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

May 22, 2022 updated by: Jie Hu, Ohio State University

TRIAD-2 Center for Health Disparities Research: A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43231
        • The Ohio State University College of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Diabetes self-management and family support
Behavioral: Diabetes self-management program for Hispanics and their families
The intervention group received an 8-weekly culturally tailored diabetes self-management and family support education program delivered in Spanish
Active Comparator: Attention control group
General health information
Behavioral: General health educational program for Hispanics and their families
The attention control group received 8-weekly education program on general health information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C
Time Frame: Week 0 (Baseline)
Glycemic control in %.
Week 0 (Baseline)
Hemoglobin A1c
Time Frame: Month 2 (post-intervention)
Glycemic control
Month 2 (post-intervention)
Hemoglobin A1c
Time Frame: Month 3 (one month post-intervention)
Glycemic control
Month 3 (one month post-intervention)
Hemoglobin A1c
Time Frame: Month 9 (6 months post-intervention)
Glycemic control
Month 9 (6 months post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life (SF-12)
Time Frame: Week 0 (Baseline)
The Medical Outcomes Study Short Form Health Survey Version 2 (SF-12). Physical Components Summary (PCS) and Mental Components Summary (MCS) were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life.
Week 0 (Baseline)
Health-related Quality of Life (SF-12)
Time Frame: Month 2 (post-intervention)
Medical Outcomes Study Short Form Health Survey Version 2 (SF-12) Physical Components Summary (PCS) and Mental Components Summary (MCS) scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life.
Month 2 (post-intervention)
Health-related Quality of Life (SF-12)
Time Frame: Month 3 (one month post-intervention)
Medical Outcomes Study Short Form Health Survey Version 2 (SF-12) Physical Components Summary (PCS) and Mental Components Summary (MCS) scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life.
Month 3 (one month post-intervention)
Health-related Quality of Life (SF-12)
Time Frame: 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
Month 9 (6 months post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
University of North Carolina, Greensboro

Investigators

  • Principal Investigator: Jie Hu, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 12, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Diabetes self-management program for Hispanics and their families

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe