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A Multiple Health Behavior Change Internet Program for College Students

Primary Purpose

Sedentary Lifestyle, Stress, Psychological, Healthy Eating

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
liveWell: A healthy foundation for life
Sponsored by
Pro-Change Behavior Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedentary Lifestyle

Eligibility Criteria

17 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • enrolled as a freshmen in college
  • English speaking

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    liveWell: A healthy foundation for life

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 15, 2011
    Last Updated
    April 27, 2015
    Sponsor
    Pro-Change Behavior Systems
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01555203
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    October 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pro-Change Behavior Systems

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sedentary Lifestyle, Stress, Psychological, Healthy Eating

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    1877 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    liveWell: A healthy foundation for life
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    liveWell: A healthy foundation for life
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Adoption of Healthy Eating at 6 & 12 months
    Description
    Continuous measure of fruit and vegetable intake: stage of readiness for fruit and vegetable intake.
    Time Frame
    Baseline, six months and twelve months
    Title
    Change from Baseline in Adoption of Exercise at 6 & 12 months
    Description
    Godin Leisure Time Exercise Questionnaire and stage of readiness for regular exercise Triaxial accelerometers in sub-sample of participants
    Time Frame
    Baseline, six months and twelve months
    Title
    Change from Baseline in Adoption of Exercise, Healthy Eating, and Effective Change from Baseline in Adoption of Effective Stress Management at 6 & 12 months
    Description
    RISCI: Rhode Island Stress and Coping Inventory and stage of readiness for effective stress management
    Time Frame
    Baseline, six months and twelve months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: enrolled as a freshmen in college English speaking Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sara Johnson, PhD
    Organizational Affiliation
    Pro-Change Behavior Systems, Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Multiple Health Behavior Change Internet Program for College Students

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