Partnership for a Hispanic Diabetes Prevention Program

Not Applicable

Completed

• Conditions: Diabetes; Pre-diabetes
• Interventions: Behavioral: Home Health Party

• Registration Number: NCT01564797
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-28
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

• Aged 18 years and older
• Haemogloblin A1c ≥ 6.5%
• Hispanic Ethnicity

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education Intervention	Home Health Party	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

Primary Outcome Measures

Name	Time	Method
Effect of the intervention on serum levels of hA1c in diabetics and pre-diabetic participants	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Effect of the intervention on changes in knowledge and attitudes about diabetes	Baseline, 3 months