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Clinical Trials/NCT03925948
NCT03925948
Completed
Not Applicable

Health Literacy Enhanced Intervention for Inner-city African Americans With Uncontrolled Diabetes: A Pilot Study

Johns Hopkins University1 site in 1 country19 target enrollmentMay 6, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uncontrolled Diabetes
Sponsor
Johns Hopkins University
Enrollment
19
Locations
1
Primary Endpoint
Change in Health literacy as assessed by the Newest Vital Sign
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Disparities in diagnosis and control of type 2 diabetes mellitus are most evident in African Americans (AAs) with lower socioeconomic status. Health literacy is an important predictor of adequate self-management and control of diabetes. The purpose of this pilot study was to test the feasibility and preliminary efficacy of a health literacy-enhanced diabetes intervention -Prevention through Lifestyle intervention And Numeracy (PLAN) 4 Success-Diabetes, in inner-city, low-income AAs with uncontrolled diabetes. To evaluate the feasibility, acceptability, and preliminary efficacy of the intervention, the investigators conducted a pilot study with 24-week follow-up. The investigators that participation in the PLAN 4 Success-diabetes intervention would be associated with a reduction in glucose outcomes and improvements in psychosocial variables.

Registry
clinicaltrials.gov
Start Date
May 6, 2015
End Date
February 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • African Americans residing in Baltimore, Maryland
  • had uncontrolled diabetes (defined as HbA1C\>7%)

Exclusion Criteria

  • Unable to give informed consent
  • Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
  • Hematological condition that would affect HbA1C assay, e.g., hemolytic anemia, sickle cell anemia

Outcomes

Primary Outcomes

Change in Health literacy as assessed by the Newest Vital Sign

Time Frame: baseline; 12 and 24 weeks

The Newest Vital Sign consists of four items and measures numeracy. After reviewing a nutrition label, participants are asked to answer questions based on some calculation of the nutritional information (e.g., fat, sodium) presented on the label. Total possible scores range from 0 to 4, with one point assigned for each correct response.

Change in Health literacy as assessed by Literacy Assessment in Diabetes (LAD).

Time Frame: baseline; 12 and 24 weeks

The Literacy Assessment in Diabetes (LAD) has high reliability and validity indices. The items on the LAD are scored as correct/incorrect, with total possible scores ranging from 0 to 60. Higher scores indicated higher health literacy levels.

Secondary Outcomes

  • Change in Diabetes knowledge measured with the validated Diabetes Knowledge Test(baseline; 12 and 24 weeks)
  • Change in Diabetes self-efficacy measured with Stanford Diabetes Self-Efficacy scale(baseline; 12 and 24 weeks)

Study Sites (1)

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