Partnership for a Hispanic Diabetes Prevention Program

Study Overview
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Brief Summary
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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

Official Title
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Partnership for a Hispanic Diabetes Prevention Program

Conditions
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Diabetes, Pre-diabetes

Intervention / Treatment
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* Behavioral: Home Health Party


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years and older Haemogloblin A1c ≥ 6.5% Hispanic Ethnicity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education Intervention<br>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<br>* 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.<br>|
| No Intervention: Control Arm<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of the intervention on changes in knowledge and attitudes about diabetes |  | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, haemoglobin A1C, Hispanic, Behavioural Intervention