Heart Healthy Lenoir Project (HHL)

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Accession Number
HLB01621717a

Study Type
Clinical Trial

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period
September 2011 to October 2014

NHLBI Division
DCVS

Dataset(s) Last Updated
January 3, 2018

Consent

Commercial Use Data Restrictions No

Data Restrictions Based On Area Of Research No

Specific Consent Restrictions
None

Objectives

The Heart Healthy Lenoir project (HHL) included two concurrent interventional studies: the High Blood Pressure study and the Lifestyle Change Study. Both studies had the goal of using novel techniques designed to reduce cardiovascular disease in a region of the United States where there is a higher prevalence of risk factors. The primary goal of the High Blood Pressure study was to investigate ways to better control hypertension and reduce blood pressure disparities between blacks and whites. The Lifestyle Change study aimed to reduce risks associated with cardiovascular disease (CVD) by using behavioral modification techniques. Participants in this study were encouraged to make better dietary choices, increase their level of physical activity, and enroll in an optional weight loss program.

Background

Strokes and cardiovascular disease share many of the same risk factors, namely, elevated blood pressure, a sedentary lifestyle, and a body mass index (BMI) greater than 25. Southeast regions of the United States are commonly referred to as the ‘stroke belt’ because there are more stroke related deaths and risk factors for developing CVD. The area is also characterized as having greater socioeconomic and racial disparities, less access to quality healthcare, and lower educational levels. In particular, blacks living in the southeast, have disproportionately less blood pressure control than their white counterparts and residents of Lenoir County have higher rates of poverty than national averages.

Reducing CVD risk factors is multifaceted and partially achievable through modifiable lifestyle patterns such as healthier dietary choices and increased physical activity. Additionally, access to healthcare and culturally appropriate healthcare education are believed to positively influence adherence to medications and overall health outcomes. In these studies, a community-based approach was used to design and develop better methods to manage obesity and hypertension and in the process, aimed to reduce the prevalence of CVD in high risk populations.

Participants

525 participants were enrolled in the High Blood Pressure study of which 58% were black and 40% were white. To participate in the High BP study, individuals needed to be at least 18 years old, be an established patient in one of the 5 participating practices, and have a systolic BP > 150 mmHg. In addition, individuals were required to be English speaking, live in Lenoir County, have access to a telephone, and be free from pregnancy and specific medical conditions.

The Lifestyle study enrolled a total of 350 participants which included 200 individuals recruited through the High BP study and 150 participants enrolled from the community. Individuals for the Lifestyle study were eligible if they were at least 18 years of age and had an interest in reducing their risk of CVD through exercise and diet. Pregnant women were excluded from participating in the weight loss program.

Design

The Heart Healthy Lenoir project had 2 interventional components: the High Blood Pressure study and the Lifestyle Change Study, both of which lasted 2 years. At baseline, participants completed a diet risk assessment questionnaire, were measured for BMI and blood pressure, and underwent blood work to check carotenoid and cholesterol levels.

The high blood pressure study was a prospective cohort study which had 2 phases: formative and implementation. During the formative phase, researchers interviewed patients and medical providers about their perceived barriers to better blood pressure control. Data collected during this phase was used to design quality improvement strategies for practice-based interventions. Strategies for medical personnel included quarterly meetings where staff could discuss participant care and methods to encourage medication adherence. Quality improvement strategies for patients primarily focused on health education such as understanding food labels and proper use of a home BP monitor. A single group assignment was used for the intervention phase of the study to assess if differences in hypertension management between blacks and whites, could be normalized.

Over a two year time frame, blood pressure measurements were taken by research staff at enrollment, then every 6 months for a total of 5 visits. Participants received monthly phone coaching where they could discuss medication, physical activity, weight control, and home BP monitoring.

The lifestyle change study was also a prospective cohort study and used a community based participatory research (CBPR) approach. It was conducted in 3 phases, the first of which, the formative phase, lasted 6 months and focused on improving dietary choices and increasing levels of physical activity. The second or implementation phase lasted 4 months and participants were either assigned to the lifestyle maintenance intervention group or could choose an optional weight loss program. The third phase was conducted during the remainder of the study and participants who lost at least 8 pounds could elect to be in a weight loss maintenance program or be assigned to the lifestyle maintenance intervention group. Subjects in the lifestyle maintenance intervention group received quarterly phone calls to discuss diet and physical activity.

Conclusions

At enrollment and throughout the study, there was no evidence of a racial disparity for BP control between blacks and whites. Compared to other studies though, the High BP study enrolled more black male participants; a group that is often underrepresented in research. All participants demonstrated a mean reduction in SPB of 6.0 mm Hg at the 12-month benchmark and at the 2-year mark, SPB had been reduced by 6.4 mm Hg.

The lifestyle change study found significant improvements in regards to diet and physical activity, but only a modest improvement in the amount of weight loss. There was a mean diet score improvement of 4.3 units and the amount of time spent walking rose to 64 minutes/week. At 12 months, there was an average 3.1 kg drop in weight for those who participated in the group weight loss phase and at 24 months, weight reduction was 2.1 kg for those in the group intervention.

Cené CW, Halladay JR, Gizlice Z, et al. A multicomponent quality improvement intervention to improve blood pressure and reduce racial disparities in rural primary care practices. The Journal of Clinical Hypertension. 2017;19(4):351-360. doi: 10.1111/jch.12944

Keyserling TC, Samuel-Hodge CD, Pitts SJ, et al. 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. BMC Public Health. 2016;16:732. doi:10.1186/s12889-016-3370-9.

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