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
  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 Theory
Behavioral: goal system theory
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Trial of 2 TeleComputer Diet Change Maintenance Programs

Resource links provided by NLM:


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 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
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.
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)
No Intervention: Comparison group
comparison group

Detailed Description:

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Robert Friedman, MD Boston University
  More Information

No publications provided

Responsible Party: Robert Friedman, MD, Principal, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00148525     History of Changes
Other Study ID Numbers: R01 CA105832-02, National Cancer Institute
Study First Received: September 6, 2005
Last Updated: June 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
automated telephony, cancer prevention, healthy diet

ClinicalTrials.gov processed this record on July 26, 2014