A Pilot Study Comparing Dietary Approaches to Decrease Hypertension in a Lower Income, African American Population at Risk for Cardiovascular Disease
Overview
- Phase
- Not Applicable
- Intervention
- Standard DPP-GLB diet
- Conditions
- Hypertension
- Sponsor
- Baylor Research Institute
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Changes in Systolic blood pressure
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Standard DPP-GLB diet
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.
Intervention: Standard DPP-GLB program modules
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.
Intervention: Very low carbohydrate diet
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.
Intervention: Standard DPP-GLB program modules
Outcomes
Primary Outcomes
Changes in Systolic blood pressure
Time Frame: 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
Time Frame: Baseline; 12 weeks; 10 months
Assess changes in diet using ASA24 online dietary recall
Secondary Outcomes
- 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)