CClinicalTrials.gg
CompletedNCT00000551Updated Mar 25, 2016

Activity Counseling Trial (ACT)

A Phase 3 interventional study of health education in Cardiovascular Diseases and Heart Diseases, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-25.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study summary

To develop and evaluate the effectiveness of various intervention approaches, delivered in primary health-care settings, in increasing and maintaining habitual physical activity and cardiorespiratory fitness among sedentary men and women patients.

Read the detailed description

BACKGROUND:

A conference on physical activity sponsored by the National Heart, Lung, and Blood Institute (NHLBI) in August 1991 recommended that one priority area for research should be the development and evaluation of interventions for adoption and maintenance of physical activity including interventions that can be incorporated into primary care practice. The 1992 NHLBI Working Group Report on Primary Prevention of Hypertension identified physical inactivity as a risk factor for hypertension. Intervention research applicable to health-care settings is particularly important in light of national recommendations advising health-care professionals to intervene, including Healthy People 2000, the U.S. Preventive Services Task Force reports, and the American Heart Association.

DESIGN NARRATIVE:

Randomized, multicenter, demonstration and education study. Men and women primary care patients at three sites in Dallas, Palo Alto, and Memphis were randomized to two patient education intervention groups or to a standard care control group of physician advice. Intervention continued for two years for all participants. The primary outcomes were cardiorespiratory fitness and physical activity. Other outcomes were effects on blood pressure, lipoproteins, and weight; the long-term maintenance of these effects; and the cost-effectiveness of various intervention approaches. Recruitment took 15 months and has been completed with the accrual of 874 subjects.

The National Institute on Aging participated in the ACT through the addition of a measurement of arterial stiffness involving approximately 700 patients. The NIA tested the hypothesis that increases in physical activity resulting from educational interventions could reduce arterial stiffness.

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Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

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Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Sedentary men and women, free of coronary heart disease, who were patients in primary care settings.

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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized

Interventions

  • Behavioralhealth education
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Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • King AC, Sallis JF, Dunn AL, Simons-Morton DG, Albright CA, Cohen S, Rejeski WJ, Marcus BH, Coday MC. Overview of the Activity Counseling Trial (ACT) intervention for promoting physical activity in primary health care settings. Activity Counseling Trial Research Group. Med Sci Sports Exerc. 1998 Jul;30(7):1086-96. doi: 10.1097/00005768-199807000-00011. PubMed 9662678 ↗
  • Simons-Morton DG. The context of the Activity Counseling Trial. Med Sci Sports Exerc. 1998 Jul;30(7):1084-5. doi: 10.1097/00005768-199807000-00010. No abstract available. PubMed 9662677 ↗
  • Blair SN, Applegate WB, Dunn AL, Ettinger WH, Haskell WL, King AC, Morgan TM, Shih JA, Simons-Morton DG. Activity Counseling Trial (ACT): rationale, design, and methods. Activity Counseling Trial Research Group. Med Sci Sports Exerc. 1998 Jul;30(7):1097-106. doi: 10.1097/00005768-199807000-00012. PubMed 9662679 ↗
  • Margitic S, Sevick MA, Miller M, Albright C, Banton J, Callahan K, Garcia M, Gibbons L, Levine BJ, Anderson R, Ettinger W. Challenges faced in recruiting patients from primary care practices into a physical activity intervention trial. Activity Counseling Trial Research Group. Prev Med. 1999 Oct;29(4):277-86. doi: 10.1006/pmed.1999.0543. PubMed 10547053 ↗
  • Havlik RJ, Brock D, Lohman K, Haskell W, Snell P, O'Toole M, Ribisl P, Vaitkevicius P, Spurgeon HA, Lakatta EG, Pullen P. High-density lipoprotein cholesterol and vascular stiffness at baseline in the activity counseling trial. Am J Cardiol. 2001 Jan 1;87(1):104-7, A9. doi: 10.1016/s0002-9149(00)01282-0. PubMed 11137844 ↗
  • Albright CL, Cohen S, Gibbons L, Miller S, Marcus B, Sallis J, Imai K, Jernick J, Simons-Morton DG. Incorporating physical activity advice into primary care: physician-delivered advice within the activity counseling trial. Am J Prev Med. 2000 Apr;18(3):225-34. doi: 10.1016/s0749-3797(99)00155-5. PubMed 10722989 ↗
  • Simons-Morton DG, Hogan P, Dunn AL, Pruitt L, King AC, Levine BD, Miller ST. Characteristics of inactive primary care patients: baseline data from the activity counseling trial. For the Activity Counseling Trial Research Group. Prev Med. 2000 Nov;31(5):513-21. doi: 10.1006/pmed.2000.0733. PubMed 11071831 ↗
  • Wee CC. Physical activity counseling in primary care: the challenge of effecting behavioral change. JAMA. 2001 Aug 8;286(6):717-9. doi: 10.1001/jama.286.6.717. No abstract available. PubMed 11495623 ↗
  • Havlik RJ, Phillips CL, Brock DB, Lohman K, Haskell W, Snell P, O'Toole M, Ribisl P, Vaitkevicius P, Spurgeon HA, Lakatta EG, Pullen P. Walking may be related to less vascular stiffness in the Activity Counseling Trial (ACT). Am Heart J. 2005 Aug;150(2):270-5. doi: 10.1016/j.ahj.2004.09.006. PubMed 16086929 ↗
  • Writing Group for the Activity Counseling Trial Research Group. Effects of physical activity counseling in primary care: the Activity Counseling Trial: a randomized controlled trial. JAMA. 2001 Aug 8;286(6):677-87. doi: 10.1001/jama.286.6.677. PubMed 11495617 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000551
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
First posted
Oct 28, 1999
Start date
Sep 1994
Completion
Sep 2002
Last update
Mar 25, 2016

Study contacts

Timothy Morgan
Bowman Gray School of Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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