N/A
Completed N=221
Family Model of Diabetes Self-Management Education in the Marshallese Community
Source: ClinicalTrials.gov NCT02407132 ↗Enrolled (actual)
221
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention. — 10.48; 10.46; 9.30; 9.91 Percent Glycated Hemoglobin (adjusted) — p=0.038
Summary
The investigators will conduct a comparative effectiveness evaluation using a randomized control trial design of a culturally adapted family model of Diabetes Self-Management Education (Adapted DSME) compared with Standard DSME within the Marshallese population. The family model will cover the same concepts as the standard format. However, the family model will incorporate culturally-adapted education and recommendations aimed at engaging family members in the management of the primary participant's diabetes, and family members will be invited to fully participate in the study. By contrast, the standard model provides diabetes self- management education to the diabetic participant only, and the participant's family members do not participate in the classes or any other part of the study. Biometric and survey data will be collected pre-intervention, post-intervention, 6 months post-intervention, and 12 months post-intervention. A qualitative debriefing session will be held for each family between the final DSME session and the 6 month post-intervention to obtain qualitative data regarding the participant's perceptions of the intervention and implementation process.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention. |
10.48; 10.46; 9.30; 9.91; 9.81; 10.26 | 0.038 sig |
| SECONDARY Change in Mean BMI From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention |
30.58; 31.46; 30.66; 31.49; 30.97; 31.39 | 0.234 |
| SECONDARY Change in Mean Total Cholesterol (mg/dL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention. |
181.39; 189.08; 170.15; 182.64; 178.69; 175.84 | 0.019 sig |
| SECONDARY Change in Mean High-density Lipoproteins (HDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention. |
36.43; 36.99; 37.53; 35.63; 39.34; 35.49 | 0.186 |
| SECONDARY Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Check Blood Glucose Daily |
0.44; 0.53; 0.94; 0.82 | 0.040 sig |
| SECONDARY Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Seen Doctor or Other Health Professional in Past 12 Months for Diabetes |
0.77; 0.82; 0.92; 0.88 | 0.312 |
| SECONDARY Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Foot Exam by Doctor or Other Health Professional in Past 12 Months |
0.49; 0.47; 0.53; 0.49 | 0.622 |
| SECONDARY Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Eye Exam in Past 12 Months |
0.35; 0.34; 0.41; 0.41 | 0.957 |
| SECONDARY Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Maintain a Normal Weight |
0.14; 0.07; 0.14; 0.08 | 0.147 |
| SECONDARY Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Engage in Recommended Level of Physical Activity |
0.09; 0.04; 0.09; 0.05 | 0.326 |
| SECONDARY Change in Mean Fasting Glucose From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention |
— | — |
| SECONDARY Change in Mean Low-density Lipoproteins (LDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention |
— | — |
| SECONDARY Change in Mean Triglycerides From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention |
— | — |
Eligibility Criteria
Inclusion Criteria
Primary Participant:
- Must be 18 years or older
- Self-reported Diabetes Mellitus Type 2 diagnosis by a health care provider
- Self-reported Marshallese ethnicity or descent
Secondary (Family) Participant:
- Must be 18 years or older
Exclusion Criteria
- Younger than 18
Data sourced from ClinicalTrials.gov (NCT02407132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.