Cardiovascular DiseasesSHU-PEPNCT02476604
Seton Hill University--Personal Empowerment Program
A study testing health coaching and electronic messaging in people with Cardiovascular Diseases, run by Walter Reed National Military Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- health coaching and electronic messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full time undergraduate student at Seton Hill University
- Ages 18 to 30 years
- Healthy
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Integrative Cardiac Health Project, Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Seton Hill University
Greensburg, Pennsylvania, 15601
About this study
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
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- health coaching and electronic messaging
- Keywords
- prevention, adult, student
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health coaching and electronic messagingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Messaging | Experimental | Subjects 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. Receives: Behavioral: health coaching and electronic messaging |
| Control | No intervention | Subjects 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
Weight Management
BMI and % body fat changes
Measured: 8 weeks
Lipid Profile
Change in chemical profile of lipid panel
Measured: 8 weeks
Glucose Metabolism
Change in fasting glucose
Measured: 8 weeks
Hemoglobin A1C
Change in hemoglobin A1C
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Seton Hill University
- Responsible party
- Sponsor
- Investigators
- Arn Eliasson, MD, Study director, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476604
- Sponsor's protocol ID
- 375278-3
- Acronym
- SHU-PEP
- Status last verified
- May 2016
- First submitted
- 9 Jun 2015
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28526664
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seton Hill University--Personal Empowerment Program
- ClinicalTrials.gov ID
- NCT02476604
- Acronym / sponsor ID
- SHU-PEP / 375278-3
- Conditions
- Cardiovascular Diseases
- Keywords
- prevention, adult, student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- Seton Hill University
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Messaging | Experimental | Behavioral: health coaching and electronic messagingSubjects 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 intervention | –Subjects 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Full time undergraduate student at Seton Hill University
- Ages 18 to 30 years
- Healthy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health coaching and electronic messagingUsing 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. | Behavioural | Electronic Messaging |
Primary outcome
A composite score for adherence to personal goals for Diet, Exercise, Stress Management and Expansion of Sleep Time.
Time frame: 8 weeks
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.
4 secondary outcomes
Weight Management
Time frame: 8 weeks
Lipid Profile
Time frame: 8 weeks
Glucose Metabolism
Time frame: 8 weeks
Hemoglobin A1C
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Derived from this study: PubMed 28526664Sandrick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arn Eliasson, MD study director
Walter Reed National Military Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health coaching and electronic messaging in people with Cardiovascular Diseases, run by Walter Reed National Military Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite score for adherence to personal goals for Diet, Exercise, Stress Management and Expansion of Sleep Time. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02476604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.