Clinical trial NCT00669630: The GoodNEWS Lifestyle Enhancement Program
Official title: The GoodNEWS (Genes, Nutrition, Exercise, Wellness, and Spiritual Growth) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Hypertension
Diabetes
Obesity
Keywords: Community-based Participatory Research (CBPR)
Vulnerable population
High-risk population
African-Americans
Health Disparities
Clinical Trial
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2008-04-30
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diet History Questionnaire; 7 - Day Physical Activity Recall
timeFrame: Baseline, 18 months, and 36 months
Secondary outcomes:
measure: Blood pressure; Total cholesterol, HDL, LDL, Triglycerides; Glucose level; Hemoglobin A1C (Diabetics only)
timeFrame: Baseline, 18-months, and 36 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Mark J. DeHaven, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carson JA, Michalsky L, Latson B, Banks K, Tong L, Gimpel N, Lee JJ, Dehaven MJ. The cardiovascular health of urban African Americans: diet-related results from the Genes, Nutrition, Exercise, Wellness, and Spiritual Growth (GoodNEWS) trial. J Acad Nutr Diet. 2012 Nov;112(11):1852-8. doi: 10.1016/j.jand.2012.06.357. Epub 2012 Sep 18.