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OpenTrials
Completed

NCT Number: NCT00800410

REACH Detroit Partnership Family Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Community Health and Social Services (CHASS)

Detroit, Michigan, 48209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community Health Worker (CHW) services

Behavioral

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

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 6 months

Secondary outcomes

  1. LDL cholesterol

    Time frame: 6 months

  2. Blood pressure

    Time frame: 6 months

  3. Diabetes self-management knowledge

    Time frame: 6 months

  4. Diabetes Self Management and Self Care Activities (physical activity, healthy eating, glucose testing, medication taking, required screening tests/exams)

    Time frame: 6 months

  5. Diabetes specific emotional distress

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

A Pilot Randomized Diabetes Intervention Among Inner-city African American and Latino Adults

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Dec 2, 2008
Registry last updated
May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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