Health Literacy Intervention for African Americans With Diabetes

Not Applicable

Completed

• Conditions: Uncontrolled Diabetes
• Interventions: Behavioral: PLAN 4 Success-Diabetes

• Registration Number: NCT03925948
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-06
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-22
• Last Update Submitted: 2019-04-22
• Study First Posted: 2019-04-24
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	PLAN 4 Success-Diabetes	This is a one arm study with all participants enrolled into this arm.

Primary Outcome Measures

Name	Time	Method
Change in Health literacy as assessed by the Newest Vital Sign	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).	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 Outcome Measures

Name	Time	Method
Change in Diabetes knowledge measured with the validated Diabetes Knowledge Test	baseline; 12 and 24 weeks	The Diabetes Knowledge Test assesses diabetes knowledge, medications, diet, and management with questions such as "What effect will an infection most likely have on blood glucose." Correct responses are given a score of one.
Change in Diabetes self-efficacy measured with Stanford Diabetes Self-Efficacy scale	baseline; 12 and 24 weeks	The Stanford Diabetes Self-Efficacy scale assesses participant's efficacy in managing diabetes and maintaining healthy lifestyles. The scale asks how confident participants are in managing different tasks such as eating meals every 4 to 5 hours every day or breakfast every day measured on a Likert scale of 0 "not at all confident" to 10 "totally confident." Participant scores are the means across all items in the instrument.

Trial Locations

Locations (1)

Wald Community Nursing Center; 🇺🇸 Baltimore, Maryland, United States