Cardiovascular DiseaseNCT01433484
Heart-Healthy Lenoir Lifestyle Study
A study testing Maintenance of Weight Loss--Experimental in people with Cardiovascular Disease and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study aims to reduce cardiovascular disease (CVD) risk and disparities in risk by improving lifestyle factors which underlie the development of CVD. The first steps will involve conducting a comprehensive formative evaluation to assess individual, interpersonal, organizational, community, and policy factors… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Obesity
- What is being tested?
- Maintenance of Weight Loss--Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Oct 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- live in Lenoir County or a neighboring county in Eastern North Carolina
- anyone enrolled in the Lifestyle study is eligible to participate in the genomics component of the project.
Who cannot join
- non-English speaking
- treatment of psychosis
- alcohol or substance abuse within the two last years
- history of malignancy, other than non-melanoma skin cancer, unless surgically cured > 5 years ago or in remission/well treated and not likely to have a negative effect on the patient's health over the next 2 years
- estimated creatinine clearance less than 30 ml/min
- lack of access to phone
Show all 11Show fewer
- advanced dementia
- participants who have been diagnosed with a myocardial infarction within the past three months will be excluded from the study if they are unable to obtain written medical clearance from their clinician to participate in the study
- Additional Exclusion Criteria - Weight Loss Intervention:
- the investigators will not invite pregnant women to take part in the weight loss study.
- if a woman becomes pregnant while taking part in this part of the study, we will withdraw her from the weight loss study and invite her to continue in the lifestyle study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Heart Healthy Lenoir Project, Kinston Enterprise Center
Kinston, North Carolina, 28501
About this study
Official title: Community-Based Lifestyle Intervention to Reduce CVD Risk & Disparities in Risk
This study aims to reduce cardiovascular disease (CVD) risk and disparities in risk by improving lifestyle factors which underlie the development of CVD. The first steps will involve conducting a comprehensive formative evaluation to assess individual, interpersonal, organizational, community, and policy factors relevant to CVD risk and risk reduction in Lenoir County. This will be followed by a community-based lifestyle intervention program designed to improve eating patterns, promote physical activity, and for those who are interested, support weight loss. A randomized trial comparing the effectiveness of two community based weight maintenance interventions will also be conducted. Community-wide policy and environmental change interventions will also be implemented to support the individual-level interventions, including partnerships with businesses to promote a healthy environment through innovative economic opportunities. In addition, this project will explore genetic factors associated with cardiovascular disease risk and treatment success.
Read the detailed description
The lifestyle intervention will enroll 350 participants. The initial lifestyle component of this study, which lasts for 4-6 months, will be provided to all participants. Participants may chose from one of two intervention formats, each with 4 contacts: individual counseling with at least one face-to-face visit and the rest face-to-face or by phone or 4 group sessions. The dietary intervention will focus on improving fat and carbohydrate quality. For fat intake, the goals include 2-4 servings per day of polyunsaturated fat primarily from plant sources and minimal intake of trans fat. For carbohydrate intake, the goals include increased intake of whole grains, fruits and vegetables, and beans and reduced consumption of refined carbohydrates. The physical activity intervention will primarily focus on walking with a goal of 7500 to 10,000 steps per day or, for those who do not wish to use a pedometer, 30 minutes of walking a day. Muscle strengthening activities will also be recommended. At the 4-6 month follow-up measures, those who wish to take part in a weight loss study may do so and those who do not will continue in a maintenance of lifestyle intervention.
The investigators anticipate approximately 200 participants will take part in the weight loss component of this study, which consists of a 6 month intensive weight loss intervention. Participants may choose from two intervention formats: 16 weekly group sessions or 5 group sessions and 10 phone counseling sessions. The weight loss goal will be 5% of body weight. At the conclusion of this program, those who lose at least 8 pounds and are willing to take part in a 1 year maintenance of weight loss intervention will be RANDOMIZED to one of two maintenance of weight loss programs. One maintenance arm will receive monthly telephone contacts for one year, while the other arm will receive bi-monthly phone contacts.
Follow-up measures for all participants will be at approximately 6, 12, 18, and 24 months.
Another related part of the project will use a systems approach to develop models integrating clinical and genomic data. Researchers have developed and tested an approach referred to as the SAMARA (Supporting A Multidisciplinary Approach to Research in Atherosclerosis) Project that applies recent, major advances in biomedical and computational sciences at UNC to develop a deeper understanding of human CVD. The Heart-Healthy Lenoir Project will expand studies into the community, using this methodology to: 1) determine the prevalence of genomic risk signatures in high-risk community populations using genome-wide Single Nucleotide Polymorphism (SNP) analysis; 2) develop novel genomic models incorporating high-risk features in this population; and 3) determine whether genomic signatures can be used to predict responsiveness to interventions that underlie CVD disparities. Participants who consent to this component of the project will have a blood specimen obtained at baseline.
- Conditions
- Cardiovascular Disease, Obesity
- Being tested
- Maintenance of Weight Loss--Control, Maintenance of Weight Loss--Experimental
- Keywords
- cardiovascular disease, coronary heart disease, obesity, weight loss, genomics
- Medical subject headings
- Cardiovascular Diseases, Obesity, Coronary Disease, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance of Weight Loss--ControlBehavioural
As the maintenance of weight loss randomized trial does not begin until a year after the start of this study, the intervention and control conditions are not yet specified. This will occur before randomization and this section will be updated before the first participant is randomized.
Maintenance of Weight Loss--ExperimentalBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Maintenance of Weight Loss--Control | Active comparator | The control arm will receive bi-monthly telephone contacts during the one-year maintenance phase. Receives: Behavioral: Maintenance of Weight Loss--Control |
| Maintenance of Weight Loss--Experimental | Experimental | The experimental arm will receive monthly telephone contacts for one year during the maintenance phase. Receives: Behavioral: Maintenance of Weight Loss--Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort study: fruit and vegetable intake at 6 months
Fruit and vegetable intake will be measured by the Block fruit and vegetable sceener and by blood carotenoids
Measured: 6 months
Embedded randomized trial: maintenance of weight loss
Weight will be measured by electronic scale
Measured: 1 year after maintenance of weight loss trial begins
Secondary outcomes (8)
Physical activity
Measured by questionnaire and pedometer
Measured: 6m, 12m, 18m, 24 m
Blood pressure
measured by automated device
Measured: 6, 12, 18, 24 months
Blood lipids
total and HDL cholesterol measured by commercial lab
Measured: 12, 24 months
A1c
measured by commercial lab
Measured: 6, 12, 24 months
Fruit and vegetable intake at 6 months
Measured by Block fruit and vegetable screener
Measured: 12, 18, and 24 months
Weight
Measured by electronic scale
Measured: 6, 12, 18, 24
Health related quality of life
SF-12 instrument
Measured: 6, 12, 24 months
Genomic predictors of lifestyle change
A systems approach to developing genomic models integrating clinical and genomic data.
Measured: 6-, 12-, 18- and 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 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
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Thomas C. Keyserling, MD, MPH, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433484
- Sponsor's protocol ID
- 10-0395LS
- Other IDs
- P50HL105184
- Status last verified
- Aug 2015
- First submitted
- 30 Aug 2011
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Embree GG, Samuel-Hodge CD, Johnston LF, Garcia BA, Gizlice Z, Evenson KR, DeWalt DA, Ammerman AS, Keyserling TC. Successful long-term weight loss among participants with diabetes receiving an intervention promoting an adapted Mediterranean-style dietary pattern: the Heart Healthy Lenoir Project. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000339. doi: 10.1136/bmjdrc-2016-000339. eCollection 2017.
PubMed 28405344Keyserling TC, Samuel-Hodge CD, Pitts SJ, Garcia BA, Johnston LF, Gizlice Z, Miller CL, Braxton DF, Evenson KR, Smith JC, Davis GB, Quenum EL, Elliott NT, Gross MD, Donahue KE, Halladay JR, Ammerman AS. A community-based lifestyle and weight loss intervention promoting a Mediterranean-style diet pattern evaluated in the stroke belt of North Carolina: the Heart Healthy Lenoir Project. BMC Public Health. 2016 Aug 5;16:732. doi: 10.1186/s12889-016-3370-9.
PubMed 27495295
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Lifestyle Intervention to Reduce CVD Risk & Disparities in Risk
- ClinicalTrials.gov ID
- NCT01433484
- Acronym / sponsor ID
- 10-0395LS
- Conditions
- Cardiovascular Disease, Obesity
- Keywords
- cardiovascular disease, coronary heart disease, obesity, weight loss, genomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Sep 2011 (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.
This study aims to reduce cardiovascular disease (CVD) risk and disparities in risk by improving lifestyle factors which underlie the development of CVD. The first steps will involve conducting a comprehensive formative evaluation to assess individual, interpersonal, organizational, community, and policy factors relevant to CVD risk and risk reduction in Lenoir County. This will be followed by a community-based lifestyle intervention program designed to improve eating patterns, promote physical activity, and for those who are interested, support weight loss. A randomized trial comparing the effectiveness of two community based weight maintenance interventions will also be conducted. Community-wide policy and environmental change interventions will also be implemented to support the individual-level interventions, including partnerships with businesses to promote a healthy environment through innovative economic opportunities. In addition, this project will explore genetic factors associated with cardiovascular disease risk and treatment success.
Detailed description
The lifestyle intervention will enroll 350 participants. The initial lifestyle component of this study, which lasts for 4-6 months, will be provided to all participants. Participants may chose from one of two intervention formats, each with 4 contacts: individual counseling with at least one face-to-face visit and the rest face-to-face or by phone or 4 group sessions. The dietary intervention will focus on improving fat and carbohydrate quality. For fat intake, the goals include 2-4 servings per day of polyunsaturated fat primarily from plant sources and minimal intake of trans fat. For carbohydrate intake, the goals include increased intake of whole grains, fruits and vegetables, and beans and reduced consumption of refined carbohydrates. The physical activity intervention will primarily focus on walking with a goal of 7500 to 10,000 steps per day or, for those who do not wish to use a pedometer, 30 minutes of walking a day. Muscle strengthening activities will also be recommended. At the 4-6 month follow-up measures, those who wish to take part in a weight loss study may do so and those who do not will continue in a maintenance of lifestyle intervention.
The investigators anticipate approximately 200 participants will take part in the weight loss component of this study, which consists of a 6 month intensive weight loss intervention. Participants may choose from two intervention formats: 16 weekly group sessions or 5 group sessions and 10 phone counseling sessions. The weight loss goal will be 5% of body weight. At the conclusion of this program, those who lose at least 8 pounds and are willing to take part in a 1 year maintenance of weight loss intervention will be RANDOMIZED to one of two maintenance of weight loss programs. One maintenance arm will receive monthly telephone contacts for one year, while the other arm will receive bi-monthly phone contacts.
Follow-up measures for all participants will be at approximately 6, 12, 18, and 24 months.
Another related part of the project will use a systems approach to develop models integrating clinical and genomic data. Researchers have developed and tested an approach referred to as the SAMARA (Supporting A Multidisciplinary Approach to Research in Atherosclerosis) Project that applies recent, major advances in biomedical and computational sciences at UNC to develop a deeper understanding of human CVD. The Heart-Healthy Lenoir Project will expand studies into the community, using this methodology to: 1) determine the prevalence of genomic risk signatures in high-risk community populations using genome-wide Single Nucleotide Polymorphism (SNP) analysis; 2) develop novel genomic models incorporating high-risk features in this population; and 3) determine whether genomic signatures can be used to predict responsiveness to interventions that underlie CVD disparities. Participants who consent to this component of the project will have a blood specimen obtained at baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance of Weight Loss--Control | Active comparator | Behavioral: Maintenance of Weight Loss--ControlThe control arm will receive bi-monthly telephone contacts during the one-year maintenance phase. |
| Maintenance of Weight Loss--Experimental | Experimental | Behavioral: Maintenance of Weight Loss--ExperimentalThe experimental arm will receive monthly telephone contacts for one year during the maintenance phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- live in Lenoir County or a neighboring county in Eastern North Carolina
- anyone enrolled in the Lifestyle study is eligible to participate in the genomics component of the project.
Key exclusion criteria (11 listed)
- non-English speaking
- treatment of psychosis
- alcohol or substance abuse within the two last years
- history of malignancy, other than non-melanoma skin cancer, unless surgically cured > 5 years ago or in remission/well treated and not likely to have a negative effect on the patient's health over the next 2 years
- estimated creatinine clearance less than 30 ml/min
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 |
|---|---|---|
| Maintenance of Weight Loss--ControlAs the maintenance of weight loss randomized trial does not begin until a year after the start of this study, the intervention and control conditions are not yet specified. This will occur before randomization and this section will be updated before the first participant is randomized. | Behavioural | Maintenance of Weight Loss--Control |
| Maintenance of Weight Loss--Experimental | Behavioural | Maintenance of Weight Loss--Experimental |
Primary outcome
Cohort study: fruit and vegetable intake at 6 months
Time frame: 6 months
Fruit and vegetable intake will be measured by the Block fruit and vegetable sceener and by blood carotenoids
Embedded randomized trial: maintenance of weight loss
Time frame: 1 year after maintenance of weight loss trial begins
Weight will be measured by electronic scale
8 secondary outcomes
Physical activity
Time frame: 6m, 12m, 18m, 24 m
Blood pressure
Time frame: 6, 12, 18, 24 months
Blood lipids
Time frame: 12, 24 months
A1c
Time frame: 6, 12, 24 months
Fruit and vegetable intake at 6 months
Time frame: 12, 18, and 24 months
Weight
Time frame: 6, 12, 18, 24
Health related quality of life
Time frame: 6, 12, 24 months
Genomic predictors of lifestyle change
Time frame: 6-, 12-, 18- and 24-month follow-up
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 Nov 2017.
- Derived from this study: PubMed 28405344Embree GG, Samuel-Hodge CD, Johnston LF, Garcia BA, Gizlice Z, Evenson KR, DeWalt DA, Ammerman AS, Keyserling TC. Successful long-term weight loss among participants with diabetes receiving an intervention promoting an adapted Mediterranean-style dietary pattern: the Heart Healthy Lenoir Project. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000339. doi: 10.1136/bmjdrc-2016-000339. eCollection 2017.
- Derived from this study: PubMed 27495295Keyserling TC, Samuel-Hodge CD, Pitts SJ, Garcia BA, Johnston LF, Gizlice Z, Miller CL, Braxton DF, Evenson KR, Smith JC, Davis GB, Quenum EL, Elliott NT, Gross MD, Donahue KE, Halladay JR, Ammerman AS. A community-based lifestyle and weight loss intervention promoting a Mediterranean-style diet pattern evaluated in the stroke belt of North Carolina: the Heart Healthy Lenoir Project. BMC Public Health. 2016 Aug 5;16:732. doi: 10.1186/s12889-016-3370-9.
- Provides information about this studyLink provided by the sponsor.
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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.
Thomas C. Keyserling, MD, MPH principal investigator
UNC-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 Maintenance of Weight Loss--Experimental in people with Cardiovascular Disease and Obesity, 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 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 20 Nov 2017. 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?
Cohort study: fruit and vegetable intake at 6 months (time frame: 6 months). 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 NCT01433484, which also lists 2 linked publications.
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 Nov 2017.