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Partnership for a Hispanic Diabetes Prevention Program

Primary Purpose

Diabetes, Pre-diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home Health Party
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Diabetes, haemoglobin A1C, Hispanic, Behavioural Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Education Intervention

    Control Arm

    Arm Description

    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

    A delayed intervention where the intervention was delivered after the hA1c level was measured for the second time (3 months after the baseline measurement)

    Outcomes

    Primary Outcome Measures

    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;
    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
    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.

    Secondary Outcome Measures

    Effect of the intervention on changes in knowledge and attitudes about diabetes

    Full Information

    First Posted
    March 23, 2012
    Last Updated
    March 4, 2015
    Sponsor
    Fred Hutchinson Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01564797
    Brief Title
    Partnership for a Hispanic Diabetes Prevention Program
    Official Title
    Partnership for a Hispanic Diabetes Prevention Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fred Hutchinson Cancer Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes, Pre-diabetes
    Keywords
    Diabetes, haemoglobin A1C, Hispanic, Behavioural Intervention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    430 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Education Intervention
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Control Arm
    Arm Type
    No Intervention
    Arm Description
    A delayed intervention where the intervention was delivered after the hA1c level was measured for the second time (3 months after the baseline measurement)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Home Health Party
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Effect of the intervention on serum levels of hA1c in diabetics and pre-diabetic participants
    Description
    Test the efficacy of an intervention to educate diabetics and pre-diabetics about the management of diabetes as assessed by decreases in hemoglobin A1c;
    Time Frame
    Baseline, 3 months
    Title
    Effect of the intervention on consumption of fresh fruit and vegetables in diabetics and pre-diabetic participants
    Description
    Test the efficacy of an intervention to increase the consumption of healthy diets as assessed by increases in fruit and vegetable consumption
    Time Frame
    Baseline, 3 months
    Title
    Effect of the intervention on physical activity levels in diabetics and pre-diabetic participants
    Description
    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.
    Time Frame
    Baseline, 3 months
    Secondary Outcome Measure Information:
    Title
    Effect of the intervention on changes in knowledge and attitudes about diabetes
    Time Frame
    Baseline, 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Aged 18 years and older Haemogloblin A1c ≥ 6.5% Hispanic Ethnicity
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Beti Thompson, PhD
    Organizational Affiliation
    Fred Hutchinson Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24576395
    Citation
    Duggan C, Carosso E, Mariscal N, Islas I, Ibarra G, Holte S, Copeland W, Linde S, Thompson B. Diabetes prevention in Hispanics: report from a randomized controlled trial. Prev Chronic Dis. 2014 Feb 27;11:E28. doi: 10.5888/pcd11.130119.
    Results Reference
    derived

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    Partnership for a Hispanic Diabetes Prevention Program

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