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

NCT ID: NCT02114814

Last Updated: 2022-05-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Diabetes self-management and family support

Group Type EXPERIMENTAL

Diabetes self-management program for Hispanics and their families

Intervention Type BEHAVIORAL

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

Attention control group

General health information

Group Type ACTIVE_COMPARATOR

General health educational program for Hispanics and their families

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

General health educational program for Hispanics and their families

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of North Carolina, Greensboro

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Jie Hu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jie Hu, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University College of Nursing

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26957533 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/26957533

A Family-Based, Culturally Tailored Diabetes Intervention for Hispanics and Their Family Members

Other Identifiers

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2P20MD002289-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P20MD002289-06

Identifier Type: NIH

Identifier Source: org_study_id

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