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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02855489
Other study ID # 13-0558
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2013
Est. completion date November 2014

Study information

Verified date July 2023
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study has three primary goals. First, to design distinct interventions that target the three core constructs of the Theory of Planned Behavior (i.e, attitudes, norms, and perceived behavioral control (PBC)). The second goal is to determine which combination of the Theory of Planned Behavior constructs is more successful at changing condom use behavior among college students. Finally, the investigators will examine the impact change in targeted constructs has on those not targeted by an intervention. The current study intends to empirically test how the constructs (i.e., attitudes, norms, PBC) in the Theory of Planned Behavior influence each other to increase condom use with college students.


Description:

Theory allows researchers to systematically explain and predict health behavior by providing an organized framework to approach research questions; the importance of theory is particularly emphasized in meta-analyses demonstrating that interventions designed from the basis of health behavior theory are more successful than those that are not theory-based. The superiority of theory-based interventions has been established, but these meta-analyses do not answer the important questions of which theoretical constructs may be the "active ingredients" of change nor of how constructs in a particular theory may work separately versus in combination to produce the greatest amount of behavior change. Health interventions on the whole have only small to moderate effects on behavior change, and perhaps this is partly due to a lack of solid understanding of how key theoretical constructs influence each other to motivate behavior change. Often times when a theory is used as the basis for an intervention only a subset of the constructs seem to produce behavior change, which calls into question the sufficiency of our current theories for producing behavior change. One possible reason for this may be that current health behavior theories are really theories of behavioral prediction and not behavior change. Health behavior theories are often used to inform intervention development-assuming that the same cognitive processes that successfully explain behavior are also the same processes that can be targeted to elicit behavior change. Past reviews show that theories like the Theory of Planned Behavior (TPB) explain 30%-50% of the variance in behavior, and when behavior change is the outcome the same predictors only produce small to moderate effects. However, it is unclear if the same predictors are working together in a similar way when using them to explain behavior versus creating behavior change. Currently, the same cognitive mechanisms are used to describe both processes, but those that explain behavior may not be the same ones that produce behavior change. There is very little literature that addresses how these processes may differ. A careful examination of the extent to which current theoretical constructs successfully produce behavior change individually or in combination may help clarify the optimal theoretical framework that should be utilized in behavior change interventions. Using the Theory of Planned Behavior (TPB) as the guiding theoretical framework, this study explores one way to experimentally determine how the constructs in the TPB influence each other and successfully produce health behavior change.


Recruitment information / eligibility

Status Completed
Enrollment 317
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 26 Years
Eligibility Inclusion Criteria: - Participants must be 18 and older and must have had vaginal or anal intercourse at least once. Exclusion Criteria: - Prior research has indicated that the predictors of condom use are dramatically different in casual versus serious relationships and that condom use is extremely difficult to change among those in established long-term relationships. Thus, we will exclude participants if they indicate that they are in a relationship and they classify that relationship as someone they are "living with" or "married to".

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Attitudes Only

Norms Only

Perceived Behavioral Control Only

Intentions Only

Three Constructs

Four Constructs


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Boulder

References & Publications (6)

Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health. 2010;31:399-418. doi: 10.1146/annurev.publhealth.012809.103604. — View Citation

Glanz K, Maddock J. On judging models and theories: research and practice, psychology and public health. J Health Psychol. 2000 Mar;5(2):151-4. doi: 10.1177/135910530000500203. No abstract available. — View Citation

Godin G, Kok G. The theory of planned behavior: a review of its applications to health-related behaviors. Am J Health Promot. 1996 Nov-Dec;11(2):87-98. doi: 10.4278/0890-1171-11.2.87. — View Citation

Noar SM. Behavioral interventions to reduce HIV-related sexual risk behavior: review and synthesis of meta-analytic evidence. AIDS Behav. 2008 May;12(3):335-53. doi: 10.1007/s10461-007-9313-9. Epub 2007 Sep 21. — View Citation

Reid AE, Aiken LS. Integration of five health behaviour models: common strengths and unique contributions to understanding condom use. Psychol Health. 2011 Nov;26(11):1499-520. doi: 10.1080/08870446.2011.572259. Epub 2011 Jun 28. — View Citation

Webb TL, Sheeran P. Does changing behavioral intentions engender behavior change? A meta-analysis of the experimental evidence. Psychol Bull. 2006 Mar;132(2):249-68. doi: 10.1037/0033-2909.132.2.249. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Risky Sexual Behavior Risky sexual behavior was a composite variable calculated using "how many times a participant had sex in the past 3 months" X "how many times they used a condom when having sex during those 3 months" (reverse coded). Higher scores indicated riskier sexual behavior. Three Months
Secondary Condom Use Condom use was measured by asking participants "In the past 3 months only, how much of the time have you used condoms when you've had sexual intercourse?" on a scale from 0% of the time to 100% of the time. Three Months
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