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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard GLB Control | Placebo Comparator | 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. |
|
| VLC-GLB Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low carbohydrate diet | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline; 12 weeks; 10 months |
| Dietary changes in carbohydrate intake | Assess changes in diet using ASA24 online dietary recall | Baseline; 12 weeks; 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fasting blood glucose | Finger stick measure of blood glucose levels collected after 8-12 hours fasting | Baseline; 12 weeks; 10 months |
| Changes in Hemoglobin A1C | Finger stick measure of hemoglobin A1C collected after 8-12 hours fasting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aisha H Montgomery, MD, MPH | Baylor Scott and White Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Research Institute | Dallas | Texas | 75210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 541040 | Background | Gillum RF. Pathophysiology of hypertension in blacks and whites. A review of the basis of racial blood pressure differences. Hypertension. 1979 Sep-Oct;1(5):468-75. doi: 10.1161/01.hyp.1.5.468. | |
| 29386200 | Background | 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, Jimenez 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. No abstract available. |
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All IPD that underlies results in publication
Data will be available within 6 months of outcome publication
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D040242 | Risk Reduction Behavior |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
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Prospective randomized 2-group study
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| Standard DPP-GLB diet | Other | 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 |
|
| Standard DPP-GLB program modules | Behavioral | Participants will learn standard DPP-GLB modules for other lifestyle modifications for stress, physical activity, etc. in sessions 1,4,6-9, 11-22 |
|
| 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 | Baseline; 12 weeks; 10 months |
| Changes in % Body weight | Change in weight measured in lbs. with digital scale; % change calculated | 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 | Baseline; 12 weeks; 10 months |
| Dietary changes in fat intake | Assess changes in diet using ASA24 online dietary recall | Baseline; 12 weeks; 10 months |
| Dietary changes in caloric intake | Assess changes in diet using ASA24 online dietary recall | 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 | Baseline; 12 weeks; 10 months |
| 24983758 | Background | Lackland DT. Racial differences in hypertension: implications for high blood pressure management. Am J Med Sci. 2014 Aug;348(2):135-8. doi: 10.1097/MAJ.0000000000000308. |
| 29153117 | Background | 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. |
| 16556884 | Background | Howard G, Prineas R, Moy C, Cushman M, Kellum M, Temple E, Graham A, Howard V. Racial and geographic differences in awareness, treatment, and control of hypertension: the REasons for Geographic And Racial Differences in Stroke study. Stroke. 2006 May;37(5):1171-8. doi: 10.1161/01.STR.0000217222.09978.ce. Epub 2006 Mar 23. |
| 8668862 | Background | Lackland DT, Keil JE. Epidemiology of hypertension in African Americans. Semin Nephrol. 1996 Mar;16(2):63-70. |
| 28807739 | Background | 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. |
| 17686957 | Background | 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. doi: 10.1152/ajprenal.00149.2007. Epub 2007 Aug 8. |
| 12489929 | Background | Meckling KA, Gauthier M, Grubb R, Sanford J. Effects of a hypocaloric, low-carbohydrate diet on weight loss, blood lipids, blood pressure, glucose tolerance, and body composition in free-living overweight women. Can J Physiol Pharmacol. 2002 Nov;80(11):1095-105. doi: 10.1139/y02-140. |
| 27327801 | Background | Rehm CD, Penalvo JL, Afshin A, Mozaffarian D. Dietary Intake Among US Adults, 1999-2012. JAMA. 2016 Jun 21;315(23):2542-53. doi: 10.1001/jama.2016.7491. |
| 24717684 | Background | Saslow LR, Kim S, Daubenmier JJ, Moskowitz JT, Phinney SD, Goldman V, Murphy EJ, Cox RM, Moran P, Hecht FM. A randomized pilot trial of a moderate carbohydrate diet compared to a very low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes. PLoS One. 2014 Apr 9;9(4):e91027. doi: 10.1371/journal.pone.0091027. eCollection 2014. |
| 22704899 | Background | 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. No abstract available. |
| 20101008 | Background | 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. |
| 12453955 | Background | Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165. |
| 25369633 | Background | Armstrong C; Joint National Committee. JNC8 guidelines for the management of hypertension in adults. Am Fam Physician. 2014 Oct 1;90(7):503-4. No abstract available. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |