Seton Hill University--Personal Empowerment Program
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 30 |
| Updated: | 5/19/2016 |
| Start Date: | January 2012 |
| End Date: | June 2015 |
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
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
This proposal aims to study the issues of health behaviors in the domains of diet, exercise,
stress, and sleep. We aim to improve health behaviors in these domains by evaluating
lifestyle choices and communication preferences with a three phase investigation. Phase 1
has the specific objective of lifestyle assessment. Phase 1 will evaluate dietary habits and
choices, exercise practices, perceived stress levels, and quantity and timing of sleep
utilizing a web-based health survey. The web-based survey tool will populate a secure
research database. The data will include demographic information, anthropometric data,
actigraphic data to measure exercise levels and sleep time, and laboratory studies that
measure glucose metabolism, lipids, and other laboratory markers for cardiovascular risk
assessment.
Phase 2 constitutes a pilot study in a limited number of university students to determine
the feasibility of causing healthy behavior change with the use of electronic messaging to
university students up to six times per week over 8 weeks. Experience from this feasibility
study will inform the design of Phase 3.
Phase 3 will measure improvements in the lifestyle behaviors of students as a result of
health coaching and electronic feedback messages over an 8 week period comparing their
indices of health with a control group that does not receive the coaching and electronic
feedback messages. Utilizing lessons learned from Phase 2, subjects randomized to an
intervention arm but not subjects randomized to a control arm, will receive health coaching
and electronic messages at the rate of up to six times per week over an 8 week period.
Before and after this intervention period, measurements of lifestyle choices,
anthropometrics, actigraphy for objective exercise and sleep patterns, and cardiac-relevant
laboratory studies will be measured. Data from the intervention group will be compared with
that of the control group.
stress, and sleep. We aim to improve health behaviors in these domains by evaluating
lifestyle choices and communication preferences with a three phase investigation. Phase 1
has the specific objective of lifestyle assessment. Phase 1 will evaluate dietary habits and
choices, exercise practices, perceived stress levels, and quantity and timing of sleep
utilizing a web-based health survey. The web-based survey tool will populate a secure
research database. The data will include demographic information, anthropometric data,
actigraphic data to measure exercise levels and sleep time, and laboratory studies that
measure glucose metabolism, lipids, and other laboratory markers for cardiovascular risk
assessment.
Phase 2 constitutes a pilot study in a limited number of university students to determine
the feasibility of causing healthy behavior change with the use of electronic messaging to
university students up to six times per week over 8 weeks. Experience from this feasibility
study will inform the design of Phase 3.
Phase 3 will measure improvements in the lifestyle behaviors of students as a result of
health coaching and electronic feedback messages over an 8 week period comparing their
indices of health with a control group that does not receive the coaching and electronic
feedback messages. Utilizing lessons learned from Phase 2, subjects randomized to an
intervention arm but not subjects randomized to a control arm, will receive health coaching
and electronic messages at the rate of up to six times per week over an 8 week period.
Before and after this intervention period, measurements of lifestyle choices,
anthropometrics, actigraphy for objective exercise and sleep patterns, and cardiac-relevant
laboratory studies will be measured. Data from the intervention group will be compared with
that of the control group.
Inclusion Criteria:
- Full time undergraduate student at Seton Hill University
- Ages 18 to 30 years
- Healthy
Exclusion Criteria:
- 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)
We found this trial at
2
sites
Bethesda, Maryland 20889
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