Improving Dietary Behavior Through Tailored Messages

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: TLC-Diet; Behavioral: WEB-Diet; Other: Assessment-only control

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 Type: Interventional
• Enrollment (Actual): 1224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TLC-Diet; Participants receive diet intervention through automated telephone system: TLC-Diet	Behavioral: TLC-Diet; Participants receive diet intervention through an automated telephone system
EXPERIMENTAL: WEB-Diet; Participants receive diet intervention through web-based system: WEB-Diet	Behavioral: WEB-Diet; Participants receive diet intervention through a web-based system
EXPERIMENTAL: Control; Assessment-only control group	Other: Assessment-only control; Assessment-only control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: University of Rhode Island
• Investigators: Principal Investigator: Robert H Friedman, MD, Boston University

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: May 2, 2013
• First Submitted That Met QC Criteria: May 24, 2013
• First Posted (ESTIMATE): May 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 30, 2013
• Last Update Submitted That Met QC Criteria: May 24, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: diet; behavioral research; health information systems
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 5R01HL081380 (NIH)