Clinical trial NCT02114814: A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community
Official title: TRIAD-2 Center for Health Disparities Research: A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
Hispanic adults
Diabetes self-management
Family-based intervention
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: University of North Carolina, Greensboro
First posted: 2014-04-15
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A total of 186 participants and their family members were recruited, 103 in the experimental group and 83 in the attention control group.

An intervention consisted of eight weekly interactive modules, for a total of 12 hours, and based on modules from National Standards for Diabetes Self-Management Education, and the National Diabetes Education Program. Data were collected at baseline, immediately post-intervention, and at 3 and 6 month follow-up visits.

Eligibility criteria: Inclusion Criteria for participants:

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

Inclusion criteria for family members/relatives are:

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

Exclusion Criteria:

We will exclude Hispanic adults and family members who are:

1. diagnosed with type 1 diabetes
2. report prior (within the past year) or current participation in other diabetes self-management intervention programs
3. cognitively impaired (not oriented to time, place, or person, or with known dementia)
4. Pregnant at the time of T1 (baseline) data collection

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: Week 0 (Baseline)
measure: Hemoglobin A1c
timeFrame: Month 2 (post-intervention)
measure: Hemoglobin A1c
timeFrame: Month 3 (one month post-intervention)
measure: Hemoglobin A1c
timeFrame: Month 9 (6 months post-intervention)
Secondary outcomes:
measure: Health-related Quality of Life (SF-12)
timeFrame: Week 0 (Baseline)
measure: Health-related Quality of Life (SF-12)
timeFrame: Month 2 (post-intervention)
measure: Health-related Quality of Life (SF-12)
timeFrame: Month 3 (one month post-intervention)
measure: Health-related Quality of Life (SF-12)
timeFrame: Month 9 (6 months post-intervention)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Nursing
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jie Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu J, Amirehsani KA, Wallace DC, McCoy TP, Silva Z. A Family-Based, Culturally Tailored Diabetes Intervention for Hispanics and Their Family Members. Diabetes Educ. 2016 Jun;42(3):299-314. doi: 10.1177/0145721716636961. Epub 2016 Mar 8.