NCT00311324

Brief Summary

The purpose of this study it to determine if a culturally appropriate, church based intervention for African Americans with type 2 diabetes, will lead to improved glycemic (blood sugar) control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2001

Typical duration for not_applicable type-2-diabetes

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
Last Updated

July 20, 2023

Status Verified

December 1, 2015

Enrollment Period

2.5 years

First QC Date

March 31, 2006

Last Update Submit

July 18, 2023

Conditions

Type 2 Diabetes

Keywords

behavioral intervention

Outcome Measures

Primary Outcomes (1)

  • Mean Hemoglobin A1c

    5 µL capillary blood collected using standard finger-stick technique and assessed by automated affinity high-performance liquid chromatography.

Secondary Outcomes (2)

  • Mean Dietary recall saturated fat consumption

  • Median number of minutes per day engaged in physical activity

Study Arms (2)

Special Intervention

EXPERIMENTAL

One individual counseling visit, twelve group sessions, three postcards, and twelve telephone calls.

Behavioral: Special Intervention

Delayed Intervention

EXPERIMENTAL

Direct mailing of two American Dietary Association pamphlets ("Healthy Eating" and "Staying Alive") and three bimonthly newsletters providing general health information and study updates.

Behavioral: Delayed Intervention

Interventions

Special InterventionBEHAVIORAL
Also known as: Diabetes self care (behavior)
Special Intervention
Delayed InterventionBEHAVIORAL
Also known as: Diabetes self care (behavior)
Delayed Intervention

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 20 or older
  • diagnosis of type 2 diabetes (diagnosis at age 20 or greater and no history of ketoacidosis)
  • clinical care provided by primary care clinician
  • plans to reside within 50 miles of church for 1 year
  • has home phone or easy access to one

You may not qualify if:

  • diabetes secondary to another condition
  • pregnancy/lactation
  • inability to speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health Promotion and Disease Prevention/UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Thomas C. Keyserling, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 31, 2006

First Posted

April 5, 2006

Study Start

February 1, 2001

Primary Completion

August 1, 2003

Study Completion

August 1, 2003

Last Updated

July 20, 2023

Record last verified: 2015-12

Locations

US(1)