Cardiovascular DiseasesNCT00005724
CVD Nutrition Modules Tailored to Low Literacy Skills
A study testing Computer Program Intervention Group, Minimal Intervention Group and Health Counselor Intervention Group in people with Cardiovascular Diseases and Heart Diseases, run by University of North Carolina, Chapel Hill.
Trial summary
To develop cardiovascular disease nutrition modules tailored to subjects with low literacy skills. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Computer Program Intervention Group, Minimal Intervention Group and Health Counselor Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- No sites listed yet
- Study dates
- Aug 1991to 31 Jul 1996
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Must have high cholesterol; Low-literacy skills; Must be patient at one of 9 community health centers recruited for study
About this study
To develop cardiovascular disease nutrition modules tailored to subjects with low literacy skills.
Read the detailed description
BACKGROUND:
The study was part of an NHLBI initiative on "CVD Nutrition Education for Low Literacy Skills". The initiative originated within the Prevention and Demonstration Branch of the DECA, was approved by the September 1988 National Heart, Lung, and Blood Advisory Council, and released in July 1990.
DESIGN NARRATIVE:
The study had three phases. The goal of Phase I was to develop two innovative care modules that used demographic, psycho-social, nutritional, and behavioral information to individually tailor nutrition treatment programs for southern patients with less than ninth grade reading skills. Counselor Directed innovative care consisted of a structured assessment and intervention package of simply written, graphically-oriented printed materials to guide the patient and health counselor (nutritionist, health educator, nurse, or physician). Computer Assisted innovative care used a user-friendly, interactive, computer assisted program permitting more sophisticated tailoring to individual needs, conveying nutrition information in a vivid, understandable format, and extending the services of the health counselor. The investigators used focus groups of patients with low literacy skills to aid in concept development and refinement of intervention delivery strategies. Reliable and valid assessments of readability and comprehension helped further refine the materials.
In Phase II, a randomized trial was conducted to determine if the innovative modules produced a meaningful reduction in cholesterol and overall cardiovascular risk compared to standard care. Subjects with high cholesterol and low literacy skills served by four community health centers were randomly assigned to one of four groups: Innovative Care-Counselor Directed, Innovative Care-Computer Assisted, Standard Care, and Usual Care for dietary treatment of cholesterol, obesity, and hypertension. Standard Care involved the same amount of time and health counselor exposure as Innovative Care, but used currently available materials. Usual Care patients were referred to their usual provider for treatment. After four months and again at one year, changes in lipids, blood pressure, and weight were assessed..
Phase Ill consisted of a feasibility study to test the ability of both innovative care modules to reach low literacy adults through county health departments, worksites, and churches. Results of the feasibility assessment helped refine a dissemination strategy using the state health department as a centralized coordinating agency, and county health departments to implement the interventions at the community level.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Being tested
- Computer Program Intervention Group, Minimal Intervention Group, Health Counselor Intervention Group
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Program Intervention GroupBehavioural
A user-friendly, interactive computer program providing dietary counseling tailored to the needs of the participant.
Minimal Intervention GroupOther
Dietary Information pamphlets.
Health Counselor Intervention GroupBehavioural
Food for Heart Program - a structured diet treatment program for low income patients with high cholesterol, given by a health counselor at 4 treatment visits.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Intervention Group | Other | Pamphlets on healthy eating mailed to participants. Receives: Other: Minimal Intervention Group |
| Health Counselor Intervention Group | Experimental | Food for Heart program, a structured diet treatment program for low-income patients with high cholesterol, given by health counselor at 4 treatment visits. Receives: Behavioral: Health Counselor Intervention Group |
| Computer Program Intervention Group | Experimental | User-friendly interactive computer program providing dietary counseling tailored to the needs of the participant. Receives: Behavioral: Computer Program Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Total cholesterol
Measured: 3-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 posted26 May 2000 (estimated)
- Study startAug 1991
- Primary completionJul 1995
- Study completion31 Jul 1996
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.
- 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
- 369 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
- Sponsor
- Investigators
- Thomas Keyserling, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005724
- Sponsor's protocol ID
- 4933
- Other IDs
- R01HL046775
- Status last verified
- Apr 2017
- First submitted
- 25 May 2000
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CVD Nutrition Modules Tailored to Low Literacy Skills
- ClinicalTrials.gov ID
- NCT00005724
- Acronym / sponsor ID
- 4933
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 1991 (actual)
- Primary completion
- Jul 1995 (actual)
- Study completion
- 31 Jul 1996 (actual)
- First posted
- 26 May 2000 (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.
To develop cardiovascular disease nutrition modules tailored to subjects with low literacy skills.
Detailed description
BACKGROUND:
The study was part of an NHLBI initiative on "CVD Nutrition Education for Low Literacy Skills". The initiative originated within the Prevention and Demonstration Branch of the DECA, was approved by the September 1988 National Heart, Lung, and Blood Advisory Council, and released in July 1990.
DESIGN NARRATIVE:
The study had three phases. The goal of Phase I was to develop two innovative care modules that used demographic, psycho-social, nutritional, and behavioral information to individually tailor nutrition treatment programs for southern patients with less than ninth grade reading skills. Counselor Directed innovative care consisted of a structured assessment and intervention package of simply written, graphically-oriented printed materials to guide the patient and health counselor (nutritionist, health educator, nurse, or physician). Computer Assisted innovative care used a user-friendly, interactive, computer assisted program permitting more sophisticated tailoring to individual needs, conveying nutrition information in a vivid, understandable format, and extending the services of the health counselor. The investigators used focus groups of patients with low literacy skills to aid in concept development and refinement of intervention delivery strategies. Reliable and valid assessments of readability and comprehension helped further refine the materials.
In Phase II, a randomized trial was conducted to determine if the innovative modules produced a meaningful reduction in cholesterol and overall cardiovascular risk compared to standard care. Subjects with high cholesterol and low literacy skills served by four community health centers were randomly assigned to one of four groups: Innovative Care-Counselor Directed, Innovative Care-Computer Assisted, Standard Care, and Usual Care for dietary treatment of cholesterol, obesity, and hypertension. Standard Care involved the same amount of time and health counselor exposure as Innovative Care, but used currently available materials. Usual Care patients were referred to their usual provider for treatment. After four months and again at one year, changes in lipids, blood pressure, and weight were assessed..
Phase Ill consisted of a feasibility study to test the ability of both innovative care modules to reach low literacy adults through county health departments, worksites, and churches. Results of the feasibility assessment helped refine a dissemination strategy using the state health department as a centralized coordinating agency, and county health departments to implement the interventions at the community level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Minimal Intervention Group | Other | Other: Minimal Intervention GroupPamphlets on healthy eating mailed to participants. |
| Health Counselor Intervention Group | Experimental | Behavioral: Health Counselor Intervention GroupFood for Heart program, a structured diet treatment program for low-income patients with high cholesterol, given by health counselor at 4 treatment visits. |
| Computer Program Intervention Group | Experimental | Behavioral: Computer Program Intervention GroupUser-friendly interactive computer program providing dietary counseling tailored to the needs of the participant. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Computer Program Intervention GroupA user-friendly, interactive computer program providing dietary counseling tailored to the needs of the participant. | Behavioural | Computer Program Intervention Group |
| Minimal Intervention GroupDietary Information pamphlets. | Other | Minimal Intervention Group |
| Health Counselor Intervention GroupFood for Heart Program - a structured diet treatment program for low income patients with high cholesterol, given by a health counselor at 4 treatment visits. | Behavioural | Health Counselor Intervention Group |
Primary outcome
Primary Outcome Measure
Time frame: 3-month follow-up
Total cholesterol
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 Apr 2017.
- 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.
Thomas Keyserling, MD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing Computer Program Intervention Group, Minimal Intervention Group and Health Counselor Intervention Group in people with Cardiovascular Diseases and Heart Diseases, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Primary Outcome Measure (time frame: 3-month follow-up). 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 18 Apr 2017.