A Pilot Study Comparing Dietary Approaches to Decrease Hypertension in a Lower Income, African American Population at Risk for Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Changes in Systolic blood pressure
研究概览
简要总结
This study will test the preliminary efficacy of adding a very low carbohydrate dietary intervention to the evidence-based DPP-GLB on blood pressure reductions for lower-income AA men and women in a community-based clinic.
详细描述
This study will evaluate the effects of consuming a very low carbohydrate (VLC) diet in a sustainable community care setting, in addition to routine medical care, to African American (AA) with pre-hypertension, hypertension (stage 1-3), or cardiovascular disease risk factors. This study will also secondarily assess the feasibility of following a VLC diet in a low-income, AA population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1) men and women aged ≥ 18 years
- •2) willingness to participate in a 10-month study
- •3) systolic blood pressure > 120 mm/Hg +/- diastolic blood pressure > 80 mm/Hg
- •4) African American race
排除标准
- •1) diagnosed congestive heart failure
- •2) Hypertension stage 4 or higher (e.g., SBP >180 mm/Hg; DBP > 110 mm/Hg)
- •3) received or needing more than 3 anti-hypertensive medications
- •4) pregnant or planning to become pregnant
- •5) receiving or needing a heart transplant
- •6) Using injected long or short-acting insulin for diabetes treatment
- •7) not African American race
- •8) unable to speak and read English with fluency
研究组 & 干预措施
Standard GLB Control
Individuals will receive the standard Diabetes Prevention Program-Group Lifestyle Balance (GLB) program as outlined by the American Diabetes Association. This program will be taught at the Baylor Scott & White Health and Wellness Center by trained research staff.
干预措施: Standard DPP-GLB diet (Other)
Standard GLB Control
Individuals will receive the standard Diabetes Prevention Program-Group Lifestyle Balance (GLB) program as outlined by the American Diabetes Association. This program will be taught at the Baylor Scott & White Health and Wellness Center by trained research staff.
干预措施: Standard DPP-GLB program modules (Behavioral)
VLC-GLB Intervention
Individuals will receive a version of the DPP-GLB program in which 4 of the 12 modules will teach a very low carbohydrate diet instead of the standard. All other components of the DPP-GLB will follow the standard. This program will be taught at the Baylor Scott & White Health and Wellness Center by trained research staff.
干预措施: Very low carbohydrate diet (Other)
VLC-GLB Intervention
Individuals will receive a version of the DPP-GLB program in which 4 of the 12 modules will teach a very low carbohydrate diet instead of the standard. All other components of the DPP-GLB will follow the standard. This program will be taught at the Baylor Scott & White Health and Wellness Center by trained research staff.
干预措施: Standard DPP-GLB program modules (Behavioral)
结局指标
主要结局
Changes in Systolic blood pressure
时间窗: Baseline; 12 weeks; 10 months
Measure changes in both systolic and diastolic blood pressure using digital sphygmomanometer; NOTE: Only Systolic BP is primary outcome, diastolic change will be a secondary outcome measure
Dietary changes in carbohydrate intake
时间窗: Baseline; 12 weeks; 10 months
Assess changes in diet using ASA24 online dietary recall
次要结局
- Changes in Fasting blood glucose(Baseline; 12 weeks; 10 months)
- Changes in Cholesterol and lipoproteins(Baseline; 12 weeks; 10 months)
- Changes in Diastolic blood pressure(Baseline; 12 weeks; 10 months)
- Changes in Body mass index (BMI)(Baseline; 12 weeks; 10 months)
- Changes in Hemoglobin A1C(Baseline; 12 weeks; 10 months)
- Dietary changes in caloric intake(Baseline; 12 weeks; 10 months)
- Changes in % Body weight(Baseline; 12 weeks; 10 months)
- Dietary changes in fat intake(Baseline; 12 weeks; 10 months)