NCT01555203

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,877

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2009

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

2.9 years

First QC Date

August 15, 2011

Last Update Submit

April 27, 2015

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

liveWell: A healthy foundation for life

EXPERIMENTAL
Behavioral: liveWell: A healthy foundation for life

Interventions

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.

liveWell: A healthy foundation for life

Eligibility Criteria

Age17 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • enrolled as a freshmen in college
  • English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sedentary BehaviorStress, Psychological

Condition Hierarchy (Ancestors)

BehaviorBehavioral Symptoms

Study Officials

  • Sara Johnson, PhD

    Pro-Change Behavior Systems, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2011

First Posted

March 15, 2012

Study Start

November 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 28, 2015

Record last verified: 2015-04