GLOH: Giving a Low Carbohydrate Diet to Overcome Hypertension
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 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. |
Other: Standard 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
Behavioral: Standard 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
|
| Experimental: 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. |
Other: Very low carbohydrate diet
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
Behavioral: Standard 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- men and women aged ≥ 18 years
-
- willingness to participate in a 10-month study
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- systolic blood pressure > 120 mm/Hg +/- diastolic blood pressure > 80 mm/Hg
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- African American race
Exclusion Criteria:
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- diagnosed congestive heart failure
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- Hypertension stage 4 or higher (e.g., SBP >180 mm/Hg; DBP > 110 mm/Hg)
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- received or needing more than 3 anti-hypertensive medications
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- pregnant or planning to become pregnant
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- receiving or needing a heart transplant
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- Using injected long or short-acting insulin for diabetes treatment
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- not African American race
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- unable to speak and read English with fluency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor Research Institute | Dallas | Texas | United States | 75210 |
Sponsors and Collaborators
- Baylor Research Institute
Investigators
- Principal Investigator: Aisha H Montgomery, MD, MPH, Baylor Scott and White Health
Study Documents (Full-Text)
None provided.More Information
Publications
- Armstrong C; Joint National Committee. JNC8 guidelines for the management of hypertension in adults. Am Fam Physician. 2014 Oct 1;90(7):503-4.
- Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. Review. Erratum in: Circulation. 2018 Mar 20;137(12 ):e493.
- Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71.
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- Kitzman H, Dodgen L, Mamun A, Slater JL, King G, Slater D, King A, Mandapati S, DeHaven M. Community-based participatory research to design a faith-enhanced diabetes prevention program: The Better Me Within randomized trial. Contemp Clin Trials. 2017 Nov;62:77-90. doi: 10.1016/j.cct.2017.08.003. Epub 2017 Aug 12.
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- Subar AF, Kirkpatrick SI, Mittl B, Zimmerman TP, Thompson FE, Bingley C, Willis G, Islam NG, Baranowski T, McNutt S, Potischman N. The Automated Self-Administered 24-hour dietary recall (ASA24): a resource for researchers, clinicians, and educators from the National Cancer Institute. J Acad Nutr Diet. 2012 Aug;112(8):1134-7. doi: 10.1016/j.jand.2012.04.016. Epub 2012 Jun 15.
- Tiwari S, Riazi S, Ecelbarger CA. Insulin's impact on renal sodium transport and blood pressure in health, obesity, and diabetes. Am J Physiol Renal Physiol. 2007 Oct;293(4):F974-84. Epub 2007 Aug 8. Review.
- Yancy WS Jr, Westman EC, McDuffie JR, Grambow SC, Jeffreys AS, Bolton J, Chalecki A, Oddone EZ. A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss. Arch Intern Med. 2010 Jan 25;170(2):136-45. doi: 10.1001/archinternmed.2009.492. Erratum in: JAMA Intern Med. 2015 Mar;175(3):470.
- Zhang D, Wang G, Zhang P, Fang J, Ayala C. Medical Expenditures Associated With Hypertension in the U.S., 2000-2013. Am J Prev Med. 2017 Dec;53(6S2):S164-S171. doi: 10.1016/j.amepre.2017.05.014.
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