A Multiple Health Behavior Change Internet Program for College Students

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pro-Change Behavior Systems
ClinicalTrials.gov Identifier:
NCT01555203
First received: August 15, 2011
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Sedentary Lifestyle
Stress, Psychological
Healthy Eating
Behavioral: liveWell: A healthy foundation for life
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Multiple Health Behavior Change Internet Program for College Students

Resource links provided by NLM:


Further study details as provided by Pro-Change Behavior Systems:

Primary Outcome Measures:
  • Change from Baseline in Adoption of Healthy Eating at 6 & 12 months [ Time Frame: Baseline, six months and twelve months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, six months and twelve months ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, six months and twelve months ] [ Designated as safety issue: No ]
    RISCI: Rhode Island Stress and Coping Inventory and stage of readiness for effective stress management


Estimated Enrollment: 2010
Study Start Date: November 2009
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: liveWell: A healthy foundation for life 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.


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

Ages Eligible for Study:   17 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • enrolled as a freshmen in college
  • English speaking

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555203

Sponsors and Collaborators
Pro-Change Behavior Systems
Investigators
Principal Investigator: Sara Johnson, PhD Pro-Change Behavior Systems, Inc.
  More Information

No publications provided

Responsible Party: Pro-Change Behavior Systems
ClinicalTrials.gov Identifier: NCT01555203     History of Changes
Other Study ID Numbers: 5R44HL074485-04
Study First Received: August 15, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 20, 2014