NCT00242658

Brief Summary

This study will test the efficacy of providing primary care physicians and their patients with computer-tailored information, based on patients' responses to survey questions. The health education messages are designed to encourage patients to become physically active and to encourage physicians to counsel their patients about exercise.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
394

participants targeted

Target at P75+ for phase_1 hypertension

Timeline
Completed

Started May 2005

Longer than P75 for phase_1 hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

June 6, 2011

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

2.6 years

First QC Date

October 19, 2005

Results QC Date

December 16, 2010

Last Update Submit

November 7, 2012

Conditions

Hypertension

Keywords

Physical ActivityWellness ProgramsHealth PromotionBlood Pressure, High

Outcome Measures

Primary Outcomes (1)

  • 7-Day Physical Activity Recall (7-Day PAR)

    Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months.

    6 months

Secondary Outcomes (1)

  • Change in Behavioral Processes of Change Between Baseline and 6 Months

    Baseline and 6 months

Study Arms (2)

Tailored Physical Activity Intervention Group

EXPERIMENTAL

Four feedback reports aimed to increase physical activity.

Behavioral: Tailored Physical Activity Intervention

No Tailored Physical Activity Intervention Group

NO INTERVENTION

General reports on preventive screening based on responses to preventive screening questions.

Interventions

Tailored Physical Activity InterventionBEHAVIORAL

Tailored physical activity computer reports will be provided to patients and physicians.

Also known as: Exercise Intervention
Tailored Physical Activity Intervention Group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to speak and read English
  • Current patient of a physician participating in this study (if selecting a new physician, may deliberately select one that is involved in the study, in order to participate)
  • Ability to complete all written surveys
  • Accessible for follow-up telephone surveys
  • Ability to undergo exercise testing

You may not qualify if:

  • Currently participating in another research study
  • Planning to move out of the Philadelphia area
  • Unable to walk without pain
  • Pregnant or planning to become pregnant in the year following study entry
  • Excessive drinking
  • Coronary heart disease
  • Congestive heart failure
  • Peripheral vascular disease
  • Cerebrovascular disease
  • Chronic obstructive pulmonary disease
  • Arrhythmia
  • Recurrent seizures
  • Dizziness
  • Balance problems
  • Psychoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jefferson Family Medicine Associates

Philadelphia, Pennsylvania, 19107, United States

Location

Jefferson Medical College, Department of Health Policy

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Carroll JK, Lewis BA, Marcus BH, Lehman EB, Shaffer ML, Sciamanna CN. Computerized tailored physical activity reports. A randomized controlled trial. Am J Prev Med. 2010 Aug;39(2):148-56. doi: 10.1016/j.amepre.2010.04.005.

    PMID: 20621262DERIVED

MeSH Terms

Conditions

HypertensionMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Results Point of Contact

Title
Chris Sciamanna, MD, MPH
Organization
Penn State Milton S. Hershey Medical Center
cns10@psu.edu
717-531-8161

Study Officials

  • Christopher N. Sciamanna, MD, MPH

    Jefferson Medical College, Department of Health Policy

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Public Health Sciences

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 20, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2007

Study Completion

March 1, 2008

Last Updated

November 12, 2012

Results First Posted

June 6, 2011

Record last verified: 2012-11

Locations

US(2)