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Exercise Instruction Via Phone or Print

Exercise Instruction Via Phone or Print

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00200278
Enrollment
228
Registered
2005-09-20
Start date
2000-08-31
Completion date
2005-03-31
Last updated
2005-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Exercise, Intervention studies, Decision-making, computer assisted Expert systems, telephone

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.

Detailed description

As many as 60% of Americans do not engage in regular physical activity and 25% are completely inactive. The risk of cardiovascular disease is almost doubled among people who are physically inactive, comparable to the risks associated with increased systolic blood pressure, cigarette smoking, and elevated serum cholesterol. To make an impact on physical activity prevalence at the population level requires a research focus at the interface between clinical efficacy trials and large-scale dissemination studies. Studies at this interface must use proven interventions that are simultaneously effective and cost-efficient. Such interventions are the focus of this proposal. 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. The two intervention arms will be matched with respect to frequency and content of contact. Data will be collected at baseline, 6, and 12 months using well-established physical activity and physical performance measures, as well as a comprehensive set of psychosocial questionnaires. 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. Additional questions of interest include evaluation of the cost-effectiveness of the two intervention delivery approaches, each in relation to each other and to the wait list control group and examination of potential moderators and mediators of the intervention-physical activity relationship. This study will contribute important information regarding the relative efficacy and cost-effectiveness of two interventions, each of which can be utilized for widespread public health dissemination.

Interventions

BEHAVIORALPROJECT STRIDE

Sponsors

Brown University
CollaboratorOTHER
Stanford University
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
The Miriam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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).

Exclusion criteria

Individuals were excluded from the study if their body mass index (BMI) was greater than 35 or if they had hypertension, heart disease of any kind or an abnormal electrocardiogram, stroke, chronic infectious disease, any musculoskeletal problem which would limit treadmill testing or impair their ability to exercise, asthma, emphysema, chronic bronchitis, or any other serious medical condition that might make exercise unsafe or unwise. Other

Design outcomes

Primary

MeasureTime frame
7 day Physical Activity Recall

Secondary

MeasureTime frame
Exercise Stages of Change
Estimated VO2 max
Treadmill time

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026