Partnership for a Hispanic Diabetes Prevention Program
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|ClinicalTrials.gov Identifier: NCT01564797|
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : March 6, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Pre-diabetes||Behavioral: Home Health Party||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||430 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Partnership for a Hispanic Diabetes Prevention Program|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Active Comparator: Education Intervention
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
Behavioral: Home Health Party
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.
No Intervention: Control Arm
A delayed intervention where the intervention was delivered after the hA1c level was measured for the second time (3 months after the baseline measurement)
- 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.
- Effect of the intervention on changes in knowledge and attitudes about diabetes [ Time Frame: Baseline, 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564797
|Principal Investigator:||Beti Thompson, PhD||Fred Hutchinson Cancer Research Center|