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Partnership for a Hispanic Diabetes Prevention Program

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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

Tracking Information
First Submitted Date  ICMJE March 23, 2012
First Posted Date  ICMJE March 28, 2012
Last Update Posted Date March 6, 2015
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
  • 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;
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
Effect of the intervention on changes in knowledge and attitudes about diabetes [ Time Frame: Baseline, 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Partnership for a Hispanic Diabetes Prevention Program
Official Title  ICMJE Partnership for a Hispanic Diabetes Prevention Program
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes
  • Pre-diabetes
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Home Health Party
  • 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)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2012)
430
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 years and older
  • Haemogloblin A1c ≥ 6.5%
  • Hispanic Ethnicity
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01564797
Other Study ID Numbers  ICMJE IR6194
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Beti Thompson, PhD Fred Hutchinson Cancer Research Center
PRS Account Fred Hutchinson Cancer Research Center
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP