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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01218412
Other study ID # 10-84E
Secondary ID
Status Recruiting
Phase Phase 1
First received October 4, 2010
Last updated April 3, 2015
Start date October 2014

Study information

Verified date April 2014
Source Karnes, Sasha
Contact Sasha L. Karnes, M.S.
Email sashaw@uwm.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The specific aims of the proposed study are:

- 1. To determine if web-based Motivational Interviewing (MI) is effective, compared to an informational web-based comparison group, in enhancing physical activity (PA) participation; and

- 2. To assess the mechanisms by which web-based MI enhances PA through changes in targeted cognitive mediators.

The specific hypotheses of the study include that:

- Hypothesis 1: Web-based MI will increase PA;

- Hypothesis 2: Web-based MI will lead to stage progression in the direction of increased readiness to participate in PA;

- Hypothesis 3: Web-based MI will influence theoretically identified cognitive variables;

- Hypothesis 4: Cognitive variables will mediate increases in PA participation.


Description:

Increasing physical activity (PA) is a public health priority. There is preliminary support for application of Motivational Interviewing (MI) for physical activity (PA), web-applications for PA promotion, web-based MI for behavior change, and finally web-based MI for PA. Based on collective findings in these areas of inquiry, it is necessary to investigate the efficacy of MI as a method that lends readily to practical applications for PA promotion. The current study seeks to investigate whether web-based MI can be applied in an adult population to enhance PA participation using a physician referral scheme. Additionally, mechanisms of behavior change are considered in order to inform future research and intervention.


Recruitment information / eligibility

Status Recruiting
Enrollment 132
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria:

- Adults referred through primary care due to insufficient physical activity standards based on Centers for Disease Control (CDC) guidelines for aerobic activity.

- Must have internet access and e-mail.

- Cleared by physician for physical activity participation.

Exclusion Criteria:

- Greater than 10,000 steps per day on average based on baseline pedometer screening over the course of 7 days.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Web-based Motivational Interviewing
Participants will engage in 4 sessions of web-based motivational interviewing over the course of 4 weeks.

Locations

Country Name City State
United States Aurora RiverCenter Milwaukee Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Karnes, Sasha University of Wisconsin, Whitewater

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Activity (pedometer recordings) Physical activity will be assessed using pedometers. 1 week post-intervention No
Primary Physical activity (self-report) Physical activity will be assessed using a self-report inventory. 3-months post-intervention No
Secondary Cognitive Mediators Cognitive mediators of physical activity participation including self-efficacy, readiness to change, motivation, intention, enjoyment, and decisional balance for physical activity will be assessed. 3 months post intervention No
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