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.

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.