Cardiovascular DiseaseNUYouNCT02496728
NUYou:mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health
A study testing Mobile Health Application, Environmental Cues and Social Support in people with Cardiovascular Disease, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of the study is to investigate the preservation or promotion of health in students during the college years. Read more about this study
- Who is it for?
- Ages 17 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Mobile Health Application, Environmental Cues and Social Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 28 Feb 2019
- 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 17 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Freshman at Northwestern University in the fall of 2015
- Live on campus
- Read, write and speak English
- Own an Iphone or Android smart phone
Who cannot join
- Pregnant or trying to become pregnant
- Established cardiovascular disease
- Unstable psychiatric or medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: American Heart Association Strategically Focused Research Network: mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health
The purpose of the study is to investigate the preservation or promotion of health in students during the college years.
Read the detailed description
Freshman college students at Northwestern University will be cluster randomized to two groups based on their dorm. The intervention for one group will target smoking, physical activity, BMI and consumption of fruits and vegetables. The intervention in the second group will target traveling behavior, sexual risk behaviors, sunscreen use and hydration. Baseline health and lifestyle measures will be assessed for each participant prior to intervention. Health assessments will measure height, weight, fasting glucose, total cholesterol and carbon monoxide. The lifestyle measure will ask questions about physical activity, diet, alcohol and tobacco use, safe sex practices, driving habits, and sunscreen use. These same measures will be repeated during the fall of the students' sophomore and junior years.
Participants will be given a mobile application and encouraged to track some behaviors. In addition, participants will be asked to answer weekly questions regarding health behaviors.
- Conditions
- Cardiovascular Disease
- Being tested
- Mobile Health Application, Environmental Cues, Social Support, Educational Materials
- Keywords
- Mobile Health, Smartphone, Cardiovascular health, College students, Smoking, Physical activity, Diet, BMI, Blood pressure, Cholesterol, Glucose, Text, Facebook, Instagram, Push Notifications, Ecological Momentary Assessment
- Medical subject headings
- Cardiovascular Diseases, Smoking, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health ApplicationBehavioural
An application on a smart phone that is designed to help individuals self-monitor health behaviors.
Environmental CuesBehavioural
Text messages, informational posts and reminders supporting healthy behaviors.
Social SupportBehavioural
Participants may interact with each other through a private Facebook group.
Educational MaterialsBehavioural
Educational materials regarding healthy behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular Health | Experimental | Participants will be given the results of their health assessment and feedback regarding their health behaviors and overall health. Recommendations for change will be given if warranted. Participants will download the study's mobile health application on their smartphone. They will then be asked to report once a week about their health behaviors on the application. Participants will also be asked to self-monitor health behaviors that are not already at ideal levels using the study application (environmental cues). Participants will be asked to join a secret Facebook group where informational materials will be posted, participants can post about study health behaviors and social interaction around health behaviors can occur (social support and environmental cues). Receives: Behavioral: Mobile Health Application; Behavioral: Environmental Cues; Behavioral: Social Support; Behavioral: Educational Materials |
| Whole Health | Active comparator | Participants will be given the results of their health assessment. They will then receive educational materials about sunscreen use, safe sex, hydration and vehicular safety. Participants will download the study's mobile health application on their smartphone. They will then be asked to report once a week about their health behaviors on the application. Participants will also be asked to self-monitor how much water they drink using the study application. Participants will be asked to join a secret Facebook group where informational materials will be posted, they can post about study health behaviors and social interaction around health behaviors can occur (social support and environmental cues). Receives: Behavioral: Mobile Health Application; Behavioral: Environmental Cues; Behavioral: Social Support; Behavioral: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Heart Association MyLifeCheck (Simple 7) score as a measure of cardiovascular health
Participant's Simple 7 score is the sum of 7 cardiovascular health metrics attained at ideal levels as defined by American Heart Association. 1) physically active - Exercising at least 150 minutes of moderate or 75 minutes of vigorous physical activity per week. 2) Good diet quality - Eating 5 servings of fruits and vegetables per day, at least 3 servings of whole grain, and no more than 16 oz. of soda per day, rarely or never eats high sodium foods or processed meats. 3) nonsmoking - nonsmoker for at least a year. 4) not overweight - BMI < 25 kg/m2. 5) normoglycemic - fasting glucose < 100 mg/dl. 6) not hypercholesterolemic : total Cholesterol < 200 mg/dl. 7) not hypertensive. Blood Pressure <120/<80.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startMay 2015
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
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 DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Bonnie Spring, Northwestern University
- Investigators
- Bonnie Spring, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496728
- Sponsor's protocol ID
- 14SFRN20480260
- Acronym
- NUYou
- Status last verified
- May 2019
- First submitted
- 29 May 2015
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pfammatter AF, Champion KE, Finch LE, Siddique J, Hedeker D, Spring B. A mHealth intervention to preserve and promote ideal cardiovascular health in college students: Design and protocol of a cluster randomized controlled trial. Contemp Clin Trials. 2020 Nov;98:106162. doi: 10.1016/j.cct.2020.106162. Epub 2020 Oct 8.
PubMed 33038506
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- American Heart Association Strategically Focused Research Network: mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health
- ClinicalTrials.gov ID
- NCT02496728
- Acronym / sponsor ID
- NUYou / 14SFRN20480260
- Conditions
- Cardiovascular Disease
- Keywords
- Mobile Health, Smartphone, Cardiovascular health, College students, Smoking, Physical activity, Diet, BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- May 2015
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 14 Jul 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.
The purpose of the study is to investigate the preservation or promotion of health in students during the college years.
Detailed description
Freshman college students at Northwestern University will be cluster randomized to two groups based on their dorm. The intervention for one group will target smoking, physical activity, BMI and consumption of fruits and vegetables. The intervention in the second group will target traveling behavior, sexual risk behaviors, sunscreen use and hydration. Baseline health and lifestyle measures will be assessed for each participant prior to intervention. Health assessments will measure height, weight, fasting glucose, total cholesterol and carbon monoxide. The lifestyle measure will ask questions about physical activity, diet, alcohol and tobacco use, safe sex practices, driving habits, and sunscreen use. These same measures will be repeated during the fall of the students' sophomore and junior years.
Participants will be given a mobile application and encouraged to track some behaviors. In addition, participants will be asked to answer weekly questions regarding health behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular Health | Experimental | Behavioral: Mobile Health Application, Behavioral: Environmental Cues, Behavioral: Social Support, Behavioral: Educational MaterialsParticipants will be given the results of their health assessment and feedback regarding their health behaviors and overall health. Recommendations for change will be given if warranted. Participants will download the study's mobile health application on their smartphone. They will then be asked to report once a week about their health behaviors on the application. Participants will also be asked to self-monitor health behaviors that are not already at ideal levels using the study application (environmental cues). Participants will be asked to join a secret Facebook group where informational materials will be posted, participants can post about study health behaviors and social interaction around health behaviors can occur (social support and environmental cues). |
| Whole Health | Active comparator | Behavioral: Mobile Health Application, Behavioral: Environmental Cues, Behavioral: Social Support, Behavioral: Educational MaterialsParticipants will be given the results of their health assessment. They will then receive educational materials about sunscreen use, safe sex, hydration and vehicular safety. Participants will download the study's mobile health application on their smartphone. They will then be asked to report once a week about their health behaviors on the application. Participants will also be asked to self-monitor how much water they drink using the study application. Participants will be asked to join a secret Facebook group where informational materials will be posted, they can post about study health behaviors and social interaction around health behaviors can occur (social support and environmental cues). |
Who may qualify
- Ages
- 17 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Freshman at Northwestern University in the fall of 2015
- Live on campus
- Read, write and speak English
- Own an Iphone or Android smart phone
Key exclusion criteria (3 listed)
- Pregnant or trying to become pregnant
- Established cardiovascular disease
- Unstable psychiatric or medical condition
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 |
|---|---|---|
| Mobile Health ApplicationAn application on a smart phone that is designed to help individuals self-monitor health behaviors. | Behavioural | Cardiovascular Health, Whole Health |
| Environmental CuesText messages, informational posts and reminders supporting healthy behaviors. | Behavioural | Cardiovascular Health, Whole Health |
| Social SupportParticipants may interact with each other through a private Facebook group. | Behavioural | Cardiovascular Health, Whole Health |
| Educational MaterialsEducational materials regarding healthy behaviors. | Behavioural | Cardiovascular Health, Whole Health |
Primary outcome
American Heart Association MyLifeCheck (Simple 7) score as a measure of cardiovascular health
Time frame: 2 years
Participant's Simple 7 score is the sum of 7 cardiovascular health metrics attained at ideal levels as defined by American Heart Association. 1) physically active - Exercising at least 150 minutes of moderate or 75 minutes of vigorous physical activity per week. 2) Good diet quality - Eating 5 servings of fruits and vegetables per day, at least 3 servings of whole grain, and no more than 16 oz. of soda per day, rarely or never eats high sodium foods or processed meats. 3) nonsmoking - nonsmoker for at least a year. 4) not overweight - BMI < 25 kg/m2. 5) normoglycemic - fasting glucose < 100 mg/dl. 6) not hypercholesterolemic : total Cholesterol < 200 mg/dl. 7) not hypertensive. Blood Pressure <120/<80.
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 20 May 2019.
- Derived from this study: PubMed 33038506Pfammatter AF, Champion KE, Finch LE, Siddique J, Hedeker D, Spring B. A mHealth intervention to preserve and promote ideal cardiovascular health in college students: Design and protocol of a cluster randomized controlled trial. Contemp Clin Trials. 2020 Nov;98:106162. doi: 10.1016/j.cct.2020.106162. Epub 2020 Oct 8.
- Individual participant dataSharing planned: No
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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.
Bonnie Spring, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Application, Environmental Cues and Social Support in people with Cardiovascular Disease, run by Northwestern University at 1 site 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 4 inclusion and 3 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 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
American Heart Association MyLifeCheck (Simple 7) score as a measure of cardiovascular health (time frame: 2 years). 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 NCT02496728, 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 20 May 2019.