Seton Hill University--Personal Empowerment Program

Cardiovascular Diseases Clinical Trial

— SHU-PEP  

Official title:

Seton Hill University--Personal Empowerment Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476604
• Other study ID #: 375278-3
• Status: Completed
• Phase: N/A
• First received: June 9, 2015
• Last updated: May 17, 2016
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: May 2016
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• health coaching and electronic messaging
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.

Locations

Country	Name	City	State
United States	Integrative Cardiac Health Project, Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Seton Hill University	Greensburg	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center	Seton Hill University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Weight Management	BMI and % body fat changes	8 weeks	No
Secondary	Lipid Profile	Change in chemical profile of lipid panel	8 weeks	No
Secondary	Glucose Metabolism	Change in fasting glucose	8 weeks	No
Secondary	Hemoglobin A1C	Change in hemoglobin A1C	8 weeks	No