Cardiovascular DiseasesHHPNCT03683134

A Mediterranean Diet Nutrition Education Program for the Reduction of Cardiovascular Disease Risk in the Southeastern U.S.

A study testing Mediterranean diet, Olive oil and mixed nuts and American Heart Association in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by Auburn University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Cardiovascular Diseases, Cardiovascular Risk Factor, Obesity
What is being tested?: Mediterranean diet, Olive oil and mixed nuts and American Heart Association
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteUnited States
Study dates: 23 Jan 2017to 7 Sep 2017
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Enrolled in Auburn University's health insurance program during the course of the study or a dependent of the enrollee during the course of the study
BMI >24.9 (kg/m2)
AND Meets two or more of the following
Screening values classified in the "yellow" or "red" zone for:
Systolic blood pressure (mmHg): Yellow zone: ≥140, Red zone: ≥160;
Diastolic Blood pressure (mmHg): Yellow zone: ≥90, Red zone: ≥ 100;

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Fasting blood glucose (mm/dL): Yellow zone: ≥100, Red zone: ≥ 126
Blood glucose (random) (mg/dL): Yellow zone: 140-200, Red zone > 200
Total Cholesterol (mg/dL): Yellow zone: ≥200, red zone: ≥250
Have a pre-existing diagnosis of hypertension, pre-diabetes, or hypercholesterolemia
Current smoker (≥1 cigarette/day)
Are: male (age: 55-80) or female (age: 60-80)
A family history of premature coronary heart disease
High risk ethnicity: Black, African American, American Indians/Alaska Natives, Non-Hispanic blacks, Mexican-Americans, Asian, Hispanic/Latino

Who cannot join

Minors that are less than 19 years of age
Individuals who are not enrolled in the Auburn University health insurance program for the 2016 plan year at baseline and have not yet completed initial visit
Individuals who have not completed their 2015 "Healthy Tigers" biometric screening between January 1st and December 31st, 2015 (these can be completed by the "Healthy Tigers" staff or by submitting a healthcare provider form from the individuals' physician to the "Healthy Tigers" office), unless enrolled in "TigerMeds".
Individuals who are pregnant or who intend to become pregnant during the 12-week health and wellness challenge.
Individuals who anticipate absence or travel throughout the study that would interfere with their ability to complete the analysis at the mid-point and end of challenge.
Patients with a peanut, tree nut, or olive oil food allergy or intolerance.

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Patients who are unable or unwilling to travel to Auburn University main campus for live health and wellness challenge events, individual assessments, personal appointments, and pre- and post- data collection
Individuals who have NOT been stabilized on medication to treat or manage high blood pressure, high cholesterol, dyslipidemia, or pre diabetes for at least 12 weeks prior to the study.
Patients who do not have access to the internet and therefore unable to complete the education portion of the study
Individuals who have a pacemaker
Patients who decline participation during informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Auburn University Pharmaceutical Care Center
Auburn, Alabama, 36849

Other trials in United States

About this study

Official title: A Pilot, Theory-Based, Nutrition Intervention Promoting a Mediterranean Diet for the Reduction of Cardiovascular Disease Risk Factors in a High-Risk Population of the Southeastern United States: The Healthy Hearts Program (HHP)

A 12-week, randomized nutrition intervention for the reduction of cardiovascular disease risk factors in a high-risk population in the southeastern United States. The primary objective of this pilot study was to assess the efficacy of a Mediterranean diet intervention (education + extra-virgin olive oil (EVOO) and mixed nut supplementation) versus that of an American Heart Association (AHA) nutrition intervention (education) on serum blood lipid levels as markers for cardiovascular disease risk. Researchers conducting this trial hypothesize that a greater reduction will be seen in cardiovascular disease risk factors in the Mediterranean diet intervention.

Conditions: Cardiovascular Diseases, Cardiovascular Risk Factor, Obesity
Being tested: Mediterranean diet, Olive oil and mixed nuts, American Heart Association
Keywords: Cardiovascular Disease, Mediterranean Diet, Nutrition education
Medical subject headings: Cardiovascular Diseases, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mediterranean dietBehavioural
Participants will receive nutrition education and educational materials from a registered dietitian on patients on the patterns of a Mediterranean style diet. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.
Olive oil and mixed nutsDietary supplement
Participants in the Mediterranean diet group will receive 3 liters of extra-virgin olive oil and 3 pounds of mixed nuts (1.5 pounds raw almonds and 1.5 pounds raw walnuts) at baseline and at 6 weeks. Participants will be educated by oral and written means, on consumption goals of the nuts and olive oil.
American Heart AssociationBehavioural
Participants will receive nutrition education and educational materials from a registered dietitian on patients on the dietary recommendations from the American Heart Association for heart health. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.

Study groups in NCT03683134
Study group	Role	What they receive
Mediterranean diet group	Experimental	Participants will receive both nutrition education on patterns of a Mediterranean style diet as well as olive oil and mixed nuts. Receives: Behavioral: Mediterranean diet; Dietary Supplement: Olive oil and mixed nuts
American Heart Association group	Active comparator	Participants will receive nutrition education on the dietary recommendations for heart health from the American Heart Association. Receives: Behavioral: American Heart Association

What is being measured

The primary outcome is the main question the study is designed to answer.

Systolic Blood Pressure Measurement
Measured in mmHg
Measured: Change from at baseline blood pressure to 6-weeks
Systolic Blood Pressure Measurement
Measured in mmHg
Measured: Change from at baseline blood pressure to 12-weeks

Secondary outcomes (20)

Diastolic Blood Pressure Measurement
Measured in mmHg
Measured: Change from at baseline weight to 6-weeks
Change in Weight
Measured in kilograms (kg)
Measured: Change from at baseline weight to 12-weeks
Calculation of Body Mass Index (BMI) (kg/m∧2)
Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m∧2)
Measured: Change from baseline weight to 6-weeks
Calculation of BMI (kg/m∧2)
Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m∧2)
Measured: Change from baseline weight to 12-weeks
Concentration of fasted total cholesterol
Measured in mg/dL
Measured: Change from baseline weight to 6-weeks
Concentration of fasted total cholesterol
Measured in mg/dL
Measured: Change from baseline weight to 12-weeks
Concentration of fasted high-density lipoprotein (HDL) cholesterol
Measured in mg/dL
Measured: Change from baseline weight to 6-weeks
Concentration of fasted high-density lipoprotein (HDL) cholesterol
Measured in mg/dL
Measured: Change from baseline weight to 12-weeks
Concentration of fasted low-density lipoprotein (LDL) cholesterol
Measured in mg/dL
Measured: Change from baseline weight to 12-weeks
Concentration of fasted low-density lipoprotein (LDL) cholesterol
Measured in mg/dL
Measured: Change from baseline weight to 6-weeks
Concentration of fasted triglycerides
Measured in mg/dL
Measured: Change from baseline weight to 6-weeks
Concentration of fasted triglycerides
Measured in mg/dL
Measured: Change from baseline weight to 12-weeks
A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio
Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio
Measured: Change from baseline weight to 12-weeks
A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio
Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio
Measured: Change from baseline weight to 6-weeks
Concentration of fasted blood glucose
Measured in mg/dL
Measured: Change from baseline weight to 6-weeks
Concentration of fasted blood glucose
Measured in mg/dL
Measured: Change from baseline weight to 12-weeks
A calculation of waist (inches) to height (inches) ratio
Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio
Measured: Change from baseline weight to 12-weeks
A calculation of waist (inches) to height (inches) ratio
Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio
Measured: Change from baseline weight to 6-weeks
Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin
Fasting plasma glucose in mg/dL and fasting serum insulin in milliUnits (mU)/I will be used to calculate HOMA-IR as an indicator for insulin resistance.
Measured: Change from baseline weight to 6-weeks
Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin
Fasting plasma glucose in mg/dL and fasting serum insulin in mU/I will be used to calculate HOMA-IR as an indicator for insulin resistance.
Measured: Change from baseline weight to 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jan 20177 Sep 2017

First posted25 Sep 2018
Study start23 Jan 2017
Primary completion7 Sep 2017
Study completion7 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Investigator
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03683134
Sponsor's protocol ID: The Healthy Hearts Program
Acronym: HHP
Status last verified: Sep 2018
First submitted: 20 Sep 2018
Last updated: 27 Sep 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot, Theory-Based, Nutrition Intervention Promoting a Mediterranean Diet for the Reduction of Cardiovascular Disease Risk Factors in a High-Risk Population of the Southeastern United States: The Healthy Hearts Program (HHP)
ClinicalTrials.gov ID: NCT03683134
Acronym / sponsor ID: HHP / The Healthy Hearts Program
Conditions: Cardiovascular Diseases, Cardiovascular Risk Factor, Obesity
Keywords: Cardiovascular Disease, Mediterranean Diet, Nutrition education
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Auburn UniversityUniversity, hospital or other
Study start: 23 Jan 2017 (actual)
Primary completion: 7 Sep 2017 (actual)
Study completion: 7 Sep 2017 (actual)
First posted: 25 Sep 2018 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Mediterranean diet group	Experimental	Behavioral: Mediterranean diet, Dietary Supplement: Olive oil and mixed nutsParticipants will receive both nutrition education on patterns of a Mediterranean style diet as well as olive oil and mixed nuts.
American Heart Association group	Active comparator	Behavioral: American Heart AssociationParticipants will receive nutrition education on the dietary recommendations for heart health from the American Heart Association.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Enrolled in Auburn University's health insurance program during the course of the study or a dependent of the enrollee during the course of the study
BMI >24.9 (kg/m2)
AND Meets two or more of the following
Screening values classified in the "yellow" or "red" zone for:
Systolic blood pressure (mmHg): Yellow zone: ≥140, Red zone: ≥160;

Key exclusion criteria (11 listed)

Minors that are less than 19 years of age
Individuals who are not enrolled in the Auburn University health insurance program for the 2016 plan year at baseline and have not yet completed initial visit
Individuals who have not completed their 2015 "Healthy Tigers" biometric screening between January 1st and December 31st, 2015 (these can be completed by the "Healthy Tigers" staff or by submitting a healthcare provider form from the individuals' physician to the "Healthy Tigers" office), unless enrolled in "TigerMeds".
Individuals who are pregnant or who intend to become pregnant during the 12-week health and wellness challenge.
Individuals who anticipate absence or travel throughout the study that would interfere with their ability to complete the analysis at the mid-point and end of challenge.

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
Mediterranean dietParticipants will receive nutrition education and educational materials from a registered dietitian on patients on the patterns of a Mediterranean style diet. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.	Behavioural	Mediterranean diet group
Olive oil and mixed nutsParticipants in the Mediterranean diet group will receive 3 liters of extra-virgin olive oil and 3 pounds of mixed nuts (1.5 pounds raw almonds and 1.5 pounds raw walnuts) at baseline and at 6 weeks. Participants will be educated by oral and written means, on consumption goals of the nuts and olive oil.	Dietary supplement	Mediterranean diet group
American Heart AssociationParticipants will receive nutrition education and educational materials from a registered dietitian on patients on the dietary recommendations from the American Heart Association for heart health. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.	Behavioural	American Heart Association group

Primary outcome

Systolic Blood Pressure Measurement
Time frame: Change from at baseline blood pressure to 6-weeks
Measured in mmHg
Systolic Blood Pressure Measurement
Time frame: Change from at baseline blood pressure to 12-weeks
Measured in mmHg

20 secondary outcomes

Diastolic Blood Pressure Measurement
Time frame: Change from at baseline weight to 6-weeks
Change in Weight
Time frame: Change from at baseline weight to 12-weeks
Calculation of Body Mass Index (BMI) (kg/m∧2)
Time frame: Change from baseline weight to 6-weeks
Calculation of BMI (kg/m∧2)
Time frame: Change from baseline weight to 12-weeks
Concentration of fasted total cholesterol
Time frame: Change from baseline weight to 6-weeks
Concentration of fasted total cholesterol
Time frame: Change from baseline weight to 12-weeks
Concentration of fasted high-density lipoprotein (HDL) cholesterol
Time frame: Change from baseline weight to 6-weeks
Concentration of fasted high-density lipoprotein (HDL) cholesterol
Time frame: Change from baseline weight to 12-weeks
Concentration of fasted low-density lipoprotein (LDL) cholesterol
Time frame: Change from baseline weight to 12-weeks
Concentration of fasted low-density lipoprotein (LDL) cholesterol
Time frame: Change from baseline weight to 6-weeks
Concentration of fasted triglycerides
Time frame: Change from baseline weight to 6-weeks
Concentration of fasted triglycerides
Time frame: Change from baseline weight to 12-weeks
A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio
Time frame: Change from baseline weight to 12-weeks
A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio
Time frame: Change from baseline weight to 6-weeks
Concentration of fasted blood glucose
Time frame: Change from baseline weight to 6-weeks
Concentration of fasted blood glucose
Time frame: Change from baseline weight to 12-weeks
A calculation of waist (inches) to height (inches) ratio
Time frame: Change from baseline weight to 12-weeks
A calculation of waist (inches) to height (inches) ratio
Time frame: Change from baseline weight to 6-weeks
Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin
Time frame: Change from baseline weight to 6-weeks
Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin
Time frame: Change from baseline weight to 12-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 27 Sep 2018.
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.

Michael W Greene, PhD study chair

Auburn University

Amy W Willis, MS, RD principal investigator

Auburn University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 11 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 27 Sep 2018. 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?

Systolic Blood Pressure Measurement (time frame: Change from at baseline blood pressure to 6-weeks). The study lists 2 primary outcomes in all. 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 NCT03683134.

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 27 Sep 2018.