Heart DiseaseNCT00153413
West Virginia WISEWOMAN Pilot Study to Test a Brief Nutrition Intervention
A study testing Cookin' Up Health in people with Heart Disease and Blood Pressure, run by Centers for Disease Control and Prevention.
Trial summary
To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Blood Pressure, Obesity
- What is being tested?
- Cookin' Up Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Dec 2003
- 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 40 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- NBCCEDP
- Aged 40-64
- Attends selected rural clinics
Who cannot join
- -
About this study
To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.
Read the detailed description
To test whether a brief, interactive, computer-based nutrition intervention (Cookin' Up Health)impacts various health outcomes
- Conditions
- Heart Disease, Blood Pressure, Obesity
- Being tested
- Cookin' Up Health
- Medical subject headings
- Heart Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cookin' Up HealthBehavioural
Also called Nutrition Intervention
A brief nutrition intervention designed to improve dietary habits
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receive Cookin' Up Health, a nutrition intervention Receives: Behavioral: Cookin' Up Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Servings of fruits and vegetables
Based on food frequency questionnaire
Measured: 3 months
Secondary outcomes (3)
Ability to read food labels
Knowledge questions
Measured: 3 months
Readiness to eat 5 fruits and vegetables per day
Based on Prochaska and DeClemente
Measured: 3 months
Dietary Fat Score
Based on self-reported food frequency score
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionJul 2003
- Study completionDec 2003
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 Heart DiseaseStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie Will, Study chair, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153413
- Sponsor's protocol ID
- CDC-NCCDPHP-4114
- Other IDs
- U58/CCU322798-01
- Status last verified
- Jul 2024
- First submitted
- 8 Sep 2005
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Santos L. The impact of nutrition and lifestyle modification on health. Eur J Intern Med. 2022 Mar;97:18-25. doi: 10.1016/j.ejim.2021.09.020. Epub 2021 Oct 17.
PubMed 34670680
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- West Virginia WISEWOMAN Pilot Study to Test a Brief Nutrition Intervention
- ClinicalTrials.gov ID
- NCT00153413
- Acronym / sponsor ID
- CDC-NCCDPHP-4114
- Conditions
- Heart Disease, Blood Pressure, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Jan 2003
- Primary completion
- Jul 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 12 Sep 2005 (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 provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.
Detailed description
To test whether a brief, interactive, computer-based nutrition intervention (Cookin' Up Health)impacts various health outcomes
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cookin' Up HealthReceive Cookin' Up Health, a nutrition intervention |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- NBCCEDP
- Aged 40-64
- Attends selected rural clinics
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Cookin' Up HealthAlso: Nutrition InterventionA brief nutrition intervention designed to improve dietary habits | Behavioural | Intervention |
Primary outcome
Servings of fruits and vegetables
Time frame: 3 months
Based on food frequency questionnaire
3 secondary outcomes
Ability to read food labels
Time frame: 3 months
Readiness to eat 5 fruits and vegetables per day
Time frame: 3 months
Dietary Fat Score
Time frame: 3 month
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 2 Aug 2024.
- Background: PubMed 34670680Santos L. The impact of nutrition and lifestyle modification on health. Eur J Intern Med. 2022 Mar;97:18-25. doi: 10.1016/j.ejim.2021.09.020. Epub 2021 Oct 17.
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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.
Julie Will study chair
Centers for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A study testing Cookin' Up Health in people with Heart Disease and Blood Pressure, run by Centers for Disease Control and Prevention.
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 2 Aug 2024. 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?
Servings of fruits and vegetables (time frame: 3 months). 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 NCT00153413, 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 2 Aug 2024.