Seton Hill University--Personal Empowerment Program
SHU-PEP
1 other identifier
interventional
70
1 country
2
Brief Summary
It is widely acknowledged that cardiovascular disease prevention requires intervention as early in the human lifespan as practical. A window of opportunity presents in early adulthood when students gain independence as young adults attending university. In a three-phase investigation, this study will evaluate the behavioral patterns of university students in the domains of diet, exercise, stress management, smoking and sleep (phase 1). Informed with information from phase 1, a pilot study (phase 2) will test the feasibility of performing an intervention in university students consisting of an 8-week period during which the students will receive up to six text messages (by phone or iPad) per week, tailored to address the behavioral issues that the student has identified as needing improvement and for which the student has indicated a desire to make change. Using lessons learned in phase 2, a randomized, controlled trial of the 8 week intervention (phase 3) will compare intervention subjects with controls for outcomes of behavior change, measures of anthropometric data, and serum markers of cardiovascular risk to test the impact of the intervention
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Jan 2012
Typical duration for not_applicable cardiovascular-diseases
2 active sites
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
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedMay 18, 2016
May 1, 2016
3.4 years
June 9, 2015
May 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A composite score for adherence to personal goals for Diet, Exercise, Stress Management and Expansion of Sleep Time.
Improvement will be determined by calculating a composite score for % achievement in adhering to goals set for Rate-Your-Plate Dietary Assessment, Exercise Minutes, Stress Reduction by Perceived Stress Scale and Total Sleep Time.
8 weeks
Secondary Outcomes (4)
Weight Management
8 weeks
Lipid Profile
8 weeks
Glucose Metabolism
8 weeks
Hemoglobin A1C
8 weeks
Study Arms (2)
Electronic Messaging
EXPERIMENTALSubjects randomized to the intervention arm will receive health coaching and electronic messages at the rate of up to six times per week over an 8 week period.
Control
NO INTERVENTIONSubjects randomized to the control arm will undergo all of the same measurements for baseline and follow up data but will not receive the intervention of health coaching and electronic messaging.
Interventions
Using using an iPAD or notebook PC, students will receive electronic messaging aimed at encouraging adherence to behavioral goals previously set via discussions with the health coaches. The messages will be received 3 to 6 times per week for the 8 week intervention period.
Eligibility Criteria
You may qualify if:
- Full time undergraduate student at Seton Hill University
- Ages 18 to 30 years
- Healthy
You may not qualify if:
- Part-time study (less than 12 semester hours of enrollment)
- Under 18 years or over 30 years of age
- Pregnant or planning to become pregnant during study
- Diagnosed eating disorder
- Diagnosed with chronic medical illness such as heart disease (including pacemaker placement), gastro-intestinal disease, diabetes, pulmonary disease
- Taking prescribed medication other than birth control pills or multivitamins on an ongoing basis
- Any condition that may preclude the ability to perform the requirements of the study (for example an orthopedic or neurological condition that prevents the accurate measurement of a subject's height).
- Persons with metal implants (plates, etc)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Integrative Cardiac Health Project, Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Seton Hill University
Greensburg, Pennsylvania, 15601, United States
Related Publications (1)
Sandrick J, Tracy D, Eliasson A, Roth A, Bartel J, Simko M, Bowman T, Harouse-Bell K, Kashani M, Vernalis M. Effect of a Counseling Session Bolstered by Text Messaging on Self-Selected Health Behaviors in College Students: A Preliminary Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 May 17;5(5):e67. doi: 10.2196/mhealth.6638.
PMID: 28526664DERIVED
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Arn Eliasson, MD
Walter Reed National Military Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2015
First Posted
June 19, 2015
Study Start
January 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 18, 2016
Record last verified: 2016-05