Improving Dietary Behavior Through Tailored Messages

NCT ID: NCT01864694

Last Updated: 2013-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TLC-Diet

Participants receive diet intervention through automated telephone system: TLC-Diet

Group Type EXPERIMENTAL

TLC-Diet

Intervention Type BEHAVIORAL

Participants receive diet intervention through an automated telephone system

WEB-Diet

Participants receive diet intervention through web-based system: WEB-Diet

Group Type EXPERIMENTAL

WEB-Diet

Intervention Type BEHAVIORAL

Participants receive diet intervention through a web-based system

Control

Assessment-only control group

Group Type EXPERIMENTAL

Assessment-only control

Intervention Type OTHER

Assessment-only control

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TLC-Diet

Participants receive diet intervention through an automated telephone system

Intervention Type BEHAVIORAL

WEB-Diet

Participants receive diet intervention through a web-based system

Intervention Type BEHAVIORAL

Assessment-only control

Assessment-only control

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Rhode Island

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert H Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5R01HL081380

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.