The Study of Automated Telephone Programs for the Maintenance of Dietary Change - Full Text View

Sponsors and Collaborators:	Boston Medical Center The University of North Carolina, Chapel Hill
Information provided by:	Boston Medical Center
ClinicalTrials.gov Identifier:	NCT00148525

Purpose

The purpose of this study is to test two different approaches to helping individuals who have recently starting eating a healthful diet maintain those healthy changes. This study will deliver a health program using an automated telephone system. The programs will be designed to help individuals maintain a healthy diet change for a lifetime.

Condition	Intervention	Phase
Cancer	Behavioral: social cognitive dietary intervention Behavioral: goal system theory dietary intervention	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Trial of 2 TeleComputer Diet Change Maintenance Programs

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:

The study hypothesis is that the goal systems intervention will out perform the social cognitive intervention and that both of these interventions will outperform the control group for fruit and vegetable consumption. [ Time Frame: July 2006-July 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory. [ Time Frame: July 2006-July 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1049
Study Start Date:	July 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental social cognitive group	Behavioral: social cognitive dietary intervention dietary intervention
2: Experimental goal systems group	Behavioral: goal system theory dietary intervention dietary intervention
3: No Intervention comparison group

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Consume fewer than 5 fruits and vegetables per day.
Understand conversational English
Have the ability to use a telephone without assistance

Exclusion Criteria:

Under 18 years of age
Diagnosis of a health condition for which dietary recommendations in the would be contraindicated,
Have cognitive impairment
Have a terminal illness, recent myocardial infarction, current or former diagnosis of an eating disorder, pregnancy
Consume > 5 servings of fruit and vegetable per day, or
Plan to move away from the Boston area in less than 30 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148525

Locations

United States, Massachusetts
Boston medical Center
Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston Medical Center

The University of North Carolina, Chapel Hill

Investigators

Principal Investigator:

Robert Friedman, MD

Boston University

More Information

Responsible Party:	Boston Medical Center ( Robert Friedman, MD, Principal )
Study ID Numbers:	R01 CA105832-02, National Cancer Institute
Study First Received:	September 6, 2005
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00148525
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Medical Center:

automated telephony, cancer prevention, healthy diet

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009