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Giving a Low Carbohydrate Diet to Overcome Hypertension (GLOH)

Primary Purpose

Hypertension, African Americans, Diet, Carbohydrate-Restricted

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Very low carbohydrate diet
Standard DPP-GLB diet
Standard DPP-GLB program modules
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Hypertension, Low carbohydrate diet, African American race, Cardiovascular disease risk, Weight loss

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Baylor Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Standard GLB Control

VLC-GLB Intervention

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
Dietary changes in carbohydrate intake
Assess changes in diet using ASA24 online dietary recall

Secondary Outcome Measures

Changes in Fasting blood glucose
Finger stick measure of blood glucose levels collected after 8-12 hours fasting
Changes in Hemoglobin A1C
Finger stick measure of hemoglobin A1C collected after 8-12 hours fasting
Changes in Cholesterol and lipoproteins
Finger stick measure of blood levels of total cholesterol, HDL, LDL, and triglycerides collected after 8-12 hours fasting
Changes in % Body weight
Change in weight measured in lbs. with digital scale; % change calculated
Changes in Body mass index (BMI)
Change in calculated BMI based upon height (in.) with stadiometer & weight (lbs.) with digital scale
Dietary changes in fat intake
Assess changes in diet using ASA24 online dietary recall
Dietary changes in caloric intake
Assess changes in diet using ASA24 online dietary recall
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

Full Information

First Posted
January 10, 2020
Last Updated
December 16, 2021
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04230928
Brief Title
Giving a Low Carbohydrate Diet to Overcome Hypertension
Acronym
GLOH
Official Title
A Pilot Study Comparing Dietary Approaches to Decrease Hypertension in a Lower Income, African American Population at Risk for Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, African Americans, Diet, Carbohydrate-Restricted, Risk Reduction Behavior
Keywords
Hypertension, Low carbohydrate diet, African American race, Cardiovascular disease risk, Weight loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized 2-group study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard GLB Control
Arm Type
Placebo Comparator
Arm 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.
Arm Title
VLC-GLB Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Very low carbohydrate diet
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard DPP-GLB diet
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard DPP-GLB program modules
Intervention Description
Participants will learn standard DPP-GLB modules for other lifestyle modifications for stress, physical activity, etc. in sessions 1,4,6-9, 11-22
Primary Outcome Measure Information:
Title
Changes in Systolic blood pressure
Description
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
Title
Dietary changes in carbohydrate intake
Description
Assess changes in diet using ASA24 online dietary recall
Time Frame
Baseline; 12 weeks; 10 months
Secondary Outcome Measure Information:
Title
Changes in Fasting blood glucose
Description
Finger stick measure of blood glucose levels collected after 8-12 hours fasting
Time Frame
Baseline; 12 weeks; 10 months
Title
Changes in Hemoglobin A1C
Description
Finger stick measure of hemoglobin A1C collected after 8-12 hours fasting
Time Frame
Baseline; 12 weeks; 10 months
Title
Changes in Cholesterol and lipoproteins
Description
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
Title
Changes in % Body weight
Description
Change in weight measured in lbs. with digital scale; % change calculated
Time Frame
Baseline; 12 weeks; 10 months
Title
Changes in Body mass index (BMI)
Description
Change in calculated BMI based upon height (in.) with stadiometer & weight (lbs.) with digital scale
Time Frame
Baseline; 12 weeks; 10 months
Title
Dietary changes in fat intake
Description
Assess changes in diet using ASA24 online dietary recall
Time Frame
Baseline; 12 weeks; 10 months
Title
Dietary changes in caloric intake
Description
Assess changes in diet using ASA24 online dietary recall
Time Frame
Baseline; 12 weeks; 10 months
Title
Changes in Diastolic blood pressure
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aisha H Montgomery, MD, MPH
Organizational Affiliation
Baylor Scott and White Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlies results in publication
IPD Sharing Time Frame
Data will be available within 6 months of outcome publication
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Giving a Low Carbohydrate Diet to Overcome Hypertension

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