The GoodNEWS Lifestyle Enhancement Program
Recruitment status was Recruiting
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Purpose
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 |
|---|---|
|
Cardiovascular Disease Hypertension Diabetes Obesity |
Behavioral: Lay Health Promoter (LHP) with maintenance |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The GoodNEWS (Genes, Nutrition, Exercise, Wellness, and Spiritual Growth) Trial |
- Diet History Questionnaire; 7 - Day Physical Activity Recall [ Time Frame: Baseline, 18 months, and 36 months ] [ Designated as safety issue: No ]
- 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 ]
| 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) |
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Behavioral: Lay Health Promoter (LHP) with maintenance
- Faith-Based Intervention
- Faith-Based Program
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| 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 |
| United States, Texas | |
| UT Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Mark J. DeHaven, Ph.D. 214-648-2974 mark.dehaven@utsouthwestern.edu | |
| Contact: Janice Rookstool, MA 214-648-2973 janice.rookstool@utsouthwestern.edu | |
| Principal Investigator: Mark J. DeHaven, Ph.D. | |
| Principal Investigator: | Mark J. DeHaven, Ph.D. | UT Southwestern Medical Center at Dallas |
More Information
No publications provided by University of Texas Southwestern Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mark J. DeHaven, Ph.D., Chief, Division of Community Health Sciences, UT Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00669630 History of Changes |
| Other Study ID Numbers: | R01HL087768, R01HL087768-01 |
| Study First Received: | April 28, 2008 |
| Last Updated: | January 11, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Texas Southwestern Medical Center:
|
Community-based Participatory Research (CBPR) Vulnerable population High-risk population |
African-Americans Health Disparities Clinical Trial |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypertension Obesity Vascular Diseases Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013