Clinical trial NCT00148525: The Study of Automated Telephone Programs for the Maintenance of Dietary Change
Official title: Trial of 2 TeleComputer Diet Change Maintenance Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: automated telephony, cancer prevention, healthy diet
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2005-09-08
Enrollment: 1049
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: July 2006-July 2009
Secondary outcomes:
measure: Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory.
timeFrame: July 2006-July 2009
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Robert Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.