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

The Ohio State University

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: General health educational program for Hispanics and their families; Behavioral: Diabetes self-management program for Hispanics and their families

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02114814

2P20MD002289-06 (U.S. NIH Grant/Contract)

P20MD002289-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

186 participants in 2 patient groups

Intervention group

Experimental group

Description:

Diabetes self-management and family support

Treatment:

Behavioral: Diabetes self-management program for Hispanics and their families

Attention control group

Active Comparator group

Description:

General health information

Treatment:

Behavioral: General health educational program for Hispanics and their families