The GoodNEWS Lifestyle Enhancement Program
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 28, 2008 | ||||||||
| Last Updated Date | January 11, 2010 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Diet History Questionnaire; 7 - Day Physical Activity Recall [ Time Frame: Baseline, 18 months, and 36 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00669630 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Blood pressure; Total cholesterol, HDL, LDL, Triglycerides; Glucose level; Hemoglobin A1C (Diabetics only) [ Time Frame: Baseline, 18-months, and 36 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The GoodNEWS Lifestyle Enhancement Program | ||||||||
| Official Title ICMJE | The GoodNEWS (Genes, Nutrition, Exercise, Wellness, and Spiritual Growth) Trial | ||||||||
| Brief Summary | This study will train Lay Health Promoters (LHPs) from African-American churches to administer healthy living lessons and activities to their congregations in order to improve overall health and address cardiovascular disease. The primary hypothesis is that LHP training combined with a well supported maintenance strategy will be more effective than LHP training alone in reducing risk factors for cardiovascular disease. |
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| Detailed Description | The GoodNEWS Trial is an 18-month effectiveness trial with an 18-month extended maintenance study, among 20 African-American and low-income congregations participating in the GoodNEWS faith-based lay health promotion program. After training, congregations will be randomized to either GoodNEWS with a health maintenance intervention (GoodNEWS-I) or GoodNEWS program alone (GoodNEWS-PA). The maintenance intervention combines elements of the medical care model and features of community-based support. Primary data collection will occur at baseline, 18, and 36 months with the two primary outcomes being levels of physical activity as measured by 7- Day Physical Activity Recall (PAR) and dietary change as measured by the Diet History Questionnaire (DHQ). The primary hypothesis is that the maintenance group will significantly increase physical activity and healthy eating behavior compared to the program only group. We also hypothesize that lipoprotein and glucose levels, and blood pressure will be significantly improved over baseline in the GoodNEWS-I group and that these changes will be significantly greater than in the GoodNEWS-PA group. At the end of the trial, both groups will continue in an 18-month extended maintenance study. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Lay Health Promoter (LHP) with maintenance
Lay Health Promoters (LHPs) and their congregations will join an existing social and organizational support network, comprised of LHPs and congregations who are part of an active community health improvement collaborative.
Other Names:
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| Publications * | |||||||||
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00669630 | ||||||||
| Other Study ID Numbers ICMJE | R01HL087768, R01HL087768-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Mark J. DeHaven, Ph.D., Chief, Division of Community Health Sciences, UT Southwestern Medical Center | ||||||||
| Study Sponsor ICMJE | University of Texas Southwestern Medical Center | ||||||||
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| Information Provided By | University of Texas Southwestern Medical Center | ||||||||
| Verification Date | January 2010 | ||||||||
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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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