A Multiple Health Behavior Change Internet Program for College Students

Phase 2

Completed

• Conditions: Sedentary Lifestyle; Stress, Psychological; Healthy Eating

• Registration Number: NCT01555203
• Lead Sponsor: Pro-Change Behavior Systems

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1877

Inclusion Criteria

• enrolled as a freshmen in college
• English speaking

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Adoption of Healthy Eating at 6 & 12 months	Baseline, six months and twelve months	Continuous measure of fruit and vegetable intake: stage of readiness for fruit and vegetable intake.
Change from Baseline in Adoption of Exercise at 6 & 12 months	Baseline, six months and twelve months	Godin Leisure Time Exercise Questionnaire and stage of readiness for regular exercise; Triaxial accelerometers in sub-sample of participants
Change from Baseline in Adoption of Exercise, Healthy Eating, and Effective Change from Baseline in Adoption of Effective Stress Management at 6 & 12 months	Baseline, six months and twelve months	RISCI: Rhode Island Stress and Coping Inventory and stage of readiness for effective stress management