Seton Hill University--Personal Empowerment Program
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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
    

Detailed description: 
      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.
    

Intervention name(s): health coaching and electronic messaging
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: prevention; adult; student