DiabetesNCT01564797
Partnership for a Hispanic Diabetes Prevention Program
A study testing Home Health Party in people with Diabetes and Pre-diabetes, run by Fred Hutchinson Cancer Center.
Trial summary
The aims of the study are to investigate 1. the effects of an intervention vs. control on levels of glycosylated haemoglobin (haemoglobin A1c) in Hispanic participants, older than 18 years, who have elevated hA1c at baseline (>6.0%). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Pre-diabetes
- What is being tested?
- Home Health Party
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years and older
- Haemogloblin A1c ≥ 6.5%
- Hispanic Ethnicity
Who cannot join
None listed.
About this study
The aims of the study are to investigate
- the effects of an intervention vs. control on levels of glycosylated haemoglobin (haemoglobin A1c) in Hispanic participants, older than 18 years, who have elevated hA1c at baseline (>6.0%). Glycosylated haemoglobin provides an indication of blood sugar levels over the past 3 months. Elevated hA1c levels are seen in diabetics and pre-diabetics.
- the effects of the intervention vs control on consumption of fresh fruit and vegetables
- the effects of the intervention vs control on levels of physical activity
- Conditions
- Diabetes, Pre-diabetes
- Being tested
- Home Health Party
- Keywords
- Diabetes, haemoglobin A1C, Hispanic, Behavioural Intervention
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Health PartyBehavioural
An education-based lay health educator-led intervention designed to educate Hispanic participants with elevated HA1c levels about diabetes, treatment of diabetes, and diet and lifestyle changes.
| Study group | Role | What they receive |
|---|---|---|
| Education Intervention | Active comparator | A series of 5 home-based lay health educator-led education sessions (Home Health Parties (HHP)), to educate a Hispanic population about diabetes, management of diabetes, and diet and exercise Receives: Behavioral: Home Health Party |
| Control Arm | No intervention | A delayed intervention where the intervention was delivered after the hA1c level was measured for the second time (3 months after the baseline measurement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the intervention on serum levels of hA1c in diabetics and pre-diabetic participants
Test the efficacy of an intervention to educate diabetics and pre-diabetics about the management of diabetes as assessed by decreases in hemoglobin A1c;
Measured: Baseline, 3 months
Effect of the intervention on consumption of fresh fruit and vegetables in diabetics and pre-diabetic participants
Test the efficacy of an intervention to increase the consumption of healthy diets as assessed by increases in fruit and vegetable consumption
Measured: Baseline, 3 months
Effect of the intervention on physical activity levels in diabetics and pre-diabetic participants
Test the efficacy of an intervention to increase physical activity as assessed by increases in the times per week engaged in strenuous or moderate activity.
Measured: Baseline, 3 months
Secondary outcomes (1)
Effect of the intervention on changes in knowledge and attitudes about diabetes
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startJul 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beti Thompson, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564797
- Sponsor's protocol ID
- IR6194
- Status last verified
- Mar 2015
- First submitted
- 23 Mar 2012
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Duggan C, Carosso E, Mariscal N, Islas I, Ibarra G, Holte S, Copeland W, Linde S, Thompson B. Diabetes prevention in Hispanics: report from a randomized controlled trial. Prev Chronic Dis. 2014 Feb 27;11:E28. doi: 10.5888/pcd11.130119.
PubMed 24576395
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership for a Hispanic Diabetes Prevention Program
- ClinicalTrials.gov ID
- NCT01564797
- Acronym / sponsor ID
- IR6194
- Conditions
- Diabetes, Pre-diabetes
- Keywords
- Diabetes, haemoglobin A1C, Hispanic, Behavioural Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of the study are to investigate
- the effects of an intervention vs. control on levels of glycosylated haemoglobin (haemoglobin A1c) in Hispanic participants, older than 18 years, who have elevated hA1c at baseline (>6.0%). Glycosylated haemoglobin provides an indication of blood sugar levels over the past 3 months. Elevated hA1c levels are seen in diabetics and pre-diabetics.
- the effects of the intervention vs control on consumption of fresh fruit and vegetables
- the effects of the intervention vs control on levels of physical activity
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Intervention | Active comparator | Behavioral: Home Health PartyA series of 5 home-based lay health educator-led education sessions (Home Health Parties (HHP)), to educate a Hispanic population about diabetes, management of diabetes, and diet and exercise |
| Control Arm | No intervention | –A delayed intervention where the intervention was delivered after the hA1c level was measured for the second time (3 months after the baseline measurement) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years and older
- Haemogloblin A1c ≥ 6.5%
- Hispanic Ethnicity
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Home Health PartyAn education-based lay health educator-led intervention designed to educate Hispanic participants with elevated HA1c levels about diabetes, treatment of diabetes, and diet and lifestyle changes. | Behavioural | Education Intervention |
Primary outcome
Effect of the intervention on serum levels of hA1c in diabetics and pre-diabetic participants
Time frame: Baseline, 3 months
Test the efficacy of an intervention to educate diabetics and pre-diabetics about the management of diabetes as assessed by decreases in hemoglobin A1c;
Effect of the intervention on consumption of fresh fruit and vegetables in diabetics and pre-diabetic participants
Time frame: Baseline, 3 months
Test the efficacy of an intervention to increase the consumption of healthy diets as assessed by increases in fruit and vegetable consumption
Effect of the intervention on physical activity levels in diabetics and pre-diabetic participants
Time frame: Baseline, 3 months
Test the efficacy of an intervention to increase physical activity as assessed by increases in the times per week engaged in strenuous or moderate activity.
1 secondary outcome
Effect of the intervention on changes in knowledge and attitudes about diabetes
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Derived from this study: PubMed 24576395Duggan C, Carosso E, Mariscal N, Islas I, Ibarra G, Holte S, Copeland W, Linde S, Thompson B. Diabetes prevention in Hispanics: report from a randomized controlled trial. Prev Chronic Dis. 2014 Feb 27;11:E28. doi: 10.5888/pcd11.130119.
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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.
Beti Thompson, PhD principal investigator
Fred Hutchinson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Home Health Party in people with Diabetes and Pre-diabetes, run by Fred Hutchinson Cancer Center.
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 3 inclusion and 0 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of the intervention on serum levels of hA1c in diabetics and pre-diabetic participants (time frame: Baseline, 3 months). The study lists 3 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 NCT01564797, 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 6 Mar 2015.