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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
64
Participants will learn to follow a very low carbohydrate diet in modified versions of GLB modules 2,3,5 \& 10. Participants will learn to track carbohydrate intake
Participants will learn to follow a very low fat, calorie-restricted diet and track fat grams and caloric intake in standard GLB modules 2,3,5, \& 10
Participants will learn standard DPP-GLB modules for other lifestyle modifications for stress, physical activity, etc. in sessions 1,4,6-9, 11-22
Baylor Research Institute
Dallas, Texas, United States
Changes in Systolic blood pressure
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
Time frame: Baseline; 12 weeks; 10 months
Dietary changes in carbohydrate intake
Assess changes in diet using ASA24 online dietary recall
Time frame: Baseline; 12 weeks; 10 months
Changes in Fasting blood glucose
Finger stick measure of blood glucose levels collected after 8-12 hours fasting
Time frame: Baseline; 12 weeks; 10 months
Changes in Hemoglobin A1C
Finger stick measure of hemoglobin A1C collected after 8-12 hours fasting
Time frame: Baseline; 12 weeks; 10 months
Changes in Cholesterol and lipoproteins
Finger stick measure of blood levels of total cholesterol, HDL, LDL, and triglycerides collected after 8-12 hours fasting
Time frame: Baseline; 12 weeks; 10 months
Changes in % Body weight
Change in weight measured in lbs. with digital scale; % change calculated
Time frame: Baseline; 12 weeks; 10 months
Changes in Body mass index (BMI)
Change in calculated BMI based upon height (in.) with stadiometer \& weight (lbs.) with digital scale
Time frame: Baseline; 12 weeks; 10 months
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Dietary changes in fat intake
Assess changes in diet using ASA24 online dietary recall
Time frame: Baseline; 12 weeks; 10 months
Dietary changes in caloric intake
Assess changes in diet using ASA24 online dietary recall
Time frame: Baseline; 12 weeks; 10 months
Changes in Diastolic blood pressure
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
Time frame: Baseline; 12 weeks; 10 months