Clinical trial NCT01864694: Improving Dietary Behavior Through Tailored Messages
Official title: Improving Dietary Behavior Through Tailored Messages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: behavioral research
diet
health information systems
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: University of Rhode Island
First posted: 2013-05-30
Enrollment: 1224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in diet from baseline to 6 months, 6 months to 18 months, and baseline to 18 months
timeFrame: Baseline, 6 months, and 18 months
Secondary outcomes:
measure: Change in psychosocial variables from baseline to 6 months, 6 months to 18 months, and baseline to 18 months
timeFrame: Baseline, 6 months, and 18 months
measure: Change in diet variables from baseline to 6 months, 6 months to 18 months, and baseline to 18 months
timeFrame: Baseline, 6 months, and 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Robert H Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References: