NCT00200278

Brief Summary

The objective of this study is to determine the differential effect of intervention delivery channel (phone versus print versus wait list control) on physical activity adoption and maintenance in previously sedentary adults. Both delivery channels have been found to be effective, but telephone-based interventions require more commitment on the part of the subjects and are more labor intensive than print-based interventions. Thus, we will conduct a randomized controlled clinical trial comparing three groups: 1) telephone-based motivationally-tailored individualized feedback; 2) print-based, motivationally-tailored individualized feedback; 3) minimal contact waiting list control condition (receive intervention after 12 months as controls). Two hundred and twenty-eight healthy, sedentary women and men ages 18-65 will be randomly assigned to one of the two interventions or the waiting-list control condition. Our primary hypothesis is that individuals randomized to either phone or print conditions will exhibit significantly higher levels of physical activity participation at 6 and 12 months than individuals in the waiting list control condition. And, in addition, that subjects randomized to the telephone condition will exhibit significantly higher levels of physical activity participation at 6 and 12 months than those in the print condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2000

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

August 1, 2000

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Cardiovascular Disease

Keywords

ExerciseIntervention studiesDecision-makingcomputer assisted Expert systemstelephone

Outcome Measures

Primary Outcomes (1)

  • 7 day Physical Activity Recall

Secondary Outcomes (3)

  • Exercise Stages of Change

  • Estimated VO2 max

  • Treadmill time

Interventions

PROJECT STRIDEBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals between the ages of 18 to 65 years were recruited for this study. Criteria for study participation were that individuals were healthy and under-active (i.e., participating in moderate or vigorous physical activity for 90 minutes or less per week).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centers for Behavioral and Preventive Medicine/Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Bess H Marcus, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2000

Study Completion

March 1, 2005

Last Updated

September 20, 2005

Record last verified: 2005-09

Locations

US(1)