NCT01864694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

2.7 years

First QC Date

May 2, 2013

Last Update Submit

May 24, 2013

Conditions

Keywords

behavioral researchdiethealth information systems

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (3)

TLC-Diet

EXPERIMENTAL

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

Behavioral: TLC-Diet

WEB-Diet

EXPERIMENTAL

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

Behavioral: WEB-Diet

Control

EXPERIMENTAL

Assessment-only control group

Other: Assessment-only control

Interventions

TLC-DietBEHAVIORAL

Participants receive diet intervention through an automated telephone system

TLC-Diet
WEB-DietBEHAVIORAL

Participants receive diet intervention through a web-based system

WEB-Diet

Assessment-only control

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Robert H Friedman, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 30, 2013

Study Start

November 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations