The GoodNEWS Lifestyle Enhancement Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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The GoodNEWS (Genes, Nutrition, Exercise, Wellness, and Spiritual Growth) Trial

Conditions
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Cardiovascular Disease, Hypertension, Diabetes, Obesity

Intervention / Treatment
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* Behavioral: Lay Health Promoter (LHP) with maintenance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet History Questionnaire; 7 - Day Physical Activity Recall |  | Baseline, 18 months, and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure; Total cholesterol, HDL, LDL, Triglycerides; Glucose level; Hemoglobin A1C (Diabetics only) |  | Baseline, 18-months, and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community-based Participatory Research (CBPR), Vulnerable population, High-risk population, African-Americans, Health Disparities, Clinical Trial