Partnership for a Hispanic Diabetes Prevention Program
Primary Purpose
Diabetes, Pre-diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home Health Party
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes focused on measuring Diabetes, haemoglobin A1C, Hispanic, Behavioural Intervention
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years and older
- Haemogloblin A1c ≥ 6.5%
- Hispanic Ethnicity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Education Intervention
Control Arm
Arm Description
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
A delayed intervention where the intervention was delivered after the hA1c level was measured for the second time (3 months after the baseline measurement)
Outcomes
Primary Outcome Measures
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;
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
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.
Secondary Outcome Measures
Effect of the intervention on changes in knowledge and attitudes about diabetes
Full Information
NCT ID
NCT01564797
First Posted
March 23, 2012
Last Updated
March 4, 2015
Sponsor
Fred Hutchinson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01564797
Brief Title
Partnership for a Hispanic Diabetes Prevention Program
Official Title
Partnership for a Hispanic Diabetes Prevention Program
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Pre-diabetes
Keywords
Diabetes, haemoglobin A1C, Hispanic, Behavioural Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education Intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
A delayed intervention where the intervention was delivered after the hA1c level was measured for the second time (3 months after the baseline measurement)
Intervention Type
Behavioral
Intervention Name(s)
Home Health Party
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of the intervention on serum levels of hA1c in diabetics and pre-diabetic participants
Description
Test the efficacy of an intervention to educate diabetics and pre-diabetics about the management of diabetes as assessed by decreases in hemoglobin A1c;
Time Frame
Baseline, 3 months
Title
Effect of the intervention on consumption of fresh fruit and vegetables in diabetics and pre-diabetic participants
Description
Test the efficacy of an intervention to increase the consumption of healthy diets as assessed by increases in fruit and vegetable consumption
Time Frame
Baseline, 3 months
Title
Effect of the intervention on physical activity levels in diabetics and pre-diabetic participants
Description
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.
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Effect of the intervention on changes in knowledge and attitudes about diabetes
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 18 years and older
Haemogloblin A1c ≥ 6.5%
Hispanic Ethnicity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beti Thompson, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24576395
Citation
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.
Results Reference
derived
Learn more about this trial
Partnership for a Hispanic Diabetes Prevention Program
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