The Study of Automated Telephone Programs for the Maintenance of Dietary Change

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Boston Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00148525
First received: September 6, 2005
Last updated: June 23, 2011
Last verified: June 2011

September 6, 2005
June 23, 2011
July 2006
August 2010   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00148525 on ClinicalTrials.gov Archive Site
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 ]
Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory.
Not Provided
Not Provided
 
The Study of Automated Telephone Programs for the Maintenance of Dietary Change
Trial of 2 TeleComputer Diet Change Maintenance Programs

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.

RCT is completed. However, the eligibility was 18 y/o or greater and living in Greater Boston area. The participants used an evidenced based dietary intervention for 3 months and then were randomized to 1 of 3 arms. Those in the experimental arm received a 6 mo intervention based on social cognitive theory or goal systems theory. The intervention was designed to help the participants maintain previously achieved changes in the their diet, e.g., fruits and vegetables. The outcome measures are fruit and vegetable consumption as measured by servings on multiple dietary measures as well as a 24 hr dietary recall.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Cancer
  • Behavioral: Social Cognitive Theory
    6 mo dietary intervention. This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on social cognitive theory.
    Other Name: Social cognitive theory (SCT)
  • Behavioral: goal system theory
    This arm received a 6 mo diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on goal systems theory and delivered by an automated telephone system.
    Other Name: Goal systems theory (GST)
  • Experimental: social cognitive theory
    This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on social cognitive theory and delivered by an automated telephone system.
    Intervention: Behavioral: Social Cognitive Theory
  • Experimental: Goal Systems Theory
    This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on goal systems theory.
    Intervention: Behavioral: goal system theory
  • No Intervention: Comparison group
    comparison group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1049
July 2011
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00148525
R01 CA105832-02, National Cancer Institute
Yes
Robert Friedman, MD, Principal, Boston Medical Center
Boston Medical Center
University of North Carolina, Chapel Hill
Principal Investigator: Robert Friedman, MD Boston University
Boston Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP