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Completed

NCT Number: NCT02114814

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University College of Nursing

Columbus, Ohio, 43231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes self-management program for Hispanics and their families

Behavioral

The intervention group received an 8-weekly culturally tailored diabetes self-management and family support education program delivered in Spanish

General health educational program for Hispanics and their families

Behavioral

The attention control group received 8-weekly education program on general health information

Primary outcomes

  1. Hemoglobin A1C

    Time frame: Week 0 (Baseline)

    Glycemic control in %.

  2. Hemoglobin A1c

    Time frame: Month 2 (post-intervention)

    Glycemic control

  3. Hemoglobin A1c

    Time frame: Month 3 (one month post-intervention)

    Glycemic control

  4. Hemoglobin A1c

    Time frame: Month 9 (6 months post-intervention)

    Glycemic control

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Apr 15, 2014
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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