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REACH Detroit Partnership Family Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00800410
First Posted: December 2, 2008
Last Update Posted: May 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
University of Michigan
  Purpose
The objectives of the proposed study are to determine whether culturally diverse community residents with diabetes are willing to participate in our community health worker intervention using randomized controlled trial (RCT) methods and to explore and document effective processes and protocols for RCT methods in these communities. The investigators will examine retention rates, identify reasons for attrition through interviews and focus groups, and determine strategies for improving recruitment, retention, and intervention methods. As a secondary objective, the investigators will explore the potential impacts of the intervention for improving healthy lifestyles, diabetes self-management, and selected health outcomes of participants.

Condition Intervention Phase
Diabetes Mellitus Behavioral: Community Health Worker (CHW) services Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Randomized Diabetes Intervention Among Inner-city African American and Latino Adults

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • LDL cholesterol [ Time Frame: 6 months ]
  • Blood pressure [ Time Frame: 6 months ]
  • Diabetes self-management knowledge [ Time Frame: 6 months ]
  • Diabetes Self Management and Self Care Activities (physical activity, healthy eating, glucose testing, medication taking, required screening tests/exams) [ Time Frame: 6 months ]
  • Diabetes specific emotional distress [ Time Frame: 6 months ]

Enrollment: 183
Study Start Date: September 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Information on community resources
Participants received information about free and publicly available community resources on healthy lifestyle activities
Experimental: Community Health Worker services Behavioral: Community Health Worker (CHW) services
CHW services included access to an 11 week healthy lifestyle education curriculum, two home visits per month, two additional phone contacts per month, and accompanied participants to one clinic visit within the six month intervention period

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Had physician-diagnosed type 2 diabetes
  • Self-identified as African American or Latino/Hispanic
  • Lived in the targeted zip codes.

Exclusion Criteria:

  • Individuals who already had serious diabetes-related complications, such as blindness, amputated limbs, and kidney failure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800410


Locations
United States, Michigan
Community Health and Social Services (CHASS)
Detroit, Michigan, United States, 48209
Sponsors and Collaborators
University of Michigan
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Michael S Spencer, PhD, MSW University of Michigan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Spencer, Associate Professor, University of Michigan School of Social Work
ClinicalTrials.gov Identifier: NCT00800410     History of Changes
Other Study ID Numbers: F012089-049555
5P60DK020572 ( U.S. NIH Grant/Contract )
First Submitted: November 18, 2008
First Posted: December 2, 2008
Last Update Posted: May 27, 2016
Last Verified: May 2016

Keywords provided by University of Michigan:
Randomized Controlled Trial

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases