Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Study Classification
INTERVENTIONAL
Study Start Date
1984-04-30
Study Completion Date
1994-11-30
Brief Summary
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The objective of the Trial of Antihypertensive Intervention Management (TAIM) was to determine the efficacy of dietary management and/or drug therapy, namely thiazide-like diuretics or a beta-blocker, in the control of mild hypertension. Additionally, the Continuation of the Trial of Antihypertensive Intervention Management (COTAIM) tested the effects of long-term weight reduction, and sodium/potassium changes added to weight reduction, as well as the original drug treatment, on the failure rate of blood pressure control.
Detailed Description
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BACKGROUND:
The Trial of Antihypertensive Intervention Management was an extension of the NHLBI-supported Dietary Intervention Study of Hypertension (DISH) which concluded in March 1984 and showed that either weight reduction or sodium restriction diets reduced relapse rates of hypertensives who had received long-term drug treatment and then been withdrawn from drugs. TAIM was initiated in April 1984 and continued for four years at three centers and added to DISH the art of evaluating combined drug and dietary treatments. COTAIM was continued at three clinical sites in July 1988. Analysis of COTAIM results continued through November 1994 under grant R01HL40072.
DESIGN NARRATIVE:
TAIM patients were randomly assigned to one of three diets and to one of three drug regimens. The dietary interventions consisted of a weight loss program, sodium reduction with increased potassium intake, or no change in diet. The drug regimen consisted of a beta-blocker (atenolol), a thiazide-like diuretic (chlorthalidone), or placebo. The major endpoint was change in diastolic blood pressure after six months of intervention. Individuals who did not reach goal blood pressure after six months received additional drugs. Other endpoints included total risk factor score change, psychological function, and lifestyle change.
COTAIM consisted of two studies with a total of 600 subjects. COTAIM I compared the TAIM weight loss group to a randomly selected half of the usual diet group. The primary endpoint of COTAIM I was the degree of control of blood pressure on initial TAIM therapy between TAIM baseline and the end of COTAIM, a five year period.
COTAIM II added a weight loss regimen both to the sodium restriction/potassium supplementation groups and to the other half of the usual diet group. The primary outcome was control of blood pressure on initial TAIM therapy between COTAIM baseline and the end of COTAIM, a two-year period.
The Trial of Antihypertensive Intervention Management was an extension of the NHLBI-supported Dietary Intervention Study of Hypertension (DISH) which concluded in March 1984 and showed that either weight reduction or sodium restriction diets reduced relapse rates of hypertensives who had received long-term drug treatment and then been withdrawn from drugs. TAIM was initiated in April 1984 and continued for four years at three centers and added to DISH the art of evaluating combined drug and dietary treatments. COTAIM was continued at three clinical sites in July 1988. Analysis of COTAIM results continued through November 1994 under grant R01HL40072.
DESIGN NARRATIVE:
TAIM patients were randomly assigned to one of three diets and to one of three drug regimens. The dietary interventions consisted of a weight loss program, sodium reduction with increased potassium intake, or no change in diet. The drug regimen consisted of a beta-blocker (atenolol), a thiazide-like diuretic (chlorthalidone), or placebo. The major endpoint was change in diastolic blood pressure after six months of intervention. Individuals who did not reach goal blood pressure after six months received additional drugs. Other endpoints included total risk factor score change, psychological function, and lifestyle change.
COTAIM consisted of two studies with a total of 600 subjects. COTAIM I compared the TAIM weight loss group to a randomly selected half of the usual diet group. The primary endpoint of COTAIM I was the degree of control of blood pressure on initial TAIM therapy between TAIM baseline and the end of COTAIM, a five year period.
COTAIM II added a weight loss regimen both to the sodium restriction/potassium supplementation groups and to the other half of the usual diet group. The primary outcome was control of blood pressure on initial TAIM therapy between COTAIM baseline and the end of COTAIM, a two-year period.
Conditions
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Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Study Design
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Allocation Method
RANDOMIZED
Primary Study Purpose
TREATMENT
Interventions
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diet, reducing
Intervention Type
BEHAVIORAL
diet, sodium-restricted
Intervention Type
BEHAVIORAL
chlorthalidone
Intervention Type
DRUG
atenolol
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
Men and women, ages 21 to 65, with mild hypertension in the range of 90 to 100 mm Hg diastolic blood pressure.
Subjects were obese (110-150 percent of ideal weight).
Subjects were obese (110-150 percent of ideal weight).
Minimum Eligible Age
21 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
lead
Principal Investigators
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Morton Blaufox
Role:
Albert Einstein College of Medicine
Kent Kirchner
Role:
University of Mississippi Medical Center
Albert Oberman
Role:
University of Alabama at Birmingham
Sylvia Wassertheil-Smoller
Role:
Albert Einstein College of Medicine
References
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Davis BR, Blaufox MD, Hawkins CM, Langford HG, Oberman A, Swencionis C, Wassertheil-Smoller S, Wylie-Rosett J, Zimbaldi N. Trial of antihypertensive interventions and management. Design, methods, and selected baseline results. Control Clin Trials. 1989 Mar;10(1):11-30. doi: 10.1016/0197-2456(89)90016-0.
Reference Type
BACKGROUND
Langford HG, Rockhold RW, Wassertheil-Smoller S, Oberman A, Davis BR, Blaufox MD. Effect of weight loss on thiazide produced erectile problems in men. Trans Am Clin Climatol Assoc. 1990;101:190-4.
Reference Type
BACKGROUND
Oberman A, Wassertheil-Smoller S, Langford HG, Blaufox MD, Davis BR, Blaszkowski T, Zimbaldi N, Hawkins CM. Pharmacologic and nutritional treatment of mild hypertension: changes in cardiovascular risk status. Ann Intern Med. 1990 Jan 15;112(2):89-95. doi: 10.7326/0003-4819-112-2-89.
Reference Type
BACKGROUND
Langford HG, Davis BR, Blaufox D, Oberman A, Wassertheil-Smoller S, Hawkins M, Zimbaldi N. Effect of drug and diet treatment of mild hypertension on diastolic blood pressure. The TAIM Research Group. Hypertension. 1991 Feb;17(2):210-7. doi: 10.1161/01.hyp.17.2.210.
Reference Type
BACKGROUND
Wassertheil-Smoller S, Blaufox MD, Oberman A, Davis BR, Swencionis C, Knerr MO, Hawkins CM, Langford HG. Effect of antihypertensives on sexual function and quality of life: the TAIM Study. Ann Intern Med. 1991 Apr 15;114(8):613-20. doi: 10.7326/0003-4819-114-8-613.
Reference Type
BACKGROUND
Langford HG. Sodium-potassium interaction in hypertension and hypertensive cardiovascular disease. Hypertension. 1991 Jan;17(1 Suppl):I155-7. doi: 10.1161/01.hyp.17.1_suppl.i155.
Reference Type
BACKGROUND
Wassertheil-Smoller S, Blaufox MD, Oberman AS, Langford HG, Davis BR, Wylie-Rosett J. The Trial of Antihypertensive Interventions and Management (TAIM) study. Adequate weight loss, alone and combined with drug therapy in the treatment of mild hypertension. Arch Intern Med. 1992 Jan;152(1):131-6.
Reference Type
BACKGROUND
Davis BR, Oberman A, Blaufox MD, Wassertheil-Smoller S, Hawkins CM, Cutler JA, Zimbaldi N, Langford HG. Effect of antihypertensive therapy on weight loss. The Trial of Antihypertensive Interventions and Management Research Group. Hypertension. 1992 Apr;19(4):393-9. doi: 10.1161/01.hyp.19.4.393.
Reference Type
BACKGROUND
Wassertheil-Smoller S, Oberman A, Blaufox MD, Davis B, Langford H. The Trial of Antihypertensive Interventions and Management (TAIM) Study. Final results with regard to blood pressure, cardiovascular risk, and quality of life. Am J Hypertens. 1992 Jan;5(1):37-44. doi: 10.1093/ajh/5.1.37.
Reference Type
BACKGROUND
Blaufox MD, Lee HB, Davis B, Oberman A, Wassertheil-Smoller S, Langford H. Renin predicts diastolic blood pressure response to nonpharmacologic and pharmacologic therapy. JAMA. 1992 Mar 4;267(9):1221-5.
Reference Type
BACKGROUND
Davis BR, Blaufox MD, Oberman A, Wassertheil-Smoller S, Zimbaldi N, Cutler JA, Kirchner K, Langford HG. Reduction in long-term antihypertensive medication requirements. Effects of weight reduction by dietary intervention in overweight persons with mild hypertension. Arch Intern Med. 1993 Aug 9;153(15):1773-82. doi: 10.1001/archinte.153.15.1773.
Reference Type
BACKGROUND
Wylie-Rosett J, Wassertheil-Smoller S, Blaufox MD, Davis BR, Langford HG, Oberman A, Jennings S, Hataway H, Stern J, Zimbaldi N. Trial of antihypertensive intervention and management: greater efficacy with weight reduction than with a sodium-potassium intervention. J Am Diet Assoc. 1993 Apr;93(4):408-15. doi: 10.1016/0002-8223(93)92286-7.
Reference Type
BACKGROUND
Davis BR, Oberman A, Blaufox MD, Wassertheil-Smoller S, Zimbaldi N, Kirchner K, Wylie-Rosett J, Langford HG. Lack of effectiveness of a low-sodium/high-potassium diet in reducing antihypertensive medication requirements in overweight persons with mild hypertension. TAIM Research Group. Trial of Antihypertensive Interventions and Management. Am J Hypertens. 1994 Oct;7(10 Pt 1):926-32. doi: 10.1093/ajh/7.10.926.
Reference Type
BACKGROUND
Wassertheil-Smoller S, Davis BR, Breuer B, Chang CJ, Oberman A, Blaufox MD. Differences in precision of dietary estimates among different population subgroups. Ann Epidemiol. 1993 Nov;3(6):619-28. doi: 10.1016/1047-2797(93)90085-i.
Reference Type
BACKGROUND
Fretts AM, Follis JL, Nettleton JA, Lemaitre RN, Ngwa JS, Wojczynski MK, Kalafati IP, Varga TV, Frazier-Wood AC, Houston DK, Lahti J, Ericson U, van den Hooven EH, Mikkila V, Kiefte-de Jong JC, Mozaffarian D, Rice K, Renstrom F, North KE, McKeown NM, Feitosa MF, Kanoni S, Smith CE, Garcia ME, Tiainen AM, Sonestedt E, Manichaikul A, van Rooij FJ, Dimitriou M, Raitakari O, Pankow JS, Djousse L, Province MA, Hu FB, Lai CQ, Keller MF, Perala MM, Rotter JI, Hofman A, Graff M, Kahonen M, Mukamal K, Johansson I, Ordovas JM, Liu Y, Mannisto S, Uitterlinden AG, Deloukas P, Seppala I, Psaty BM, Cupples LA, Borecki IB, Franks PW, Arnett DK, Nalls MA, Eriksson JG, Orho-Melander M, Franco OH, Lehtimaki T, Dedoussis GV, Meigs JB, Siscovick DS. Consumption of meat is associated with higher fasting glucose and insulin concentrations regardless of glucose and insulin genetic risk scores: a meta-analysis of 50,345 Caucasians. Am J Clin Nutr. 2015 Nov;102(5):1266-78. doi: 10.3945/ajcn.114.101238. Epub 2015 Sep 9.
Reference Type
DERIVED
Other Identifiers
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32
Identifier Type: -
Identifier Source: org_study_id