The GoodNEWS Lifestyle Enhancement Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00669630
First received: April 28, 2008
Last updated: January 11, 2010
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Diet History Questionnaire; 7 - Day Physical Activity Recall [ Time Frame: Baseline, 18 months, and 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    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.
    Other Names:
    • Faith-Based Intervention
    • Faith-Based Program
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669630

Contacts
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

Locations
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.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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 July 31, 2014