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N/A Completed N=186 Treatment

A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community

Source: ClinicalTrials.gov NCT02114814 ↗
Enrolled (actual)
186
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Hemoglobin A1C — 8.5; 9.4 mean percentage of HbA1c

Summary

The aim of this study was to compare the efficacy of an intervention and an attention control group in producing changes in diabetes self-management, glycemic control (HbA1c) and health related quality of life in Hispanics with type 2 diabetes. Hypothesis: The experimental group who receive an 8 week intervention program would show significantly greater improvements than an attention control group at 1 and 6 months after the intervention in: behavioral influences of diabetes knowledge, diabetes self-efficacy, and family support, outcomes of self-reported management of diabetes (physical activity, diet, medications, and glucose monitoring), HbA1c levels, and psychological outcomes of health-related quality of life.

Outcome Measures

OutcomeResultp-value
PRIMARY
Hemoglobin A1C
8.4; 8.2
SECONDARY
Health-related Quality of Life (SF-12)
53.3; 50.3; 48.9; 55.7

Eligibility Criteria

Inclusion Criteria for participants:

  • Community-dwelling
  • Self-identification as Hispanic
  • Age 18 years or older
  • Self-identification as having a medical diagnosis of type 2 diabetes
  • An adult family member willing to participate in the study.
  • Must be able to speak either English or Spanish

Inclusion criteria for family members/relatives are:

  • Family member is over 18
  • Reside in the same household as the participant with diabetes
  • Must be able to speak either English or Spanish

Exclusion Criteria

We will exclude Hispanic adults and family members who are:

  • diagnosed with type 1 diabetes
  • report prior (within the past year) or current participation in other diabetes self-management intervention programs
  • cognitively impaired (not oriented to time, place, or person, or with known dementia)
  • Pregnant at the time of T1 (baseline) data collection
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02114814). 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.

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