Cardiovascular DiseaseNCT01864694
Improving Dietary Behavior Through Tailored Messages
A study testing TLC-Diet and WEB-Diet in people with Cardiovascular Disease, run by Boston Medical Center at 1 site in United States.
Trial summary
The aim of this study is to compare a Web-based system and a computer telephone system to determine their effectiveness in improving diet behaviors compared to each other and a control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- TLC-Diet and WEB-Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,224 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jul 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Be at risk with regard to saturated fat
- Have access to basic computer hardware and software
- Use the Internet regularly (defined as 1 times per week) and with basic proficiency
- Read and speak English at a fifth grade level
- Have access to a telephone and be able to use it independently.
Who cannot join
- Prescribed a diet that would conflict with a low saturated fat (e.g., a colectomy diet)
- Have a serious medical, psychiatric, or cognitive disease that would interfere with participation (e.g., cancer undergoing chemotherapy, psychotic disorder, Alzheimer's disease, etc.)
- If the individual does not use the Internet at least once a week
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare a Web-based system and a computer telephone system to determine their effectiveness in improving diet behaviors compared to each other and a control group.
Read the detailed description
The aim of this study is to compare a Web-based system (WEB-DIET) and a computer telephone system (TLC [Telephone Linked Communications]-DIET) for affecting dietary behavior change. These interventions will target the same dietary behaviors (consumption of fat and fruits and vegetables). The behavior change strategies and content will be derived from the same behavior change theory (the Transtheoretical Model [TTM]). A representative sample of ~1200 adults from a large urban area will be recruited through a list-assisted telephone list which will be bought by the University of Rhode Island so that subjects can be randomized into one of three groups: a Web-based system (WEB- DIET), a computer telephone system (TLC [Telephone Linked Communications]-DIET), or assessment only control. The study hypotheses, which will be evaluated both at the end of the 6-month intervention period and at the end of 18-month follow-up (post-baseline) observation period, are: 1. TLC-DIET> Control 2. WEB-DIET> Control 3. WEB-DIET> TLC-DIET.
- Conditions
- Cardiovascular Disease
- Being tested
- TLC-Diet, WEB-Diet, Assessment-only control
- Keywords
- behavioral research, diet, health information systems
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC-DietBehavioural
Participants receive diet intervention through an automated telephone system
WEB-DietBehavioural
Participants receive diet intervention through a web-based system
Assessment-only controlOther
Assessment-only control
| Study group | Role | What they receive |
|---|---|---|
| TLC-Diet | Experimental | Participants receive diet intervention through automated telephone system: TLC-Diet Receives: Behavioral: TLC-Diet |
| WEB-Diet | Experimental | Participants receive diet intervention through web-based system: WEB-Diet Receives: Behavioral: WEB-Diet |
| Control | Experimental | Assessment-only control group Receives: Other: Assessment-only control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diet from baseline to 6 months, 6 months to 18 months, and baseline to 18 months
Self-reported diet questionnaire to measure fat and fruits/vegetables
Measured: Baseline, 6 months, and 18 months
Secondary outcomes (2)
Change in psychosocial variables from baseline to 6 months, 6 months to 18 months, and baseline to 18 months
Additional theoretical variables, such as Stages of change, as measured by self-reported questionnaire
Measured: Baseline, 6 months, and 18 months
Change in diet variables from baseline to 6 months, 6 months to 18 months, and baseline to 18 months
Additional diet variables, such as total calories, trans fat, and carotenoids, as measured by self-reported food frequency questionnaire
Measured: Baseline, 6 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startNov 2008
- Primary completionJul 2011
- Study completionJul 2011
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 Boston Medical CenterThe 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
- 1,224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rhode Island
- Responsible party
- Sponsor
- Investigators
- Robert H Friedman, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864694
- Sponsor's protocol ID
- 5R01HL081380
- Status last verified
- May 2013
- First submitted
- 2 May 2013
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Dietary Behavior Through Tailored Messages
- ClinicalTrials.gov ID
- NCT01864694
- Acronym / sponsor ID
- 5R01HL081380
- Conditions
- Cardiovascular Disease
- Keywords
- behavioral research, diet, health information systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,224 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- University of Rhode Island
- Study start
- Nov 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 May 2013 (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 aim of this study is to compare a Web-based system and a computer telephone system to determine their effectiveness in improving diet behaviors compared to each other and a control group.
Detailed description
The aim of this study is to compare a Web-based system (WEB-DIET) and a computer telephone system (TLC [Telephone Linked Communications]-DIET) for affecting dietary behavior change. These interventions will target the same dietary behaviors (consumption of fat and fruits and vegetables). The behavior change strategies and content will be derived from the same behavior change theory (the Transtheoretical Model [TTM]). A representative sample of ~1200 adults from a large urban area will be recruited through a list-assisted telephone list which will be bought by the University of Rhode Island so that subjects can be randomized into one of three groups: a Web-based system (WEB- DIET), a computer telephone system (TLC [Telephone Linked Communications]-DIET), or assessment only control. The study hypotheses, which will be evaluated both at the end of the 6-month intervention period and at the end of 18-month follow-up (post-baseline) observation period, are: 1. TLC-DIET> Control 2. WEB-DIET> Control 3. WEB-DIET> TLC-DIET.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TLC-Diet | Experimental | Behavioral: TLC-DietParticipants receive diet intervention through automated telephone system: TLC-Diet |
| WEB-Diet | Experimental | Behavioral: WEB-DietParticipants receive diet intervention through web-based system: WEB-Diet |
| Control | Experimental | Other: Assessment-only controlAssessment-only control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Be at risk with regard to saturated fat
- Have access to basic computer hardware and software
- Use the Internet regularly (defined as 1 times per week) and with basic proficiency
- Read and speak English at a fifth grade level
Key exclusion criteria (3 listed)
- Prescribed a diet that would conflict with a low saturated fat (e.g., a colectomy diet)
- Have a serious medical, psychiatric, or cognitive disease that would interfere with participation (e.g., cancer undergoing chemotherapy, psychotic disorder, Alzheimer's disease, etc.)
- If the individual does not use the Internet at least once a week
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 |
|---|---|---|
| TLC-DietParticipants receive diet intervention through an automated telephone system | Behavioural | TLC-Diet |
| WEB-DietParticipants receive diet intervention through a web-based system | Behavioural | WEB-Diet |
| Assessment-only controlAssessment-only control | Other | Control |
Primary outcome
Change in diet from baseline to 6 months, 6 months to 18 months, and baseline to 18 months
Time frame: Baseline, 6 months, and 18 months
Self-reported diet questionnaire to measure fat and fruits/vegetables
2 secondary outcomes
Change in psychosocial variables from baseline to 6 months, 6 months to 18 months, and baseline to 18 months
Time frame: Baseline, 6 months, and 18 months
Change in diet variables from baseline to 6 months, 6 months to 18 months, and baseline to 18 months
Time frame: Baseline, 6 months, and 18 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 30 May 2013.
Related trials for Cardiovascular Disease
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Recruiting
Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial
Dyslipidemias, Atherosclerotic Cardiovascular Disease
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.
Robert H Friedman, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLC-Diet and WEB-Diet in people with Cardiovascular Disease, run by Boston Medical Center 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 6 inclusion and 3 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 30 May 2013. 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 diet from baseline to 6 months, 6 months to 18 months, and baseline to 18 months (time frame: Baseline, 6 months, and 18 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 30 May 2013.