Hypertension, African Americans, Diet, Carbohydrate-Restricted, Risk Reduction Behavior
Conditions
Keywords
Hypertension, Low carbohydrate diet, African American race, Cardiovascular disease risk, Weight loss
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.
Interventions
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
OTHERStandard DPP-GLB diet
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
BEHAVIORALStandard DPP-GLB program modules
Participants will learn standard DPP-GLB modules for other lifestyle modifications for stress, physical activity, etc. in sessions 1,4,6-9, 11-22
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective randomized 2-group study
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Systolic blood pressure | 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 | Baseline; 12 weeks; 10 months | Assess changes in diet using ASA24 online dietary recall |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Fasting blood glucose | Baseline; 12 weeks; 10 months | Finger stick measure of blood glucose levels collected after 8-12 hours fasting |
| Changes in Hemoglobin A1C | Baseline; 12 weeks; 10 months | Finger stick measure of hemoglobin A1C collected after 8-12 hours fasting |
| Changes in Cholesterol and lipoproteins | Baseline; 12 weeks; 10 months | Finger stick measure of blood levels of total cholesterol, HDL, LDL, and triglycerides collected after 8-12 hours fasting |
| Changes in % Body weight | Baseline; 12 weeks; 10 months | Change in weight measured in lbs. with digital scale; % change calculated |
| Changes in Body mass index (BMI) | Baseline; 12 weeks; 10 months | Change in calculated BMI based upon height (in.) with stadiometer \& weight (lbs.) with digital scale |
| Dietary changes in fat intake | Baseline; 12 weeks; 10 months | Assess changes in diet using ASA24 online dietary recall |
| Dietary changes in caloric intake | Baseline; 12 weeks; 10 months | Assess changes in diet using ASA24 online dietary recall |
| Changes in Diastolic blood pressure | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAisha H Montgomery, MD, MPH
Baylor Scott and White Health
Outcome results
None listed