Partnership for a Hispanic Diabetes Prevention Program

NCT ID: NCT01564797

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Diabetes Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Home Health Party

Intervention Type BEHAVIORAL

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.

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years and older
* Haemogloblin A1c ≥ 6.5%
* Hispanic Ethnicity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beti Thompson, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

References

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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.

Reference Type DERIVED
PMID: 24576395 (View on PubMed)

Other Identifiers

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IR6194

Identifier Type: -

Identifier Source: org_study_id

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