Diabetes Mellitus, Type 2NCT02114814
A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community
A study testing Diabetes self-management program for Hispanics and their families and General health educational program for Hispanics and their families in people with Diabetes Mellitus, Type 2, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes self-management program for Hispanics and their families and General health educational program for Hispanics and their families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Family member is over 18
- Reside in the same household as the participant with diabetes
- Must be able to speak either English or Spanish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Nursing
Columbus, Ohio, 43231
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diabetes self-management program for Hispanics and their families, General health educational program for Hispanics and their families
- Keywords
- Type 2 Diabetes, Hispanic adults, Diabetes self-management, Family-based intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes self-management program for Hispanics and their familiesBehavioural
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 familiesBehavioural
The attention control group received 8-weekly education program on general health information
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Diabetes self-management and family support Receives: Behavioral: Diabetes self-management program for Hispanics and their families |
| Attention control group | Active comparator | General health information Receives: Behavioral: General health educational program for Hispanics and their families |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
Glycemic control in %.
Measured: Week 0 (Baseline)
Hemoglobin A1c
Glycemic control
Measured: Month 2 (post-intervention)
Hemoglobin A1c
Glycemic control
Measured: Month 3 (one month post-intervention)
Hemoglobin A1c
Glycemic control
Measured: Month 9 (6 months post-intervention)
Secondary outcomes (4)
Health-related Quality of Life (SF-12)
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.
Measured: Week 0 (Baseline)
Health-related Quality of Life (SF-12)
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.
Measured: Month 2 (post-intervention)
Health-related Quality of Life (SF-12)
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.
Measured: Month 3 (one month post-intervention)
Health-related Quality of Life (SF-12)
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
Measured: Month 9 (6 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJun 2012
- Primary completionMay 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of North Carolina, Greensboro
- Responsible party
- Principal investigator, Jie Hu, Ohio State University
- Investigators
- Jie Hu, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114814
- Sponsor's protocol ID
- P20MD002289-06
- Other IDs
- 2P20MD002289-06
- Status last verified
- May 2022
- First submitted
- 3 Apr 2014
- Last updated
- 24 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26957533
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIAD-2 Center for Health Disparities Research: A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community
- ClinicalTrials.gov ID
- NCT02114814
- Acronym / sponsor ID
- P20MD002289-06
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes, Hispanic adults, Diabetes self-management, Family-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of North Carolina, Greensboro
- Study start
- Jun 2012 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Diabetes self-management program for Hispanics and their familiesDiabetes self-management and family support |
| Attention control group | Active comparator | Behavioral: General health educational program for Hispanics and their familiesGeneral health information |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes self-management program for Hispanics and their familiesThe intervention group received an 8-weekly culturally tailored diabetes self-management and family support education program delivered in Spanish | Behavioural | Intervention group |
| General health educational program for Hispanics and their familiesThe attention control group received 8-weekly education program on general health information | Behavioural | Attention control group |
Primary outcome
Hemoglobin A1C
Time frame: Week 0 (Baseline)
Glycemic control in %.
Hemoglobin A1c
Time frame: Month 2 (post-intervention)
Glycemic control
Hemoglobin A1c
Time frame: Month 3 (one month post-intervention)
Glycemic control
Hemoglobin A1c
Time frame: Month 9 (6 months post-intervention)
Glycemic control
4 secondary outcomes
Health-related Quality of Life (SF-12)
Time frame: Week 0 (Baseline)
Health-related Quality of Life (SF-12)
Time frame: Month 2 (post-intervention)
Health-related Quality of Life (SF-12)
Time frame: Month 3 (one month post-intervention)
Health-related Quality of Life (SF-12)
Time frame: Month 9 (6 months post-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26957533Hu 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.
- A Family-Based, Culturally Tailored Diabetes Intervention for Hispanics and Their Family MembersLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Hu, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes self-management program for Hispanics and their families and General health educational program for Hispanics and their families in people with Diabetes Mellitus, Type 2, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (time frame: Week 0 (Baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02114814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.