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Sponsored by: |
University of Texas Southwestern Medical Center |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00669630 |
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.
Condition | Intervention |
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Cardiovascular Disease Hypertension Diabetes Obesity |
Behavioral: Lay Health Promoter (LHP) with maintenance |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment |
Official Title: | The GoodNEWS (Genes, Nutrition, Exercise, Wellness, and Spiritual Growth) Trial |
Estimated Enrollment: | 400 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark J. DeHaven, Ph.D. | 214-648-2974 | Mark.DeHaven@UTSouthwestern.edu |
Contact: Natalie Hsieh, M.S. | 214-648-2012 | Natalie.Hsieh@UTSouthwestern.edu |
Principal Investigator: | Mark J. DeHaven, Ph.D. | UT Southwestern Medical Center at Dallas |
Responsible Party: | UT Southwestern Medical Center ( Mark J. DeHaven, Ph.D., Chief, Division of Community Health Sciences ) |
Study ID Numbers: | R01HL087768, R01HL087768-01 |
Study First Received: | April 28, 2008 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00669630 |
Health Authority: | United States: Institutional Review Board |
Community-based Participatory Research (CBPR) Vulnerable population High-risk population |
African-Americans Health Disparities Clinical Trial |
Body Weight Signs and Symptoms Obesity Vascular Diseases Diabetes Mellitus |
Nutrition Disorders Overweight Overnutrition Hypertension |
Cardiovascular Diseases |