| April 28, 2008 |
| February 12, 2009 |
| September 2008 |
| September 2011 (final data collection date for primary outcome measure) |
| Diet History Questionnaire; 7 - Day Physical Activity Recall [ Time Frame: Baseline, 18 months, and 36 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00669630 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Same as current |
| |
| The GoodNEWS Lifestyle Enhancement Program |
| The GoodNEWS (Genes, Nutrition, Exercise, Wellness, and Spiritual Growth) Trial |
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. |
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. |
| |
| Interventional |
| Prevention, Randomized, Open Label, Parallel Assignment |
- Cardiovascular Disease
- Hypertension
- Diabetes
- Obesity
|
| Behavioral: Lay Health Promoter (LHP) with maintenance |
| |
| |
| |
| Recruiting |
| 400 |
| June 2012 |
| September 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Member of selected church congregations in the predominantly African-American geographical area of Dallas, Texas, known as South Dallas or the Southern Sector.
- Between the ages of 18 -70 years
Exclusion Criteria:
- Anyone under the age of 18
- Anyone who is not an active member of one of the participating churches
|
| Both |
| 18 Years to 70 Years |
| Yes |
|
|
| United States |
| |
| NCT00669630 |
| Mark J. DeHaven, Ph.D., Chief, Division of Community Health Sciences, UT Southwestern Medical Center |
| R01HL087768, R01HL087768-01 |
| University of Texas Southwestern Medical Center |
|
| Principal Investigator: |
Mark J. DeHaven, Ph.D. |
UT Southwestern Medical Center at Dallas |
|
|
| University of Texas Southwestern Medical Center |
| February 2009 |
