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.

Applicability of Precision Medicine Approaches to Managing Hypertension in Rural Populations.

As part of the Heart Healthy Lenoir Project, we developed a practice level intervention to improve blood pressure control. The goal of this study was: (i) to determine if single nucleotide polymorphisms (SNPs) that associate with blood pressure variation, identified in large studies, are applicable to blood pressure control in subjects from a rural population; (ii) to measure the association of these SNPs with subjects' responsiveness to the hypertension intervention; and (iii) to identify other SNPs that may help understand patient-specific responses to an intervention. We used a combination of candidate SNPs and genome-wide analyses to test associations with either baseline systolic blood pressure (SBP) or change in systolic blood pressure one year after the intervention in two genetically defined ancestral groups: African Americans (AA) and Caucasian Americans (CAU). Of the 48 candidate SNPs, 13 SNPs associated with baseline SBP in our study; however, one candidate SNP, rs592582, also associated with a change in SBP after one year. Using our study data, we identified 4 and 15 additional loci that associated with a change in SBP in the AA and CAU groups, respectively. Our analysis of gene-age interactions identified genotypes associated with SBP improvement within different age groups of our populations. Moreover, our integrative analysis identified AQP4-AS1 and PADI2 as genes whose expression levels may contribute to the pleiotropy of complex traits involved in cardiovascular health and blood pressure regulation in response to an intervention targeting hypertension. In conclusion, the identification of SNPs associated with the success of a hypertension treatment intervention suggests that genetic factors in combination with age may contribute to an individual's success in lowering SBP. If these findings prove to be applicable to other populations, the use of this genetic variation in making patient-specific interventions may help providers with making decisions to improve patient outcomes. Further investigation is required to determine the role of this genetic variance with respect to the management of hypertension such that more precise treatment recommendations may be made in the future as part of personalized medicine.

Eating Well While Dining Out: Collaborating with Local Restaurants to Promote Heart Healthy Menu Items.

BACKGROUND: As Americans commonly consume restaurant foods with poor dietary quality, effective interventions are needed to improve food choices at restaurants. PURPOSE: To design and evaluate a restaurant-based intervention to help customers select and restaurants promote heart healthy menu items with healthful fats and high quality carbohydrates. METHODS: The intervention included table tents outlining 10 heart healthy eating tips, coupons promoting healthy menu items, an information brochure, and link to study website. Pre and post intervention surveys were completed by restaurant managers and customers completed a brief "intercept" survey. RESULTS: Managers (n = 10) reported the table tents and coupons were well received, and several noted improved personal nutrition knowledge. Overall, 4214 coupons were distributed with 1244 (30%) redeemed. Of 300 customers surveyed, 126 (42%) noticed the table tents and of these, 115 (91%) considered the nutrition information helpful, 42 (33%) indicated the information influenced menu items purchased, and 91 (72%) reported the information will influence what they order in the future. DISCUSSION: The intervention was well-received by restaurant managers and positively influenced menu item selection by many customers. TRANSLATION TO HEALTH EDUCATION PRACTICE: Further research is needed to assess effective strategies for scaling up and sustaining this intervention approach.

Examining the Association between Intervention-Related Changes in Diet, Physical Activity, and Weight as Moderated by the Food and Physical Activity Environments among Rural, Southern Adults.

BACKGROUND: Few studies have been conducted in rural areas assessing the influence of community-level environmental factors on residents' success improving lifestyle behaviors. OBJECTIVE: Our aim was to examine whether 6-month changes in diet, physical activity, and weight were moderated by the food and physical activity environment in a rural adult population receiving an intervention designed to improve diet and physical activity. DESIGN: We examined associations between self-reported and objectively measured changes in diet, physical activity, and weight, and perceived and objectively measured food and physical activity environments. Participants were followed for 6 months. PARTICIPANTS/SETTING: Participants were enrolled in the Heart Healthy Lenoir Project, a lifestyle intervention study conducted in Lenoir County, located in rural southeastern North Carolina. Sample sizes ranged from 132 to 249, depending on the availability of the data. INTERVENTION: Participants received four counseling sessions that focused on healthy eating (adapted Mediterranean diet pattern) and increasing physical activity. POTENTIAL MODERATING FACTORS: Density of and distance to food and physical activity venues, modified food environment index, Walk Score, crime, and perceived nutrition and physical activity neighborhood barriers were the potential mediating factors. OUTCOME MEASURES: Diet quality, physical activity, and weight loss were the outcomes measured. STATISTICAL ANALYSES: Statistical analyses included correlation and linear regression and controlling for potential confounders (baseline values of the dependent variables, age, race, education, and sex). RESULTS: In adjusted analysis, there was an inverse association between weight change and the food environment, suggesting that participants who lived in a less-healthy food environment lost more weight during the 6-month intervention period (P=0.01). Also, there was a positive association between self-reported physical activity and distance to private gyms (P=0.04) and an inverse association between private gym density and pedometer-measured steps (P=0.03), indicating that those who lived farther from gyms and in areas with lower density of gyms had greater increases in physical activity and steps, respectively. CONCLUSIONS: Contrary to our hypotheses, results indicated that those living in less-favorable food and physical activity environments had greater improvements in diet, physical activity, and weight, compared to those living in more favorable environments. Additional research should be undertaken to address these paradoxical findings and, if confirmed, to better understand them.

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.

A community-based lifestyle and weight loss intervention promoting a Mediterranean-style diet pattern evaluated in the stroke belt of North Carolina: the Heart Healthy Lenoir Project.

BACKGROUND: Because residents of the southeastern United States experience disproportionally high rates of cardiovascular disease (CVD), it is important to develop effective lifestyle interventions for this population. METHODS: The primary objective was to develop and evaluate a dietary, physical activity (PA) and weight loss intervention for residents of the southeastern US. The intervention, given in eastern North Carolina, was evaluated in a 2 year prospective cohort study with an embedded randomized controlled trial (RCT) of a weight loss maintenance intervention. The intervention included: Phase I (months 1-6), 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/m(2) offered in 2 formats (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 RCT for those losing ≥ 8 lb with all other participants receiving a lifestyle maintenance intervention. Change in diet and PA behaviors, CVD risk factors, and weight were assessed at 6, 12, and 24 month follow-up. RESULTS: Baseline characteristics (N = 339) were: 260 (77 %) females, 219 (65 %) African Americans, mean age 56 years, and mean body mass index 36 kg/m(2). In Phase I, among 251 (74 %) that returned for 6 month follow-up, there were substantial improvements in diet score (4.3 units [95 % CI 3.7 to 5.0]), walking (64 min/week [19 to 109]), and systolic blood pressure (-6.4 mmHg [-8.7 to -4.1]) that were generally maintained through 24 month follow-up. In Phase II, 138 (57 group only, 81 group/phone) chose the weight loss intervention and at 12 months, weight change was: -3.1 kg (-4.9 to -1.3) for group (N = 50) and -2.1 kg (-3.2 to -1.0) for group/phone combination (N = 75). In Phase III, 27 participants took part in the RCT. At 24 months, weight loss was -2.1 kg (-4.3 to 0.0) for group (N = 51) and -1.1 kg (-2.7 to 0.4) for combination (N = 72). Outcomes for African American and whites were similar. CONCLUSIONS: The intervention yielded substantial improvement in diet, PA, and blood pressure, but weight loss was modest. TRIAL REGISTRATION: clinicaltrials.gov Identifier: 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.

Outcomes of cardiovascular disease risk factor screening and referrals in a family planning clinic.

BACKGROUND: Cardiovascular disease (CVD) screening in Title X settings can identify low-income women at risk of future chronic disease. This study examines follow-up related to newly identified CVD risk factors in a Title X setting. METHODS: Female patients at a North Carolina Title X clinic were screened for CVD risk factors (n=462) and 167/462 (36.1%) were rescreened one year later. Clinical staff made protocol-driven referrals for women identified with newly diagnosed CVD risk factors. We used paired t-tests and chi square tests to compare screening and rescreening results (two-tailed, p<0.05). RESULTS: Among 11 women in need of referrals for newly diagnosed hypertension or diabetes, 9 out of 11 (81.8%) were referred, and 2 of 11 (18.2%) completed referrals. Among hypertensive women who were rescreened (n=21), systolic blood pressure decreased (139 to 132 mmHg, p=0.001) and diastolic blood pressure decreased (90 to 83 mmHg, p=0.006). Hemoglobin A1c did not improve among rescreened diabetic women (n=5, p=0.640). Among women who reported smoking at enrollment, 129 of 148 (87.2%) received cessation counseling and 8 of 148 (5.4%) accepted tobacco quitline referrals. Among smokers, 53 out of 148 (35.8%) were rescreened and 11 of 53 (20.8%) reported nonsmoking at that time. Among 188 women identified as obese at enrollment, 22 (11.7%) scheduled nutrition appointments, but only one attended. Mean weight increased from 221 to 225 pounds (p 0<.05) among 70 out of 188 (37.2%) obese women who were rescreened. CONCLUSIONS: The majority of women in need of referrals for CVD risk factors received them. Few women completed referrals. Future research should examine barriers and facilitators of referral care among low-income women.

Psychometric properties of the modified RESIDE physical activity questionnaire among low-income overweight women.

OBJECTIVES: This study explored the criterion-related validity and test-retest reliability of the modified RESIDential Environment physical activity questionnaire and whether the instrument's validity varied by body mass index, education, race/ethnicity, or employment status. DESIGN: Validation study using baseline data collected for randomized trial of a weight loss intervention. METHODS: Participants recruited from health departments wore an ActiGraph accelerometer and self-reported non-occupational walking, moderate and vigorous physical activity on the modified RESIDential Environment questionnaire. We assessed validity (n=152) using Spearman correlation coefficients, and reliability (n=57) using intraclass correlation coefficients. RESULTS: When compared to steps, moderate physical activity, and bouts of moderate/vigorous physical activity measured by accelerometer, these questionnaire measures showed fair evidence for validity: recreational walking (Spearman correlation coefficients 0.23-0.36), total walking (Spearman correlation coefficients 0.24-0.37), and total moderate physical activity (Spearman correlation coefficients 0.18-0.36). Correlations for self-reported walking and moderate physical activity were higher among unemployed participants and women with lower body mass indices. Generally no other variability in the validity of the instrument was found. Evidence for reliability of RESIDential Environment measures of recreational walking, total walking, and total moderate physical activity was substantial (intraclass correlation coefficients 0.56-0.68). CONCLUSIONS: Evidence for questionnaire validity and reliability varied by activity domain and was strongest for walking measures. The questionnaire may capture physical activity less accurately among women with higher body mass indices and employed participants. Capturing occupational activity, specifically walking at work, may improve questionnaire validity.

Associations between neighborhood-level factors related to a healthful lifestyle and dietary intake, physical activity, and support for obesity prevention polices among rural adults.

We examined cross-sectional associations among neighborhood- and individual-level factors related to a healthful lifestyle and dietary intake, physical activity (PA), and support for obesity prevention polices in rural eastern North Carolina adults. We examined perceived neighborhood barriers to a healthful lifestyle, and associations between neighborhood barriers to healthy eating and PA, participants' support for seven obesity prevention policies, and dependent variables of self-reported dietary and PA behaviors, and measured body mass index (BMI) (n = 366 study participants). We then used participants' residential addresses and Geographic Information Systems (GIS) software to assess neighborhood-level factors related to access to healthy food and PA opportunities. Correlational analyses and adjusted linear regression models were used to examine associations between neighborhood-level factors related to a healthful lifestyle and dietary and PA behaviors, BMI, and obesity prevention policy support. The most commonly reported neighborhood barriers (from a list of 18 potential barriers) perceived by participants included: not enough bicycle lanes and sidewalks, not enough affordable exercise places, too much crime, and no place to buy a quick, healthy meal to go. Higher diet quality was inversely related to perceived and GIS-assessed neighborhood nutrition barriers. There were no significant associations between neighborhood barriers and PA. More perceived neighborhood barriers were positively associated with BMI. Support for obesity prevention policy change was positively associated with perceptions of more neighborhood barriers. Neighborhood factors that promote a healthful lifestyle were associated with higher diet quality and lower BMI. Individuals who perceived more neighborhood-level barriers to healthy eating and PA usually supported policies to address those barriers. Future studies should examine mechanisms to garner such support for health-promoting neighborhood changes.

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.

A pilot study comparing two weight loss maintenance interventions among low-income, mid-life women.

BACKGROUND: Despite high obesity prevalence rates, few low-income midlife women participate in weight loss maintenance trials. This pilot study aims to assess the effectiveness of two weight loss maintenance interventions in this under-represented population. METHODS: Low-income midlife women who completed a 16-week weight loss intervention and lost ≥ 8 lbs (3.6 kg) were eligible to enroll in one of two 12-month maintenance programs. The programs were similar in content and had the same number of total contacts, but were different in the contact modality (Phone + Face-to-Face vs. Face-to-Face Only). Two criteria were used to assess successful weight loss maintenance at 12 months: (1) retaining a loss of ≥ 5% of body weight from the start of the weight loss phase and (2) a change in body weight of < 3%, from the start to the end of the maintenance program. Outcome measures of changes in physiologic and psychosocial factors, and evaluations of process measures and program acceptability (measured at 12 months) are also reported. For categorical variables, likelihood ratio or Fisher's Exact (for small samples) tests were used to evaluate statistically significant relationships; for continuous variables, t-tests or their equivalents were used to assess differences between means and also to identify correlates of weight loss maintenance. RESULTS: Overall, during the 12-month maintenance period, 41% (24/58) of participants maintained a loss of ≥ 5% of initial weight and 43% (25/58) had a <3% change in weight. None of the comparisons between the two maintenance programs were statistically significant. However, improvements in blood pressure and dietary behaviors remained significant at the end of the 12-month maintenance period for participants in both programs. Participant attendance and acceptability were high for both programs. CONCLUSIONS: The effectiveness of two pilot 12-month maintenance interventions provides support for further research in weight loss maintenance among high-risk, low-income women. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00288301.

Translation of a behavioral weight loss intervention for mid-life, low-income women in local health departments.

OBJECTIVE: To translate a behavioral weight loss intervention for mid-life, low-income women in real world settings. DESIGN AND METHODS: In this pragmatic clinical trial, we randomly selected six North Carolina county health departments and trained their current staff to deliver a 16-session evidence-based behavioral weight loss intervention (special intervention, SI). SI weight loss outcomes were compared to a delayed intervention (DI) control group. RESULTS: Of 432 women expressing interest, 189 completed baseline measures and were randomized within health departments to SI (N = 126) or DI (N = 63). At baseline, average age was 51 years, 53% were African American, mean weight was 100 kg, and BMI averaged 37 kg/m2 . A total of 96 (76%) SI and 55 (87%) DI participants returned for 5-month follow-up measures. The crude weight change was -3.1 kg in the SI and -0.4 kg in the DI group, for a difference of 2.8 kg (95% CI 1.4 to 4.1, p = 0.0001). Diet quality and physical activity improved significantly more in the SI group, and estimated intervention costs were $327 per participant. CONCLUSION: This pragmatic short-term weight loss intervention targeted to low-income mid-life women yielded meaningful weight loss when translated to the county health department setting.

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.

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.

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

Low-income women in the United States have the highest rates of obesity, yet they are seldom included in weight loss trials. To address this research gap, components of two evidence-based weight loss interventions were adapted to create a 16-week intervention for low-income women (Weight Wise Program), which was evaluated in a randomized trial with the primary outcome of weight loss at 5-month follow-up. Participants were low-income women (40-64 years) with a BMI of 25-45. Of 143 participants, 72 were randomized to the Weight Wise Program (WWP) and 71 to the Control Group (CG). Five-month follow-up data were obtained from 64 (89%) WWP and 62 (87%) CG participants. With baseline values carried forward for missing data, WWP participants had a weight change of -3.7 kg compared to 0.7 kg in the CG (4.4 kg difference, 95% confidence interval (CI), 3.2-5.5, P<0.001). For systolic blood pressure (SBP), change in the WWP was -6.5 mm Hg compared to -0.4 mm Hg among controls (6.2 mm Hg difference, 95% CI, 1.7-10.6, P=0.007); for diastolic BP (DBP), changes were -4.1 mm Hg for WWP compared to -1.3 mm Hg for controls (2.8 mm Hg difference, 95% CI, 0.0-5.5, P=0.05). Of the 72 WWP participants, 64, 47, and 19% lost at least 3, 5, and 7% of their initial body weight, respectively. In conclusion, the WWP was associated with statistically significant and clinically important short-term weight loss.

A randomized trial of a church-based diabetes self-management program for African Americans with type 2 diabetes.

PURPOSE: This study developed and tested a culturally appropriate, church-based intervention to improve diabetes self-management. Research Design and Methods This was a randomized trial conducted at 24 African American churches in central North Carolina. Churches were randomized to receive the special intervention (SI; 13 churches, 117 participants) or the minimal intervention (MI; 11 churches, 84 participants). The SI included an 8-month intensive phase, consisting of 1 individual counseling visit, 12 group sessions, monthly phone contacts, and 3 encouragement postcards, followed by a 4-month reinforcement phase including monthly phone contacts. The MI received standard educational pamphlets by mail. Outcomes were assessed at 8 and 12 months; the primary outcome was comparison of 8-month A1C levels. RESULTS: At baseline, the mean age was 59 years, A1C 7.8%, and body mass index 35.0 kg/m(2); 64% of participants were female. For the 174 (87%) participants returning for 8-month measures, mean A1C (adjusted for baseline and group randomization) was 7.4% for SI and 7.8% for MI, with a difference of 0.4% (95% confidence interval [CI], 0.1-0.6, P = .009). In a larger model adjusting for additional variables, the difference was 0.5% (95% CI, 0.2-0.7, P < .001). At 12 months, the difference between groups was not significant. Diabetes knowledge and diabetes-related quality of life significantly improved in the SI group compared with the MI group. Among SI participants completing an acceptability questionnaire, intervention components and materials were rated as highly acceptable. CONCLUSIONS: The church-based intervention was well received by participants and improved short-term metabolic control.

Randomized trial of a clinic-based, community-supported, lifestyle intervention to improve physical activity and diet: the North Carolina enhanced WISEWOMAN project.

OBJECTIVE: To determine if a clinic-based behavioral intervention program for low-income mid-life women that emphasizes use of community resources will increase moderate intensity physical activity (PA) and improve dietary intake. METHODS: Randomized trial conducted from May 2003 to December 2004 at one community health center in Wilmington, NC. A total of 236 women, ages 40-64, were randomized to receive an Enhanced Intervention (EI) or Minimal Intervention (MI). The EI consisted of an intensive phase (6 months) including 2 individual counseling sessions, 3 group sessions, and 3 phone calls from a peer counselor followed by a maintenance phase (6 months) including 1 individual counseling session and 7 monthly peer counselor calls. Both phases included efforts to increase participants' use of community resources that promote positive lifestyle change. The MI consisted of a one-time mailing of pamphlets on diet and PA. Outcomes, measured at 6 and 12 months, included the comparison of moderate intensity PA between study groups as assessed by accelerometer (primary outcome) and questionnaire, and dietary intake assessed by questionnaire and serum carotenoids (6 months only). RESULTS: For accelerometer outcomes, follow-up was 75% at 6 months and 73% at 12 months. Though moderate intensity PA increased in the EI and decreased in the MI, the difference between groups was not statistically significant (p=0.45; multivariate model, p=0.08); however, moderate intensity PA assessed by questionnaire (92% follow-up at 6 months and 75% at 12 months) was greater in the EI (p=0.01; multivariate model, p=0.001). For dietary outcomes, follow-up was 90% for questionnaire and 92% for serum carotenoids at 6 months and 74% for questionnaire at 12 months. Dietary intake improved more in the EI compared to the MI (questionnaire at 6 and 12 months, p<0.001; serum carotenoid index, p=0.05; multivariate model, p=0.03). CONCLUSION: The EI did not improve objectively measured PA, but was associated with improved self-reported and objective measures of dietary intake.