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.

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.

Patient and practice perspectives on strategies for controlling blood pressure, North Carolina, 2010-2012.

INTRODUCTION: Patient and practice perspectives can inform development of team-based approaches to improving blood pressure control in primary care. We used a community-based participatory research approach to assess patient and practice perceptions regarding the value of team-based strategies for controlling blood pressure in a rural North Carolina population from 2010 through 2012. METHODS: In-depth interviews were conducted with 41 adults with hypertension, purposely sampled to include diversity of sex, race, literacy, and blood pressure control, and with key office staff at 5 rural primary care practices in the southeastern US "stroke belt." Interviews explored barriers to controlling blood pressure, the practice's role in controlling blood pressure, and opinions on the use of team care delivery. RESULTS: Patients reported that provider strategies to optimize blood pressure control should include regular visits, medication adjustment, side-effect discussion, and behavioral counseling. When discussing team-based approaches to hypertension care, patients valued verbal encouragement, calls from the doctor's office, and the opportunity to ask questions. However, they voiced concerns about the effect of having too many people involved in their care. Practice staff focused on multiple, broad methods to control blood pressure including counseling, regular office visits, media to improve awareness, and support groups. An explicit focus of delivering care as teams was a newer concept. CONCLUSION: When developing a team approach to hypertension treatment, patients value high-quality communication and not losing their primary relationship with their provider. Practice staff members were open to a team-based approach but had limited knowledge of what such an approach would entail.

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.

The Heart Healthy Lenoir project--an intervention to reduce disparities in hypertension control: study protocol.

BACKGROUND: Racial disparities in blood pressure control are well established; however the impact of low health literacy (LHL) on blood pressure has garnered less attention. Office based interventions that are created with iterative patient, practice and community stakeholder input and are rolled out incrementally, may help address these disparities in hypertension control. This paper describes our study protocol. METHODS/DESIGN: Using a community based participatory research (CBPR) approach, we designed and implemented a cohort study that includes both a practice level and patient level intervention to enhance the care and support of patients with hypertension in primary care practices in a rural region of eastern North Carolina. The study is divided into a formative phase and an ongoing 2.5 year implementation phase. Our main care enhancement activities include the integration of a community health coach, using home blood pressure monitoring in clinical decision making, standardizing care delivery processes, and working to improve medication adherence. Main outcomes include overall blood pressure change, the differential change in blood pressure by race (African American vs. White) and health literacy level (low vs. higher health literacy). DISCUSSION: Using a community based participatory approach in primary care practice settings has helped to engage patients and practice staff and providers in the research effort and in making practice changes to support hypertension care. Practices have engaged at varying levels, but progress has been made in implementing and iteratively improving upon the interventions to date. TRIAL REGISTRATION: ClinicalTrials.gov NCT01425515.

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.

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.

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.

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.

The association of health literacy and blood pressure reduction in a cohort of patients with hypertension: The heart healthy lenoir trial.

OBJECTIVE: Lower health literacy is associated with poorer health outcomes. Few interventions poised to mitigate the impact of health literacy in hypertensive patients have been published. We tested if a multi-level quality improvement intervention could differentially improve Systolic Blood Pressure (SBP) more so in patients with low vs. higher health literacy. METHODS: We conducted a non-randomized prospective cohort trial of 525 patients referred with uncontrolled hypertension. Stakeholder informed and health literacy sensitive strategies were implemented at the practice and patient level. Outcomes were assessed at 0, 6, 12, 18 and 24 months. RESULTS: At 12 months, the low and higher health literacy groups had statistically significant decreases in mean SBP (6.6 and 5.3mmHg, respectively), but the between group difference was not significant (Δ 1.3mmHg, P=0.067). At 24 months, the low and higher health literacy groups reductions were 8.1 and 4.6mmHg, respectively, again the between group difference was not significant (Δ 3.5mmHg, p=0.25). CONCLUSIONS/PRACTICE IMPLICATIONS: A health literacy sensitive multi-level intervention may equally lower SBP in patients with low and higher health literacy. Practical health literacy appropriate tools and methods can be implemented in primary care settings using a quality improvement approach.

Lessons Learned From Implementing Health Coaching in The Heart Healthy Lenoir Hypertension Study.

BACKGROUND: Health coaching is increasingly important in patient-centered medical homes. OBJECTIVES: Describe formative evaluation results and lessons learned from implementing health coaching to improve hypertension self-management in rural primary care. METHODS: A hypertension collaborative was formed consisting of six primary care sites. Twelve monthly health coaching phone calls were attempted for 487 participants with hypertension. LESSONS LEARNED: Participant engagement was challenging; 58% remained engaged, missing fewer than three consecutive calls. Multivariate analyses revealed that older age (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01-1.05), African American race (O,R 1.73; 95% CI, 1.15-2.60), greater number of comorbidities (OR, 1.17; 95% CI, 1.05-1.30) and receiving coaching closer to enrollment (OR, 5.03; 95% CI, 2.53-9.99) were correlated independently with engagement. Participants reported the coaching valuable; 96% would recommend health coaching to others. CONCLUSIONS: Health coaching in hypertension care can be successful strategy for engaging more vulnerable groups. A more tailored approach may improve engagement with counseling.

Development, adaptation, and implementation of a cardiovascular health program for Alaska native women.

Southcentral Foundation's Traditions of the Heart program is an innovative cardiovascular disease prevention program for women designed to build on the strengths of the Alaska Native culture as a way to support and encourage positive lifestyle behaviors that focus on healthy eating, active living, stress management, and tobacco cessation. After conducting assessments of existing intervention programs and formative data collection, we adapted two existing programs, Native Nutrition Circles and A New Leaf... Choices for Healthy Living, to develop the Traditions of the Heart program. We implemented and evaluated a pilot intervention study to determine the program's acceptance among Alaska Native women. We used the evaluation results to further refine our study protocol. This article describes the adaptation of these programs to the cultural needs and strengths of Alaska Native women and the results of the formative evaluation used to improve the program design. The complete pilot study outcomes will be published separately.

Extending the reach of public health nutrition: training community practitioners in multilevel approaches.

BACKGROUND: Cardiovascular disease (CVD) is a major public health concern in the United States. We developed an annual training course, Nutrition and Public Health, A Course for Community Practitioners (NPH), to address the identified training needs of state staff responsible for designing and implementing the Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) program and to support other health professionals working in programs that address chronic disease prevention and management. METHODS: After conducting a needs assessment with state-level WISEWOMAN staff in 2001 to identify topics of interest, we formed an advisory committee to provide guidance on topics, theoretical frameworks, training concerns, and multilevel intervention approaches. The first week-long training course, which included an intensive field practicum, was implemented in the fall of 2002. RESULTS: Participants rated three fourths of the elements listed in a posttraining evaluation as a course strength, giving particularly high ratings to various indicators of course quality (100%) and networking opportunities (95%). Just over half (55%) rated the field practicum as a course strength. Four fifths (83%) of participants responded to a 6-month follow-up evaluation, and most indicated that the course had increased their knowledge and skills and increased their confidence in planning programs. CONCLUSIONS: Unique features of the course include its suitability for public health practitioners not previously trained in nutrition, its promotion of multilevel interventions, and its focus on CVD risk reduction and nutrition interventions for underinsured and uninsured populations.

Implementing the WISEWOMAN program in local health departments: staff attitudes, beliefs, and perceived barriers.

BACKGROUND: Although most health departments recognize the need for programs to reduce the risk of cardiovascular disease (CVD) among older, low-income women, they face numerous barriers to successfully implementing such programs. This paper explores counselors' attitudes and beliefs about patients and perceived barriers to implementing the North Carolina Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) program. METHODS: Health departments were assigned to provide patients with either an enhanced intervention (EI) or a minimum intervention (MI). Cross-sectional baseline and 12-month follow-up surveys were completed by health department counselors designated to deliver the MI or EI. Both surveys addressed counselors' beliefs about patients' motivation and attitudes, their counseling practices, and their personal diet and physical activity behaviors and attitudes. The follow-up survey also addressed opinions about the feasibility of long-term WISEWOMAN implementation. RESULTS: Counselors were skeptical about patients' motivation to improve their lifestyle, citing high perceived cost and burden. At follow-up, EI counselors reported having higher self-efficacy for counseling, incorporating more behavioral change strategies, and spending more time counseling than did counselors at MI sites. They were also more likely to report making healthful personal lifestyle choices. All counselors identified lack of time as a major barrier to counseling, and most cited obtaining low-cost medications for patients, ensuring that patients made follow-up visits, and implementing the program with existing staff as key challenges to the long-term sustainability of WISEWOMAN. CONCLUSIONS: Our findings provide insight into the organizational challenges of implementing a CVD risk-reduction program for low-income women. We discuss ways in which intervention and training programs can be improved.

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.

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.

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.

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.

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.