Partnership for a Hispanic Diabetes Prevention Program

This study has been completed.

Sponsor:

Information provided by:

Fred Hutchinson Cancer Research Center

ClinicalTrials.gov Identifier:

NCT01564797

First received: March 23, 2012

Last updated: March 26, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 23, 2012

Last Updated Date

March 26, 2012

Start Date ^ICMJE

July 2008

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effect of the intervention on serum levels of hA1c in diabetics and pre-diabetic participants [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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

Complete list of historical versions of study NCT01564797 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effect of the intervention on changes in knowledge and attitudes about diabetes [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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)

Intervention: Behavioral: Home Health Party

Publications *

Not Provided

* 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

Enrollment ^ICMJE

430

Completion Date

December 2011

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01564797

Other Study ID Numbers ^ICMJE

IR6194

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Fred Hutchinson Cancer Research Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Beti Thompson, PhD

Fred Hutchinson Cancer Research Center

Information Provided By

Fred Hutchinson Cancer Research Center

Verification Date

March 2012

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

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