NCT00148525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,049

participants targeted

Target at P75+ for phase_1 cancer

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 2, 2015

Status Verified

June 1, 2011

Enrollment Period

4.1 years

First QC Date

September 6, 2005

Last Update Submit

July 1, 2015

Conditions

Cancer

Keywords

automated telephony, cancer prevention, healthy diet

Outcome Measures

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.

    July 2006-July 2009

Secondary Outcomes (1)

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

    July 2006-July 2009

Study Arms (3)

social cognitive theory

EXPERIMENTAL

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

Goal Systems Theory

EXPERIMENTAL

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

Comparison group

NO INTERVENTION

comparison group

Interventions

Social Cognitive TheoryBEHAVIORAL

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.

Also known as: Social cognitive theory (SCT)
social cognitive theory
goal system theoryBEHAVIORAL

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.

Also known as: Goal systems theory (GST)
Goal Systems Theory

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consume fewer than 5 fruits and vegetables per day.
  • Understand conversational English
  • Have the ability to use a telephone without assistance

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • 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.

    PMID: 25387065DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Robert Friedman, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

July 1, 2006

Primary Completion

August 1, 2010

Study Completion

July 1, 2011

Last Updated

July 2, 2015

Record last verified: 2011-06

Locations

US(1)