A Multiple Health Behavior Change Internet Program for College Students

Stress, Psychological Clinical Trial

Official title:

A Multiple Health Behavior Change Internet Program for College Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555203
• Other study ID #: 5R44HL074485-04
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2011
• Last updated: April 27, 2015
• Start date: November 2009
• Est. completion date: October 2012

Study information

• Verified date: April 2015
• Source: Pro-Change Behavior Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this Phase II research is to evaluate the effectiveness of a population-based, individually tailored multiple health behavior change program for exercise, healthy eating, and stress management in a randomized trial including approximately 1,500 college students.

Description:

Despite the importance of shaping a solid foundation of health behaviors early in life, college students have been understudied as a population for health promotion programs. This study represents innovative research for impacting the promotion of healthy lifestyles among college students. The objective is to develop and test a population-based, multiple health behavior change program for college students, liveWell: A Healthy Foundation for Life.

The multiple behavior multimedia program will offer Transtheoretical Model-based (TTM) computer tailored feedback on regular exercise, fruit and vegetable consumption, and effective stress management, as well as providing access to a stage-matched dynamic web portal. The TTM is a comprehensive model that integrates ideas from several different theories and approaches to change (hence the name "Transtheoretical") to explain and predict how and when individuals end high-risk behaviors or adopt healthy ones. Thirty years of research has consistently demonstrated that change is a process that unfolds over time through a series of stages: Precontemplation, Contemplation, Preparation, Action, and Maintenance. It matches specific principles and processes of change to each person's stage of change and guides individuals through the change process. The TTM has been applied throughout the world to behaviors such as smoking cessation, alcohol reduction, bullying prevention, weight management, and medication adherence.

A primary goal of this Phase II grant is to assess the effectiveness of liveWell in a randomized trial including 1680 students from 2 large universities in the U.S. Students will be recruited via freshman orientation classes and will complete follow-up assessments at 6-and 12-months. Effectiveness will be assessed by comparing improvements in continuous outcome measures and movement to public health criteria for each behavior. This intervention offers a cost-effective, science-based, and easily deliverable solution to improve multiple health behaviors, and overall health and well-being, of college students.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1877
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 25 Years

Eligibility

Inclusion Criteria:

• enrolled as a freshmen in college

• English speaking

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Healthy Eating
• Sedentary Lifestyle
• Stress, Psychological

Intervention

Behavioral:
• liveWell: A healthy foundation for life
liveWell is a unique online, mobile-compatible, multi-media, evidence-based program designed to help college students exercise, eat healthy, and manage stress. At the core of the Transtheoretical Model-based intervention is a computer-tailored behavior change intervention (CTI) that analyzes students' responses to reliable and valid assessments of key behavior change constructs using empirically derived pre-programmed decision rules. The rules determine which feedback users receive on how they are doing compared to their peers in their same stage. At follow-up, feedback is further tailored to how students are doing compared to their last session. In addition to the CTI, completed three times during the semester, liveWell includes a dynamic portal that is populated with a variety of engaging and interactive stage-matched activities and resources. The portal provides more content and specifics on how to apply each of the processes and principles of change introduced in the CTI.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pro-Change Behavior Systems

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Adoption of Healthy Eating at 6 & 12 months	Continuous measure of fruit and vegetable intake: stage of readiness for fruit and vegetable intake.	Baseline, six months and twelve months	No
Primary	Change from Baseline in Adoption of Exercise at 6 & 12 months	Godin Leisure Time Exercise Questionnaire and stage of readiness for regular exercise; Triaxial accelerometers in sub-sample of participants	Baseline, six months and twelve months	No
Primary	Change from Baseline in Adoption of Exercise, Healthy Eating, and Effective Change from Baseline in Adoption of Effective Stress Management at 6 & 12 months	RISCI: Rhode Island Stress and Coping Inventory and stage of readiness for effective stress management	Baseline, six months and twelve months	No