Interventions to Support Behavioral Self-Management of Chronic Diseases.

A majority of the US adult population has one or more chronic conditions that require medical intervention and long-term self-management. Such conditions are among the 10 leading causes of mortality; an estimated 86% of the nation's $2.7 trillion in annual health care expenditures goes toward their treatment and management. Patient self-management of chronic diseases is increasingly essential to improve health behaviors, health outcomes, and quality of life and, in some cases, has demonstrated effectiveness for reducing health care utilization and the societal cost burden of chronic conditions. This review synthesizes the current state of the science of chronic disease self-management interventions and the evidence for their effectiveness, especially when applied with a systematic application of theories or models that account for a wide range of influences on behavior. Our analysis of selected outcomes from randomized controlled trials of chronic disease self-management interventions contained in 10 Cochrane systematic reviews provides additional evidence to demonstrate that self-management can improve quality of life and reduce utilization across several conditions.

The Prevalence of Cognitive Impairment Among Adults With Incident Heart Failure: The "Reasons for Geographic and Racial Differences in Stroke" (REGARDS) Study.

BACKGROUND: Cognitive impairment (CI) is estimated to be present in 25%-80% of heart failure (HF) patients, but its prevalence at diagnosis is unclear. To improve our understanding of cognition in HF, we determined the prevalence of CI among adults with incident HF in the REGARDS study. METHODS AND RESULTS: REGARDS is a longitudinal cohort study of adults ≥45 years of age recruited in the years 2003-2007. Incident HF was expert adjudicated. Cognitive function was assessed with the Six-Item Screener. The prevalence of CI among those with incident HF was compared with the prevalence of CI among an age-, sex-, and race-matched cohort without HF. The 436 participants with incident HF had a mean age of 70.3 years (SD 8.9), 47% were female, and 39% were black. Old age, black race, female sex, less education, and anticoagulation use were associated with CI. The prevalence of CI among participants with incident HF (14.9% [95% CI 11.7%-18.6%]) was similar to the non-HF matched cohort (13.4% [11.6%-15.4%]; P < .43). CONCLUSIONS: A total of 14.9% of the adults with incident HF had CI, suggesting that the majority of cognitive decline occurs after HF diagnosis. Increased awareness of CI among newly diagnosed patients and ways to mitigate it in the context of HF management are warranted.

Nocturnal systemic hypotension increases the risk of glaucoma progression.

OBJECTIVE: The objective of this prospective, longitudinal study of patients with normal-tension glaucoma (NTG) was to determine whether patients with nocturnal hypotension are at greater risk for visual field (VF) loss over 12 months than those without nocturnal hypotension. DESIGN: Prospective, longitudinal study. PARTICIPANTS: Consecutive patients with NTG with at least 5 prior VF tests were screened for eligibility. METHODS: The baseline evaluation assessed demographic and clinical characteristics, covering systemic comorbid conditions, including systemic hypertension. All oral and ophthalmologic medications were recorded. A complete ophthalmological examination was performed at baseline and follow-up. Patients had their blood pressure (BP) monitored every 30 minutes for 48 hours with an ambulatory recording device at baseline and 6 and 12 months. MAIN OUTCOME MEASURES: The primary outcome was based on the global rates of VF progression by linear regression of the mean VF threshold sensitivity over time (decibels/year). RESULTS: Eighty-five patients with NTG (166 eyes; mean age, 65 years; 67% were women) were included. Of the 85 patients, 29% had progressed in the 5 VFs collected before study enrollment. The nocturnal mean arterial pressure (MAP) was compared with the daytime MAP. Multivariate analysis showed that the total time that sleep MAP was 10 mmHg below the daytime MAP was a significant predictor of subsequent VF progression (P<0.02). CONCLUSIONS: Cumulative nocturnal hypotension predicted VF loss in this cohort. Our data suggest that the duration and magnitude of decrease in nocturnal blood pressure below the daytime MAP, especially pressures that are 10 mmHg lower than daytime MAP, predict progression of NTG. Low nocturnal blood pressure, whether occurring spontaneously or as a result of medications, may lead to worsening of VF defects.

Financial exploitation of older adults: a population-based prevalence study.

BACKGROUND: Financial exploitation is the most common and least studied form of elder abuse. Previous research estimating the prevalence of financial exploitation of older adults (FEOA) is limited by a broader emphasis on traditional forms of elder mistreatment (e.g., physical, sexual, emotional abuse/neglect). OBJECTIVES: 1) estimate the one-year period prevalence and lifetime prevalence of FEOA; 2) describe major FEOA types; and 3) identify factors associated with FEOA. DESIGN: Prevalence study with a random, stratified probability sample. PARTICIPANTS: Four thousand, one hundred and fifty-six community-dwelling, cognitively intact adults age ≥ 60 years. SETTING: New York State. MAIN MEASURES: Comprehensive tool developed for this study measured five FEOA domains: 1) stolen or misappropriated money/property; 2) coercion resulting in surrendering rights/property; 3) impersonation to obtain property/services; 4) inadequate contributions toward household expenses, but respondent still had enough money for necessities and 5) respondent was destitute and did not receive necessary assistance from family/friends. KEY RESULTS: One-year period FEOA prevalence was 2.7% (95% CI, 2.29-3.29) and lifetime prevalence was 4.7% (95% CI, 4.05-5.34). Greater relative risk (RR) of one-year period prevalence was associated with African American/black race (RR, 3.80; 95 % CI, 1.11-13.04), poverty (RR, 1.72; 95 % CI, 1.09-2.71), increasing number of non-spousal household members (RR, 1.16; 95 % CI, 1.06-1.27), and ≥ 1 instrumental activity of daily living (IADL) impairments (RR, 1.69; 95 % CI, 1.12-2.53). Greater RR of lifetime prevalence was associated with African American/black race (RR, 2.61; 95 % CI, 1.37-4.98), poverty (RR, 1.47; 95 % CI, 1.04-2.09), increasing number of non-spousal household members (RR, 1.16; 95 % CI, 1.12-1.21), and having ≥1 IADL (RR, 1.45; 95 % CI, 1.11-1.90) or ≥1 ADL (RR, 1.52; 95 % CI, 1.06-2.18) impairment. Living with a spouse/partner was associated with a significantly lower RR of lifetime prevalence (RR, 0.39; 95 % CI, 0.26-0.59) CONCLUSIONS: Financial exploitation of older adults is a common and serious problem. Elders from groups traditionally considered to be economically, medically, and sociodemographically vulnerable are more likely to self-report financial exploitation.

Contemplative self healing in women breast cancer survivors: a pilot study in underserved minority women shows improvement in quality of life and reduced stress.

BACKGROUND: Among underserved, largely minority women who were breast cancer survivors, this pilot project was designed to evaluate the quality of life outcomes of a 20 week Contemplative Self-Healing Program. METHODS: Women previously treated for stage I-III breast cancer were assessed before and after the 20 week program with the FACT-G, FACT-B, FACIT-Spirituality, ECOG, and the Impact of Events Scale. They participated in a 20-week intervention involving guided meditation and cognitive-affective-behavioral learning. RESULTS: With an average age of 63, 62% of the participants were African-American or Latino. With an average of 5.4 years since the diagnosis of breast cancer, 72% had an ECOG performance status of 1. 57% were currently working. Their baseline FACT-G was 80.5 ± 15.1, and their baseline Impact of Events Scale was 26.3 ± 18.9. The within-patient improvement on the FACT-G was 4.6 ± 10.9 (p = .01); in parallel the FACT-B improved by 2.8 ± 12.8 points (p = .03). The Impact of Events Scale improved by 6.6 ± 15.5 points (p = .01). There was significant within-patient improvement on both the avoidance scale (3.8 ± 9.2) and on the intrusion scale (2.9 ± 7.9). Patients who attended more sessions and conducted more home practice had greater improvements in quality of life. CONCLUSION: Persons receiving a 20-session contemplative self healing intervention showed improved quality of life, with a clinically and statistically significant increase in the FACT-G. In addition, this population showed a significant reduction in post-traumatic stress symptoms assessed by the Impact of Events Scale. TRIAL REGISTRATION: Clinical Trials Gov NCT00278837.

Perspectives on bullying among children who present to the emergency department with behavioral misconduct: a qualitative study.

UNLABELLED: The problem of bullying is an increasing public health threat encountered by emergency physicians especially in inner city emergency departments (EDs). Bullying may result in emotional disturbances and psychological trauma in children. Many children sent to the ED because of behavioral misconduct require immediate stabilization and treatment. The emergency physician performs an initial assessment and stabilization. Emergency departments are increasingly on the frontline of the bullying problem. OBJECTIVES: Our objective was to explore children's perspective of bullying and their views of potential solutions. METHODS: A qualitative study was conducted in a cohort of 50 children (age, 8-17 years), who were referred to the ED from school because of their behavioral misconduct. An interview survey tool about bullying was administered. It focused on what bullying meant to them and what advice they have for a child who is bullied. They were also asked what advice they would have for adults who try to help. We used grounded theory to analyze the data. Similar concepts were grouped, and the categories with similar properties and dimensions were defined. Common themes were then identified. RESULTS: We interviewed 50 children, of whom 27 were boys and 23 were girls. Their mean (SD) age was 12.5 (2.12) years (range, 8-17 years). Bullying was identified by children as including physical, verbal, and emotional actions. Several themes emerged. First, a power imbalance between a bully and victim may render an individual vulnerable to bullying. Being different and weak also increases the risk of being bullied. Second, bullying is wrong, and the bully should be punished. Third, children should learn how to handle bullying situations and develop resilience against bullying. Finally, adults need to be more proactive to prevent or stop bullying. CONCLUSIONS: Our results provide insights into the perceptions of children regarding bullying. We have garnered a better understanding of what these children feel adults should do to prevent bullying.

Recruitment and retention techniques for developing faith-based research partnerships, New York city, 2009-2012.

BACKGROUND: Faith-based organizations are recognized as an influential venue for behavioral health interventions. However, less is known about efficient approaches for identifying and recruiting these organizations and about the processes that enable successful partnership. COMMUNITY CONTEXT: In 2007, 66% of Latinos and 70% of blacks in New York City reported being overweight or obese. Project SCALE (Small Changes and Lasting Effects) is a 5-year randomized behavioral weight loss intervention trial aimed to help black and Latino adults lose weight by making small changes in eating behaviors and daily leisure physical activity. The study partnered with faith-based organizations. METHODS: Faith-based organizations were identified primarily through direct referrals. Recruitment consisted of screening faith-based organizations, establishing a memorandum of understanding, and intervention modification. Partnership maintenance occurred primarily via progress meetings. OUTCOMES: We identified processes that supported and impeded study recruitment and retention. Obtaining leadership support and using group orientation sessions were successful recruitment and retention processes. A balance must be found between leadership, advocacy, and causing members to feel pressured to participate in the study. INTERPRETATION: Behavioral health interventions implemented in faith-based organizations can reduce health disparities. However, researchers must determine whether faith-based organizations have the capacity to partner in intensive interventions. Focusing on the establishment of strong partnerships at the onset will help ensure that mutual objectives are achieved and sustained long-term.

Attrition in longitudinal randomized controlled trials: home visits make a difference.

BACKGROUND: Participant attrition in longitudinal studies can introduce systematic bias, favoring participants who return for follow-up, and increase the likelihood that those with complications will be underestimated. Our aim was to examine the effectiveness of home follow-up (Home F/U) to complete the final study evaluation on potentially "lost" participants by: 1) evaluating the impact of including and excluding potentially "lost" participants (e.g., those who required Home F/U to complete the final evaluation) on the rates of study complications; 2) examining the relationship between timing and number of complications on the requirement for subsequent Home F/U; and 3) determining predictors of those who required Home F/U. METHODS: We used data from a randomized controlled trial (RCT) conducted from 1991-1994 among coronary artery bypass graft surgery patients that investigated the effect of High mean arterial pressure (MAP) (intervention) vs. Low MAP (control) during cardiopulmonary bypass on 5 complications: cardiac morbidity/mortality, neurologic morbidity/mortality, all-cause mortality, neurocognitive dysfunction and functional decline. We enhanced completion of the final 6-month evaluation using Home F/U. RESULTS: Among 248 participants, 61 (25%) required Home F/U and the remaining 187 (75%) received Routine F/U. By employing Home F/U, we detected 11 additional complications at 6 months: 1 major neurologic complication, 6 cases of neurocognitive dysfunction and 4 cases of functional decline. Follow-up of 61 additional Home F/U participants enabled us to reach statistical significance on our main trial outcome. Specifically, the High MAP group had a significantly lower rate of the Combined Trial Outcome compared to the Low MAP group, 16.1% vs. 27.4% (p=0.032). In multivariate analysis, participants who were ≥ 75 years (OR=3.23, 95% CI 1.52-6.88, p=0.002) or on baseline diuretic therapy (OR=2.44, 95% CI 1.14-5.21, p=0.02) were more likely to require Home F/U. In addition, those in the Home F/U group were more likely to have sustained 2 or more complications (p=0.05). CONCLUSIONS: Home visits are an effective approach to reduce attrition and improve accuracy of study outcome reporting. Trial results may be influenced by this method of reducing attrition. Older participants, those with greater medical burden and those who sustain multiple complications are at higher risk for attrition.

The adaptive neuroplasticity hypothesis of behavioral maintenance.

Physical activity is a seemingly simple and clinically potent method to decrease morbidity and mortality in people with coronary heart disease (CHD). Nonetheless, long-term maintenance of physical activity remains a frustratingly elusive goal for patients and practitioners alike. In this paper, we posit that among older adults with CHD, recidivism after the initiation of physical activity reflects maladaptive neuroplasticity of malleable neural networks, and people will revert back to learned and habitual physical inactivity patterns, particularly in the setting of stress or depression. We hypothesize that behavioral interventions that successfully promote physical activity may also enhance adaptive neuroplasticity and play a key role in the maintenance of physical activity through the development of new neuronal pathways that enhance functional ability in older adults. Conversely, without such adaptive neuroplastic changes, ingrained maladaptive neuroplasticity will prevail and long-term maintenance of physical activity will fail. In this paper we will: (1) describe the enormous potential for neuroplasticity in older adults; (2) review stress and depression as examples of maladaptive neuroplasticity; (3) describe an example of adaptive neuroplasticity achieved with a behavioral intervention that induced positive affect in people with CHD; and (4) discuss implications for future work in bench to bedside translational research.

Patient care outside of office visits: a primary care physician time study.

BACKGROUND: Patient care provided by primary care physicians outside of office visits is important for care coordination and may serve as a substitute for office visits. OBJECTIVES: To describe primary care physicians' ambulatory patient care activities outside of office visits ("AOVs") and their perceptions of the extent to which AOVs substitute for visits and may be performed by support staff. DESIGN: Cross-sectional direct observational study. PARTICIPANTS: Thirty-three general internists in 20 practices in two health care systems (one public, one private) in the New York metropolitan area. MAIN MEASURES: Duration of AOVs by type of activity and whether they pertain to a patient visit on the study day (visit specific) or not (non-visit specific). Physician perceptions of the: (1) extent that non-visit-specific AOVs substitute for visits that would have otherwise occurred, (2) extent that visits that occurred could have been substituted for by AOVs, and (3) potential role of support staff in AOVs. KEY RESULTS: Physicians spent 20% of their workday performing AOVs, 62% of which was for non-visit specific AOVs. They perceived that a median of 37% of non-visit-specific AOV time substituted for visits, representing a potential five visits saved per day. They also perceived that 15% of total AOV time (excluding charting) could be performed by support staff. Forty-two percent of physicians indicated that one or more visits during the study day could be substituted for by AOVs. CONCLUSIONS: Though time spent on AOVs is generally not reimbursed, primary care general internists spent significant time performing AOVs, much of which they perceived to substitute for visits that would otherwise have occurred. Policies supporting physician and staff time spent on AOVs may reduce health care costs, save time for patients and physicians, and improve care coordination.

Vasectomy in Men without Children: Demographics and Family Planning Attitudes from the National Survey for Family Growth.

INTRODUCTION: To investigate the ethically challenging scenario of a childless man requesting a vasectomy, we compared vasectomy reversal rates and family planning attitudes in men who underwent vasectomy with and without fathering a child. METHODS: We performed an analysis of the 2002 to 2006, 2006 to 2010, 2011 to 2013, 2013 to 2015 and 2015 to 2017 waves of the National Survey for Family Growth, a nationally representative survey of family planning in the United States. We compared demographic information and family planning attitudes among men who had undergone vasectomy with and without having children. RESULTS: Of the 29,192 men surveyed 1,043 (3.6%) reported undergoing a vasectomy. Of the men reporting vasectomy, 4.4% (95% CI 3.2-6.0) underwent the procedure without having had children. Compared to men with children, men without children were less likely to have ever been married and were more likely to not identify with any religion. Whereas 1.2% (95% CI 0.5-2.4) of men with children underwent vasectomy reversal during the followup, 0% of men without children underwent reversal. CONCLUSIONS: Men who undergo vasectomy without having children constitute a small but distinct population of men. During 7-year followup after vasectomy, men who have not fathered children do not express higher rates of postvasectomy regret.

The effect of a contemplative self-healing program on quality of life in women with breast and gynecologic cancers.

Stress-related symptoms-intense fear, avoidance, intrusive thoughts--are common among breast and gynecologic cancer patients after chemotherapy and radiation. The objective of this pilot study was to determine the impact of a 20-week contemplative self-healing program among breast and gynecologic cancer survivors on self-reported quality of life (QOL), the main outcome. Assessments were performed at the first session and at 20 weeks, including QOL (FACIT-G, FACIT subscales, SF-36), anxiety, and depression (HADS). Biologic markers of immune function were obtained. A 20-week program was implemented: the initial 8 weeks addressed open-mindfulness, social-emotional self-care, visualization, and deep breathing followed by 12 weeks of exposing stress-reactive habits and developing self-healing insights. Daily practice involved CD-guided meditation and manual contemplations. Sixty-eight women were enrolled, and 46 (68%) completed the program. Participants had significant within-patient changes on FACIT-G, improving by a mean of 6.4 points. In addition, they reported clinically important improvement in emotional and functional domains and social, role-emotional, and mental health status domains on SF-36. Biologic data revealed significant improvement in maximum AM cortisol and a reduction in resting heart rate at 20 weeks. These findings suggest a contemplative self-healing program can be effective in significantly improving QOL and reducing distress and disability among female breast and gynecologic cancer survivors.

Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: rationale, trial design, and methods.

Secondary prevention of adverse outcomes in patients with cardiopulmonary disease requires that patients become actively engaged in self-management efforts such as participation in physical activity or medication adherence. However, despite assiduous efforts to find strategies that help cardiovascular patients to adopt and maintain such behaviors, many studies of interventions designed to improve physical activity and adherence to medication have shown disappointing results. To this end, the Translational Behavioral Science Research Consortium was created by the National Heart, Lung, and Blood Institute to identify promising, but underutilized findings from basic behavioral science that might have potential application for translation to clinical populations where behavioral change has been refractory to standard intervention approaches. This paper describes the rationale and methods of a novel research project designed to test the efficacy of a behavioral intervention that combines constructs from two behavioral science theories (positive affect and self-affirmation) in order to help patients with coronary artery disease, asthma, and hypertension successfully change behaviors. The project consists of an intervention framed upon positive affect and self-affirmation and tested in three concurrent randomized controlled trials among three distinct populations. Each trial had a qualitative phase that served as a formative stage to inform the intervention; a pilot phase during which the feasibility of the intervention was tested and refined; and a randomized controlled phase conducted to investigate the effects of the interventions in these three patient groups.

Stress and Response to Treatment: Insights From a Pilot Study Using a 4-week Contemplative Self-Healing Meditation Intervention for Posttraumatic Stress in Breast Cancer.

Along with symptoms of anxiety and depression, many breast cancer survivors experience symptoms of posttraumatic stress disorder (PTSD) that may worsen in the setting of other stressful life events. The aim of this pilot study was to evaluate whether a 4-week version of our Contemplative Self-Healing program would have different effects in reducing PTSD symptoms between breast cancer survivors with or without chronic stress at baseline. PTSD symptoms were measured using the Impact of Events scale (IES). A linear mixed model analysis was used to evaluate within patients changes in IES score. Results showed that breast cancer patients who were experiencing chronic stress reported greater improvement in IES score than those without chronic stress. Our preliminary findings shed light on the need to evaluate life stressors in breast cancer patients. Evaluating chronic stress may be essential in predicting which cancer patients may benefit most from a psychological intervention.

Innovative approaches to weight loss in a high-risk population: The small changes and lasting effects (SCALE) trial.

OBJECTIVE: To evaluate the efficacy of a small change behavioral weight loss intervention with or without a positive affect/self-affirmation (PA/SA) component on weight loss at 12 months. METHODS: Black and Hispanic adults (N = 405) with body mass index 25-50 kg/m2 selected one of ten small change eating strategies and a physical activity goal, randomly with/without PA/SA. Participants were followed by community health workers at set intervals (weekly in months 1-3; biweekly in months 4-9; once monthly in months 10-12). RESULTS: There was no difference in weight loss at 12 months between participants in the small change approach alone (1.1%) versus the small change PA/SA intervention (1.2%). During treatment, 9% of participants lost at least 7% of their initial body weight. Participants who reported more interval life events had a lower likelihood of losing weight (P < 0.0001). However, those randomized to the small change PA/SA intervention gained less weight (+0.3% vs. 2.3% gain; P < 0.0001). CONCLUSIONS: The small change PA/SA intervention did not lead to a significant difference in weight loss in comparison to the small change approach alone. It did, however, decrease the negative impact of psychosocial stressors on weight gain among participants with more interval life events.

Sex- and Race-Related Differences in Characteristics and Outcomes of Hospitalizations for Heart Failure With Preserved Ejection Fraction.

BACKGROUND: Sex and race have emerged as important contributors to the phenotypic heterogeneity of heart failure with preserved ejection fraction (HFpEF). However, there remains a need to identify important sex- and race-related differences in characteristics and outcomes using a nationally representative cohort. METHODS AND RESULTS: Data were obtained from the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project-Nationwide Inpatient Sample files between 2008 and 2012. Hospitalizations with a diagnosis of HFpEF were included for analysis. Demographics, hospital characteristics, and age-adjusted comorbidity prevalence rates were compared between men and women and whites and blacks. In-hospital mortality was determined and compared for each subgroup. Multivariable regression analyses were used to identify and compare correlates of in-hospital mortality for each subgroup. A sample of 1 889 608 hospitalizations was analyzed. Men with HFpEF were slightly younger than women with HFpEF and had a higher Elixhauser comorbidity score. Men experienced higher in-hospital mortality compared with women, a finding that was attenuated after adjusting for comorbidity. Blacks with HFpEF were younger than whites with HFpEF, with lower rates of most comorbidities. Hypertension, diabetes, anemia, and chronic renal failure were more common among blacks. Blacks experienced lower in-hospital mortality compared with whites, even after adjusting for age and comorbidity. Important correlates of mortality among all 4 subgroups included pulmonary circulation disorders, liver disease, and chronic renal failure. Atrial fibrillation was an important correlate of mortality only among women and blacks. CONCLUSIONS: Differences in patient characteristics and outcomes reinforce the notion that sex and race contribute to the phenotypic heterogeneity of HFpEF.

Social network characteristics associated with weight loss among black and hispanic adults.

OBJECTIVE: To examine social network member characteristics associated with weight loss. METHODS: A cross-sectional examination included egocentric network data from 245 Black and Hispanic adults with BMI ≥ 25 kg/m(2) enrolled in a small change weight loss study. The relationships between weight loss at 12 months and characteristics of helpful and harmful network members (relationship, contact frequency, living proximity, and body size) were examined. RESULTS: There were 2,571 network members identified. Mean weight loss was -4.8 (±11.3) lbs. among participants with network help and no harm with eating goals vs. +3.4 (±7.8) lbs. among participants with network harm alone. In a multivariable regression model, greater weight loss was associated with help from a child with eating goals (P = 0.0002) and coworker help with physical activity (P = 0.01). Weight gain was associated with having network members with obesity living in the home (P = 0.048) and increased network size (P = 0.002). CONCLUSIONS: There was greater weight loss among participants with support from children and coworkers. Weight gain was associated with harmful network behaviors and having network members with obesity in the home. Incorporating child and coworker support and evaluating network harm and the body size of network members should be considered in future weight loss interventions.

Small Changes and Lasting Effects (SCALE) Trial: the formation of a weight loss behavioral intervention using EVOLVE.

BACKGROUND: Obesity is a major health problem that disproportionately affects Black and Hispanic adults. This paper presents the rationale and innovative design of a small change eating and physical activity intervention (SC) combined with a positive affect and self-affirmation (PA/SA) intervention versus the SC intervention alone for weight loss. METHODS: Using a mixed methods translational model (EVOLVE), we designed and tested a SC approach intervention in overweight and/ or obese African American and Hispanic adults. In Phase I, we explored participant's values and beliefs about the small change approach. In Phase II, we tested and refined the intervention and then, in Phase III we conducted a RCT. Participants were randomized to the SC approach with PA/SA intervention vs. a SC approach alone for 12 months. The primary outcome was clinically significant weight loss at 12 months. RESULTS: Over 4.5 years a total of 574 participants (67 in Phase I, 102 in Phase II and 405 in Phase III) were enrolled. Phase I findings were used to create a workbook based on real life experiences about weight loss and to refine the small change eating strategies. Phase II results shaped the recruitment and retention strategy for the RCT, as well as the final intervention. The RCT results are currently under analysis. CONCLUSION: The present study seeks to determine if a SC approach combined with a PA/SA intervention will result in greater weight loss at 12 months in Black and Hispanic adults compared to a SC approach alone.