The Study of Automated Telephone Programs for the Maintenance of Dietary Change
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 6, 2005 | ||||
| Last Updated Date | June 23, 2011 | ||||
| Start Date ICMJE | July 2006 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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. | ||||
| Change History | Complete list of historical versions of study NCT00148525 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Study of Automated Telephone Programs for the Maintenance of Dietary Change | ||||
| Official Title ICMJE | Trial of 2 TeleComputer Diet Change Maintenance Programs | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE | Cancer | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1049 | ||||
| Estimated Completion Date | July 2011 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00148525 | ||||
| Other Study ID Numbers ICMJE | R01 CA105832-02, National Cancer Institute | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Robert Friedman, MD, Principal, Boston Medical Center | ||||
| Study Sponsor ICMJE | Boston Medical Center | ||||
| Collaborators ICMJE | University of North Carolina, Chapel Hill | ||||
| Investigators ICMJE |
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| Information Provided By | Boston Medical Center | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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