The Study of Automated Telephone Programs for the Maintenance of Dietary Change
This study is ongoing, but not recruiting participants.
Sponsor:
Boston Medical Center
Collaborator:
University of North Carolina, Chapel Hill
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00148525
First received: September 6, 2005
Last updated: June 23, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Behavioral: Social Cognitive Theory Behavioral: goal system theory |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Trial of 2 TeleComputer Diet Change Maintenance Programs |
Resource links provided by NLM:
Further study details as provided by Boston Medical Center:
Primary Outcome Measures:
- 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. [ Time Frame: July 2006-July 2009 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory. [ Time Frame: July 2006-July 2009 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1049 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | July 2011 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Behavioral: 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.
Other Name: Social cognitive theory (SCT)
|
|
Experimental: 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.
|
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.
Other Name: Goal systems theory (GST)
|
|
No Intervention: Comparison group
comparison group
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148525
Locations
| United States, Massachusetts | |
| Boston medical Center | |
| Boston, Massachusetts, United States, 02118 | |
Sponsors and Collaborators
Boston Medical Center
University of North Carolina, Chapel Hill
Investigators
| Principal Investigator: | Robert Friedman, MD | Boston University |
More Information
No publications provided
| Responsible Party: | Robert Friedman, MD, Principal, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT00148525 History of Changes |
| Other Study ID Numbers: | R01 CA105832-02, National Cancer Institute |
| Study First Received: | September 6, 2005 |
| Last Updated: | June 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston Medical Center:
|
automated telephony, cancer prevention, healthy diet |
ClinicalTrials.gov processed this record on May 16, 2013