Improving Dietary Behavior Through Tailored Messages

Cardiovascular Disease Clinical Trial

Official title:

Improving Dietary Behavior Through Tailored Messages

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864694
• Other study ID #: 5R01HL081380
• Status: Completed
• Phase: N/A
• First received: May 2, 2013
• Last updated: May 24, 2013
• Start date: November 2008
• Est. completion date: July 2011

Study information

• Verified date: May 2013
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1224
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• TLC-Diet
Participants receive diet intervention through an automated telephone system
• WEB-Diet
Participants receive diet intervention through a web-based system

Other:
• Assessment-only control
Assessment-only control

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	University of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 6 months, and 18 months	No
Secondary	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	Baseline, 6 months, and 18 months	No
Secondary	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	Baseline, 6 months, and 18 months	No