Partnership for a Hispanic Diabetes Prevention Program

March 4, 2015 updated by: Fred Hutchinson Cancer Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

430

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
Baseline, 3 months
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
Baseline, 3 months
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.
Baseline, 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Investigators

  • Principal Investigator: Beti Thompson, PhD, Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR6194

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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