NCT00669630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

April 28, 2008

Last Update Submit

February 8, 2019

Conditions

Keywords

Community-based Participatory Research (CBPR)Vulnerable populationHigh-risk populationAfrican-AmericansHealth DisparitiesClinical Trial

Outcome Measures

Primary Outcomes (1)

  • Diet History Questionnaire; 7 - Day Physical Activity Recall

    Baseline, 18 months, and 36 months

Secondary Outcomes (1)

  • Blood pressure; Total cholesterol, HDL, LDL, Triglycerides; Glucose level; Hemoglobin A1C (Diabetics only)

    Baseline, 18-months, and 36 months

Interventions

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.

Also known as: Faith-Based Intervention, Faith-Based Program

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Anyone under the age of 18
  • Anyone who is not an active member of one of the participating churches

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionDiabetes MellitusObesity

Condition Hierarchy (Ancestors)

Vascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark J. DeHaven, Ph.D.

    UT Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2008

First Posted

April 30, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2011

Study Completion

June 1, 2012

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations