Clinical trial NCT01555203: A Multiple Health Behavior Change Internet Program for College Students
Official title: A Multiple Health Behavior Change Internet Program for College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sedentary Lifestyle
Stress, Psychological
Healthy Eating
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 1877
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* enrolled as a freshmen in college
* English speaking

Exclusion Criteria:

-

Primary outcomes:
measure: Change from Baseline in Adoption of Healthy Eating at 6 & 12 months
timeFrame: Baseline, six months and twelve months
measure: Change from Baseline in Adoption of Exercise at 6 & 12 months
timeFrame: Baseline, six months and twelve months
measure: Change from Baseline in Adoption of Exercise, Healthy Eating, and Effective Change from Baseline in Adoption of Effective Stress Management at 6 & 12 months
timeFrame: Baseline, six months and twelve months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pro-Change Behavior Systems, Inc.
name: Sara Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: