A controlled trial of dissemination and implementation of a cardiovascular risk reduction strategy in small primary care practices.

OBJECTIVE: To assess the effect of dissemination and implementation of an intervention consisting of practice facilitation and a risk-stratified, population management dashboard on cardiovascular risk reduction for patients at high risk in small, primary care practices. STUDY SETTING: A total of 219 small primary care practices (≤10 clinicians per site) across North Carolina with primary data collection from electronic health records (EHRs) from the fourth quarter of 2015 through the second quarter of 2018. STUDY DESIGN: We performed a stepped-wedge, stratified, cluster randomized trial of a one-year intervention consisting of practice facilitation utilizing quality improvement techniques coupled with a cardiovascular dashboard that included lists of risk-stratified adults, aged 40-79 years and their unmet treatment opportunities. The primary outcome was change in 10-Year ASCVD Risk score among all patients with a baseline score ≥10 percent from baseline to 3 months postintervention. DATA COLLECTION/ EXTRACTION METHODS: Data extracts were securely transferred from practices on a nightly basis from their EHR to the research team registry. PRINCIPLE FINDINGS: ASCVD risk scores were assessed on 437 556 patients and 146 826 had a calculated 10-year risk ≥10 percent. The mean baseline risk was 23.4 percent (SD ± 12.6 percent). Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4). Models considering calendar time and stepped-wedge controls revealed most of the improvement (4.0 of 6.3 percent) was attributable to the intervention and not secular trends. In multivariate analysis, male gender, age >65 years, low-income (<$40 000), and Black race (P < .001 for all variables) were each associated with greater risk reductions. CONCLUSION: A risk-stratified, population management dashboard combined with practice facilitation led to substantial reductions of 10-year ASCVD risk for patients at high risk. Similar approaches could lead to effective dissemination and implementation of other new evidence, especially in rural and other under-resourced practices. Registration: ClinicalTrials.Gov 15-0479.

Projections of incident atherosclerotic cardiovascular disease and incident type 2 diabetes across evolving statin treatment guidelines and recommendations: A modelling study.

BACKGROUND: Experimental and observational research has suggested the potential for increased type 2 diabetes (T2D) risk among populations taking statins for the primary prevention of atherosclerotic cardiovascular disease (ASCVD). However, few studies have directly compared statin-associated benefits and harms or examined heterogeneity by population subgroups or assumed treatment effect. Thus, we compared ASCVD risk reduction and T2D incidence increases across 3 statin treatment guidelines or recommendations among adults without a history of ASCVD or T2D who were eligible for statin treatment initiation. METHODS AND FINDINGS: Simulations were conducted using Markov models that integrated data from contemporary population-based studies of non-Hispanic African American and white adults aged 40-75 years with published meta-analyses. Statin treatment eligibility was determined by predicted 10-year ASCVD risk (5%, 7.5%, or 10%). We calculated the number needed to treat (NNT) to prevent one ASCVD event and the number needed to harm (NNH) to incur one incident case of T2D. The likelihood to be helped or harmed (LHH) was calculated as ratio of NNH to NNT. Heterogeneity in statin-associated benefit was examined by sex, age, and statin-associated T2D relative risk (RR) (range: 1.11-1.55). A total of 61,125,042 U.S. adults (58.5% female; 89.4% white; mean age = 54.7 years) composed our primary prevention population, among whom 13-28 million adults were eligible for statin initiation. Overall, the number of ASCVD events prevented was at least twice as large as the number of incident cases of T2D incurred (LHH range: 2.26-2.90). However, the number of T2D cases incurred surpassed the number of ASCVD events prevented when higher statin-associated T2D RRs were assumed (LHH range: 0.72-0.94). In addition, females (LHH range: 1.74-2.40) and adults aged 40-50 years (LHH range: 1.00-1.14) received lower absolute benefits of statin treatment compared with males (LHH range: 2.55-3.00) and adults aged 70-75 years (LHH range: 3.95-3.96). Projected differences in LHH by age and sex became more pronounced as statin-associated T2D RR increased, with a majority of scenarios projecting LHHs < 1 for females and adults aged 40-50 years. This study's primary limitation was uncertainty in estimates of statin-associated T2D risk, highlighting areas in which additional clinical and public health research is needed. CONCLUSIONS: Our projections suggest that females and younger adult populations shoulder the highest relative burden of statin-associated T2D risk.

Validity and Reliability of a Brief Dietary Assessment Questionnaire in a Cardiac Rehabilitation Program.

PURPOSE: Dietary assessment is vital to inform individualized nutrition care and to evaluate the success of interventions aimed at improving diet for participants in cardiac rehabilitation (CR) programs. The purpose of this study was to assess the validity and reliability of an instrument developed to reflect current evidence-informed dietary recommendations advocated to reduce cardiovascular risk. METHODS: This study was conducted at a single CR program at the University of North Carolina, Chapel Hill. Two dietary assessments were administered: Picture Your Plate (PYP) and a reference instrument, the Harvard/Willett Food Frequency Questionnaire (HWFFQ). The PYP is a modification of a previously validated instrument, the Dietary Risk Assessment-New Leaf (DRA-New Leaf). Concurrent validity was assessed by comparing the PYP total score with 3 diet quality indexes (Alternative Health Eating Index [AHEI], Dietary Approaches to Stop Hypertension [DASH], and Alternative Mediterranean Diet [aMED]) calculated from the HWFFQ and by assessment of agreement in tertile cross-classification. An intraclass correlation (ICC) was calculated to assess test-retest reliability. RESULTS: Among the 108 participants, crude and adjusted Spearmen correlation coefficients between the PYP and 3 indexes of dietary quality were AHEI-2010 (0.71-0.72), DASH (0.70-0.71), and aMED (0.52-0.58) (P < .0001, all comparisons). Agreement of tertiles comparing PYP and AHEI-2010 was 67% and the score in opposite tertiles was 6%. The weighted kappa value (κw) = 0.71. The test-retest ICC was 0.91 (95% CI, 0.85-0.93; n = 91). CONCLUSIONS: Results support the PYP as a valid and reliable dietary assessment tool for use in CR programs. Continued research in additional CR program populations is recommended.

Diet quality trends among adults with diabetes by socioeconomic status in the U.S.: 1999-2014.

BACKGROUND: The diet quality of adults living in the United States has improved overtime. We aim to determine whether diet quality among adults with diabetes mellitus has changed over time, and to examine trends in socioeconomic disparities in diet quality. METHODS: Repeated cross-sectional analysis of eight National Health and Nutrition Examination Survey (NHANES) cycles (1999-2000 through 2013-2014). We included 5882 adult participants (age 20 or older) with diabetes mellitus (type 1 or 2) who completed 24-h dietary recalls. Diet quality was measured by the Healthy Eating Index 2010 (HEI) score (range 0-100, higher scores indicate better diet quality). We tested whether there were differences in diet quality across education, income, and food security categories, and whether any differences changed over time, using weighted linear regression models accounting for the complex survey design and adjusted for age, gender, and race/ethnicity. RESULTS: Twenty nine percent of US adults with diabetes had less than a high school diploma, 17% had income < 100% of federal poverty level, and 15% reported food insecurity. Average adjusted HEI score increased from 49.4 to 52.4 over the study period (p for trend = 0.003). We observed differences in HEI between high and low education (4.1, 95% CI 3.0-5.3), high and low income (3.7, 95%CI 2.4-5.0) and food secure relative to food insecure (2.1, 95% CI 0.8-3.3). These differences did not improve over time for education (p = 0.56), income (p = 0.65) or food security (p = 0.39) categories. CONCLUSIONS: Diet quality for adults with diabetes in the U.S. has improved overall; however, substantial disparities exist and have not improved. A concerted effort to improve diet quality in vulnerable groups may be needed.

Incidence of Heart Failure Observed in Emergency Departments, Ambulatory Clinics, and Hospitals.

Reports on the burden of heart failure (HF) have largely omitted HF diagnosed in outpatient settings. We quantified annual incidence rates ([IR] per 1,000 person years) of HF identified in ambulatory clinics, emergency departments (EDs), and during hospital stays in a national probability sample of Medicare beneficiaries from 2008 to 2014, by age and race/ethnicity. A 20% random sample of Medicare beneficiaries ages ≥65 years with continuous Medicare Parts A, B, and D coverage was used to estimate annual IRs of HF identified using International Classification of Diseases, Ninth Revision, Clinical Modification codes. Of the 681,487 beneficiaries with incident HF from 2008 to 2014, 283,451 (41%) presented in ambulatory clinics, 76,919 (11%) in EDs, and 321,117 (47%) in hospitals. Overall, incidence of HF in ambulatory clinics decreased from 2008 (IR 22.2, 95% confidence interval [CI] 22.0, 22.4) to 2014 (IR 15.0, 95% CI 14.8, 15.1). Similarly, incidence of HF-related ED visits without an admission to the hospital decreased somewhat from 2008 (IR 5.5, 95% CI 5.4, 5.6) to 2012 (IR 4.2, 95% CI 4.1, 4.3) and stabilized from 2013 to 2014. Similar to previous reports, HF hospitalizations, both International Classification of Diseases, Ninth Revision, Clinical Modification code 428.x in the primary and any position, decreased over the study period. More than half of all new cases of HF in Medicare beneficiaries presented in an ambulatory clinic or ED. The overall incidence of HF decreased from 2008 to 2014, regardless of health-care setting. In conclusion, consideration of outpatient HF is warranted to better understand the burden of HF and its temporal trends.

Successful long-term weight loss among participants with diabetes receiving an intervention promoting an adapted Mediterranean-style dietary pattern: the Heart Healthy Lenoir Project.

OBJECTIVE: To examine weight change by diabetes status among participants receiving a Mediterranean-style diet, physical activity, and weight loss intervention adapted for delivery in the southeastern USA, where rates of cardiovascular disease (CVD) are disproportionately high. RESEARCH DESIGN AND METHODS: The intervention included: Phase I (months 1-6), an individually tailored intervention promoting a Mediterranean-style dietary pattern and increased walking; Phase II (months 7-12), option of a 16-week weight loss intervention for those with BMI≥25 kg/m2 offered as 16 weekly group sessions or 5 group sessions and 10 phone calls, or a lifestyle maintenance intervention; and Phase III (months 13-24), weight loss maintenance intervention for those losing ≥8 pounds with all others receiving a lifestyle maintenance intervention. Weight change was assessed at 6, 12, and 24-month follow-up. RESULTS: Baseline characteristics (n=339): mean age 56, 77% female, 65% African-American, 124 (37%) with diabetes; mean weight 103 kg for those with diabetes and 95 kg for those without. Among participants with diabetes, average weight change was -1.2 kg (95% CI -2.1 to -0.4) at 6 months (n=92), -1.5 kg (95% CI -2.9 to -0.2) at 12 months (n=96), and -3.7 kg (95% CI -5.2 to -2.1) at 24 months (n=93). Among those without diabetes, weight change was -0.4 kg (95% CI -1.4 to 0.6) at 24 months (n=154). CONCLUSIONS: Participants with diabetes experienced sustained weight loss at 24-month follow-up. High-risk US populations with diabetes may experience clinically important weight loss from this type of lifestyle intervention. TRIAL REGISTRATION NUMBER: NCT01433484.

Assessing the Feasibility of a Web-Based Weight Loss Intervention for Low-Income Women of Reproductive Age: A Pilot Study.

BACKGROUND: Low-income women of reproductive age are at increased risk for obesity and resulting increases in the risk of maternal/fetal complications and mortality and morbidity. Very few weight-loss interventions, however, have been targeted to this high-risk group. Based on the high prevalence of social media use among young and low-income individuals and previous successes using group formats for weight-loss interventions, the use of social media as a platform for weight-loss intervention delivery may benefit low-income women of reproductive age. OBJECTIVE: Examine the feasibility of delivering group-based weight-loss interventions to low-income women of reproductive age using face-to-face meetings and Web-based modalities including social media. METHODS: Participants attended a family planning clinic in eastern North Carolina and received a 5-month, group- and Web-based, face-to-face weight-loss intervention. Measures were assessed at baseline and 20 weeks. RESULTS: Forty participants enrolled, including 29 (73%) African American women. The mean body mass index of enrollees was 39 kg/m(2). Among the 12 women who completed follow-up, mean weight change was -1.3 kg. Participation in the intervention was modest and retention at 5 months was 30%. Returnees suggested sending reminders to improve participation and adding activities to increase familiarity among participants. CONCLUSIONS: Engagement with the intervention was limited and attrition was high. Additional formative work on the barriers and facilitators to participation may improve the intervention's feasibility with low-income women of reproductive age.

A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial.

IMPORTANCE: Most primary care clinicians lack the skills and resources to offer effective lifestyle and medication (L&M) counseling to reduce coronary heart disease (CHD) risk. Thus, effective and feasible CHD prevention programs are needed for typical practice settings. OBJECTIVE: To assess the effectiveness, acceptability, and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats. DESIGN, SETTING, AND PARTICIPANTS: A comparative effectiveness trial in 5 diverse family medicine practices in North Carolina. Participants were established patients, aged 35 to 79 years, with no known cardiovascular disease, and at moderate to high risk for CHD (10-year Framingham Risk Score [FRS], ≥10%). INTERVENTIONS: Participants were randomized to counselor-delivered or web-based format, each including 4 intensive and 3 maintenance sessions. After randomization, both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies. Participants chose the risk-reducing strategies they wished to follow. MAIN OUTCOMES AND MEASURES: The primary outcome was within-group change in FRS at 4-month follow-up. Other measures included standardized assessments of blood pressure, blood lipid levels, lifestyle behaviors, and medication adherence. Acceptability and cost-effectiveness were also assessed. Outcomes were assessed at 4 and 12 months. RESULTS: Of 2274 screened patients, 385 were randomized (192 counselor; 193 web): mean age, 62 years; 24% African American; and mean FRS, 16.9%. Follow-up at 4 and 12 months included 91% and 87% of the randomized participants, respectively. There was a sustained reduction in FRS at both 4 months (primary outcome) and 12 months for both counselor-based (-2.3% [95% CI, -3.0% to -1.6%] and -1.9% [95% CI, -2.8% to -1.1%], respectively) and web-based groups (-1.5% [95% CI, -2.2% to -0.9%] and -1.7% [95% CI, -2.6% to -0.8%] respectively). At 4 months, the adjusted difference in FRS between groups was -1.0% (95% CI, -1.8% to -0.1%) (P = .03), and at 12 months, it was -0.6% (95% CI, -1.7% to 0.5%) (P = .30). The 12-month costs from the payer perspective were $207 and $110 per person for the counselor- and web-based interventions, respectively. CONCLUSIONS AND RELEVANCE: Both intervention formats reduced CHD risk through 12-month follow-up. The web format was less expensive. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01245686.

Examining the Influence of price and accessibility on willingness to shop at farmers' markets among low-income eastern North Carolina women.

OBJECTIVE: To examine the influence of farmers' market pricing and accessibility on willingness to shop at farmers' markets, among low-income women. DESIGN: Qualitative interviews using scenarios with quantitative assessment of willingness to shop at farmers' markets given certain pricing and accessibility scenarios. SETTING: Eastern North Carolina. PARTICIPANTS: A total of 37 low-income women of childbearing age (18-44 years) receiving family planning services at the health department. PHENOMENON OF INTEREST: Willingness to shop at a farmers' market. ANALYSIS: Fisher's exact test was used to examine associations between willingness to shop at farmers' markets by urban/rural residence, race, and employment status. Direct quotations relevant to participants' use of farmers' markets were extracted based on a positive deviance framework. RESULTS: Participants were increasingly willing to shop at the farmers' market when price savings increased and when the market was incrementally closer to their residence. Willingness was highest when there was at least a 20% price savings. Participants seemed to be influenced more by a visual representation of a greater quantity of produce received with the price savings rather than a quantitative representation of the money saved by the reduced price. CONCLUSIONS AND IMPLICATIONS: Future farmers' market interventions should take into account these consumer level preferences.

Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: methods and participant characteristics for the Heart to Health study.

BACKGROUND: Although lifestyle and medications are effective for coronary heart disease (CHD) risk reduction, few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction. In this paper, we report on the design and baseline characteristics of participants for just such a trial. METHODS: We conducted a randomized trial of the same lifestyle and medication intervention delivered in two alternate formats: counselor-delivered or web-based. The trial was conducted at 5 diverse practices in a family medicine research network and included men and women age 35-79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10% or a known history of cardiovascular disease. After individual-level randomization, participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months. The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease. Secondary outcomes, measured among all participants, included changes in CHD risk factors, cost-effectiveness, and acceptability at 4 and 12-month follow-up. RESULTS: We randomized 489 eligible patients: 389 without and 100 with a known history of cardiovascular disease. Mean age was 62.3. 75% were white, 25% African-American. 45% had a college education. 88% had health insurance. Mean 10-year predicted CHD risk was 16.9%. CONCLUSION: We have successfully recruited a diverse sample of practices and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention.

Associations between access to farmers' markets and supermarkets, shopping patterns, fruit and vegetable consumption and health indicators among women of reproductive age in eastern North Carolina, U.S.A.

OBJECTIVE: We examined associations between access to food venues (farmers' markets and supermarkets), shopping patterns, fruit and vegetable consumption and health indicators among women of reproductive age in eastern North Carolina, U.S.A. DESIGN: Access to food venues was measured using a Geographic Information System incorporating distance, seasonality and business hours, to quantify access to farmers' markets. Produce consumption was assessed by self-report of eating five or more fruits and vegetables daily. BMI and blood pressure were assessed by clinical measurements. Poisson regression with robust variance was used for dichotomous outcomes and multiple linear regression was used for continuous outcomes. As the study occurred in a university town and university students are likely to have different shopping patterns from non-students, we stratified analyses by student status. SETTING: Eastern North Carolina. SUBJECTS: Low-income women of reproductive age (18­44 years) with valid address information accessing family planning services at a local health department (n 400). RESULTS: Over a quarter reported ever shopping at farmers' markets (114/400). A larger percentage of women who shopped at farmers' markets consumed five or more fruits and vegetables daily (42.1%) than those who did not (24.0%; P < 0.001). The mean objectively measured distance to the farmers' markets where women reported shopping was 11.4 (SD 9.0) km (7.1 (SD 5.6) miles), while the mean distance to the farmers' market closest to the residence was 4.0 (SD 3.7) km (2.5 (SD 2.3) miles). CONCLUSIONS: Among non-students, those who shopped at farmers' markets were more likely to consume five or more servings of fruits and vegetables daily. Future research should further explore potential health benefits of farmers' markets.

Addressing rural health disparities through policy change in the stroke belt.

CONTEXT: Obesity-prevention policies are needed, particularly in low-income rural areas of the southern United States, where obesity and chronic disease prevalence are high. In 2009, the Centers for Disease Control and Prevention issued the "Common Community Measures for Obesity Prevention" (COCOMO), a set of 24 recommended community-level obesity-prevention strategies. OBJECTIVE: A variety of stakeholders in Lenoir County, North Carolina, were surveyed and interviewed, ranking the winnability, defined as feasibility and acceptability, of each of the 24 COCOMO-recommended strategies based on local culture, infrastructure, funding, and community support. DESIGN: Mixed-methods. SETTING: This study was part of the Heart Healthy Lenoir project, a community-based project to reduce cardiovascular disease risk and disparities in risk in Lenoir County, North Carolina. PARTICIPANTS: COCOMO assessments were conducted with 19 Community Advisory Council members and in-depth interviews were conducted with 11 community stakeholders. Heart Healthy Lenoir lifestyle intervention participants (n = 366) completed surveys wherein they ranked their support for 7 obesity-prevention strategies (based on the COCOMO strategies). MAIN OUTCOME MEASURES: Ranking of obesity-prevention strategies. RESULTS: Policies to improve physical activity opportunities were deemed the most winnable, whereas policies that would limit advertisement of unhealthy food and beverages were deemed the least winnable. The most winnable food-related strategy was improving mechanisms to procure food from local farms. Stakeholders perceived the public as unfavorably disposed toward government mandates, taxes, and incentives. Among Heart Healthy Lenoir participants, males indicated lower levels of support for COCOMO-related strategies than females, and African Americans indicated higher levels of support than white participants. CONCLUSION: The formative work presented here provides insight into the winnability of proposed obesity-prevention policy change strategies in Lenoir County, North Carolina.

A community assessment to inform a multilevel intervention to reduce cardiovascular disease risk and risk disparities in a rural community.

To complete a formative evaluation to identify community-level assets and barriers to healthy lifestyle choices, we conducted qualitative interviews, community audits, and secondary data analyses. We solicited local leaders' perspectives regarding winnability of obesity prevention policy options. Participants noted that many resources were available, yet a barrier was high cost. There were more parks per capita in low-income areas, but they were of lower quality. The most winnable obesity prevention policy was incentives for use of food from local farms. Results are being used to inform an intervention to reduce cardiovascular disease risk in rural eastern North Carolina.

Development and evaluation of a brief questionnaire to assess dietary fat quality in low-income overweight women in the southern United States.

OBJECTIVE: To develop a brief questionnaire to assess dietary fat quality, the Dietary Fat Quality Assessment (DFQA), for use in dietary counseling to reduce heart disease risk. METHODS: A subsample of 120 underserved, midlife women enrolled in a randomized, controlled weight loss trial completed baseline and follow-up telephone surveys. Main outcome measures included dietary fat components (total fat, saturated fat, polyunsaturated fat, monounsaturated fat, omega-3 fatty acids, and cholesterol). RESULTS: Assessments of major dietary fat components using the DFQA and a food frequency questionnaire were significantly correlated, with correlation coefficients of 0.54-0.66 (P < .001). Intra-class correlation coefficients to assess reliability ranged from 0.48 to 0.59 for each of the fat components studied. CONCLUSIONS AND IMPLICATIONS: The DFQA provides a reasonable assessment of dietary fat quality associated with coronary heart disease risk and may prove useful as a brief assessment tool to guide dietary counseling given to reduce heart disease risk.

Associations between body mass index, shopping behaviors, amenity density, and characteristics of the neighborhood food environment among female adult Supplemental Nutrition Assistance Program (SNAP) participants in eastern North Carolina.

We examined associations between body mass index (BMI) and the food environment among adult female Supplemental Nutrition Assistance Program (SNAP) participants (N = 197) in eastern North Carolina. Food venue proximity to residential addresses was calculated using a geographic information system. Walk Score was used as a measure of amenity density. Correlation and linear regression analyses were used to examine associations between BMI and distance to and use of food venues, and residential amenity density. Frequency of supercenter use was significantly inversely associated with distance to supercenters. Walk Score was significantly inversely associated with BMI. BMI was not associated with distance to or use of any particular food venue. Future studies should examine specific health-promoting elements of amenity-dense neighborhoods accessible to limited-income populations.

Promoting use of nutrition and physical activity community resources among women in a family planning clinic setting.

Research increasingly supports promotion of nutrition and physical activity community resources to support individual-level health promotion interventions. However, even when such resources exist, they are often not well used. In this article, the authors describe the results of formative research regarding patient and health promotion professionals' perspectives on methods to encourage use of community resources among patients accessing family planning services at a local health department in eastern North Carolina. In March through May of 2010, the authors conducted qualitative in-depth interviews with 30 female patients, aged 18-44 years, and five local key informants. Interviews were transcribed verbatim, imported into Atlas Ti for data management, and independently double-coded. Free, easily accessible, and family-friendly resources were most appealing to participants. Key informants offered creative ideas for promoting the use of resources, such as parks and farmers' markets, and included integration of such resources into health care provider prescriptions and taking group trips to resources. Results of this study can guide similar programs attempting to promote the use of resources among hard-to-reach groups.

Rationale, design, and sample characteristics of a practical randomized trial to assess a weight loss intervention for low-income women: the Weight-Wise II Program.

Obesity is common among low-income mid-life women, yet most published weight loss studies have not focused on this population and have been highly resourced efficacy trials. Thus, practical type 2 translational studies are needed to evaluate weight loss interventions for low-income women. In this paper, we present the rationale, study design, and baseline characteristics of a type 2 translational study that evaluates both the processes and outcomes of a weight loss intervention for low-income women given at 6 county health departments in North Carolina. Key features of this study include random selection of study sites, intervention delivery by current staff at study sites, efforts to integrate the intervention with local community resources, a focus on evaluating the processes of translation using the RE-AIM framework, use of an evidence-based weight loss intervention, a detailed description of participant recruitment and representativeness, and a practical randomized trial designed to assess the effectiveness of the intervention. Of 81 health departments invited to participate, 30 (37%) were eligible and willing, and 6 were selected at random to deliver the intervention. Of 432 potential participants screened by phone, 213 (49%) were eligible and of these, 189 (89%) completed baseline measures and were randomized to receive a 5-month weight loss intervention or a delayed intervention. The mean age was 51, mean BMI 37 kg/m(2), 53% were African American, and 43% had no health insurance. The results of this study should be informative to key stakeholders interested in real world weight loss interventions for low-income mid-life women.

Optimized probability sampling of study sites to improve generalizability in a multisite intervention trial.

INTRODUCTION: Studies of type 2 translation, the adaption of evidence-based interventions to real-world settings, should include representative study sites and staff to improve external validity. Sites for such studies are, however, often selected by convenience sampling, which limits generalizability. We used an optimized probability sampling protocol to select an unbiased, representative sample of study sites to prepare for a randomized trial of a weight loss intervention. METHODS: We invited North Carolina health departments within 200 miles of the research center to participate (N = 81). Of the 43 health departments that were eligible, 30 were interested in participating. To select a representative and feasible sample of 6 health departments that met inclusion criteria, we generated all combinations of 6 from the 30 health departments that were eligible and interested. From the subset of combinations that met inclusion criteria, we selected 1 at random. RESULTS: Of 593,775 possible combinations of 6 counties, 15,177 (3%) met inclusion criteria. Sites in the selected subset were similar to all eligible sites in terms of health department characteristics and county demographics. CONCLUSION: Optimized probability sampling improved generalizability by ensuring an unbiased and representative sample of study sites.

Cost-effectiveness of a behavioral weight loss intervention for low-income women: the Weight-Wise Program.

OBJECTIVE: Assess the cost-effectiveness of a 16-week weight loss intervention (Weight-Wise) for low-income midlife women. METHOD: A randomized controlled trial conducted in North Carolina in 2007 tested a weight loss intervention among 143 women (40-64 years old, mean BMI=35.1 kg/m(2)). Women were randomized to one of two arms-special intervention (n=72) and a wait-listed control group (n=71). Effectiveness measures included changes in weight, systolic and diastolic blood pressure, total cholesterol, and HDL cholesterol. Cost-effectiveness measures calculated life years gained (LYG) from changes in weight, based on excess years life lost (YLL) algorithm. RESULTS: Intervention participants had statistically significant decreases in weight (kg) (-4.4 95% CI=-5.6, -3.2) and in systolic blood pressure (-6.2 mm Hg, 95% CI=-10.6, -1.7) compared to controls. Total cost of conducting Weight-Wise was $17,403, and the cost per participant in intervention group was $242. The incremental cost per life year gained (discounted) from a decrease in obesity was $1862. CONCLUSION: Our results suggest the Weight-Wise intervention may be a cost-effective approach to improving the health of low-income women.

Validation of a brief dietary assessment to guide counseling for cardiovascular disease risk reduction in an underserved population.

BACKGROUND: Brief dietary assessment tools are needed to guide counseling in underserved populations to reduce cardiovascular disease (CVD) risk. The Dietary Risk Assessment is one such tool modified over time to reflect emerging evidence concerning diet and CVD risk. OBJECTIVE: To examine the capacity of the modified Dietary Risk Assessment tool to measure aspects of diet quality in a sample of underserved, midlife (aged 40 to 64 years) women, by comparing Dietary Risk Assessment results to those of a longer food frequency questionnaire (FFQ) and with serum carotenoids. DESIGN: This study used baseline data from women enrolled in a CVD risk reduction intervention trial. The Dietary Risk Assessment was administered to 236 women and results were compared to those from a longer FFQ administered to 104 women, and to serum carotenoids results from all participants. RESULTS: Correlations between Dietary Risk Assessment indexes and corresponding measures from the FFQ were statistically significant: fruit and vegetable, r=-0.53 (P<0.0001, correlation is negative as a lower Dietary Risk Assessment score indicates greater fruit and vegetable intake); saturated fat, r=0.60 (P<0.0001). In linear regression models stratified by smoking and adjusted for body mass index, low-density lipoprotein cholesterol level, high-density lipoprotein cholesterol level, very-low-density lipoprotein cholesterol level, and age, the Dietary Risk Assessment fruit and vegetable index was significantly associated with serum carotenoids (parameter estimate for nonsmokers -0.22, P=0.01; smokers -0.45, P=0.003). Correlation coefficients between Dietary Risk Assessment total score and three diet quality index scores derived from FFQ variables were statistically significant, ranging in magnitude from 0.57 to 0.60. CONCLUSIONS: The modified Dietary Risk Assessment provides a reasonable assessment of dietary factors associated with CVD risk; thus, it is appropriate for use to guide dietary counseling in CVD prevention programs for underserved, midlife, women.