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Partnership for a Hispanic Diabetes Prevention Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564797
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research 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

Condition or disease Intervention/treatment Phase
Diabetes Pre-diabetes Behavioral: Home Health Party Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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;

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. Effect of the intervention on changes in knowledge and attitudes about diabetes [ Time Frame: Baseline, 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
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Principal Investigator: Beti Thompson, PhD Fred Hutchinson Cancer Research Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01564797    
Other Study ID Numbers: IR6194
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Fred Hutchinson Cancer Research Center:
Diabetes
haemoglobin A1C
Hispanic
Behavioural Intervention
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases