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

NCT ID: NCT00148525

Last Updated: 2015-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1049 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Social Cognitive Theory

Intervention Type 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.

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.

Group Type EXPERIMENTAL

goal system theory

Intervention Type 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.

Comparison group

comparison group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Social cognitive theory (SCT) Goal systems theory (GST)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

Robert H. Friedman

OTHER

Sponsor Role lead

Responsible Party

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Robert H. Friedman

Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Wright JA, Quintiliani LM, Turner-McGrievy GM, Migneault JP, Heeren T, Friedman RH. Comparison of two theory-based, fully automated telephone interventions designed to maintain dietary change in healthy adults: study protocol of a three-arm randomized controlled trial. JMIR Res Protoc. 2014 Nov 10;3(4):e62. doi: 10.2196/resprot.3367.

Reference Type DERIVED
PMID: 25387065 (View on PubMed)

Other Identifiers

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National Cancer Institute

Identifier Type: -

Identifier Source: secondary_id

R01CA105832-02

Identifier Type: NIH

Identifier Source: org_study_id

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