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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Diabetes self-management program for Hispanics and their families; Behavioral: General health educational program for Hispanics and their families

• Registration Number: NCT02114814
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-12
• Study First Posted: 2014-04-15
• Primary Completion: 2015-05
• Study Completion: 2016-04
• Results First Submitted: 2019-03-28
• Results First Submitted QC: 2021-01-29
• Results First Posted: 2021-02-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-22
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Diabetes self-management program for Hispanics and their families	Diabetes self-management and family support
Attention control group	General health educational program for Hispanics and their families	General health information

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	Month 9 (6 months post-intervention)	Glycemic control
Hemoglobin A1C	Week 0 (Baseline)	Glycemic control in %.

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of Life (SF-12)	Month 9 (6 months post-intervention)	The Medical Outcomes Study Short Form Health Survey, the SF-12 PCS and MCS scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life

Trial Locations

Locations (1)

The Ohio State University College of Nursing; 🇺🇸 Columbus, Ohio, United States