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

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02114814
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD) (NIH), University of North Carolina, Greensboro (Other)
• Enrollment: 186
• Location: 1
• Arms: 2
• Actual Duration (Months): 46
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: Diabetes self-management program for Hispanics and their families; Behavioral: General health educational program for Hispanics and their families	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 186 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: TRIAD-2 Center for Health Disparities Research: A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community
• Actual Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hemoglobin A1C [Week 0 (Baseline)]

   Glycemic control in %.

2. Hemoglobin A1c [Month 2 (post-intervention)]

   Glycemic control

3. Hemoglobin A1c [Month 3 (one month post-intervention)]

   Glycemic control

4. Hemoglobin A1c [Month 9 (6 months post-intervention)]

   Glycemic control

Secondary Outcome Measures

1. Health-related Quality of Life (SF-12) [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) [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) [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) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University College of Nursing	Columbus	Ohio	United States	43231

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Jie Hu, Principal Investigator, Ohio State University
• ClinicalTrials.gov Identifier: NCT02114814
• Other Study ID Numbers: P20MD002289-06; 2P20MD002289-06
• First Posted: Apr 15, 2014
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jie Hu, Principal Investigator, Ohio State University: Type 2 Diabetes; Hispanic adults; Diabetes self-management; Family-based intervention
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Recruitment Details	Participants who had T2DM and their family members were recruited at 6 sites including clinics, physician offices, and churches in rural counties in central North Carolina between June 2012 and May 2015.

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	A Family-Based Diabetes Self-Management Intervention	General Health Education
Period Title: Overall Study
STARTED	103	83
COMPLETED	88	74
NOT COMPLETED	15	9

Baseline Characteristics

Arm/Group Title	Family-based Diabetes Intervention	Attention Control	Total
Arm/Group Description	The family-based intervention consisted of eight weekly group sessions for participants with diabetes and family members and two sessions (baseline and T4) with the family for data collection.	Participants and their family members in the attention control group received eight weekly group sessions on general health information and two sessions with the family for data collection in addition to usual care.	Total of all reporting groups
Overall Participants	103	83	186
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	94 91.3%	80 96.4%	174 93.5%
>=65 years	9 8.7%	3 3.6%	12 6.5%
Sex: Female, Male (Count of Participants)
Female	65 63.1%	53 63.9%	118 63.4%
Male	38 36.9%	30 36.1%	68 36.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	103 100%	83 100%	186 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Body Mass Index (BMI) (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	30.9 (5.7)	31.6 (4.6)	31.2 (5.2)
Systolic Blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	128.6 (18.3)	133.1 (11.0)	130.6 (15.6)
Physical Activity (the Short International Physical Activity Questionnaire) (MET min/week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [MET min/week]	4983.1 (6906.2)	3932.0 (5871.2)	4514.9 (6425.5)
Dietary Intake ( BFRSS fruits/vegetables) servings/day (servings/day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [servings/day]	2.6 (0.4)	2.7 (0.4)	2.6 (0.4)
Family Support (Supportive Resources (CIRS)) (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	1.4 (0.3)	1.7 (0.4)	1.6 (0.4)
Diabetes self-efficacy (DSE) (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	6.4 (1.8)	6.8 (2.4)	6.6 (2.1)
Diabetes self-management (Revised Summary of Diabetes Self-Care Activities) (days/week) [Mean (Standard Deviation) ]
Diabetes self-management: Diet	3.0 (1.5)	3.2 (1.4)	3.1 (1.4)
Diabetes self-management:General diet	3.0 (1.9)	3.3 (2.1)	3.1 (2.0)
Diabetes self-management: Blood glucose	1.8 (2.3)	1.7 (2.1)	1.7 (2.3)
Diabetes self-management: Foot check	2.6 (2.4)	4.1 (2.5)	3.3 (2.5)
Diabetes self-management: Medication	6.1 (2.1)	6.6 (1.3)	6.3 (1.8)
Diabetes knowledge (Spoken Knowledge of Diabetes in Low Literacy Patients with Diabetes ) (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	2.9 (2.5)	4.2 (2.2)	3.5 (2.4)
Medical Outcomes Study Short Form Health Survey Version 2 (SF-12v2) (scores on a scale) [Mean (Standard Deviation) ]
SF-12v2 PCS	48.9 (9.2)	47.5 (7.7)	48.3 (8.6)
SF-12v2 MCS	45.9 (10.2)	50.2 (12.7)	47.8 (11.5)
HbA1c (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	8.5 (2.1)	9.5 (2.0)	8.9 (2.1)

Outcome Measures

1. Primary Outcome

Title	Hemoglobin A1C
Description	Glycemic control in %.
Time Frame	Week 0 (Baseline)

Outcome Measure Data

Analysis Population Description

Hispanic adults with type 2 diabetes and their family members

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	Diabetes Self-Management	General Health education
Measure Participants	103	83
Mean (95% Confidence Interval) [mean percentage of HbA1c]	8.5	9.4

2. Primary Outcome

Title	Hemoglobin A1c
Description	Glycemic control
Time Frame	Month 2 (post-intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Attention Control Group
Arm/Group Description	Diabetes self-management and family support 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	General health information General health educational program for Hispanics and their families: The attention control group received 8-weekly education program on general health information
Measure Participants	90	78
Mean (95% Confidence Interval) [percentage of HbA1c]	7.7	8.7

3. Primary Outcome

Title	Hemoglobin A1c
Description	Glycemic control
Time Frame	Month 3 (one month post-intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	A Family-Based Diabetes Self-Management Intervention	General Health Education
Measure Participants	88	74
Mean (95% Confidence Interval) [Mean percentage of HbA1c]	7.7	9.0

4. Primary Outcome

Title	Hemoglobin A1c
Description	Glycemic control
Time Frame	Month 9 (6 months post-intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	A Family-Based Diabetes Self-Management Intervention	General Health Education
Measure Participants	82	67
Mean (95% Confidence Interval) [Mean percentage of HbA1c]	8.4	8.2

5. Secondary Outcome

Title	Health-related Quality of Life (SF-12)
Description	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.
Time Frame	Week 0 (Baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	A Family-Based Diabetes Self-Management Intervention	General Health Education
Measure Participants	100	80
SF-12 Physical Health (PCS)	49.5	49.1
SF-12 Mental Health (MCS)	47.2	50.0

6. Secondary Outcome

Title	Health-related Quality of Life (SF-12)
Description	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.
Time Frame	Month 2 (post-intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	A Family-Based Diabetes Self-Management Intervention	General Health Education
Measure Participants	90	78
SF-12 Physical Health (PCS)	50.6	49.5
SF-12 Mental Health (MCS)	47.7	51.7

7. Secondary Outcome

Title	Health-related Quality of Life (SF-12)
Description	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.
Time Frame	Month 3 (one month post-intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	A Family-Based Diabetes Self-Management Intervention	General Health Education
Measure Participants	88	74
SF-12 Physical Health (PCS)	51.1	49.6
SF-12 Mental Health (MCS)	47.9	52.4

8. Secondary Outcome

Title	Health-related Quality of Life (SF-12)
Description	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
Time Frame	Month 9 (6 months post-intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	A Family-Based Diabetes Self-Management Intervention	General Health Education
Measure Participants	82	67
SF-12 Physical Components Summary (PCS)	53.3	50.3
SF-12 Mental Components Summary (MCS)	48.9	55.7

Adverse Events

Time Frame	9 months
Arm/Group Title	Intervention		Attention Control
Arm/Group Description	Family-based diabetes self-management		General health education
All Cause Mortality
	Intervention		Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/103 (0%)		0/83 (0%)
Serious Adverse Events
	Intervention		Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/103 (0%)		0/83 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/103 (0%)		0/83 (0%)

Limitations/Caveats

The study used a quasi-experimental design.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.