Improving Dietary Behavior Through Tailored Messages

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Behavioral: TLC-Diet; Behavioral: WEB-Diet; Other: Assessment-only control

• Registration Number: NCT01864694
• Lead Sponsor: Boston Medical Center

Brief 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.

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 Timeline

• Study Start: 2008-11
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-05
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-24
• Last Update Submitted: 2013-05-24
• Study First Posted: 2013-05-30
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1224

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TLC-Diet	TLC-Diet	Participants receive diet intervention through automated telephone system: TLC-Diet
WEB-Diet	WEB-Diet	Participants receive diet intervention through web-based system: WEB-Diet
Control	Assessment-only control	Assessment-only control group

Primary Outcome Measures

Name	Time	Method
Change in diet from baseline to 6 months, 6 months to 18 months, and baseline to 18 months	Baseline, 6 months, and 18 months	Self-reported diet questionnaire to measure fat and fruits/vegetables

Secondary Outcome Measures

Name	Time	Method
Change in psychosocial variables from baseline to 6 months, 6 months to 18 months, and baseline to 18 months	Baseline, 6 months, and 18 months	Additional theoretical variables, such as Stages of change, as measured by self-reported questionnaire
Change in diet variables from baseline to 6 months, 6 months to 18 months, and baseline to 18 months	Baseline, 6 months, and 18 months	Additional diet variables, such as total calories, trans fat, and carotenoids, as measured by self-reported food frequency questionnaire

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States