Giving a Low Carbohydrate Diet to Overcome Hypertension (GLOH)

Baylor Scott and White Health (BSWH)

Status: Unknown

Conditions: Diet, Carbohydrate-Restricted; Hypertension; Risk Reduction Behavior; African Americans

Treatments: Other: Standard DPP-GLB diet; Behavioral: Standard DPP-GLB program modules; Other: Very low carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04230928

019-268

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups, including a placebo group

Standard GLB Control

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Standard DPP-GLB program modules

Other: Standard DPP-GLB diet

VLC-GLB Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Standard DPP-GLB program modules

Other: Very low carbohydrate diet