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

July 1, 2015 updated by: Robert H. Friedman

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1049

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Goal systems theory (GST)
No Intervention: Comparison group
comparison group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
July 2006-July 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory.
Time Frame: July 2006-July 2009
July 2006-July 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert H. Friedman

Collaborators

University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

July 2, 2015

Last Update Submitted That Met QC Criteria

July 1, 2015

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01CA105832-02 (U.S. NIH Grant/Contract)
  • National Cancer Institute (P50CA058187)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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