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

Study Overview
=================
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.

Official Title
-----------------
Trial of 2 TeleComputer Diet Change Maintenance Programs

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Social Cognitive Theory
* Behavioral: goal system theory


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: social cognitive theory<br>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<br>* 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.<br>* Other names: Social cognitive theory (SCT);|
| Experimental: Goal Systems Theory<br>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<br>* 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.<br>* Other names: Goal systems theory (GST);|
| No Intervention: Comparison group<br>comparison group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory. |  | July 2006-July 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
automated telephony, cancer prevention, healthy diet