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Intervention to Enhance Numeracy in Diabetes (IntEND)

Intervention to Enhance Numeracy in Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02414217
Acronym
IntEND
Enrollment
65
Registered
2015-04-10
Start date
2015-07-31
Completion date
2016-10-31
Last updated
2017-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

numeracy, health literacy

Brief summary

The objective of this project is to test two interventions designed to improve diabetes-related numeracy. Numeracy is the ability to understand and use numbers. People with diabetes use numbers in a variety of ways in managing their condition (e.g., understanding blood sugar values, counting carbohydrates, taking medications at the right dose and time). As part of this project, the investigators developed and pilot tested two interventions to improve diabetes-related numeracy: (1) a series of in-person education classes and (2) a one-time, online diabetes education class. The investigators will look to see whether participants in the education classes show improvements in their diabetes-related numeracy skills, self-care behavior and attitudes, and clinical outcomes (i.e., body mass index, blood pressure, blood sugar \[A1c\]).

Detailed description

Sixty-five American Indians with diabetes were enrolled. Each participant was randomly assigned to 1 of 3 study arms: (1) the in-person education group, (2) the online education group, and (3) a control group. The in-person intervention group attended four class sessions addressing numeracy skills used in the management of diabetes (e.g., counting carbohydrates). The online education group completed a single online module providing training on diabetes-related numeracy skills. The control group received written diabetes educational materials. The investigators collected data at baseline, then again immediately after intervention participation (in-person or online classes), and one final time about three months after the conclusion of the intervention. The investigators will conduct analyses to determine if intervention participants experienced positive changes in diabetes numeracy (the primary outcome) as well as several secondary outcome measures following intervention. Secondary outcomes include: diabetes knowledge, self-efficacy, outcome expectancies, readiness to change, self-care behavior, and clinical outcomes (i.e., body mass index, blood pressure, blood sugar \[A1c\]) . The investigators also will assess whether change in numeracy predicts change in these secondary outcomes.

Interventions

BEHAVIORALIn-Person Diabetes Numeracy Education

Participants randomized to the in-person education group attended four group classes, each addressing a specific set of diabetes self-care skills (i.e., understanding and using blood glucose numbers, counting carbohydrates, taking medications at the right dose and time). So that each class included a stable group of 8 and 16 participants, we ran classes in cohorts of 8-16 people. A participant always attended classes with his/her cohort.

BEHAVIORALOnline Diabetes Numeracy Education

Participants randomized to the online education group attended a single session, at which he/she completed a computerized education module that addressed understanding blood sugar values and using them to examine the impact of food, exercise, and medicines on blood sugar.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

* American Indian/Alaska Native; * 18 to 89 years old; * diabetes diagnosis documented in medical records; * active patient of the Yakama Indian Health Service.

Exclusion criteria

* Does not speak English; * pregnancy; * dialysis; * current cancer treatment; * blindness; * active alcohol/substance abuse; * planning to move out of the area in the next six months.

Design outcomes

Primary

MeasureTime frameDescription
Change in Objective Diabetes Numeracy from Baseline to ≈6 weeks≈6 weeksAdapted version of the Diabetes Numeracy Test

Secondary

MeasureTime frameDescription
Change in Subjective Numeracy from Baseline to ≈6 weeks≈6 weeksSubjective Numeracy Scale
Change in Subjective Numeracy from Baseline to ≈3 months≈3 monthsSubjective Numeracy Scale
Change in Diabetes Knowledge from Baseline to ≈6 weeks≈6 weeksAdapted version of the Diabetes Knowledge Test
Change in Diabetes Knowledge from Baseline to ≈3 months≈3 monthsAdapted version of the Diabetes Knowledge Test
Change in Diabetes Self-Efficacy from Baseline to ≈6 weeks≈6 weeksAdapted items from existing instruments
Change in Diabetes Self-Efficacy from Baseline to ≈3 months≈3 monthsAdapted items from existing instruments
Change in Outcome Expectancies from Baseline to ≈6 weeks≈6 weeksAdapted items from existing instruments
Change in Outcome Expectancies from Baseline to ≈3 months≈3 monthsAdapted items from existing instruments
Change in Objective Diabetes Numeracy from Baseline to ≈3 months≈3 monthsAdapted version of the Diabetes Numeracy Test
Change in Readiness to Change from Baseline to ≈3 months≈3 monthsNewly developed items
Change in Diabetes Self-Care Behavior from Baseline to ≈6 weeks≈6 weeksSummary of Diabetes Self-Care Activities Scale plus additional relevant items
Change in Diabetes Self-Care Behavior from Baseline to ≈3 months≈3 monthsSummary of Diabetes Self-Care Activities Scale plus additional relevant items
Change in Body Mass Index from Baseline to ≈6 weeks≈6 weeksBody Mass Index
Change in Body Mass Index from Baseline to ≈3 months≈3 monthsBody Mass Index
Change in Blood Pressure from Baseline to ≈6 weeks≈6 weeksSystolic and Diastolic Blood Pressure
Change in Blood Pressure from Baseline to ≈3 months≈3 monthsSystolic and Diastolic Blood Pressure
Change in Glycemic Control from Baseline to ≈3 months≈3 monthsHemoglobin A1c
Change in Readiness to Change from Baseline to ≈6 weeks≈6 weeksNewly developed items

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026