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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Behavioral: goal system theory; Behavioral: Social Cognitive Theory

• Registration Number: NCT00148525
• Lead Sponsor: Robert H. Friedman

Brief 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.

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 Timeline

• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Study Start: 2006-07
• Primary Completion: 2010-08
• Status Verified: 2011-06
• Study Completion: 2011-07
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1049

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal Systems Theory	goal system 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.
social cognitive theory	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory.	July 2006-July 2009

Trial Locations

Locations (1)

Boston medical Center; 🇺🇸 Boston, Massachusetts, United States