Cardiovascular DiseaseHHLNCT02208180
Heart Healthy Lenoir: Return of Results Study
A study testing Return of genomic results on cardiovascular disease risk in people with Cardiovascular Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The investigators are conducting a two group intervention to study to the effect of individualized heart disease genomic risk results on motivation towards diet and physical activity behaviors to reduce heart disease risk. The intervention includes provided participants with genomic and lifestyle risk estimates. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Return of genomic results on cardiovascular disease risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2016
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled in Heart Healthy Lenoir Genomics
- African-American (self-identified)
- Wants to be contacted for future studies
Who cannot join
- Enrolled in an arm of the Heart Healthy Lenoir Lifestyle study with intense behavioral intervention (e.g. weight loss or weight maintenance programs)
Trial locations and contacts
1 site in 1 country.
United States1 site
Heart Healthy Lenoir Field Office
Kinston, North Carolina, 28501
About this study
The investigators are conducting a two group intervention to study to the effect of individualized heart disease genomic risk results on motivation towards diet and physical activity behaviors to reduce heart disease risk. The intervention includes provided participants with genomic and lifestyle risk estimates. Investigators will follow participants for 3 months to determine if motivation towards and engagement in diet and physical activity behaviors change.
- Conditions
- Cardiovascular Disease
- Being tested
- Return of genomic results on cardiovascular disease risk
- Keywords
- Return of results, Genomics
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Return of genomic results on cardiovascular disease riskBehavioural
Experimental group: Participants will receive genomic cardiovascular disease risk information.
Comparator: Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study.
| Study group | Role | What they receive |
|---|---|---|
| Return of genomic results on cardiovascular disease risk | Experimental | Participants will receive genomic cardiovascular disease risk information. Receives: Behavioral: Return of genomic results on cardiovascular disease risk |
| Return of lifestyle results on cardiovascular disease risk | Active comparator | Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study. Receives: Behavioral: Return of genomic results on cardiovascular disease risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motivation
The Prevention and Planning Behaviors Scale is a recently developed tool that provides a direct measure of degrees of influence on participants' motivation to change their health behavior in translational genomic studies. It has 23-items where participants rate themselves using a 5-point Likert scale (1=A Lot Less Motivated to 5=A Lot More Motivated).
Measured: Baseline, Post-interview, 3 months
Secondary outcomes (2)
Change in Eating Habits
Eating habits will be assessed using a 10-item Block questionnaire designed to capture the frequency with which participants eat particular items from different food groups. Participants will rate themselves on a 6-point scale ranging from "Less than 1 time per WEEK" to "2+ a DAY."
Measured: Baseline, 3 months
Change in Physical Activity
The 16-item RESIDE Neighborhood Physical Activity Questionnaire will be used to assess context-specific walking behavior through self-report. Participants are asked how often they walk, how long, to where, and similar questions about what other types of physical activity they might engage in. Giles-Corti B, Timperio A, Cutt H, Pikora TJ, Bull FC, Knuiman M, et al. Development of a reliable measure of walking within and outside the local neighborhood: RESIDE's Neighborhood Physical Activity Questionnaire. Preventive medicine 2006;42(6):455-459.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Harlyn Skinner, MS, University of North Carolina, Chapel Hill
- Investigators
- Harlyn G Skinner, MS, Principal investigator, University of North Carolina, Chapel HillAlice Ammerman, DrPH, MPH, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208180
- Sponsor's protocol ID
- 14-1500
- Other IDs
- 1P50HL105184-01
- Acronym
- HHL
- Status last verified
- Jun 2016
- First submitted
- 30 Jul 2014
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Healthy Lenoir: Return of Results Study
- ClinicalTrials.gov ID
- NCT02208180
- Acronym / sponsor ID
- HHL / 14-1500
- Conditions
- Cardiovascular Disease
- Keywords
- Return of results, Genomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Aug 2014 (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 investigators are conducting a two group intervention to study to the effect of individualized heart disease genomic risk results on motivation towards diet and physical activity behaviors to reduce heart disease risk. The intervention includes provided participants with genomic and lifestyle risk estimates. Investigators will follow participants for 3 months to determine if motivation towards and engagement in diet and physical activity behaviors change.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Return of genomic results on cardiovascular disease risk | Experimental | Behavioral: Return of genomic results on cardiovascular disease riskParticipants will receive genomic cardiovascular disease risk information. |
| Return of lifestyle results on cardiovascular disease risk | Active comparator | Behavioral: Return of genomic results on cardiovascular disease riskParticipants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled in Heart Healthy Lenoir Genomics
- African-American (self-identified)
- Wants to be contacted for future studies
Key exclusion criteria (1 listed)
- Enrolled in an arm of the Heart Healthy Lenoir Lifestyle study with intense behavioral intervention (e.g. weight loss or weight maintenance programs)
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 |
|---|---|---|
| Return of genomic results on cardiovascular disease riskExperimental group: Participants will receive genomic cardiovascular disease risk information. Comparator: Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study. | Behavioural | Return of genomic results on cardiovascular disease risk, Return of lifestyle results on cardiovascular disease risk |
Primary outcome
Change in motivation
Time frame: Baseline, Post-interview, 3 months
The Prevention and Planning Behaviors Scale is a recently developed tool that provides a direct measure of degrees of influence on participants' motivation to change their health behavior in translational genomic studies. It has 23-items where participants rate themselves using a 5-point Likert scale (1=A Lot Less Motivated to 5=A Lot More Motivated).
2 secondary outcomes
Change in Eating Habits
Time frame: Baseline, 3 months
Change in Physical Activity
Time frame: Baseline, 3 months
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 7 Jun 2016.
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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.
Harlyn G Skinner, MS principal investigator
University of North Carolina, Chapel Hill
Alice Ammerman, DrPH, MPH study chair
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Return of genomic results on cardiovascular disease risk in people with Cardiovascular Disease, run by University of North Carolina, Chapel Hill 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 3 inclusion and 1 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 7 Jun 2016. 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?
Change in motivation (time frame: Baseline, Post-interview, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2016.