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Improving Dietary Behavior Through Tailored Messages

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ClinicalTrials.gov Identifier: NCT01864694
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : May 30, 2013
Sponsor:
Collaborator:
University of Rhode Island
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: TLC-Diet Behavioral: WEB-Diet Other: Assessment-only control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Dietary Behavior Through Tailored Messages
Study Start Date : November 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Additional theoretical variables, such as Stages of change, as measured by self-reported questionnaire

  2. 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 ]
    Additional diet variables, such as total calories, trans fat, and carotenoids, as measured by self-reported food frequency questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864694


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
University of Rhode Island
Investigators
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Principal Investigator: Robert H Friedman, MD Boston University

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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01864694     History of Changes
Other Study ID Numbers: 5R01HL081380 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013
Keywords provided by Boston Medical Center:
behavioral research
diet
health information systems
Additional relevant MeSH terms:
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Cardiovascular Diseases