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

Cancer Clinical Trial

Official title:

Trial of 2 TeleComputer Diet Change Maintenance Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148525
• Other study ID #: R01CA105832-02
• Secondary ID: National Cancer
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2005
• Last updated: July 1, 2015
• Start date: July 2006
• Est. completion date: July 2011

Study information

• Verified date: June 2011
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1049
• Est. completion date: July 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Boston medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Robert H. Friedman	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		July 2006-July 2009	No
Secondary	Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory.		July 2006-July 2009	No