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Completed

NCT Number: NCT00148525

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boston medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Social Cognitive Theory

Behavioral

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)

goal system theory

Behavioral

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory.

    Time frame: July 2006-July 2009

Sponsors and collaborators

Lead sponsor

Robert H. Friedman

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

Trial of 2 TeleComputer Diet Change Maintenance Programs

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Sep 8, 2005
Registry last updated
Jul 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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