANTS: N = 16,368 (16.5% with diabetes mellitus) who remained in the cohort an average of 11.1 years later and who had complete data. MAIN MEASURES: Depressive symptoms were measured using the 4-item Centers for Epidemiologic Study of Depression (CES-D) questionnaire at baseline and again at a mean follow-up of 5.07 (SD = 1.66) years. Adjudicated incident stroke, coronary heart disease (CHD), CV mortality, and a composite outcome were assessed in a subsequent follow-up period of 6.1 (SD = 2.6) years. METHODS: The association of changes in depressive symptoms (CES-D scores) across 5 years with incident CV events was assessed using Cox proportional hazards modeling. KEY RESULTS: Compared to participants with no depressive symptoms at either time point, participants without diabetes but with persistently elevated depressive symptoms at both baseline and follow-up demonstrated a significantly increased risk of incident stroke (HR (95% CI) = 1.84 (1.03, 3.30)), a pattern which was substantially more prevalent in blacks (HR (95% CI) = 2.64 (1.48, 4.72)) compared to whites (HR (95% CI) = 1.06 (0.50, 2.25)) and in those not taking anti-depressants (HR (95% CI) = 2.01 (1.21, 3.35)) in fully adjusted models. CONCLUSIONS: The persistence of depressive symptoms across 5 years of follow-up in participants without diabetes identifies individuals at increased risk for incident stroke. This was particularly evident in black participants and among those not taking anti-depressants.

The influence of sex and maturation on carotid and vertebral artery hemodynamics and associations with free-living (in)activity in 6-17-year-olds.

We explored the influence of sex and maturation on resting cervical artery hemodynamics (common carotid artery, CCA; internal carotid artery, ICA; and vertebral artery, VA), free-living physical activity, and sedentary behavior in children 6-17 yr of age. In addition, we investigated the relationship between physical activity, sedentary behavior, and cervical artery hemodynamics. Seventy-eight children and adolescents, girls (n = 42; mean age, 11.4 ± 2.5 yr) and boys (n = 36; mean age, 11.0 ± 2.6 yr), completed anthropometric measures, duplex ultrasound assessment of the cervical arteries, and wore an activPAL accelerometer to assess physical activity (indexed by steps/day) and sedentary behavior for 7 days. The ICA and VA diameters were similar between prepubertal and pubertal groups, as was volumetric blood flow (Q); however, the CCA diameter was significantly larger in the pubertal group (P < 0.05). Boys were found to have larger diameters in all cervical arteries than girls, as well as higher QCCA, QICA, and global cerebral blood flow (P < 0.05). The pubertal group was more sedentary (100 min/day more; P < 0.05) and took 3,500 fewer steps/day than the prepubertal group (P < 0.05). Shear rate (SR) and Q of the cervical arteries showed no relationship to physical activity or prolonged bouts of sedentary behavior; however, a significant negative relationship was apparent between total sedentary time and internal carotid artery shear rate (ICASR) after covarying for steps/day and maturation (P < 0.05). These findings provide novel insight into the potential influence sedentary behavior may have on cerebrovascular blood flow in healthy girls and boys.NEW & NOTEWORTHY Cerebral blood flow is known to change with age; however, assessing these age-related changes is complex and requires consideration of pubertal status. This, to our knowledge, is the first study to investigate the influence of sex and maturation on resting cervical artery hemodynamics and subsequently explore associations with physical activity and sedentary behavior in healthy children and adolescents. Our findings suggest that habitual sedentary behavior may influence cervical artery hemodynamics in youth, independent of physical activity, maturation, and sex.

The Effect of Aerobic Training and Increasing Nonexercise Physical Activity on Cardiometabolic Risk Factors.

PURPOSE: Epidemiological studies suggest that sedentary behavior is an independent risk factor for cardiovascular mortality independent of meeting physical activity guidelines. However, limited evidence of this relationship is available from prospective interventions. The purpose of the present study is to evaluate the combined effect of aerobic training and increasing nonexercise physical activity on body composition and cardiometabolic risk factors. METHODS: Obese adults (N = 45) were randomized to 6 months of aerobic training (AERO), aerobic training and increasing nonexercise physical activity (~3000 steps above baseline levels; AERO-PA), or a control (CON) group. The AERO and AERO-PA groups performed supervised aerobic training (3-4 times per week). The AERO-PA group wore Fitbit One accelerometers and received behavioral coaching to increase nonexercise physical activity. RESULTS: There was a larger increase in fitness in the AERO-PA group (0.27 L·min-1; confidence interval (CI), 0.16 to 0.40 L·min-1) compared with the AERO group (0.09 L·min-1; CI, -0.04 to 0.22 L·min-1) and the CON group (0.01; CI, -0.11 to 0.12 L·min-1). Although significant findings were not observed in the entire study sample, when the analysis was restricted to participants compliant to the intervention (n = 33), we observed significant reductions in waist circumference, percent weight loss, body fat, 2-h glucose, and 2-h insulin in comparison to the CON group (P < 0.05), but not the AERO group. Furthermore, linear regression models showed that change in steps was associated with 21% and 26% of the variation in percent weight loss and percent fat loss, respectively. CONCLUSIONS: Increasing nonexercise physical activity with aerobic training may represent a viable strategy to augment the fitness response in comparison to aerobic training alone and has promise for other health indicators.

A Tailored Cognitive-Behavioural Intervention Produces Comparable Reductions in Regimen-Related Distress in Adults With Type 2 Diabetes Regardless of Insulin Use: 12-Month Outcomes From the COMRADE Trial.

OBJECTIVES: Our aim in this study was to determine whether a cognitive-behavioural therapy plus small changes lifestyle intervention can produce comparable improvements in insulin users vs patients not using insulin with uncontrolled type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms. METHODS: This study is a secondary analysis of Collaborative Care Management for Distress and Depression in Rural Diabetes Study, a randomized, controlled trial of a 16-session, severity-tailored cognitive-behavioural therapy plus small changes lifestyle intervention compared with usual care. Outcomes included glycated hemoglobin (A1C), regimen-related distress, depression, medication adherence and diabetes self-care. Our investigation provides 2 sets of contrasts: 1) insulin users in the intervention group compared with insulin users in the usual-care group and 2) insulin users compared with noninsulin users in the intervention group only. RESULTS: Of the 139 participants, 72 (52%) were using insulin at baseline and had significantly higher levels of A1C (10.2±2.1% vs 8.9±1.6%) and RRD (3.3±1.4 vs 2.8±1.1), and significantly poorer medication adherence (5.2±2.1 days/wk vs 5.5±1.7 days/wk). Intervention patients using insulin exhibited significantly greater reductions in RRD and marginally significant improvements in medication adherence and A1C compared with insulin users in usual care. Within the intervention group, changes in RRD, medication adherence and A1C did not differ significantly by insulin use. CONCLUSIONS: Tailored cognitive-behavioural therapy with a small-changes lifestyle intervention improved elevated RRD and A1C outcomes at least as effectively in insulin users as non‒insulin users. Future powered studies need to address the role of insulin use in uptake and treatment outcomes.

Does Happiness Improve Health? Evidence From a Randomized Controlled Trial.

Happier people are healthier, but does becoming happier lead to better health? In the current study, we deployed a comprehensive, 3-month positive psychological intervention as an experimental tool to examine the effects of increasing subjective well-being on physical health in a nonclinical population. In a 6-month randomized controlled trial with 155 community adults, we found effects of treatment on self-reported physical health-the number of days in the previous month that participants felt healthy or sick, as assessed by questions from the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System Questionnaire. In a subsample of 100 participants, we also found evidence that improvements in subjective well-being over the course of the program predicted subsequent decreases in the number of sick days. Combining experimental and longitudinal methodologies, this work provides some evidence for a causal effect of subjective well-being on self-reported physical health.

ENHANCE: Evidence for the efficacy of a comprehensive intervention program to promote subjective well-being.

Building from the growing empirical science of happiness, or subjective well-being (SWB), we have developed a 12-week comprehensive intervention program-Enduring Happiness and Continued Self-Enhancement (ENHANCE)-to increase SWB and enable a thorough examination of the mechanistic processes of program content and administrative structure for SWB change over time. In a randomized controlled trial, participants (N = 155; 55 using the in-person format, 100 online format) were randomly assigned to participate in ENHANCE or to a waitlist control condition. All participants completed assessments of SWB, including non-self-report measures, and process variables at baseline, posttest, and follow-up (3 months). We found evidence supporting the efficacy of ENHANCE for increasing SWB, whether administered in-person or online. Furthermore, development of the skills targeted in the program (e.g., gratitude, mindfulness) accounted for SWB improvements. This study provides initial evidence that ENHANCE can promote SWB and offers insights regarding the processes involved in these changes. To bolster these findings, we present additional data (n = 74) from a fourth assessment showing within-person maintenance of SWB gains over 6 months in the original treatment condition (n = 39) and a replication of the immediate ENHANCE treatment effects in the waitlist condition (n = 36). We discuss potential avenues for the utilization of ENHANCE in basic research and applied disseminations. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Randomized Trial of a Tailored Cognitive Behavioral Intervention in Type 2 Diabetes With Comorbid Depressive and/or Regimen-Related Distress Symptoms: 12-Month Outcomes From COMRADE.

OBJECTIVE: This study evaluated the effect of cognitive behavioral therapy (CBT) plus lifestyle counseling in primary care on hemoglobin A1c (HbA1c) in rural adult patients with type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms. RESEARCH DESIGN AND METHODS: This study was a randomized controlled trial of a 16-session severity-tailored CBT plus lifestyle counseling intervention compared with usual care. Outcomes included changes in HbA1c, RRD, depressive symptoms, self-care behaviors, and medication adherence across 12 months. RESULTS: Patients included 139 diverse, rural adults (mean age 52.6 ± 9.5 years; 72% black; BMI 37.0 ± 9.0 kg/m2) with T2D (mean HbA1c 9.6% [81 mmol/mol] ± 2.0%) and comorbid depressive or distress symptoms. Using intent-to-treat analyses, patients in the intervention experienced marginally significant improvements in HbA1c (-0.92 ± 1.81 vs. -0.31 ± 2.04; P = 0.06) compared with usual care. However, intervention patients experienced significantly greater improvements in RRD (-1.12 ± 1.05 vs. -0.31 ± 1.22; P = 0.001), depressive symptoms (-3.39 ± 5.00 vs. -0.90 ± 6.17; P = 0.01), self-care behaviors (1.10 ± 1.30 vs. 0.58 ± 1.45; P = 0.03), and medication adherence (1.00 ± 2.0 vs. 0.17 ± 1.0; P = 0.02) versus usual care. Improvement in HbA1c correlated with improvement in RRD (r = 0.3; P = 0.0001) and adherence (r = -0.23; P = 0.007). CONCLUSIONS: Tailored CBT with lifestyle counseling improves behavioral outcomes and may improve HbA1c in rural patients with T2D and comorbid depressive and/or RRD symptoms.

COMRADE: A randomized trial of an individually tailored integrated care intervention for uncontrolled type 2 diabetes with depression and/or distress in the rural southeastern US.

BACKGROUND: Emerging evidence suggests that people living with Type 2 diabetes mellitus (T2D) are also at greater risk for depression and distress. If left untreated, these comorbid mental health concerns can have long-lasting impacts on medical and physical health outcomes. DESIGN: This prospective trial randomized rural men and women with uncontrolled T2D (HbA1c ≥ 7.0) who screened positive for co-morbid depressive (PHQ-2 > 3) or distress (DDS-2 > 3) symptoms in a primary medical care setting to receive either: 1) 16 sessions of cognitive and/or behavioral intervention tailored to symptom severity across 12 months along with routine medical care, or 2) usual primary care. Outcomes included change from baseline to 12-months in HbA1c, diabetes related distress, depressive symptoms, and diabetes self-care activities. BASELINE RESULTS: 139 patients (Mean age = 52.6 ±â€¯9.6 years) with T2D from impoverished rural communities were enrolled (almost half reporting annual income of <$10,000 per year). Baseline data indicated that patients were experiencing profoundly uncontrolled T2D of a long duration (Mean HbA1c = 9.61 ±â€¯2.0; Mean BMI = 37.0 ±â€¯9.1; Mean duration = 11.2 ±â€¯8.9 years) along with high levels of distress (Mean DDS-17 Scale Score = 2.5 ±â€¯1.0) and/or depressive symptoms (Mean PHQ-9 Scale Score = 9.3 ±â€¯6.1). CONCLUSION: Patients with uncontrolled T2D of long duration manifest complex co-morbidities including associated obesity, depressive symptoms and/or diabetes related distress. A behavioral intervention for T2D that concurrently targets symptoms of depression and distress may lead to more effective outcomes in this high-risk population. CLINICAL TRIAL REGISTRATION: NCT02863523.

Weight Loss Strategies Utilized in a Men's Weight Loss Intervention.

Men are underrepresented in weight loss programs and little is currently known about the weight loss strategies men prefer. This study describes the weight loss strategies used by men during a men-only weight loss program. At baseline, 3 months, and 6 months, participants reported how frequently they used 45 weight loss strategies including strategies frequently recommended by the program (i.e., mentioned during every intervention contact; e.g., daily self-weighing), strategies occasionally recommended by the program (i.e., mentioned at least once during the program; e.g., reduce calories from beverages), and strategies not included in the program (e.g., increase daily steps). At baseline participants ( N = 107, 44.2 years, body mass index = 31.4 kg/m2, 76.6% White) reported regularly using 7.3 ± 6.6 ( M ± SD) strategies. The intervention group increased the number of strategies used to 19.1 ± 8.3 at 3 months and 17.1 ± 8.4 at 6 months with no changes in the waitlist group. The intervention group reported increased use of most of the strategies frequently recommended by the program (4 of 5), nearly half of the strategies occasionally recommended by the program (10 of 24), and one strategy not included in the program (of 16) at 6 months. The intervention effect at 6 months was significantly mediated by the number of strategies used at 3 months. This study adds to what is known about men's use of weight loss strategies prior to and during a formal weight loss program and will help future program developers create programs that are tailored to men.

A Community Health Worker-Delivered Intervention in African American Women with Type 2 Diabetes: A 12-Month Randomized Trial.

OBJECTIVE: To evaluate the effectiveness of a community health worker (CHW)-delivered lifestyle intervention for African American women with type 2 diabetes. METHODS: Participants were randomized to either 16 phone-based lifestyle intervention sessions aimed at making small changes in their diet and activity or 16 educational mailings sent across 12 months. Main outcomes included glycosylated hemoglobin (HbA1c), blood pressure (BP), and weight (kg) changes. RESULTS: Two hundred middle-aged (mean = 53 ± 10.24 years), rural, African American women with moderate obesity (mean BMI = 37.7 ± 8.02) and type 2 diabetes (mean HbA1c = 9.1 ± 1.83) were enrolled. At 12 months, the intervention group exhibited no significant differences in HbA1c (-0.29 ± 1.84 vs. + 0.005 ± 1.61; P = 0.789) or BP (-1.01 ± 20.46/+0.66 ± 13.24 vs. + 0.22 ± 25.33/-2.87 ± 1.52; P = 0.100) but did exhibit greater weight loss (-1.35 ± 6.22 vs. -0.39 ± 4.57 kg, respectively; P = 0.046) compared with controls. Exploratory post hoc analyses revealed that participants not using insulin had significantly greater reductions in HbA1c (-0.70 ± 1.86 vs. + 0.07 ± 2.01; P = 0.000), diastolic BP (-5.17 ± 14.16 vs. -3.40 ± 14.72 mmHg; P = 0.035), and weight (-2.36 ± 6.59 vs. -1.64 ± 4.36 kg; P = 0.003) compared to controls not on insulin. CONCLUSIONS: A phone-based CHW intervention resulted in no significant improvements in HbA1c or BP but did demonstrate modest improvements in weight. Women not using insulin showed significant improvements in all primary outcomes.

The effects of a low-dose physical activity intervention on physical activity and body mass index in severely obese adolescents.

Background While severe obesity in childhood poses the greatest long-term health risks, access to treatment is a common barrier. The present pilot study examined the effect of a 7-week low-dose physical activity (PA) intervention on PA and body mass index (BMI) in severe obese adolescents delivered via telephone and mail. Methods Adolescents (n = 64) receiving care from a pediatric obesity medical clinic were randomized to a control (n = 30) or intervention (n = 34) group. Height and weight were measured and BMI z-scores were calculated. PA was assessed by a pedometer. All measurements were completed pre- and post-intervention. The intervention group received weekly newsletters and telephone calls discussing various PA topics based on motivational interviewing for 7 weeks. The control group received no contact. A series of 2 × 2 (group by time) repeated measures analysis of covariances (ANCOVAs) adjusting for length of time between visits were performed to examine the effect of the intervention on PA and BMI z-scores. Results The majority of adolescents were severely obese (77%, BMI: > 99th percentile). Intention-to-treat analysis revealed intervention effects were not observed for either pedometer steps or BMI z-score (p > 0.05). Among those with complete data, adolescents who successfully changed their BMI z-score had larger BMI z-score changes than those who did not change their BMI z-score (p = 0.0001). This improvement was due to something other than PA as the change in BMI z-score was similar among those who did and did not successfully increase PA levels (p > 0.05). Conclusions More intensive, comprehensive, and longer-term treatment is needed in this high risk population.

Impact of Distress Reduction on Behavioral Correlates and A1C in African American Women with Uncontrolled Type 2 Diabetes: Results from EMPOWER.

OBJECTIVE: Symptoms of emotional distress related to diabetes have been associated with inadequate self-care behaviors, medication non-adherence, and poor glycemic control that may predispose patients to premature death. African American women, in whom diabetes is more common and social support is often insufficient, may be at particularly high risk. The objective of this study was to examine the impact of lowering diabetes-related emotional distress on glycemic control and associated behavioral correlates in rural African American women with uncontrolled type 2 diabetes (T2D). DESIGN: Post-hoc analysis of prospective, randomized, controlled trial. SETTING: Rural communities in the southeastern United States. PATIENTS: 129 rural middle-aged African American women with uncontrolled type 2 diabetes (T2D)(A1C ≥ 7.0). PRIMARY INDEPENDENT VARIABLE: Diabetes-related distress. MAIN OUTCOME MEASURES: Changes from baseline to 12-month follow-up in diabetes-related distress, and associated changes in medication adherence, self-care activities, self-efficacy, and glycemic control (A1C). RESULTS: Patients with a reduction in diabetes-related distress (n=79) had significantly greater improvement in A1C, medication adherence, self-care activities, and self-efficacy compared with those in whom diabetes distress worsened or was unchanged (n=50). Changes in distress were also significantly and inversely correlated with improvements in medication adherence, self-care activities, and self-efficacy. CONCLUSIONS: Among rural African American women, reductions in diabetes-related distress may be associated with lower A1C and improvements in self-efficacy, self-care behaviors, and medication adherence.

Behavioral Treatment for Veterans with Obesity: 24-Month Weight Outcomes from the ASPIRE-VA Small Changes Randomized Trial.

BACKGROUND: Small Changes (SC) is a weight management approach that demonstrated superior 12-month outcomes compared to the existing MOVE!® Weight Management Program at two Veterans Affairs (VA) sites. However, approaches are needed to help graduates of treatment continue to lose or maintain their weight over the longer term. OBJECTIVE: The purpose of the present study was to examine the effectiveness of a second year of low-intensity SC support compared to support offered by the usual care MOVE! programs. DESIGN: Following participation in the year-long Aspiring to Lifelong Health in VA (ASPIRE-VA) randomized controlled trial, participants were invited to extend their participation in their assigned program for another year. Three programs were extended to include six SC sessions delivered via telephone (ASPIRE-Phone) or an in-person group (ASPIRE-Group), or 12 sessions offered by the MOVE! programs. PARTICIPANTS: Three hundred thirty-two overweight/obese veterans who consented to extend their participation in the ASPIRE-VA trial by an additional year. MAIN MEASURES: Twenty-four-month weight change (kg). KEY RESULTS: Twenty-four months after baseline, participants in all three groups had modest weight loss (-1.40 kg [-2.61 to -0.18] in the ASPIRE-Group, -2.13 kg [-3.43 to -0.83] in ASPIRE-Phone, and -1.78 kg [-3.07 to -0.49] in MOVE!), with no significant differences among the three groups. Exploratory post hoc analyses revealed that participants diagnosed with diabetes initially benefited from the ASPIRE-Group program (-2.6 kg [-4.37 to 0.83]), but experienced significant weight regain during the second year (+2.8 kg [0.92-4.69]) compared to those without diabetes. CONCLUSIONS: Participants in all three programs lost weight and maintained a statistically significant, though clinically modest, amount of weight loss over a 24-month period. Although participants in the ASPIRE-Group initially had greater weight loss, treatment was not sufficient to sustain weight loss through the second year, particularly in veterans with diabetes. Consistent, continuous-care treatment is needed to address obesity in the VA.

Mental health and behavioral weight loss: 24-month outcomes in Veterans.

BACKGROUND: Individuals with mental health (MH) disorders have an increased risk of being overweight/obese; however research on behavioral weight loss interventions has been limited. A priori hypothesis was that Veterans with serious mental illness (SMI) and/or affective disorders (AD) would lose significantly less weight and have a different pattern of weight loss than Veterans without these diagnoses. METHODS: Secondary data analysis of ASPIRE-VA study, three-arm randomized, effectiveness weight loss trial among Veterans (n=409) categorized by MH diagnoses: 1) SMI, 2) AD without SMI, or 3) No SMI/No AD. Linear mixed-effects model analyzed weight changes from baseline thru 24 months. RESULTS: SMI and AD were diagnosed in 10% (n=41) and 31% (n=125). Participants attended approximately 15 sessions from baseline to 24 months. On average, participants lost a modest amount of weight over 24 months regardless of MH diagnosis. Longitudinally, no statistically significant differences were found in weight loss patterns by MH diagnosis. Unadjusted average weight loss (kg) was 1.6±4.0 at 3 months (n=373), 1.9±6.5 at 12 months (n=361), 1.5±7.8 at 18 months (n=289), and 1.4±8.0 at 24 months (n=279). LIMITATIONS: ASPIRE-VA study was not designed or powered to detect weight loss differences among MH diagnostic groups. CONCLUSIONS: Veterans achieved and maintained modest weight loss, through 24 months, with the three behavioral weight loss interventions. Contrary to our hypotheses, the amount and pattern of weight loss did not differ by MH diagnosis. Greater inclusion of individuals with MH diagnoses may be warranted in behavioral weight loss interventions not specifically tailored for them.

ENHANCE: Design and rationale of a randomized controlled trial for promoting enduring happiness & well-being.

Individuals who are higher in subjective well-being not only feel happier, they are more likely have fulfilling relationships, increased work performance and income, better physical health, and longer lives. Over the past several decades, the science of subjective well-being has produced insights into these benefits of happiness, and-recognizing their importance-has begun to examine the factors that lead to greater well-being, from cultivating strong relationships to pursuing meaningful goals. However, studies to date have typically focused on improving subjective well-being by intervening with singular constructs, using primarily college student populations, and were short-term in nature. Moreover, little is understood about the impact of a well-being treatment delivered online vs. in-person. In the present article, we describe a comprehensive intervention program including 3-month initial treatment followed by a 3-month follow-up, ENHANCE: Enduring Happiness and Continued Self-Enhancement. One-hundred and sixty participants will be recruited from two different sites to participate in one of two versions of ENHANCE: in-person (n=30) vs. wait-list control (n=30); or online (n=50) vs. wait-list control (n=50). Assessments will be completed at baseline, three months and six months. Our primary outcome is change in subjective well-being across treatment (3months) and follow-up (6months). Secondary outcomes include self-report and objective measures of health, as well as a psychological mediators (e.g., psychological needs) and moderators (e.g., personality) of treatment outcomes. We hope to provide researchers, practitioners, and individuals with an evidence-based treatment to improve happiness and subjective well-being.

Development and validation of the ASPIRE-VA coaching fidelity checklist (ACFC): a tool to help ensure delivery of high-quality weight management interventions.

Practical and valid instruments are needed to assess fidelity of coaching for weight loss. The purpose of this study was to develop and validate the ASPIRE Coaching Fidelity Checklist (ACFC). Classical test theory guided ACFC development. Principal component analyses were used to determine item groupings. Psychometric properties, internal consistency, and inter-rater reliability were evaluated for each subscale. Criterion validity was tested by predicting weight loss as a function of coaching fidelity. The final 19-item ACFC consists of two domains (session process and session structure) and five subscales (sets goals and monitor progress, assess and personalize self-regulatory content, manages the session, creates a supportive and empathetic climate, and stays on track). Four of five subscales showed high internal consistency (Cronbach alphas > 0.70) for group-based coaching; only two of five subscales had high internal reliability for phone-based coaching. All five sub-scales were positively and significantly associated with weight loss for group- but not for phone-based coaching. The ACFC is a reliable and valid instrument that can be used to assess fidelity and guide skill-building for weight management interventionists.

Theoretical and Behavioral Mediators of a Weight Loss Intervention for Men.

OBJECTIVE: Men are currently underrepresented in weight loss trials despite similar obesity rates, which limit our understanding about the most effective elements of treatment for men. The purpose of this study was to test the theoretical (autonomous motivation, self-efficacy, outcome expectancies, and self-regulation) and behavioral (calorie intake, physical activity, self-weighing) mediators of a men-only, Internet-delivered weight loss intervention focused on innovative and tailored treatment elements specifically for men. METHOD: Data comes from a 6-month randomized trial (N = 107) testing the intervention compared to a waitlist control group. Changes in the theoretical mediators between baseline and 3 months were tested as mediators of the intervention effect on weight change at 6 months in both single and multiple mediator models. Changes in behaviors between baseline and 6 months were tested in the same manner. RESULTS: The intervention produced greater weight losses compared to the control group (-5.57 kg ± 6.6 vs. -0.65 kg ± 3.3, p < 0.001) and significant changes (p's < 0.05) in most of the theoretical and behavior mediators. In multiple mediator models, changes in diet-related autonomous motivation, self-efficacy, and self-regulation all significantly mediated the relationship between the intervention and weight loss. The intervention effect was also mediated by changes in dietary intake and self-weighing frequency. CONCLUSIONS: By testing the theoretical mediators of this intervention in a multiple mediator context, this study contributes to current knowledge related to the development of weight loss interventions for men and suggests that interventions should target diet-focused constructs.

The intervention composed of aerobic training and non-exercise physical activity (I-CAN) study: Rationale, design and methods.

Recent data has suggested that prolonged sedentary behavior is independent risk factor for cardiovascular and all-cause mortality independent of adequate amounts of moderate to vigorous physical activity. However, few studies have prospectively evaluated if exercise training and increasing non-exercise physical activity leads to greater reduction in cardiometabolic risk compared to aerobic training alone. The purpose of the Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN) study is to determine whether a physical activity program composed of both aerobic training (consistent with public health recommendations) and increasing non-exercise physical activity (3000 steps above baseline levels) leads to enhanced improvements in waist circumference, oral glucose tolerance, systemic inflammation, body composition, and fitness compared to aerobic training alone in obese adults (N=45). Commercially available accelerometers (Fitbits) will be used to monitor physical activity levels and behavioral coaching will be used to develop strategies of how to increase non-exercise physical activity levels. In this manuscript, we describe the design, rationale, and methodology associated with the I-CAN study.