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Trial of 2 TeleComputer Diet Change Maintenance Programs


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

Trial of 2 TeleComputer Diet Change Maintenance Programs


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

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.

Outcome Time Frame:

July 2006-July 2009

Safety Issue:

No

Principal Investigator

Robert Friedman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston University

Authority:

United States: Institutional Review Board

Study ID:

R01 CA105832-02

NCT ID:

NCT00148525

Start Date:

July 2006

Completion Date:

July 2011

Related Keywords:

  • Cancer
  • automated telephony, cancer prevention, healthy diet

Name

Location

Boston Medical Center Boston, Massachusetts  02118