Partnership for a Hispanic Diabetes Prevention Program

Diabetes Clinical Trial

Official title:

Partnership for a Hispanic Diabetes Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564797
• Other study ID #: IR6194
• Status: Completed
• Phase: N/A
• First received: March 23, 2012
• Last updated: March 4, 2015
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: March 2015
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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%). Glycosylated haemoglobin provides an indication of blood sugar levels over the past 3 months. Elevated hA1c levels are seen in diabetics and pre-diabetics.

2. the effects of the intervention vs control on consumption of fresh fruit and vegetables

3. the effects of the intervention vs control on levels of physical activity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years and older

• Haemogloblin A1c = 6.5%

• Hispanic Ethnicity

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Pre-diabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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;	Baseline, 3 months	No
Primary	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	Baseline, 3 months	No
Primary	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.	Baseline, 3 months	No
Secondary	Effect of the intervention on changes in knowledge and attitudes about diabetes		Baseline, 3 months	No